Regulatory Agenda:

As Enacted ( Federal Register)

Cited authorities 405

Cited in

December 20, 2010 (Volume 75, Number 243)

Unified Agenda

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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REGULATORY INFORMATION SERVICE CENTER

Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The

Regulatory Plan

Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The

Regulatory Plan

Page 79449

Introduction to The Regulatory Plan and the Unified Agenda of Federal

Regulatory and Deregulatory Actions

AGENCY: Regulatory Information Service Center.

ACTION: Introduction to The Regulatory Plan and the Unified Agenda of

Federal Regulatory and Deregulatory Actions.

SUMMARY: The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed

September 30, 1993 (58 FR 51735) and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. Section 4 of Executive Order 12866 also directs that each agency prepare, as part of its submission to the fall edition of the Unified Agenda, a regulatory plan of the most important significant regulatory actions that the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year. The

Regulatory Plan (Plan) and the Unified Agenda of Federal Regulatory and

Deregulatory Actions (Unified Agenda) help agencies fulfill these requirements.

Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2010, including The Regulatory Plan, is available to the public at: http://reginfo.gov.

The fall 2010 Unified Agenda publication appearing in the Federal

The complete fall 2010 Unified Agenda contains the plans of 29

Federal agencies and the regulatory agendas for these and 29 other

Federal agencies.

ADDRESSES: Regulatory Information Service Center (MI), General Services

Administration, 1800 F Street NW., Suite 3039, Washington, DC 20405.

FOR FURTHER INFORMATION CONTACT: For further information about specific regulatory actions, please refer to the Agency Contact listed for each entry.

To provide comment on or to obtain further information about this publication, contact: John C. Thomas, Executive Director, Regulatory

Information Service Center (MI), General Services Administration, 1800

F Street NW., Suite 3039, Washington, DC 20405, (202) 482-7340. You may also send comments to us by e-mail at: risc@gsa.gov

SUPPLEMENTARY INFORMATION:

TABLE OF CONTENTS

Page

Introduction to the Regulatory Plan and the Unified Agenda of Federal

Regulatory and Deregulatory Actions

I. What Are The Regulatory Plan and the Unified Agenda?......... 79450

II. Why Are The Regulatory Plan and the Unified Agenda

79451

Published?.....................................................

III. How Are The Regulatory Plan and the Unified Agenda

79451

Organized?.....................................................

IV. What Information Appears for Each Entry?.................... 79452

V. Abbreviations................................................ 79454

VI. How Can Users Get Copies of the Plan and the Agenda?........ 79454

Introduction to the Fall 2010 Regulatory Plan................... 79455

AGENCY REGULATORY PLANS

Cabinet Departments

Department of Agriculture....................................... 79467

Department of Commerce.......................................... 79496

Department of Defense........................................... 79504

Department of Education......................................... 79509

Department of Energy............................................ 79512

Department of Health and Human Services......................... 79518

Department of Homeland Security................................. 79536

Department of Housing and Urban Development..................... 79572

Department of the Interior...................................... 79576

Department of Justice........................................... 79583

Department of Labor............................................. 79587

Department of Transportation.................................... 79606

Department of the Treasury...................................... 79626

Department of Veterans Affairs.................................. 79639

Other Executive Agencies

Environmental Protection Agency................................. 79640

Equal Employment Opportunity Commission......................... 79669

Financial Stability Oversight Council........................... 79671

General Services Administration................................. 79672

National Aeronautics and Space Administration................... 79675

National Archives and Records Administration.................... 79677

Office of Personnel Management.................................. 79679

Pension Benefit Guaranty Corporation............................ 79681

Small Business Administration................................... 79683

Social Security Administration.................................. 79687

Independent Regulatory Agencies

Consumer Financial Protection Bureau............................ 79692

Consumer Product Safety Commission.............................. 79693

Federal Trade Commission........................................ 79695

National Indian Gaming Commission............................... 79706

Postal Regulatory Commission.................................... 79708

AGENCY AGENDAS

Cabinet Departments

Department of Agriculture....................................... 79709

Department of Commerce.......................................... 79725

Department of Defense........................................... 79751

Department of Education......................................... 79755

Department of Energy............................................ 79759

Department of Health and Human Services......................... 79763

Department of Homeland Security................................. 79787

Department of the Interior...................................... 79795

Department of Justice........................................... 79799

Department of Labor............................................. 79803

Department of Transportation.................................... 79811

Department of the Treasury...................................... 79837

Other Executive Agencies

Environmental Protection Agency................................. 79843

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General Services Administration................................. 79859

Small Business Administration................................... 79863

Joint Authority

Department of Defense/General Services Administration/National

79873

Aeronautics and Space Administration (Federal Acquisition

Regulation)....................................................

Independent Regulatory Agencies

Federal Communications Commission............................... 79877

Federal Deposit Insurance Corporation........................... 79921

Federal Reserve System.......................................... 79925

Federal Trade Commission........................................ 79929

Nuclear Regulatory Commission................................... 79933

Securities and Exchange Commission.............................. 79937

INTRODUCTION TO THE REGULATORY PLAN AND THE UNIFIED AGENDA OF

FEDERAL REGULATORY AND DEREGULATORY ACTIONS

I. What Are The Regulatory Plan and the Unified Agenda?

The Regulatory Plan serves as a defining statement of the

Administration's regulatory and deregulatory policies and priorities.

The Plan is part of the fall edition of the Unified Agenda. Each participating agency's regulatory plan contains: (1) A narrative statement of the agency's regulatory priorities and, for most agencies,

(2) a description of the most important significant regulatory and deregulatory actions that theagency reasonably expects to issue in proposed or final form during the upcoming fiscal year. This edition includes the regulatory plans of 29 agencies.

The Unified Agenda provides information about regulations that the

Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register twice each year since 1983 and has been available online since 1995. To further the objective of using modern technology to deliver better service to the American people for lower cost, beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda, including The

Regulatory Plan, is available to the public at http://reginfo.gov. The online Unified Agenda offers flexible search tools and will soon offer access to the entire historic Unified Agenda database.

The fall 2010 Unified Agenda publication appearing in the Federal

Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at: http://reginfo.gov.

These publication formats meet the publication mandates of the

Regulatory Flexibility Act and Executive Order 12866, as well as move the Agenda process toward the goal of e-Government, at a substantially reduced printing cost compared with prior editions. The current format does not reduce the amount of information available to the public, but it does limit most of the content of the Agenda to online access. The complete online edition of the Unified Agenda includes regulatory agendas from 56 Federal agencies. Agencies of the United States

Congress are not included.

The following agencies have no entries identified for inclusion in the printed regulatory flexibility agenda. An asterisk (*) indicates agencies that appear in The Regulatory Plan. The regulatory agendas of these agencies are available to the public at: http://reginfo.gov.

Department of Housing and Urban Development *

Department of State

Department of Veterans Affairs *

Agency for International Development

Architectural and Transportation Barriers Compliance Board

Commission on Civil Rights

Committee for Purchase From People Who Are Blind or Severely

Disabled

Corporation for National and Community Service

Court Services and Offender Supervision Agency for the District of

Columbia

Equal Employment Opportunity Commission *

Federal Mediation and Conciliation Service

Institute of Museum and Library Services

National Aeronautics and Space Administration *

National Archives and Records Administration *

National Endowment for the Humanities

National Science Foundation

Office of Government Ethics

Office of Management and Budget

Office of Personnel Management *

Peace Corps

Pension Benefit Guaranty Corporation *

Railroad Retirement Board

Selective Service System

Social Security Administration *

Commodity Futures Trading Commission

Consumer Product Safety Commission *

Farm Credit Administration

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission *

National Credit Union Administration

National Indian Gaming Commission *

Postal Regulatory Commission *

Recovery Accountability and Transparency Board

Surface Transportation Board

The Regulatory Information Service Center (the Center) compiles the

Plan and the Unified Agenda for the Office of Information and

Regulatory Affairs (OIRA), part of the Office of Management and Budget.

OIRA is responsible for overseeing the Federal Government's regulatory, paperwork, and information resource management activities, including implementation of Executive Order 12866. The Center also provides information about Federal regulatory activity to the President and his

Executive Office, the Congress, agency managers, and the public.

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The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters.

Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change.

Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The Regulatory Plan and the Unified

Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it.

II. Why Are The Regulatory Plan and the Unified Agenda Published?

The Regulatory Plan and the Unified Agenda help agencies comply with their obligations under the Regulatory Flexibility Act and various

Executive orders and other statutes.

Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to identify those rules that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Agencies meet that requirement by including the information in their submissions for the Unified

Agenda. Agencies may also indicate those regulations that they are reviewing as part of their periodic review of existing rules under the

Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272 entitled ``Proper Consideration of Small Entities in Agency

Rulemaking,'' signed August 13, 2002 (67 FR 53461), provides additional guidance on compliance with the Act.

Executive Order 12866

Executive Order 12866 entitled ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), requires covered agencies to prepare an agenda of all regulations under development or review. The

Order also requires that certain agencies prepare annually a regulatory plan of their ``most important significant regulatory actions,'' which appears as part of the fall Unified Agenda. Executive Order 13497, signed January 30, 2009 (74 FR 6113), revoked the amendments to

Executive Order 12866 that were contained in Executive Order 13258 and

Executive Order 13422.

Executive Order 13132

Executive Order 13132 entitled ``Federalism,'' signed August 4, 1999 (64 FR 43255), directs agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have ``federalism implications'' as defined in the Order. Under the Order, an agency that is proposing regulations with federalism implications, which either preempt State law or impose nonstatutory unfunded substantial direct compliance costs on State and local governments, must consult with

State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the

Office of Management and Budget a federalism summary impact statement for such regulations, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications.

Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II) requires agencies to prepare written assessments of the costs and benefits of significant regulatory actions ``that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more . . . in any 1 year .

. . .'' The requirement does not apply to independent regulatory agencies, nor does it apply to certain subject areas excluded by section 4 of the Act. Affected agencies identify in the Unified Agenda those regulatory actions they believe are subject to title II of the

Act.

Executive Order 13211

Executive Order 13211 entitled ``Actions Concerning Regulations

That Significantly Affect Energy Supply, Distribution, or Use,'' signed

May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent possible, information regarding the adverse effects that agency actions may have on the supply, distribution, and use of energy. Under the

Order, the agency must prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory

Affairs, Office of Management and Budget, for ``those matters identified as significant energy actions.'' As part of this effort, agencies may optionally include in their submissions for the Unified

Agenda information on whether they have prepared or plan to prepare a

Statement of Energy Effects for their regulatory actions.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, title II) established a procedure for congressional review of rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the effective date of a ``major'' rule for at least 60 days from the publication of the final rule in the Federal Register. The Act specifies that a rule is ``major'' if it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the

Administrator of OIRA will make the final determination as to whether a rule is major.

III. How Are The Regulatory Plan and the Unified Agenda

Organized?

The Regulatory Plan appears in part II of a daily edition of the

Federal Register. The Plan is a single document beginning with an introduction, followed by a table of contents, followed by each agency's section of the Plan. Following the Plan in the Federal

Register, as separate parts, are the regulatory flexibility agendas for each agency whose agenda includes entries for rules that are likely to have a significant economic impact on a substantial number of small entities or rules that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Each printed agenda appears as a separate part. The sections of the Plan and the parts of the Unified Agenda are

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organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority (Agenda only); and independent regulatory agencies. Agencies may in turn be divided into subagencies. Each printed agency agenda has a table of contents listing the agency's printed entries that follow.

Each agency's section of the Plan contains a narrative statement of regulatory priorities and, for most agencies, a description of the agency's most important significant regulatory and deregulatory actions. Each agency's part of the Agenda contains a preamble providing information specific to that agency plus descriptions of the agency's regulatory and deregulatory actions.

The online, complete Unified Agenda contains the preambles of all participating agencies. Unlike the printed edition, the online Agenda has no fixed ordering. In the online Agenda, users can select the particular agencies whose agendas they want to see. Users have broad flexibility to specify the characteristics of the entries of interest to them by choosing the desired responses to individual data fields. To see a listing of all of an agency's entries, a user can select the agency without specifying any particular characteristics of entries.

Each entry in the Agenda is associated with one of five rulemaking stages. In the Plan, only the first three stages are applicable. Some agencies use subheadings to identify regulations that are grouped according to particular topics. The rulemaking stages are: 1. Prerule Stage -- actions agencies will undertake to determine whether or how to initiate rulemaking. Such actions occur prior to a

Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of

Proposed Rulemaking (ANPRMs) and reviews of existing regulations. 2. Proposed Rule Stage -- actions for which agencies plan to publish a Notice of Proposed Rulemaking as the next step in their rulemaking process or for which the closing date of the NPRM Comment

Period is the next step. 3. Final Rule Stage -- actions for which agencies plan to publish a final rule or an interim final rule or to take other final action as the next step. 4. Long-Term Actions -- items under development but for which the agency does not expect to have a regulatory action within the 12 months after publication of this edition of the Unified Agenda. Some of the entries in this section may contain abbreviated information. 5. Completed Actions -- actions or reviews the agency has completed or withdrawn since publishing its last agenda. This section also includes items the agency began and completed between issues of the

Agenda.

A bullet () preceding the title of an entry indicates that the entry is appearing in the Unified Agenda for the first time.

In the printed edition, all entries are numbered sequentially from the beginning to the end of the publication. The sequence number preceding the title of each entry identifies the location of the entry in this edition. The sequence number is used as the reference in the printed table of contents. Sequence numbers are not used in the online

Unified Agenda because the unique Regulation Identifier Number (RIN) is able to provide this cross-reference capability.

Editions of the Unified Agenda prior to fall 2007 contained several indexes, which identified entries with various characteristics. These included regulatory actions for which agencies believe that the

Regulatory Flexibility Act may require a Regulatory Flexibility

Analysis, actions selected for periodic review under section 610(c) of the Regulatory Flexibility Act, and actions that may have federalism implications as defined in Executive Order 13132 or other effects on levels of government. These indexes are no longer compiled, because users of the online Unified Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the Federal

Register Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases.

IV. What Information Appears for Each Entry?

All entries in the Unified Agenda contain uniform data elements including, at a minimum, the following information:

Title of the Regulation -- a brief description of the subject of the regulation. In the printed edition, the notation ``Section 610

Review'' following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory

Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated completions of section 610 reviews or rulemaking actions resulting from completed section 610 reviews. In the online edition, these notations appear in a separate field.

Priority -- an indication of the significance of the regulation.

Agencies assign each entry to one of the following five categories of significance.

(1) Economically Significant

As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more, or will adversely affect, in a material way, the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities. The definition of an ``economically significant'' rule is similar but not identical to the definition of a ``major'' rule under 5 U.S.C. 801 (Pub. L. 104-121). (See below.)

(2) Other Significant

A rulemaking that is not Economically Significant but is considered

Significant by the agency. This category includes rules that the agency anticipates will be reviewed under Executive Order 12866 or rules that are a priority of the agency head. These rules may or may not be included in the agency's regulatory plan.

(3) Substantive, Nonsignificant

A rulemaking that has substantive impacts but is neither Significant, nor Routine and Frequent, nor Informational/Administrative/Other.

(4) Routine and Frequent

A rulemaking that is a specific case of a multiple recurring application of a regulatory program in the Code of Federal

Regulations and that does not alter the body of the regulation.

(5) Informational/Administrative/Other

A rulemaking that is primarily informational or pertains to agency matters not central to accomplishing the

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agency's regulatory mandate but that the agency places in the

Unified Agenda to inform the public of the activity.

Major -- whether the rule is ``major'' under 5 U.S.C. 801 (Pub. L. 104-121) because it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of the

Office of Information and Regulatory Affairs will make the final determination as to whether a rule is major.

Unfunded Mandates -- whether the rule is covered by section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act requires that, before issuing an NPRM likely to result in a mandate that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of more than

$100 million in 1 year, agencies, other than independent regulatory agencies, shall prepare a written statement containing an assessment of the anticipated costs and benefits of the Federal mandate.

Legal Authority -- the section(s) of the United States Code

(U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s) the regulatory action. Agencies may provide popular name references to laws in addition to these citations.

CFR Citation -- the section(s) of the Code of Federal Regulations that will be affected by the action.

Legal Deadline -- whether the action is subject to a statutory or judicial deadline, the date of that deadline, and whether the deadline pertains to an NPRM, a Final Action, or some other action.

Abstract -- a brief description of the problem the regulation will address; the need for a Federal solution; to the extent available, alternatives that the agency is considering to address the problem; and potential costs and benefits of the action.

Timetable -- the dates and citations (if available) for all past steps and a projected date for at least the next step for the regulatory action. A date printed in the form 08/00/11 means the agency is predicting the month and year the action will take place but not the day it will occur. In some instances, agencies may indicate what the next action will be, but the date of that action is ``To Be

Determined.'' ``Next Action Undetermined'' indicates the agency does not know what action it will take next.

Regulatory Flexibility Analysis Required -- whether an analysis is required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because the rulemaking action is likely to have a significant economic impact on a substantial number of small entities as defined by the Act.

Small Entities Affected -- the types of small entities

(businesses, governmental jurisdictions, or organizations) on which the rulemaking action is likely to have an impact as defined by the

Regulatory Flexibility Act. Some agencies have chosen to indicate likely effects on small entities even though they believe that a

Regulatory Flexibility Analysis will not be required.

Government Levels Affected -- whether the action is expected to affect levels of government and, if so, whether the governments are

State, local, tribal, or Federal.

International Impacts --whether the regulation is expected to have international trade and investment effects, or otherwise may be of interest to the Nation's international trading partners.

Federalism -- whether the action has ``federalism implications'' as defined in Executive Order 13132. This term refers to actions ``that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.''

Independent regulatory agencies are not required to supply this information.

Agency Contact -- the name and phone number of at least one person in the agency who is knowledgeable about the rulemaking action. The agency may also provide the title, address, fax number, e-mail address, and TDD for each agency contact.

Some agencies have provided the following optional information:

RIN Information URL -- the Internet address of a site that provides more information about the entry.

Public Comment URL -- the Internet address of a site that will accept public comments on the entry. Alternatively, timely public comments may be submitted at the Governmentwide e-rulemaking site, http://www.regulations.gov.

Additional Information -- any information an agency wishes to include that does not have a specific corresponding data element.

Compliance Cost to the Public -- the estimated gross compliance cost of the action.

Affected Sectors -- the industrial sectors that the action may most affect, either directly or indirectly. Affected Sectors are identified by North American Industry Classification System (NAICS) codes.

Energy Effects -- an indication of whether the agency has prepared or plans to prepare a Statement of Energy Effects for the action, as required by Executive Order 13211 ``Actions Concerning Regulations That

Significantly Affect Energy Supply, Distribution, or Use,'' signed May 18, 2001 (66 FR 28355).

Related RINs-- one or more past or current RINs associated with activity related to this action, such as merged RINs, split RINs, new activity for previously completed RINs, or duplicate RINs.

Entries appearing in The Regulatory Plan include some or all of the following additional data elements, but will, at a minimum, include information in Statement of Need and in Anticipated Costs and Benefits:

Statement of Need -- a description of the need for the regulatory action.

Summary of the Legal Basis -- a description of the legal basis for the action, including whether any aspect of the action is required by statute or court order.

Alternatives -- a description of the alternatives the agency has considered or will consider as required by section 4(c)(1)(B) of

Executive Order 12866.

Anticipated Costs and Benefits -- a description of preliminary estimates of the anticipated costs and benefits of the action.

Risks -- a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk and this risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction.

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V. Abbreviations

The following abbreviations appear throughout this publication:

ANPRM -- An Advance Notice of Proposed Rulemaking is a preliminary notice, published in the Federal Register, announcing that an agency is considering a regulatory action. An agency may issue an ANPRM before it develops a detailed proposed rule. An ANPRM describes the general area that may be subject to regulation and usually asks for public comment on the issues and options being discussed. An ANPRM is issued only when an agency believes it needs to gather more information before proceeding to a notice of proposed rulemaking.

CFR -- The Code of Federal Regulations is an annual codification of the general and permanent regulations published in the Federal

Register by the agencies of the Federal Government. The Code is divided into 50 titles, each title covering a broad area subject to Federal regulation. The CFR is keyed to and kept up to date by the daily issues of the Federal Register.

EO -- An Executive order is a directive from the President to

Executive agencies, issued under constitutional or statutory authority.

Executive orders are published in the Federal Register and in title 3 of the Code of Federal Regulations.

FR -- The Federal Register is a daily Federal Government publication that provides a uniform system for publishing Presidential documents, all proposed and final regulations, notices of meetings, and other official documents issued by Federal agencies.

FY -- The Federal fiscal year runs from October 1 to September 30.

NPRM -- A Notice of Proposed Rulemaking is the document an agency issues and publishes in the Federal Register that describes and solicits public comments on a proposed regulatory action. Under the

Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum:

A statement of the time, place, and nature of the public rulemaking proceeding;

A reference to the legal authority under which the rule is proposed; and

Either the terms or substance of the proposed rule or a description of the subjects and issues involved.

PL (or Pub. L.) -- A public law is a law passed by Congress and signed by the President or enacted over his veto. It has general applicability, unlike a private law that applies only to those persons or entities specifically designated. Public laws are numbered in sequence throughout the 2-year life of each Congress; for example, PL 111-5 is the fifth public law of the 111th Congress.

RFA -- A Regulatory Flexibility Analysis is a description and analysis of the impact of a rule on small entities, including small businesses, small governmental jurisdictions, and certain small not- for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires each agency to prepare an initial RFA for public comment when it is required to publish an NPRM and to make available a final RFA when the final rule is published, unless the agency head certifies that the rule would not have a significant economic impact on a substantial number of small entities.

RIN -- The Regulation Identifier Number is assigned by the

Regulatory Information Service Center to identify each regulatory action listed in The Regulatory Plan and the Unified Agenda, as directed by Executive Order 12866 (section 4(b)). Additionally, OMB has asked agencies to include RINs in the headings of their Rule and

Proposed Rule documents when publishing them in the Federal Register, to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development.

Seq. No. -- The sequence number identifies the location of an entry in the printed edition of the Unified Agenda. Note that a specific regulatory action will have the same RIN throughout its development but will generally have different sequence numbers if it appears in different printed editions of The Regulatory Plan and the

Agenda. Sequence numbers are not used in the online Unified Agenda.

USC -- The United States Code is a consolidation and codification of all general and permanent laws of the United States. The USC is divided into 50 titles, each title covering a broad area of Federal law.

VI. How Can Users Get Copies of the Plan and the Agenda?

Copies of the Federal Register issue containing the printed edition of The Regulatory Plan and the Unified Agenda (agency regulatory flexibility agendas) are available from the Superintendent of

Documents, U.S. Government Printing Office, P.O. Box 371954,

Pittsburgh, PA 15250-7954. Telephone: (202) 512-1800 or 1-866-512-1800

(toll-free).

Copies of individual agency materials may be available directly from the agency or may be found on the agency's website. Please contact the particular agency for further information.

All editions of The Regulatory Plan and the Unified Agenda of

Federal Regulatory and Deregulatory Actions since fall 1995 are available in electronic form at http://reginfo.gov. This site currently offers flexible search tools for recent editions. Searchable access to the entire historic Unified Agenda database back to 1983 will be added to the site in time.

In accordance with regulations for the Federal Register, the

Government Printing Office's GPO Access website contains copies of the

Agendas and Regulatory Plans that have been printed in the Federal

Dated: November 29, 2010.

John C. Thomas,

Director.

December 20, 2010 (Volume 75, Number 243)

Unified Agenda

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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DEPARTMENT OF AGRICULTURE (USDA)

The Regulatory Plan

Page 79455

OPEN GOVERNMENT AND EVIDENCE-BASED REGULATION

There is a close connection, even an inextricable relationship, between open government and evidence- based regulation. If regulatory choices are based on careful analysis of the evidence, and if opportunities are provided for public review and comment, we will be able to identify sensible and pragmatic approaches that are designed to promote entrepreneurship, innovation, job creation, and economic growth.

Since his inauguration, President Obama has placed a great deal of emphasis on open government. In requiring openness, the President has emphasized three separate points. First, he has stressed the importance of accountability. In his words, openness ``will strengthen our democracy and promote efficiency and effectiveness in Government.'' Second, the President has said that ``[k]nowledge is widely dispersed in society, and public officials benefit from having access to that dispersed knowledge'' and hence to

``collective expertise and wisdom.'' Third, he has emphasized the importance of providing people with information that they ``can readily find and use.'' For this reason, he has said that agencies ``should harness new technologies'' and ``solicit public feedback to identify information of greatest use to the public.''

At the same time, the Administration has been placing a great deal of emphasis on sound analysis and on ensuring a careful accounting of the anticipated consequences of regulation, including both benefits and costs. While regulation can promote vital public goods, such as protection of safety, health, and financial stability, the President has said, ``Sometimes regulation fails, and sometimes its benefits do not justify its costs.''

The word ``analysis,'' of course, includes a number of distinct but overlapping approaches, such as the cost- benefit analysis required by Executive Order 12866 and the regulatory flexibility analysis required by the

Regulatory Flexibility Act. Executive Order 12866 requires agencies, to the extent permitted by law, to give careful consideration to both costs and benefits and to ensure that the benefits of regulation justify the costs. It is worth noting that, in part because of this Administration's commitment to careful analysis, the quantified benefits of final rules significantly exceeded the quantified costs for calendar year 2009- and that the net benefits of final regulations for the first year of the Obama Administration far exceeded those of the first year for the Clinton and Bush

Administrations:

Page 79456

Figure 1: Annual Estimated Net Benefits of

Major Rules

First Calendar Year of an Administration (1/21 to 12/31)

It is important to emphasize that the monetized benefits are high. We have issued rules and undertaken initiatives that are saving lives on the highways and in workplaces; reducing air and water pollution; increasing fuel economy, thus saving money while reducing pollution; making both trains and planes safer; helping students to obtain school loans and so to attend college; protecting consumers and investors against manipulation, fraud, and conflicts of interest; increasing energy efficiency, saving billions of dollars while increasing energy security; combating childhood obesity; and creating a ``race to the top'' in education.

A central goal for the upcoming period is to ensure that regulations do not impose unjustified burdens and that if the costs and burdens are significant, they are producing even more significant gains. Analysis of regulatory consequences is part of a broad effort to subject regulatory decisions to public scrutiny, with close reference to evidence, and thus improving them-- not least by pointing the way toward reduced burdens and innovative solutions.

By promoting accountability, open government policies can help to track government's own performance. In that way, such policies make public officials accountable for what they do, including in the regulatory arena.

Performance review matters; it is a hallmark of this

Administration. Regulatory analysis is best seen as a form of performance review for Federal rules, typically done in advance (and sometimes done retrospectively).

Before acting, regulators should attempt to obtain a clear and concrete understanding of the likely consequences of what they propose to do. In its 2009

Report on the Benefits and Costs of Federal

Regulations, OMB specifically underlined the relationship among careful analysis, evidence-based regulation, and open government. As the Report says,

``Indeed, careful regulatory analysis, if transparent in its assumptions and subject to public scru

Page 79457

tiny, should be seen as part and parcel of open government. It helps to ensure that policies are not based on speculation and guesswork, but instead on a sense of the likely consequences of alternative courses of action. It helps to reduce the risk of insufficiently justified regulation, imposing serious burdens and costs for inadequate reason. It also helps to reduce the risk of insufficiently protective regulation, failing to go as far as proper analysis suggests. We believe that regulatory analysis should be developed and designed in a way that fits with the commitment to open government.''

With these points in mind, the Office of Information and Regulatory Affairs issued (in November 2010) an

``Agency Checklist'' for Regulatory Impact Analysis, designed to promote clarity and transparency with respect to the anticipated effects of regulation (see http://www.whitehouse.gov/sites/default/files/omb/ inforeg/regpol/RIA--Checklist.pdf). The checklist emphasizes that agencies must assess costs and benefits

(to the extent feasible), explore alternatives, and demonstrate the need for regulatory action. In these ways, we have been seeking to increase openness and improve our regulatory practices.

The second function of open government is very different: Openness promotes not merely accountability, but also access to widely dispersed information. The central idea is that officials often lack information that is held by numerous others, especially in the private sphere. When it is working well, open government can ensure that rules are properly informed by such information, which will often help to increase benefits, reduce costs, or identify new and creative alternatives.

Consider the rulemaking process itself. A large advantage of notice-and-comment rulemaking is that it allows agencies to offer proposals, and supporting analyses, that are subject to public scrutiny, and that can benefit from knowledge that is widely dispersed in society. On numerous occasions in the last 21 months, final rules have been significantly different from proposed rules, and public comments are a key reason.

In its 2010 Report on the Benefits and Costs of Federal

Regulations, OMB specifically noted that ``some regulations have significant adverse effects on small business'' and that ``it is appropriate to take steps to create flexibility in the event that those adverse effects cannot be justified by commensurate benefits.''

To tap dispersed knowledge, OMB requested public suggestions about regulatory changes that might serve to promote economic growth, with particular reference to increasing employment, innovation, and competitiveness. More specifically, OMB sought suggestions for regulatory reforms that have significant net benefits, that might increase exports, and that might promote growth, innovation, and competitiveness for small business, perhaps through increasing flexibility. We continue to seek such suggestions in an effort to reduce the risk that regulation will impose unjustified costs or contain unjustified rigidity--and to square important regulatory goals with the interest in economic recovery.

Finally, in emphasizing the value of providing access to information that people ``can readily find and use,'' the President signaled a distinctive idea--that openness promotes learning by making data and evidence accessible. Anecdotes, speculation, and guesswork can be replaced with information and evidence. The point bears directly on the role of regulatory impact analysis. Such analysis is something that members of the public can ``find and use,'' not least because advance notice promotes predictability and avoids unfair surprise.

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In its Memorandum of July 23, 2010, on the Regulatory

Plan and Unified Agenda, the Office of Information and

Regulatory Affairs noted:

``Executive Order 12866 identifies a number of principles that you should keep in mind, to the extent permitted by law, as you set priorities and prepare your submissions.

First, Executive Order 12866 directs agencies to propose or adopt a regulation `only upon a reasoned determination that the benefits of the intended regulation justify the costs' (recognizing that some benefits are difficult to quantify but are nonetheless essential to consider, such as visibility in national parks).

Second, it requires each agency to `tailor its regulations to impose the least burden on society . . . taking into account, among other things, and to the extent practicable, the costs of cumulative regulations.'

Third, it requires agencies to `identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as the public.'

Fourth, it directs agencies to design regulations `in the most cost-effective manner to achieve the regulatory objective.'

Fifth, it asks each agency to `avoid regulations that are inconsistent, incompatible, or duplicative with its other regulations or those of other Federal agencies.'

Sixth, it directs agencies to `select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach.'''

OIRA asked agencies to ``comply with these requirements as you develop your submissions.'' It also asked agencies, among other things, to ``highlight rulemakings that simplify or streamline regulations and reduce or eliminate unjustified burdens'' and to identify ``regulations that are of particular concern to small businesses.'' Before they can be finalized, the regulations on the plans that follow will, of course, be subject to a rigorous process of assessment and scrutiny, with careful attention to the foregoing principles. The list of regulations is intended to provide a public account of regulations that are under consideration; agencies are under no obligation to issue these regulations (unless some independent source of law requires them to do so).

In the current economic environment, it is especially important to see that analysis and openness are mutually reinforcing. If the two are taken together, they can help to promote important social goals, to eliminate unjustified costs, and to identify approaches that will promote entrepreneurship, innovation, job growth, and competitiveness.

Page 79459

DEPARTMENT OF AGRICULTURE

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Wholesale Pork Reporting Program

0581-AD07

Proposed Rule

Stage 2

National Dairy Promotion and Research Program; Dairy Import Assessments, DA-08-0050

0581-AC87 Final Rule Stage 3

Animal Welfare; Regulations and Standards for Birds

0579-AC02

Proposed Rule

Stage 4

Plant Pest Regulations; Update of General Provisions

0579-AC98

Proposed Rule

Stage 5

Importation of Live Dogs

0579-AD23

Proposed Rule

Stage 6

Animal Disease Traceability

0579-AD24

Proposed Rule

Stage 7

Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not

0579-AC03 Final Rule Stage

Authorized for Importation Pending Pest Risk Analysis 8

Multi-Family Housing (MFH) Reinvention

0575-AC13 Final Rule Stage 9

Enforcement of the Packers and Stockyards Act

0580-AB07

Final Rule Stage 10

Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and

0584-AD87

Proposed Rule

Energy Act of 2008

Stage 11

Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions

0584-AD88

Proposed Rule

Stage 12

Fresh Fruit and Vegetable Program

0584-AD96

Proposed Rule

Stage 13

Child and Adult Care Food Program: Improving Management and Program Integrity

0584-AC24 Final Rule Stage 14

Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant,

0584-AD60

Final Rule Stage and Runaway Children for Free Meals in the NSLP, SBP, and SMP 15

Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC

0584-AD77

Final Rule Stage

Food Packages 16

Egg Products Inspection Regulations

0583-AC58

Proposed Rule

Stage 17

New Poultry Slaughter Inspection

0583-AD32

Proposed Rule

Stage 18

Mandatory Inspection of Catfish and Catfish Products

0583-AD36

Proposed Rule

Stage 19

Electronic Imported Product Inspection Applications; Electronic Foreign Imported Product and

0583-AD39

Proposed Rule

Foreign Establishment Certifications; Deletion of Streamlined Inspection Procedures for Canadian

Stage

Product 20

Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the

0583-AD41

Proposed Rule

Requirements for Official Export Inspection Marks, Devices, and Certificates

Stage 21

Performance Standards for the Production of Processed Meat and Poultry Products; Control of

0583-AC46 Final Rule Stage

Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products 22

Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products

0583-AC60 Final Rule Stage 23

Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments

0583-AD34

Final Rule Stage 24

Federal-State Interstate Shipment Cooperative Inspection Program

0583-AD37

Final Rule Stage 25

Value-Added Producer Grant Program

0570-AA79

Final Rule Stage 26

Rural Broadband Access Loans and Loan Guarantees

0572-AC06 Final Rule Stage

DEPARTMENT OF COMMERCE

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Designation of Critical Habitat for the North Atlantic Right Whale

0648-AY54

Proposed Rule

Stage 28

Certification of Nations Whose Fishing Vessels Are Engaged in Illegal, Unreported, and Unregulated

0648-AV51

Final Rule Stage

Fishing or Bycatch of Protected Living Marine Resources

Page 79460

Critical Habitat Designation for Cook Inlet Beluga Whale Under the Endangered Species Act

0648-AX50

Final Rule Stage 30

Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Amendments 20 and 21; Trawl

0648-AY68

Final Rule Stage

Rationalization Program

DEPARTMENT OF DEFENSE

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Voluntary Education Programs

0790-AI50

Final Rule Stage 32

TRICARE; Reimbursement of Sole Community Hospitals

0720-AB41

Proposed Rule

Stage

DEPARTMENT OF EDUCATION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Title IV of the Higher Education Act of 1965, as Amended

1840-AD05

Proposed Rule

Stage 34

Program Integrity: Gainful Employment--Measures

1840-AD06

Final Rule Stage

DEPARTMENT OF ENERGY

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Energy Efficiency Standards for Clothes Dryers and Room Air Conditioners

1904-AA89

Proposed Rule

Stage 36

Energy Efficiency Standards for Residential Central Air Conditioners and Heat Pumps

1904-AB47

Proposed Rule

Stage 37

Energy Efficiency Standards for Fluorescent Lamp Ballasts

1904-AB50

Proposed Rule

Stage 38

Energy Efficiency Standards for Residential Furnaces

1904-AC06

Proposed Rule

Stage 39

Energy Efficiency Standards for Manufactured Housing

1904-AC11

Proposed Rule

Stage 40

Energy Efficiency Standards for Residential Refrigerators, Refrigerator-Freezers, and Freezers

1904-AB79

Final Rule Stage

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information

0991-AB57

Final Rule Stage

Technology for Economic and Clinical Health Act 42

Transparency Reporting

0950-AA07

Proposed Rule

Stage 43

Rate Review

0950-AA03

Final Rule Stage 44

Uniform Explanation of Benefits, Coverage Facts, and Standardized Definitions

0950-AA08

Final Rule Stage 45

Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics

0910-AC52

Proposed Rule

Stage 46

Unique Device Identification

0910-AG31

Proposed Rule

Stage 47

Cigarette Warning Label Statements

0910-AG41

Proposed Rule

Stage

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Food Labeling: Nutrition Labeling for Food Sold in Vending Machines

0910-AG56

Proposed Rule

Stage 49

Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants

0910-AG57

Proposed Rule

Stage 50

Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification

0910-AF27

Final Rule Stage

Requirements; Records and Reports; and Quality Factors 51

Medical Device Reporting; Electronic Submission Requirements

0910-AF86

Final Rule Stage 52

Electronic Registration and Listing for Devices

0910-AF88

Final Rule Stage 53

Requirements for Long-Term Care Facilities: Notification of Facility Closure (CMS-3230-IFC)

0938-AQ09

Proposed Rule

Stage 54

Medicare Shared Savings Program: Accountable Care Organizations (CMS-1345-P)

0938-AQ22

Proposed Rule

Stage 55

Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and

0938-AQ24

Proposed Rule

FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates (CMS-1518-P)

Stage 56

Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS-1524-P)

0938-AQ25

Proposed Rule

Stage 57

Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center

0938-AQ26

Proposed Rule

Payment System for CY 2012 (CMS-1525-P)

Stage 58

Civil Money Penalties for Nursing Homes (CMS-2435-F)

0938-AQ02

Final Rule Stage 59

Designation Renewal of Head Start Grantees

0970-AC44

Proposed Rule

Stage 60

Community Living Assistance Services and Supports Enrollment and Eligibility Rules Under the

0985-AA07

Proposed Rule

Affordable Care Act

Stage

DEPARTMENT OF HOMELAND SECURITY

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Secure Handling of Ammonium Nitrate Program

1601-AA52

Proposed Rule

Stage 62

Collection of Alien Biometric Data Upon Exit From the United States at Air and Sea Ports of

1601-AA34

Final Rule Stage

Departure; United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT) 63

Asylum and Withholding Definitions

1615-AA41

Proposed Rule

Stage 64

Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Aliens Subject

1615-AB71

Proposed Rule to Numerical Limitations

Stage 65

Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and

1615-AB89

Proposed Rule

Withholding of Removal

Stage 66

New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T

1615-AA59

Final Rule Stage

Nonimmigrant Status 67

Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status

1615-AA60

Final Rule Stage 68

New Classification for Victims of Criminal Activity; Eligibility for the ``U'' Nonimmigrant Status

1615-AA67

Final Rule Stage 69

E-2 Nonimmigrant Status for Aliens in the Commonwealth of the Northern Mariana Islands With Long-

1615-AB75

Final Rule Stage

Term Investor Status 70

Commonwealth of the Northern Mariana Islands Transitional Worker Classification

1615-AB76

Final Rule Stage 71

Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands

1615-AB77

Final Rule Stage 72

Outer Continental Shelf Activities

1625-AA18

Proposed Rule

Stage

Page 79462

Inspection of Towing Vessels

1625-AB06

Proposed Rule

Stage 74

Assessment Framework and Organizational Restatement Regarding Preemption for Certain Regulations

1625-AB32

Proposed Rule

Issued by the Coast Guard

Stage 75

Updates to Maritime Security

1625-AB38

Proposed Rule

Stage 76

Standards for Living Organisms in Ships' Ballast Water Discharged in U.S. Waters

1625-AA32

Final Rule Stage 77

Importer Security Filing and Additional Carrier Requirements

1651-AA70

Final Rule Stage 78

Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization

1651-AA72

Final Rule Stage

(ESTA) Program 79

Establishment of Global Entry Program

1651-AA73

Final Rule Stage 80

Implementation of the Guam-CNMI Visa Waiver Program

1651-AA77

Final Rule Stage 81

Large Aircraft Security Program, Other Aircraft Operator Security Program, and Airport Operator

1652-AA53

Proposed Rule

Security Program

Stage 82

Public Transportation and Passenger Railroads--Security Training of Employees

1652-AA55

Proposed Rule

Stage 83

Freight Railroads--Security Training of Employees

1652-AA57

Proposed Rule

Stage 84

Over-the-Road Buses--Security Training of Employees

1652-AA59

Proposed Rule

Stage 85

Aircraft Repair Station Security

1652-AA38

Final Rule Stage 86

Air Cargo Screening

1652-AA64

Final Rule Stage 87

Continued Detention of Aliens Subject to Final Orders of Removal

1653-AA60

Proposed Rule

Stage 88

Continued Detention of Aliens Subject to Final Orders of Removal

1653-AA13

Final Rule Stage 89

Extending Period for Optional Practical Training by 17 Months for F-1 Nonimmigrant Students With

1653-AA56

Final Rule Stage

STEM Degrees and Expanding the CAP-GAP Relief for All F-1 Students With Pending H-1B Petitions 90

Update of FEMA's Public Assistance Regulations

1660-AA51

Proposed Rule

Stage

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Title I Energy Retrofit Property Improvement Loans (FR-5445)

2502-AI93

Proposed Rule

Stage 92

Housing Counseling: New Program Requirements (FR-5446)

2502-AI94

Proposed Rule

Stage

DEPARTMENT OF JUSTICE

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

National Standards to Prevent, Detect, and Respond to Prison Rape

1105-AB34

Proposed Rule

Stage

DEPARTMENT OF LABOR

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

Construction Contractor Affirmative Action Requirements

1250-AA01

Proposed Rule

Stage

Page 79463

Persuader Agreements: Employer and Labor Relations Consultant Reporting Under the LMRDA

1245-AA03

Proposed Rule

Stage 96

Right To Know Under the Fair Labor Standards Act

1235-AA04

Proposed Rule

Stage 97

Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than

1205-AB58

Proposed Rule

Agriculture or Registered Nursing in the United States (H-2B Workers)

Stage 98

Equal Employment Opportunity in Apprenticeship and Training, Amendment of Regulations

1205-AB59

Proposed Rule

Stage 99

Lifetime Income Options for Participants and Beneficiaries in Retirement Plans

1210-AB33

Prerule Stage 100

Definition of ``Fiduciary''

1210-AB32

Proposed Rule

Stage 101

Respirable Crystalline Silica Standard

1219-AB36

Proposed Rule

Stage 102

Lowering Miners' Exposure to Coal Mine Dust, Including Continuous Personal Dust Monitors

1219-AB64

Proposed Rule

Stage 103

Safety and Health Management Programs for Mines

1219-AB71

Proposed Rule

Stage 104

Pattern of Violations

1219-AB73

Proposed Rule

Stage 105

Maintenance of Incombustible Content of Rock Dust in Underground Coal Mines

1219-AB76

Proposed Rule

Stage 106

Proximity Detection Systems for Underground Mines

1219-AB65

Final Rule Stage 107

Infectious Diseases

1218-AC46

Prerule Stage 108

Injury and Illness Prevention Program

1218-AC48

Prerule Stage 109

Backing Operations

1218-AC52

Prerule Stage 110

Occupational Exposure to Crystalline Silica

1218-AB70

Proposed Rule

Stage 111

Occupational Injury and Illness Recording and Reporting Requirements--Modernizing OSHA's Reporting

1218-AC49

Proposed Rule

System

Stage 112

Hazard Communication

1218-AC20 Final Rule Stage

DEPARTMENT OF TRANSPORTATION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

113

Enhancing Airline Passenger Protections--Part 2

2105-AD92

Final Rule Stage 114

Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers

2120-AJ00

Proposed Rule

Stage 115

Air Ambulance and Commercial Helicopter Operations; Safety Initiatives and Miscellaneous Amendments

2120-AJ53

Proposed Rule

Stage 116

Flight and Duty Time Limitations and Rest Requirements

2120-AJ58

Final Rule Stage 117

Carrier Safety Fitness Determination

2126-AB11

Proposed Rule

Stage 118

Electronic On-Board Recorders and Hours of Service Supporting Documents

2126-AB20

Proposed Rule

Stage 119

Hours of Service

2126-AB26

Proposed Rule

Stage 120

Drivers of Commercial Vehicles: Restricting the Use of Cellular Phones

2126-AB29

Proposed Rule

Stage 121

National Registry of Certified Medical Examiners

2126-AA97

Final Rule Stage 122

Passenger Car and Light Truck Corporate Average Fuel Economy Standards MYs 2017 and Beyond

2127-AK79

Prerule Stage 123

Federal Motor Vehicle Safety Standard No. 111, Rearview Mirrors

2127-AK43

Proposed Rule

Stage

Page 79464

124

Commercial Medium- and Heavy-Duty On-Highway Vehicles and Work Truck Fuel Efficiency Standards

2127-AK74

Proposed Rule

Stage 125

Ejection Mitigation

2127-AK23

Final Rule Stage 126

Hours of Service: Passenger Train Employees

2130-AC15

Proposed Rule

Stage 127

Major Capital Investment Projects

2132-AB02

Proposed Rule

Stage 128

Hazardous Materials: Limiting the Use of Mobile Telephones by Highway

2137-AE65

Proposed Rule

Stage 129

Hazardous Materials: Limiting the Use of Electronic Devices by Highway

2137-AE63

Final Rule Stage

ENVIRONMENTAL PROTECTION AGENCY

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

130

Review of the National Ambient Air Quality Standards for Carbon Monoxide

2060-AI43

Proposed Rule

Stage 131

Review of the National Ambient Air Quality Standards for Particulate Matter

2060-AO47

Proposed Rule

Stage 132

Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of

2060-AO72

Proposed Rule

Sulfur

Stage 133

National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired Electric Utility

2060-AP52

Proposed Rule

Steam Generating Units

Stage 134

Control of Greenhouse Gas Emissions From Medium and Heavy-Duty Vehicles

2060-AP61

Proposed Rule

Stage 135

Review of the National Ambient Air Quality Standards for Lead

2060-AQ44

Proposed Rule

Stage 136

NPDES Electronic Reporting Rule

2020-AA47

Proposed Rule

Stage 137

Regulations To Facilitate Compliance With the Federal Insecticide, Fungicide, and Rodenticide Act

2070-AJ32

Proposed Rule by Producers of Plant-Incorporated Protectants (PIPs)

Stage 138

Mercury; Regulation of Use in Certain Products

2070-AJ46

Proposed Rule

Stage 139

Nanoscale Materials; Reporting Under TSCA Section 8(a)

2070-AJ54

Proposed Rule

Stage 140

Nanoscale Materials; Significant New Use Rule (SNUR)

2070-AJ67

Proposed Rule

Stage 141

Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

2070-AJ76

Proposed Rule

Stage 142

Hazardous Waste Management Systems: Identification and Listing of Hazardous Waste: Carbon Dioxide

2050-AG60

Proposed Rule

(CO2) Injectate in Geological Sequestration Activities

Stage 143

Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the

2050-AG61

Proposed Rule

Hard Rock Mining Industry

Stage 144

NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection Systems, Municipal

2040-AD02

Proposed Rule

Satellite Collection Systems, Sanitary Sewer Overflows, and Peak Excess Flow Treatment Facilities

Stage 145

Criteria and Standards for Cooling Water Intake Structures

2040-AE95

Proposed Rule

Stage 146

Stormwater Regulations Revision To Address Discharges From Developed Sites

2040-AF13

Proposed Rule

Stage

Page 79465

147

National Pollutant Discharge Elimination System (NPDES) Permit Regulations for New Dischargers and

2040-AF17

Proposed Rule the Appropriate Use of Offsets With Regard to Water Quality Permitting

Stage 148

Concentrated Animal Feeding Operations (CAFO) Information Collection Request Rule

2040-AF22

Proposed Rule

Stage 149

National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial,

2060-AM44

Final Rule Stage and Institutional Boilers 150

Transport Rule (CAIR Replacement Rule)

2060-AP50

Final Rule Stage 151

Revision to Pb Ambient Air Monitoring Requirements

2060-AP77

Final Rule Stage 152

Reconsideration of the 2008 Ozone Primary and Secondary National Ambient Air Quality Standards

2060-AP98

Final Rule Stage 153

Revisions to Motor Vehicle Fuel Economy Label

2060-AQ09

Final Rule Stage 154

National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial,

2060-AQ25

Final Rule Stage and Institutional Boilers and Process Heaters 155

Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting Program

2070-AJ57

Final Rule Stage 156

Identification of Non-Hazardous Secondary Materials That Are Solid Wastes

2050-AG44

Final Rule Stage

EQUAL EMPLOYMENT OPPORTUNITY COMMISSION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

157

Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act

3046-AA85

Final Rule Stage

Amendments Act

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

158

Office of Government Information Services

3095-AB62

Proposed Rule

Stage 159

Declassification of National Security Information

3095-AB64

Proposed Rule

Stage

SMALL BUSINESS ADMINISTRATION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

160

Small Business Jobs Act: Multiple Award Contracts and Small Business Set-Asides

3245-AG20

Proposed Rule

Stage 161

Small Business Size Regulations; (8)a Business Development/Small Disadvantaged Business Status

3245-AF53

Final Rule Stage

Determination 162

Small Business Jobs Act: 504 Loan Program Debt Refinancing

3245-AG17

Final Rule Stage 163

Small Business Jobs Act: Small Business Intermediary Lending Pilot Program

3245-AG18

Final Rule Stage

SOCIAL SECURITY ADMINISTRATION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

164

Revised Medical Criteria for Evaluating Respiratory System Disorders (859P)

0960-AF58

Proposed Rule

Stage 165

Revised Medical Criteria for Evaluating Hematological Disorders (974P)

0960-AF88

Proposed Rule

Stage

Page 79466

166

Revised Medical Criteria for Evaluating Endocrine System Disorders (436P)

0960-AD78

Final Rule Stage 167

Revised Medical Criteria for Evaluating Mental Disorders (886P)

0960-AF69

Final Rule Stage 168

Reestablishing Uniform National Disability Adjudication Provisions (3502F)

0960-AG80

Final Rule Stage 169

Amendments to Regulations Regarding Major Life-Changing Events Affecting Income-Related Monthly

0960-AH06

Final Rule Stage

Adjustments Amounts to Medicare Part B Premiums (3574F) 170

Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of

0960-AH07

Final Rule Stage

Benefits (3573I)

CONSUMER PRODUCT SAFETY COMMISSION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

171

Testing, Certification, and Labeling of Certain Consumer Products

3041-AC71 Final Rule Stage

NATIONAL INDIAN GAMING COMMISSION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

172

Tribal Background Investigation Submission Requirements and Timing

3141-AA15

Proposed Rule

Stage 173

Class II and Class III Minimum Internal Control Standards

3141-AA27

Proposed Rule

Stage

POSTAL REGULATORY COMMISSION

Regulation

Sequence

Title

Identifier

Rulemaking Stage

Number

174

Periodic Reporting Exceptions

3211-AA06

Final Rule Stage

FR Doc. 2010-30473 Filed 12-17-10;8:45 am

BILLING CODE 6820-27-S

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Agricultural Marketing Service (AMS)

Page 79468

2000 planning rule that is now in effect to the new planning rule that will update planning procedures to reflect contemporary collaborative planning practices.

Marketing and Regulatory Programs. USDA will work to support the organic sector and continue regulatory work to protect the health and value of U.S. agricultural and natural resources. USDA will also implement regulations to enhance enforcement of the Packers and Stockyards Act. In addition,

USDA is working with stakeholders to develop acceptable animal disease traceability standards. Regarding plant health, USDA anticipates revising the permitting of plant pests and biological control organisms. USDA will also amend regulations for importing nursery stock to better address plant health risks associated with propagative material. For the Animal Welfare Act, USDA will propose specific standards for the humane care of birds and dogs imported for resale. USDA will also implement regulations to implement dairy promotion and research provisions of the 2008 Farm Bill.

Reducing Paperwork Burden on Customers

USDA continues to make substantial progress in implementing the goal of the Paperwork Reduction Act of 1995 to reduce the burden of information collection on the public. To meet the requirements of the E-Government

Act, agencies across USDA are providing electronic alternatives to their traditionally paper-based customer transactions. As a result, producers increasingly have the option to electronically file forms and all other documentation online. To facilitate the expansion of electronic government, USDA implemented an electronic authentication capability that allows customers to ``sign-on'' once and conduct business with all USDA agencies. Supporting these efforts are ongoing analyses to identify and eliminate redundant data collections and streamline collection instructions. The end result of implementing these initiatives is better service to our customers, enabling them to choose when and where to conduct business with USDA.

Major Regulatory Priorities

This document represents summary information on prospective significant regulations as called for in Executive Order 12866. The following USDA agencies are represented in this regulatory plan, along with a summary of their mission and key regulatory priorities in 2011:

Food and Nutrition Service

Mission: FNS increases food security and reduces hunger in partnership with cooperating organizations by providing children and low-income people access to food, a healthful diet, and nutrition education in a manner that supports American agriculture and inspires public confidence.

Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS' 2011 regulatory plan supports USDA's goal to ensure that all of

America's children have access to safe, nutritious, and balanced meals:

Increase Access to Nutritious Food. This objective represents

FNS' efforts to improve nutrition by providing access to program benefits (food consumed at home, school meals, commodities) and distributing State administrative funds to support program operations. To advance this objective, FNS plans to publish a proposed rule to codify provisions of the 2008 Farm Bill that expand access to Supplemental

Nutrition Assistance Program (SNAP) benefits and address other eligibility, certification, employment, and training issues. An interim rule implementing provisions of the

Child Nutrition and WIC Reauthorization Act of 2004 to establish automatic eligibility for homeless children for school meals further supports this objective.

Promote Healthy Diet and Physical Activity Behaviors.This objective represents FNS' efforts to improve the diets of its clients through nutrition education, support the national effort to reduce obesity by promoting healthy eating and physical activity, and to ensure that program benefits meet appropriate standards to effectively improve nutrition for program participants. In support of this objective, FNS plans to propose a rule updating the nutrition standards in the school meals programs, finalize a rule updating the WIC food packages, and establish permanent rules for the Fresh Fruit and Vegetable Program, which currently operates in a select number of schools in each State, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands.

Food Safety and Inspection Service

Mission: The Food Safety and Inspection Service (FSIS) is responsible for ensuring that meat, poultry, egg, and catfish products in interstate and foreign commerce are wholesome, not adulterated, and properly marked, labeled, and packaged.

Priorities: FSIS is committed to developing and issuing science-based regulations intended to ensure that meat, poultry, egg, and catfish products are wholesome and not adulterated or misbranded. FSIS regulatory actions support the objective to protect public health by ensuring that food is safe under USDA's goal to ensure access to safe food. To reduce the number of foodborne illnesses and increase program efficiencies, FSIS will continue to review its existing authorities and regulations to ensure that it can address emerging food safety challenges, to streamline excessively prescriptive regulations, and to revise or remove regulations that are inconsistent with the FSIS' hazard analysis and critical control point (HACCP) regulations. FSIS is also working with the Food and Drug Administration (FDA) to improve coordination and increase the effectiveness of inspection activities.

FSIS' priority initiatives are as follows:

Rulemakings that support initiatives of the President's Food

Safety Working Group:

- Poultry Slaughter Inspection. FSIS plans to amend poultry products inspection regulations to put in place a system in which the establishment sorts the carcasses for defects and FSIS verifies that the system is under control and producing safe and wholesome product. FSIS will propose to adopt performance standards designed to ensure that the establishments are carrying out slaughter, dressing, and chilling operations in a manner that ensures no significant growth of pathogens.

- Revision of Egg Products Inspection Regulations. FSIS is planning to propose requirements for federally inspected egg product plants to develop and implement HACCP systems and sanitation standard operating procedures.

FSIS will be proposing pathogen reduction performance standards for egg products and will remove prescriptive requirements for egg product plants.

Initiatives that provide for disclosure or that enable economic growth. FSIS plans to issue two final rules to promote disclosure of information to the public or that provide flexibility for the adoption of new technologies and that promote economic growth:

- Nutrition Labeling of Single-Ingredient Products and Ground or

Page 79469

Chopped Meat and Poultry Products. Regulations have been proposed to require nutrition information on the major cuts of single-ingredient, raw meat and poultry products to appear on the product label or at the point of purchase, unless an exemption applies. These regulations would also require nutrition labeling on all ground or chopped meat or poultry products unless an exemption applies.

- Permission to Use Air Inflation of Meat Carcasses and Parts. FSIS has proposed to revise the Federal meat inspection regulations to permit establishments that slaughter livestock or prepare livestock carcasses and parts to inflate carcasses and parts with air if they develop, implement, and maintain written controls to ensure that the procedure does not cause insanitary conditions or adulterate product. In addition, FSIS has proposed to amend its regulations to remove the approved methods for inflating livestock carcasses and parts by air and the requirement that establishments seek approval from FSIS for inflation procedures not listed in the regulations.

Interstate Shipment of State-Inspected Meat and Poultry

Products. As authorized by the 2008 Farm Bill, FSIS will issue final regulations to implement a new voluntary

Federal-State cooperative inspection program under which

State-inspected establishments with 25 or fewer employees would be eligible to ship meat and poultry products in interstate commerce.

Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments. As authorized by the 2008

Farm Bill, FSIS will issue final regulations that will require establishments that are subject to inspection to promptly notify FSIS when an adulterated or misbranded product received by or originating from the establishment has entered into commerce. The regulations also will require the establishments to prepare and maintain current procedures for the recall of all products produced and shipped by the establishments and to document each reassessment of the establishments' process control plans.

Catfish Inspection. FSIS is developing regulations to implement provisions of the 2008 Farm Bill provisions that make catfish an amenable species under the Federal Meat

Inspection Act (FMIA).

Public Health Information System. To support its food safety inspection activities, FSIS is developing the Public Health

Information System (PHIS). PHIS, which is user-friendly and

Web-based, will replace many of FSIS' current systems and automate many business processes. To facilitate the implementation of some PHIS components, FSIS is proposing to provide for electronic export and import application and certification processes as alternatives to the current paper-based systems for these certifications.

Other planned initiatives. FSIS plans to finalize a February 2001 proposed rule to establish food safety performance standards for all processed ready-to-eat (RTE) meat and poultry products and for partially heat-treated meat and poultry products that are not ready-to-eat. Some provisions of the proposal addressed post-lethality contamination of

RTE products with Listeria monocytogenes. In June 2003,

FSIS published an interim final rule requiring establishments to prevent L. monocytogenes contamination of

RTE products. FSIS has carefully reviewed its economic analysis of the interim final rule and is planning to affirm the interim rule as a final rule with changes.

FSIS small business implications. The great majority of businesses regulated by FSIS are small businesses. Some of the regulations listed above substantially affect small businesses. Some rulemakings can benefit small businesses.

For example, the rule on interstate shipment of State- inspected products will open interstate markets to some small State-inspected establishments that previously could only sell their products within State boundaries.

FSIS conducts a small business outreach program that provides critical training, access to food safety experts, and information resources

(such as compliance guidance and questions and answers on various topics) in forms that are uniform, easily comprehended, and consistent.

FSIS collaborates in this effort with other USDA agencies and cooperating State partners. For example, FSIS makes plant owners and operators aware of loan programs, available through USDA's Rural

Business and Cooperative programs, to help them in upgrading their facilities. FSIS employees meet with small and very small plant operators to learn more about their specific needs and provide joint training sessions for small and very small plants and FSIS employees.

Animal and Plant Health Inspection Service

Mission: A major part of the mission of the Animal and Plant Health

Inspection Service (APHIS) is to protect the health and value of

American agricultural and natural resources. APHIS regulatory actions support USDA's goal of ensuring access to safe, plentiful, and nutritious food by minimizing major diseases and pests that have the potential for reducing agricultural productivity. In support of this goal, APHIS conducts programs to prevent the introduction of exotic pests and diseases into the United States and conducts surveillance, monitoring, control, and eradication programs for pests and diseases in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health. APHIS also conducts programs to ensure the humane handling, care, treatment, and transportation of animals under the Animal Welfare

Act.

Priorities: With respect to animal health, APHIS is working with State and tribal representatives to identify a regulatory approach that will provide national traceability standards for livestock moved interstate while allowing each State and tribe the flexibility to work with their producers to develop standards that will work best for them. In the area of animal welfare, APHIS plans to propose standards for the humane handling, care, treatment, and transportation of birds covered under the Animal Welfare Act and to establish regulations to ensure the humane treatment of dogs imported into the United States for resale.

Regarding plant health, APHIS anticipates publishing a proposed rule that would revise the current regulations governing the permitting of plant pests and biological control organisms. APHIS is also preparing a final rule that will conclude the first phase of its comprehensive revision to its regulations for importing nursery stock (plants for planting) to better address plant health risks associated with propagative material.

Agricultural Marketing Service

Mission: The Agricultural Marketing Service (AMS) provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. The AMS

Page 79470

also manages the government's food purchases, supervises food quality grading, maintains food quality standards, and supervises the Federal research and promotion programs. AMS programs contribute to the achievement of a number of objectives under the Department's goal to assist rural communities to create prosperity and the goal to ensure that all of America's children have access to safe, nutritious, and balanced meals.

Priorities:

National Organic Program (NOP). AMS' priority items for the next year include several rulemakings that impact the organic industry. Statistics indicating rapid growth in the organic sector have highlighted issues that need to be addressed, including:

- Origin of Livestock. On October 24, 2008, NOP published a proposed rule with request for comments on the access to pasture requirements for ruminants. This proposed rule included a change in the origin of livestock requirements for dairy animals under section 205.236 of the NOP regulations. Many of the comments received on the October 2008 proposed rule suggested that the origin of livestock issue should be pursued through a separate rulemaking from access to pasture. As a result, the proposed change to the origin of livestock requirements was not retained in the final rule on access to pasture published on February 17, 2010. AMS plans to develop a proposed rule specific to origin of livestock under the NOP during fiscal year (FY) 2011.

- Periodic Pesticide Residue Testing. The Organic Foods Production Act

(OFPA) of 1990 included language requiring certifying agents to conduct periodic residue testing of organic products produced or handled in accordance with the NOP. This requirement was meant to identify organic products that contained pesticides or other nonorganic residues in violation with the NOP or other applicable laws. In March 2010, an Office of Inspector General (OIG) audit of the NOP suggested that a legal review by the Office of General Counsel (OGC) of the current NOP regulations was needed to assess whether the existing regulations are in compliance with the residue testing requirement under OFPA. As a result of the legal opinion received by the NOP on this issue, AMS will publish a proposed rule on new periodic pesticide residue testing requirements in 2011.

- Streamlining Enforcement Related Actions. The March 2010 Office of

Inspector General (OIG) audit of the NOP raised issues related to the program's process for imposing enforcement actions. One concern was that organic producers and handlers facing revocation or suspension of their certification are able to market their products as organic during what can be a lengthy appeals process. As a result, AMS will publish a proposed rule in 2011 to streamline the NOP appeals process such that appeals are reviewed and responded to in a timely manner.

Dairy Promotion and Research Program (Dairy Import

Assessments). AMS has entered the final stage of establishing the National Dairy Promotion and Research

Program. The Dairy Production Stabilization Act of 1983

(Dairy Act) authorized USDA to create a national producer program for dairy product promotion, research, and nutrition education as part of a comprehensive strategy to increase human consumption of milk and dairy products.

Dairy farmers fund this self-help program through a mandatory assessment on all milk produced in the contiguous 48 States and marketed commercially. Dairy farmers administer the national program through the National Dairy

Promotion and Research Board (Dairy Board).

The 2008 Farm Bill extended the program to include producers in Alaska,

Hawaii, and Puerto Rico, who will pay an assessment of $0.15 per hundredweight of milk production. Imported dairy products will be assessed at $0.075 per hundredweight of fluid milk equivalent. AMS published proposed regulations establishing the program in the May 19, 2009, Federal Register. The proposal had a 30-day comment period. The final rule is expected to be published by the end of 2010.

Grain, Inspection, Packers and Stockyards Administration

Mission: The Grain Inspection, Packers and Stockyards Administration

(GIPSA) facilitates the marketing of livestock, poultry, meat, cereals, oilseeds, and related agricultural products and promotes fair and competitive trading practices for the overall benefit of consumers and

American agriculture.GIPSA's activities contribute significantly to the

Department's goal to increase prosperity in rural areas by supporting a competitive agricultural system.

Priorities: GIPSA intends to issue a final rule that will define practices or conduct that are unfair, unjustly discriminatory, or deceptive, and/or that represent the making or giving of an undue or unreasonable preference or advantage, and ensure that producers and growers can fully participate in any arbitration process that may arise relating to livestock or poultry contracts. This regulation is being finalized in accordance with the authority granted to the Secretary by the Packers and Stockyards Act of 1921 and with the requirements of sections 11005 and 11006 of the 2008 Farm Bill.

Farm Service Agency

Mission: The Farm Service Agency's (FSA) mission is to equitably serve all farmers, ranchers, and agricultural partners through the delivery of effective, efficient agricultural programs, which contributes to two

USDA goals. The goal of assisting rural communities in creating prosperity so they are self-sustaining, re-populating, and economically thriving; and the goal to enhance the Nation's natural resource base by assisting owners and operators of farms and ranches to conserve and enhance soil, water, and related natural resources. It supports the first goal by stabilizing farm income, providing credit to new or existing farmers and ranchers who are temporarily unable to obtain credit from commercial sources, and helping farm operations recover from the effects of disaster. FSA supports the second goal by administering several conservation programs directed toward agricultural producers. The largest program is the Conservation Reserve

Program (CRP), which protects nearly 32 million acres of environmentally sensitive land.

Priorities:

Disaster Assistance. Regulations will be issued to establish a new disaster assistance program, the Emergency Forest

Restoration Program. This program requires new regulations and minor revisions to the existing related Emergency

Conservation Program regulations.

Biomass Crop Assistance Program. Final regulations were published to complete implementation of the Biomass Crop

Assistance Program. This program supports the

Administration's energy initiative to accelerate the investment in and production of biofuels. The program will provide financial assistance to

Page 79471

agricultural and forest land owners and operators to establish and produce eligible crops, including woody biomass, for conversion to bioenergy, and the collection, harvest, storage, and transportation of eligible material for use in a biomass conversion facility.

Farm Loan Programs. FSA will develop and issue regulations to amend programs for farm operating loans, down payment loans, and emergency loans to include socially disadvantaged farmers, increase loan limits, loan size, funding targets, interest rates, and graduating borrowers to commercial credit. In addition, the regulations will establish a new direct and guaranteed loan program to assist farmers in implementing conservation practices.

Forest Service

Mission: The mission of the Forest Service is to sustain the health, productivity, and diversity of the Nation's forests and rangelands to meet the needs of present and future generations. This includes protecting and managing National Forest System lands, providing technical and financial assistance to States, communities, and private forest landowners, and developing and providing scientific and technical assistance and scientific exchanges in support of international forest and range conservation. Forest Service regulatory priorities support the accomplishment of the Department's goal to ensure our National forests are conserved, restored, and made more resilient to climate change, while enhancing our water resources.

Priorities:

Land Management Planning Rule. The Forest Service is required to issue rulemaking for National Forest System land management planning under 16 U.S.C. 1604. The first planning rule was adopted in 1979 and amended in 1982. The

Forest Service published a new planning rule on April 21, 2008 (73 FR 21468). On June 30, 2009, the United States

District Court for the Northern District of California invalidated the Forest Service's 2008 Planning Rule published at 36 CFR 219 based on violations of NEPA and ESA in the rulemaking process. The District Court vacated the 2008 rule, enjoined the USDA from further implementing it, and remanded it to the USDA for further proceedings. USDA has determined that the 2000 planning rule is now in effect, including its transition provisions as amended in 2002 and 2003, and as clarified by interpretative rules issued in 2001 and 2004, which allows the use of the provisions of the 1982 planning rule to amend or revise plans. The Forest Service is now in the 2000 planning rule transition period. The Forest Service is proposing a new planning rule. In so doing, the Forest Service plans to correct deficiencies that have been identified over two decades of forest planning and update planning procedures to reflect contemporary collaborative planning practices.

Community Forest and Open Space Conservation Program. The purpose of the Community Forest Program is to achieve community benefits through financial assistance grants to local governments, tribal governments, and nonprofit organizations to establish community forests by acquiring and protecting private forestlands. Community forest benefits are specified in the authorizing statute and include economic benefits from sustainable forest management, natural resource conservation, forest-based educational programs, model forest stewardship activities, and recreational opportunities.

Closure of NFS Lands to Protect Privacy of Tribal Activities.

There is currently no provision for a special closure of

NFS lands to protect the privacy of tribal activities for traditional and cultural purposes. The Forest Service will amend its regulations to allow special closure of NFS land to protect the privacy of tribal activities for traditional and cultural purposes.

Rural Business-Cooperative Service

Mission: Promoting a dynamic business environment in rural America is the goal of the Rural Business-Cooperative Service (RBS). Business

Programs works in partnership with the private sector and the community-based organizations to provide financial assistance and business planning, and helps fund projects that create or preserve quality jobs and/or promote a clean rural environment. The financial resources are often leveraged with those of other public and private credit source lenders to meet business and credit needs in under-served areas. Recipients of these programs may include individuals, corporations, partnerships, cooperatives, public bodies, nonprofit corporations, Indian tribes, and private companies. The mission of

Cooperative Programs of RBS is to promote understanding and use of the cooperative form of business as a viable organizational option for marketing and distributing agricultural products.

Priorities: In support of the Department's goal to increase the prosperity of rural communities, RBS regulatory priorities will facilitate sustainable renewable energy development and enhance the opportunities necessary for rural families to thrive economically.

RBS's priority will be to publish regulations to fully implement the 2008 Farm Bill. This includes promulgating regulations for the

Biorefinery Assistance Program (sec. 9003), the Repowering Assistance

Program (sec. 9004), the Bioenergy Program for Advanced Biofuels (sec. 9005), and the Rural Microentrepreneur Assistance Program (RMAP). RBS has been administering sections 9003, 9004, and 9005 through the use of

Notices of Funds Availability and Notices of Contract Proposals.

Revisions to the Rural Energy for America Program (sec. 9007) will be made to incorporate Energy Audits and Renewable Energy Development

Assistance and Feasibility Studies for Rural Energy Systems as eligible grant purposes, as well as other Farm Bill initiatives and various technical changes throughout the rule. In addition, revisions to the

Business and Industry Guaranteed Loan Program will be made to implement 2008 Farm Bill provisions and other program initiatives. These rules will minimize program complexity and burden on the public while enhancing program delivery and RBS oversight.

Rural Utilities Service

Mission: The mission of the Rural Utilities Service is to improve the quality of life in rural America by providing investment capital for the deployment of critical rural utilities telecommunications, electric, and water and waste disposal infrastructure. Financial assistance is provided to rural utilities, municipalities, commercial corporations, limited liability companies, public utility districts,

Indian tribes, and cooperative, nonprofit, limited-dividend, or mutual associations. The public-private partnership, which is forged between the Rural Utilities Service (RUS) and these industries, results in billions of dollars in rural infrastructure development and creates thousands of jobs for the American economy.

Priorities: RUS' regulatory priorities will be to achieve the

President's goal to bring affordable broadband to all rural Americans.

To accomplish this, RUS will continue to improve the Broadband Program established by the 2002 Farm

Page 79472

Bill. The 2002 Farm Bill authorized RUS to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. The 2008 Farm Bill is significantly changing the statutory requirements of the Broadband Loan Program. As such, RUS will be issuing an interim rule to implement the statutory changes and will request comments on the section of the rule that was not part of the proposed rule that was published in May 2007. In addition, the regulations will be issued to implement provisions of the American

Recovery and Reinvestment Act that expanded RUS's authority to make loans and provided new authority to make grants to facilitate broadband deployment in rural areas.

Departmental Management

Mission: Departmental Management's mission is to provide management leadership to ensure that USDA administrative programs, policies, advice, and counsel meet the needs of USDA program organizations, consistent with laws and mandates, and provide safe and efficient facilities and services to customers.

Priorities: In support of the Department's goal to increase rural prosperity, USDA's Departmental Management will finalize regulations establishing a program allowing manufacturers and vendors of eligible products made from biobased feedstocks to display the label on their packaging and marketing materials. Once completed, this regulation will implement a section of the 2008 Farm Bill and will promote alternative uses of agriculture and forest materials.

Aggregate Costs and Benefits

USDA will ensure that its regulations provide benefits that exceed costs, but is unable to provide an estimate of the aggregated impacts of its regulations. Problems with aggregation arise due to differing baselines, data gaps, and inconsistencies in methodology and the type of regulatory costs and benefits considered. In addition, aggregation omits benefits and costs that cannot be reliably quantified, such as improved health resulting from increased access to more nutritious foods, higher levels of food safety, and increased quality of life derived from investments in rural infrastructure. Some benefits and costs associated with rules listed in the regulatory plan cannot currently be quantified as the rules are still being formulated. For 2011, the Department's focus will be to implement the changes to programs in such a way as to provide benefits while minimizing program complexity and regulatory burden for program participants.

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 1. WHOLESALE PORK REPORTING PROGRAM

Priority:

Other Significant

Legal Authority: 7 USC 1635 to 1636

CFR Citation: 7 CFR 59

Legal Deadline:

Final, Statutory, March 28, 2012.

With the passage of S. 3656, the Mandatory Price Reporting Act of 2010, the Secretary of Agriculture is required to amend chapter 3 of subtitle

B of the Agricultural Marketing Act of 1946 by adding a new section for mandatory reporting of wholesale pork cuts. To make these amendments, the Secretary was directed to promulgate a final rule no later than one and a half years after the date of the enactment of the Act.

Accordingly, a final rule will be promulgated by March 28, 2012.

Abstract:

On September 15, 2010, Congress passed the Mandatory Price Reporting

Act of 2010 reauthorizing Livestock Mandatory Reporting for 5 years and adding a provision for mandatory reporting of wholesale pork cuts. The

Act was signed by the President on September 28, 2010. Congress directed the Secretary to engage in negotiated rulemaking to make required regulatory changes for mandatory wholesale pork reporting.

Further, Congress required that the negotiated rulemaking committee include representatives from (i) organizations representing swine producers; (ii) organizations representing packers of pork, processors of pork, retailers of pork, and buyers of wholesale pork; (iii) the

Department of Agriculture; and (iv) among interested parties that participate in swine or pork production.

Statement of Need:

Implementation of mandatory pork reporting is required by Congress.

Congress delegated responsibility to the Secretary for determining what information is necessary and appropriate. The Food, Conservation, and

Energy Act of 2008 (Pub. L. 110-234) directed the Secretary to conduct a study to determine advantages, drawbacks, and potential implementation issues associated with adopting mandatory wholesale pork reporting. The report from this study generally concluded that voluntary wholesale pork price reporting is thin and becoming thinner, and some degree of support for moving to mandatory price reporting exists at every segment of the industry interviewed. The report was delivered to Congress on March 25, 2010.

Summary of Legal Basis:

Livestock Mandatory Reporting is authorized under the Agricultural

Marketing Act (7 U.S.C. 1635 to 1636). The Livestock and Seed Program of USDA's Agricultural Marketing Service has day-to-day responsibility for collecting and disseminating LMR data.

Alternatives:

There are no alternatives, as this rulemaking is a matter of law based on the Mandatory Price Reporting Act of 2010.

Anticipated Cost and Benefits:

Estimation of costs will follow the previous methodology used in earlier Livestock Mandatory Reporting rulemaking. The focus of the cost estimation is the burden placed on reporting companies in providing pork marketing data to the Livestock and Seed Program. Previous rulemaking cost estimates of boxed beef reporting of similar data found the burden to be an annual total of 65 hours in additional reporting requirements per firm. Because no official USDA grade standards are used in the marketing of pork, and fewer cutting styles, the burden for pork reporting firms in comparison with beef reporting firms could be lower. However, the impact is not truly known at this stage.

Timetable:

Action

Date

FR Cite

Notice

12/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Page 79473

Agency Contact:

Warren Preston

Department of Agriculture

Agricultural Marketing Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-6231

Fax: 202 690-3732

Email: warren.preston@usda.gov

RIN: 0581-AD07

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--AMS

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 2. NATIONAL DAIRY PROMOTION AND RESEARCH PROGRAM; DAIRY IMPORT

ASSESSMENTS, DA-08-0050

Priority:

Other Significant

Legal Authority: 7 USC 4501 to 4514; 7 USC 7401

CFR Citation: 7 CFR 1150

Legal Deadline:

Final, Statutory, September 19, 2008, Assessments on imported dairy products must be implemented by deadline.

With the passage of section 1507 in the 2008 Farm Bill, the Dairy Act was amended to apply certain assessments to Alaska, Hawaii, the

District of Columbia, and the Commonwealth of Puerto Rico. The 2008

Farm Bill authorized the Secretary to issue regulations to implement the mandatory dairy import assessment without providing a notice and comment period. However, due to the interest of affected parties, a notice and comment period was provided.

Abstract:

The Dairy Act authorizes the Order for dairy product promotion, research, and nutrition education as part of a comprehensive strategy to increase human consumption of milk and dairy products and to reduce milk surpluses. The program functions to strengthen the dairy industry's position in the marketplace by maintaining and expanding domestic and foreign consumption of fluid milk and dairy products.

Amendments to the Order are pursuant to the 2002 and 2008 Farm Bills.

The 2002 Farm Bill mandates that the Order be amended to implement an assessment on imported dairy products to fund promotion and research.

The 2008 Farm Bill specifies a mandatory assessment rate of 7.5-cent per hundredweight of milk, or equivalent thereof, on dairy products imported into the United States. Additionally, in accordance with the 2008 Farm Bill, the term ``United States'' is the Dairy Act is amended to mean all States, the District of Columbia, and the Commonwealth of

Puerto Rico. Producers in these areas will be assessed 15 cents per hundredweight for all milk produced and marketed.

Statement of Need:

In response to the May 19, 2009 (74 FR 23359), proposed rule (National

Dairy Promotion and Research Program; Proposed Rule on Amendments to the Order), AMS received 189 timely comments from consumers, dairy producers, foreign governments, importers, exporters, manufacturers, members of Congress, trade associations, and other interested parties.

The comments covered a wide range of topics, including 39 in opposition to the proposal and 150 in support of the proposal. Opponents of the proposal expressed concern over the lack of a referendum requirement among those affected; default assessment rates; lack of ability to no longer promote State-branded dairy products; lack of importer organizations eligible to become a Qualified Program; disputed the cost-benefit analysis for importers and producers; and cited unreasonable importer paperwork and record keeping burdens.

Proponents of the proposal expressed support for an expedited implementation of the dairy import assessment; cited the enhanced benefits both domestic producers and importers will receive as a result of implementation; recommended new Harmonized Tariff Schedule codes; use of a default assessment rate; recommended regular reporting of the products and assessments on imports; and all thresholds for compliance with U.S. trade obligations have been met.

AMS plans to issue a final rule implementing the dairy import assessment in the near future. In response to the comments received and after consultation with USTR, AMS is addressing, in the final rule, referenda, alternative assessment rates, and compliance and enforcement activity. All remaining changes are miscellaneous and minor in nature in order to clarify regulatory text.

Summary of Legal Basis:

The National Dairy Promotion and Research Program (National Program) is authorized under the authorized under the provisions of the Dairy

Production Stabilization Act of 1983 (7 U.S.C. 4501 to 4514), and the

Dairy Promotion and Research Order (7 CFR part 1150). The Dairy

Programs unit of USDA's Agricultural Marketing Service has day--to--day oversight responsibilities for the National Program.

Alternatives:

There are no alternatives, as this rulemaking is a matter of law based on the 2002 and 2008 Farm Bills.

Anticipated Cost and Benefits:

Assessments to dairy producers under the Order are relatively small compared to producer revenue. If dairy producers in Alaska, Hawaii, the

District of Columbia, and the Commonwealth of Puerto Rico had paid assessments of $0.15 per hundredweight of milk marketed in 2007, it is estimated that $1.1 million would have been paid. This is about 0.6 percent of the $192 million total value of milk produced and marketed in these areas.

Benefits to producers in these areas are assumed to be similar to those benefits received by producers of other U.S. geographical regions.

Cornell University has conducted an independent economic analysis of the Program that is included in the annual report to Congress. Cornell determined that from 1998 through 2007, each dollar invested in generic dairy marketing by dairy farmers during the period would return between

$5.52 and $5.94, on average, in net revenue to farmers.

Assessments collected from importers under the National Program will be relatively small compared to the value of dairy imports. If importers had been assessed $0.075 per hundredweight, or equivalent thereof, for imported dairy products in 2007 as specified in this rule, it is estimated that less than $6.1 million would have been paid. This is about 0.3 percent of the $2.4 billion value of the dairy products imported in 2007.

Risks:

If the amendments are not implemented, USDA would be in violation of the 2002 and 2008 Farm Bills.

Timetable:

Action

Date

FR Cite

NPRM

05/19/09

74 FR 23359

Page 79474

NPRM Comment Period End

06/18/09

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

None

Agency Contact:

Whitney Rick

Promotion and Research Branch Chief

Department of Agriculture

Agricultural Marketing Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-6909

Fax: 202 720-0285

Email: whitney.rick@usda.gov

RIN: 0581-AC87

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Animal and Plant Health Inspection Service (APHIS)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 3. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS

Priority:

Other Significant

Legal Authority: 7 USC 2131 to 2159

CFR Citation: 9 CFR 1 to 3

Legal Deadline:

None

Abstract:

APHIS intends to establish standards for the humane handling, care, treatment, and transportation of birds other than birds bred for use in research.

Statement of Need:

The Farm Security and Rural Investment Act of 2002 amended the definition of animal in the Animal Welfare Act (AWA) by specifically excluding birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research. While the definition of animal in the regulations contained in 9 CFR part 1 has excluded rats of the genus

Rattus and mice of the genus Mus bred for use in research, that definition has also excluded all birds (i.e., not just those birds bred for use in research). In line with this change to the definition of animal in the AWA, APHIS intends to establish standards in 9 CFR part 3 for the humane handling, care, treatment, and transportation of birds other than those birds bred for use in research and to revise the regulations in 9 CFR parts 1 and 2 to make them applicable to birds.

Summary of Legal Basis:

The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to promulgate standards and other requirements governing the humane handling, care, treatment, and transportation of certain animals by dealers, research facilities, exhibitors, operators of auction sales, and carriers and immediate handlers. Animals covered by the AWA include birds that are not bred for use in research.

Alternatives:

To be identified.

Anticipated Cost and Benefits:

To be determined.

Risks:

Not applicable.

Timetable:

Action

Date

FR Cite

NPRM

08/00/11

NPRM Comment Period End

11/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Undetermined

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Johanna Briscoe

Veterinary Medical Officer and Avian Specialist, Animal Care

Department of Agriculture

Animal and Plant Health Inspection Service 4700 River Road, Unit 84

Riverdale, MD 20737-1234

Phone: 301 734-0658

RIN: 0579-AC02

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 4. PLANT PEST REGULATIONS; UPDATE OF GENERAL PROVISIONS

Priority:

Other Significant

Legal Authority: 7 USC 450; 7 USC 2260; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 7 USC 8301 to 8817; 19 USC 136; 21 USC 111; 21 USC 114a; 21 USC 136 and 136a; 31 USC 9701; 42 USC 4331 to 4332

CFR Citation: 7 CFR 318 to 319; 7 CFR 330; 7 CFR 352

Legal Deadline:

None

Abstract:

We are proposing to revise our regulations regarding the movement of plant pests. We are proposing to regulate the movement of not only plant pests, but also biological control organisms and associated articles. We are proposing risk-based criteria regarding the movement of biological control organisms, and are proposing to exempt certain types of plant pests from permitting requirements for their interstate movement and movement for environmental release. We are also proposing to revise our regulations regarding the movement of soil, and to establish regulations governing the biocontainment facilities in which plant pests, biological control organisms, and associated articles are held. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations.

Statement of Need:

APHIS is preparing a proposed rule to revise its regulations regarding the movement of plant pests. The revised regulations would address the importation and interstate movement of plant pests, biological control organisms, and associated articles and the release into the environment of biological control organisms. The revision would also address the movement of soil and establish regulations governing the biocontainment facilities in which

Page 79475

plant pests, biological control organisms, and associated articles are held. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms, facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture, and address gaps in the current regulations.

Summary of Legal Basis:

Under section 411(a) of the Plant Protection Act (PPA), no person shall import, enter, export, or move in interstate commerce any plant pest, unless the importation, entry, exportation, or movement is authorized under a general or specific permit and in accordance with such regulations as the Secretary of Agriculture may issue to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States.

Under section 412 of the PPA, the Secretary may restrict the importation or movement in interstate commerce of biological control organisms by requiring the organisms to be accompanied by a permit authorizing such movement and by subjecting the organisms to quarantine conditions or other remedial measures deemed necessary to prevent the spread of plant pests or noxious weeds. That same section of the PPA also gives the Secretary explicit authority to regulate the movement of associated articles.

Alternatives:

The alternatives we considered were taking no action at this time or implementing a comprehensive risk reduction plan. This latter alternative would be characterized as a broad risk mitigation strategy that could involve various options such as increased inspection, regulations specific to a certain organism or group of related organisms, or extensive biocontainment requirements.

We decided against the first alternative because leaving the regulations unchanged would not address the needs identified immediately above. We decided against the latter alternative, because available scientific information, personnel, and resources suggest that it would be impracticable at this time.

Anticipated Cost and Benefits:

Undetermined at this time.

Risks:

Unless we issue such a proposal, the regulations will not provide a clear protocol for obtaining permits that authorize the movement and environmental release of biological control organisms. This, in turn, could impede research to explore biological control options for various plant pests and noxious weeds known to exist within the United States, and could indirectly lead to the further dissemination of such pests and weeds.

Moreover, unless we revise the soil regulations, certain provisions in the regulations will not adequately address the risk to plants, plant parts, and plant products within the United States that such soil might present.

Timetable:

Action

Date

FR Cite

Notice of Intent to

Prepare an

Environmental Impact

Statement

10/20/09

74 FR 53673

Notice Comment Period End

11/19/09

NPRM

01/00/11

NPRM Comment Period End

03/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

Local, State, Tribal

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Shirley Wager-Page

Chief, Pest Permitting Branch, Plant Health Programs, PPQ

Department of Agriculture

Animal and Plant Health Inspection Service 4700 River Road, Unit 131

Riverdale, MD 20737-1236

Phone: 301 734-8453

RIN: 0579-AC98

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 5. IMPORTATION OF LIVE DOGS

Priority:

Other Significant

Legal Authority: 7 USC 2148

CFR Citation: 9 CFR 1 and 2

Legal Deadline:

None

Abstract:

This rulemaking would amend the Animal Welfare Act (AWA) regulations to regulate dogs imported for resale as required by a recent amendment to the AWA. Importation of dogs for resale would be prohibited unless the dogs are in good health, have all necessary vaccinations, and are 6 months of age or older. This proposal will also reflect the exemptions provided in the amendment to the AWA for dogs imported for research purposes or veterinary treatment and for dogs legally imported into the

State of Hawaii from the British Isles, Australia, Guam, or New

Zealand.

Statement of Need:

The Food, Conservation, and Energy Act of 2008 mandates that the

Secretary of Agriculture promulgate regulations to implement and enforce new provisions of the Animal Welfare Act (AWA) regarding the importation of dogs for resale. In line with the changes to the AWA,

APHIS intends to amend the regulations in 9 CFR parts 1 and 2 to regulate the importation of dogs for resale.

Summary of Legal Basis:

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, signed into law on June 18, 2008) added a new section to the Animal Welfare

Act (7 U.S.C. 2147) to restrict the importation of live dogs for resale. As amended, the AWA now prohibits the importation of dogs into the United States for resale unless the Secretary of Agriculture determines that the dogs are in good health, have received all necessary vaccinations, and are at least 6 months of age. Exceptions are provided for dogs imported for research purposes or veterinary treatment. An exception to the 6-month age requirement is also provided for dogs that are lawfully imported into Hawaii for resale purposes from the British Isles, Australia, Guam, or New Zealand in compliance with the applicable regulations of Hawaii, provided the dogs are vaccinated, are in good health, and are not transported out of Hawaii for resale purposes at less than 6 months of age.

Page 79476

Alternatives:

To be identified.

Anticipated Cost and Benefits:

To be determined.

Risks:

Not applicable.

Timetable:

Action

Date

FR Cite

NPRM

12/00/10

NPRM Comment Period End

02/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

None

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Gerald Rushin

Veterinary Medical Officer, Animal Care

Department of Agriculture

Animal and Plant Health Inspection Service 4700 River Road, Unit 84

Riverdale, MD 20737-1234

Phone: 301 734-0954

RIN: 0579-AD23

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 6. ANIMAL DISEASE TRACEABILITY

Priority:

Other Significant

Legal Authority: 7 USC 8305

CFR Citation: 9 CFR 90

Legal Deadline:

None

Abstract:

This rulemaking would establish a new part in the Code of Federal

Regulations containing general identification and documentation requirements for livestock moving interstate. The purpose of the new regulations is to improve our ability to trace livestock in the event that disease is found. The regulations will provide national traceability standards for livestock moved interstate and allow each

State and tribe the flexibility to develop ways of meeting the standards that will work best for them.

Statement of Need:

Preventing and controlling animal disease is the cornerstone of protecting American animal agriculture. While ranchers and farmers work hard to protect their animals and their livelihoods, there is never a guarantee that their animals will be spared from disease. To support their efforts, USDA has enacted regulations to prevent, control, and eradicate disease, and to increase foreign and domestic confidence in the safety of animals and animal products. Traceability helps give that reassurance. Traceability does not prevent disease, but knowing where diseased and at-risk animals are, where they have been, and when, is indispensable in emergency response and in ongoing disease programs.

The primary objectives of these proposed regulations are to improve our ability to trace livestock in the event that disease is found and to provide national standards to ensure the smooth flow of livestock in interstate commerce, while also allowing States and tribes the flexibility to develop systems for tracing animals within their State and tribal lands that work best for them.

Summary of Legal Basis:

Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the

Secretary of Agriculture may prohibit or restrict the interstate movement of any animal to prevent the introduction or dissemination of any pest or disease of livestock, and may carry out operations and measures to detect, control, or eradicate any pest or disease of livestock. The Secretary may promulgate such regulations as may be necessary to carry out the Act.

Alternatives:

As part of its ongoing efforts to safeguard animal health, APHIS initiated implementation of the National Animal Identification System

(NAIS) in 2004. More recently, the Agency launched an effort to assess the level of acceptance of NAIS through meetings with the Secretary, listening sessions in 14 cities, and public comments. Although there was some support for NAIS, the vast majority of participants were highly critical of the program and of USDA's implementation efforts.

The feedback revealed that NAIS has become a barrier to achieving meaningful animal disease traceability in the United States in partnership with America's producers.

The option we are proposing pertains strictly to interstate movement and gives States and tribes the flexibility to identify and implement the traceability approaches that work best for them.

Anticipated Cost and Benefits:

A workable and effective animal traceability system would enhance animal health programs, leading to more secure market access and other societal gains. Traceability can reduce the cost of disease outbreaks, minimizing losses to producers and industries by enabling current and previous locations of potentially exposed animals to be readily identified. Trade benefits can include increased competitiveness in global markets generally, and when outbreaks do occur, the mitigation of export market losses through regionalization. Markets benefit through more efficient and timely epidemiological investigation of animal health issues. Other societal benefits include improved animal welfare during natural disasters.

Costs of an animal traceability system would include those for tags and tagging and would vary, depending on the method of identification chosen (e.g., metal tags vs. microchip implants). Costs are expected to vary by both type of operation and whether traceability would be by individual animal or by lot or group. Per head costs of traceability programs for the principal farm animals are estimated to be highest for cattle operations, followed by sheep, swine, and poultry operations.

Larger operations would likely reap economies of scale, that is, incur lower costs per head than smaller operations. However, there will be exemptions for small producers who raise animals to feed themselves, their families, and their immediate neighbors. In addition, only operations moving livestock interstate would be required to comply with the regulations.

Risks:

This rulemaking is being undertaken to address the animal health risks posed by gaps in the existing regulations concerning identification of livestock being moved interstate. The current lack of a comprehensive animal traceability program is impairing our ability to trace animals that may be affected with disease.

Page 79477

Timetable:

Action

Date

FR Cite

NPRM

04/00/11

NPRM Comment Period End

06/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

State, Tribal

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Neil Hammerschmidt

NAIS Coordinator, Surveillance and Identification Programs, NCAHP, VS

Department of Agriculture

Animal and Plant Health Inspection Service 4700 River Road, Unit 200

Riverdale, MD 20737-1231

Phone: 301 734-5571

RIN: 0579-AD24

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--APHIS

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 7. IMPORTATION OF PLANTS FOR PLANTING; ESTABLISHING A NEW CATEGORY OF

PLANTS FOR PLANTING NOT AUTHORIZED FOR IMPORTATION PENDING PEST RISK

ANALYSIS (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)

Priority:

Other Significant

Legal Authority: 7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 21 USC 136 and 136a

CFR Citation: 7 CFR 319

Legal Deadline:

None

Abstract:

This rulemaking will amend the regulations to establish a new category of regulated articles in the regulations governing the importation of nursery stock, also known as plants for planting. This category will list taxa of plants for planting whose importation is not authorized pending pest risk analysis. If scientific evidence indicates that a taxon of plants for planting is a quarantine pest or a host of a quarantine pest, we will publish a notice that will announce our determination that the taxon is a quarantine pest or a host of a quarantine pest, cite the scientific evidence we considered in making this determination, and give the public an opportunity to comment on our determination. If we receive no comments that change our determination, the taxon will subsequently be added to the new category. We will allow any person to petition for a pest risk analysis to be conducted for a taxon that has been added to the new category.

After the pest risk analysis is completed, we will remove the taxon from the category and allow its importation subject to general requirements, allow its importation subject to specific restrictions, or prohibit its importation. We will consider applications for permits to import small quantities of germplasm from taxa whose importation is not authorized pending pest risk analysis, for experimental or scientific purposes under controlled conditions. This new category will allow us to take prompt action on evidence that the importation of a taxon of plants for planting poses a risk while continuing to allow for public participation in the process.

Statement of Need:

APHIS typically relies on inspection at a Federal plant inspection station or port of entry to mitigate the risks of pest introduction associated with the importation of plants for planting. Importation of plants for planting is further restricted or prohibited only if there is specific evidence that such importation could introduce a quarantine pest into the United States. Most of the taxa of plants for planting currently being imported have not been thoroughly studied to determine whether their importation presents a risk of introducing a quarantine pest into the United States. The volume and the number of types of plants for planting have increased dramatically in recent years, and there are several problems associated with gathering data on what plants for planting are being imported and on the risks such importation presents. In addition, quarantine pests that enter the

United States via the importation of plants for planting pose a particularly high risk of becoming established within the United

States. The current regulations need to be amended to better address these risks.

Summary of Legal Basis:

The Secretary of Agriculture may prohibit or restrict the importation or entry of any plant if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United

States of a plant pest or noxious weed (7 U.S.C. 7712).

Alternatives:

APHIS has identified one alternative to the approach we are considering. We could prohibit the importation of all nursery stock pending risk evaluation, approval, and notice-and-comment rulemaking, similar to APHIS' approach to regulating imported fruits and vegetables. This approach would lead to a major interruption in international trade and would have significant economic effects on both

U.S. importers and U.S. consumers of plants for planting.

Anticipated Cost and Benefits:

Undetermined.

Risks:

In the absence of some action to revise the nursery stock regulations to allow us to better address pest risks, increased introductions of plant pests via imported nursery stock are likely, causing extensive damage to both agricultural and natural plant resources.

Timetable:

Action

Date

FR Cite

NPRM

07/23/09

74 FR 36403

NPRM Comment Period End

10/21/09

Final Rule

12/00/10

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Page 79478

Agency Contact:

Arnold T. Tschanz

Senior Plant Pathologist, Risk Management and Plants for Planting

Policy, RPM, PPQ

Department of Agriculture

Animal and Plant Health Inspection Service 4700 River Road, Unit 133

Riverdale, MD 20737-1231

Phone: 301 734-0627

RIN: 0579-AC03

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Rural Housing Service (RHS)

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 8. MULTI-FAMILY HOUSING (MFH) REINVENTION

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 5 USC 301; 42 USC 1490a; 7 USC 1989; 42 USC 1475; 42 USC 1479; 42 USC 1480; 42 USC 1481; 42 USC 1484; 42 USC 1485; 42 USC 1486

CFR Citation: 7 CFR 1806; 7 CFR 1822; 7 CFR 1902; 7 CFR 1925; 7 CFR 1930; 7 CFR 1940; 7 CFR 1942; 7 CFR 1944; 7 CFR 1951; 7 CFR 1955; 7 CFR 1956; 7 CFR 1965; 7 CFR 3560; 7 CFR 3565

Legal Deadline:

None

Abstract:

The Rural Housing Service has consolidated and streamlined the regulations pertaining to section 515 Rural Rental Housing, section 514

Farm Labor Housing Loans, section 516 Farm Labor Housing Grants, and section 521 Rental Assistance Payments. Fourteen published regulations have been reduced to one regulation and handbooks for program administration. This will simplify loan origination and portfolio management for applicants, borrowers, and housing operators, as well as

Rural Development field staff. This also provides flexibility for program modifications to reflect current and foreseeable changes. The consolidated regulations save time and simplify costs. Finally, the regulation is more customer friendly and responsive to the needs of the public.

Statement of Need:

The new regulation for the program known as the Multi-Family Housing

Loan and Grant Programs will be more user-friendly for lenders, borrowers, and Agency staff. These changes are essential to allow for improved service to the public and for an expanded program with increased impact on rural housing opportunities without a corresponding expansion in Agency staff. The regulations will be shorter, better organized, and more simple and clear. Many documentation requirements will be eliminated or consolidated into more convenient formats.

Summary of Legal Basis:

The existing statutory authority for the MFH programs was established in title V of the Housing Act of 1949, which gave authority to the RHS

(then the Farmers Home Administration) to make housing loans to farmers. As a result of this Act, the Agency established single-family and multi-family housing programs. Over time, the sections of the

Housing Act of 1949 addressing MFH have been amended a number of times.

Amendments have involved issues such as the provision of interest credit, broadening definitions of eligible areas and populations to be served, participation of limited profit entities, the establishment of a rental assistance program, and the imposition of a number of restrictive use provisions and prepayment restrictions.

Alternatives:

To not publish the rule would substantially restrict RHS' ability to effectively administer the programs and cost the Agency significant credibility with the public and oversight organizations.

Anticipated Cost and Benefits:

Based on analysis of the proposed rule, the following impacts may occur, some of which could be considered significant:

There would be cost savings due to reduced paperwork, estimated to be about $1.8 million annually for the public and about $10.1 million for the Government.

Risks:

Without the streamlining, there will be a decrease in the ability of the Agency to provide safe, decent, and sanitary housing to program beneficiaries.

Timetable:

Action

Date

FR Cite

NPRM

06/02/03

68 FR 32872

NPRM Comment Period End

08/01/03

Interim Final Rule

11/26/04

69 FR 69032

Interim Final Rule

Comment Period End

12/27/04

Interim Final Rule

Effective

02/22/05

70 FR 8503

Final Action

10/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

Agency Contact:

Laurence Anderson

MFH Preservation and Direct Loans

Department of Agriculture

Rural Housing Service

STOP 0781 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-1611

Email: laurence.anderson@wdc.usda.gov

Related RIN: Merged with 0575-AC24

RIN: 0575-AC13

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Grain Inspection, Packers and Stockyards Administration (GIPSA)

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 9. ENFORCEMENT OF THE PACKERS AND STOCKYARDS ACT

Priority:

Other Significant

Legal Authority: 7 USC 181

CFR Citation: 9 CFR 201

Legal Deadline:

Final, Statutory, June 18, 2010.

Abstract:

GIPSA is proposing regulations under the Packers and Stockyards Act, 1921, that clarify when certain conduct in the livestock and poultry industries represents the making or giving of an undue or unreasonable preference or advantage or subjects a person or locality to an undue or unreasonable prejudice or disadvantage. These proposed regulations also establish criteria GIPSA will consider in determining whether a live poultry

Page 79479

dealer has provided reasonable notice to poultry growers of any suspension of the delivery of birds under a poultry growing arrangement; when a requirement of additional capital investments over the life of a poultry growing arrangement or swine production contract constitutes a violation of the P&S Act; and whether a live poultry dealer or swine contractor has provided a reasonable period of time for a poultry grower or a swine production contract grower to remedy a breach of contract that could lead to termination of the poultry growing arrangement or swine production contract. The Farm Bill also instructed the Secretary to promulgate regulations to ensure that producers and growers are afforded the opportunity to fully participate in the arbitration process if they so choose.

Statement of Need:

In enacting title XI of the Food, Conservation, and Energy Act of 2008

(Farm Bill) (Pub. L. 110-246), Congress recognized the nature of problems encountered in the livestock and poultry industries and amended the Packers and Stockyards Act (P&S Act). These amendments established new requirements for participants in the livestock and poultry industries and required the Secretary of Agriculture

(Secretary) to establish criteria to consider when determining that certain other conduct is in violation of the P&S Act.

The Grain Inspection, Packers and Stockyards Administration's (GIPSA) attempts to enforce the broad prohibitions of the P&S Act have been frustrated, in part because it has not previously defined what conduct constitutes an unfair practice or the giving of an undue preference or advantage. The new regulations that GIPSA is proposing describe and clarify conduct that violates the P&S Act and allow for more effective and efficient enforcement by GIPSA. They will clarify conditions for industry compliance with the P&S Act and provide for a fairer market place.

In accordance with the Farm Bill, GIPSA is proposing regulations under the P&S Act that would clarify when certain conduct in the livestock and poultry industries represents the making or giving of an undue or unreasonable preference or advantage or subjects a person or locality to an undue or unreasonable prejudice or disadvantage. These proposed regulations also establish criteria that GIPSA will consider in determining whether a live poultry dealer has provided reasonable notice to poultry growers of a suspension of the delivery of birds under a poultry growing arrangement; when a requirement of additional capital investments over the life of a poultry growing arrangement or swine production contract constitutes a violation of the P&S Act; and whether a packer, swine contractor or live poultry dealer has provided a reasonable period of time for a grower or a swine producer to remedy a breach of contract that could lead to termination of the growing arrangement or production contract.

The Farm Bill also instructed the Secretary to promulgate regulations to ensure that poultry growers, swine production contract growers and livestock producers are afforded the opportunity to fully participate in the arbitration process, if they so choose. We are proposing a required format for providing poultry growers, swine production contract growers, and livestock producers the opportunity to decline the use of arbitration in contracts requiring arbitration. We are also proposing criteria that we will consider in finding that poultry growers, swine production contract growers, and livestock producers have a meaningful opportunity to participate fully in the arbitration process if they voluntarily agree to do so. We will use these criteria to assess the overall fairness of the arbitration process.

In addition to proposing regulations in accordance with the Farm Bill,

GIPSA is proposing regulations that would prohibit certain conduct because it is unfair, unjustly discriminatory or deceptive, in violation of the P&S Act. These additional proposed regulations are promulgated under the authority of section 407 of the P&S Act and complement those required by the Farm Bill to help ensure fair trade and competition in the livestock and poultry industries.

These regulations are intended to address the increased use of contracting in the marketing and production of livestock and poultry by entities under the jurisdiction of the P&S Act, and practices that result from the use of market power and alterations in private property rights, which violate the spirit and letter of the P&S Act. The effect increased contracting has had, and continues to have, on individual agricultural producers has significantly changed the industry and the rural economy as a whole, making these proposed regulations necessary.

Summary of Legal Basis:

Section 407 of the P&S Act (7 U.S.C. 228) provides that the Secretary

``may make such rules, regulations, and orders as may be necessary to carry out the provisions of this Act.'' Sections 11005 and 11006 of the

Farm Bill became effective June 18, 2008, and instruct the Secretary to promulgate additional regulations as described in this notice of proposed rulemaking.

Alternatives:

The Farm Bill explicitly directs the Secretary to promulgate certain regulations. GIPSA determined that additional regulations are necessary to provide notice to all regulated entities of types of practices and conduct that GIPSA considers ``unfair'' so that regulated entities are fully informed of actions or practices that are considered ``unfair'' and, therefore, prohibited. Within both the mandatory and discretionary regulatory provisions, we considered alternative options.

For example, GIPSA considered shorter notice periods in situations when a live poultry dealer suspends delivery of birds to a poultry grower.

These alternatives would not have provided adequate trust and integrity in the livestock and poultry markets. Other alternatives may have been more restrictive. We considered prohibiting the use of arbitration to resolve disputes; however, that option goes against a popular method of dispute resolution in other industries and is not in line with the spirit of the 2008 Farm Bill. GIPSA believes that this proposed rule represents the best option to level the playing field between packers, swine contractors, live poultry dealers, and the Nation's poultry growers, swine production contract growers, or livestock producers for the benefit of more efficient marketing and public good.

Anticipated Cost and Benefits:

Costs:

Costs are aggregated into three major types: 1) Administrative costs, which include items such as office work, postage, filing, and copying; 2) costs of analysis, such as a business conducting a profit-loss analysis; and 3) adjustment costs, such as costs related to changing business behavior to achieve compliance with the proposed regulation.

Benefits:

Benefits are also aggregated into three major groups: 1) Increased pricing

Page 79480

efficiency; 2) allocation efficiency; and 3) competitive efficiency.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

06/22/10

75 FR 35338

NPRM Comment Period End

08/23/10

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

H. Tess Butler

Regulatory Liaison

Department of Agriculture

Grain Inspection, Packers and Stockyards Administration 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-7486

Fax: 202 690-2173

Email: h.tess.butler@usda.gov

RIN: 0580-AB07

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Food and Nutrition Service (FNS)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 10. ELIGIBILITY, CERTIFICATION, AND EMPLOYMENT AND TRAINING PROVISIONS

OF THE FOOD, CONSERVATION, AND ENERGY ACT OF 2008

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

PL 110-246; PL 104-121

CFR Citation: 7 CFR 273

Legal Deadline:

None

Abstract:

This proposed rule would amend the regulations governing the

Supplemental Nutrition Assistance Program (SNAP) to implement provisions from the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246) (FCEA) concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this proposed rule would revise the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food

Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. Food and Nutrition Service (FNS) is also proposing two discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers.

These provisions would allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule would impact the associated paperwork burdens (08-006).

Statement of Need:

This proposed rule would amend the regulations governing SNAP to implement provisions from the FCEA concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this proposed rule would revise the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. FNS is also proposing 2 discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions would allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule would impact the associated paperwork burdens.

Summary of Legal Basis:

Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246).

Alternatives:

Because this proposed rule is under development, alternatives are not yet articulated. The rule would implement statutory requirements set forth by the Food, Conservation, and Energy Act of 2008 concerning SNAP eligibility and certification rules.

Anticipated Cost and Benefits:

FNS is currently developing estimates of the anticipated costs and benefits of this rule. Anticipated principle effects would be on paperwork burdens.

Risks:

The statutory changes and discretionary ones under consideration would streamline program operations. The changes are expected to reduce the risk of inefficient operations.

Timetable:

Action

Date

FR Cite

NPRM

01/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service 10th Floor 3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: james.herbert@fns.usda.gov

RIN: 0584-AD87

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 11. SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM: FARM BILL OF 2008

RETAILER SANCTIONS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

PL 110-246

CFR Citation: 7 CFR 276

Legal Deadline:

None

Abstract:

This proposed rule would implement provisions under section 4132 of the

Food, Conservation, and Energy Act of 2008, also referred to as the

Farm Bill of 2008. Under section 4132, the Department of Agriculture's

Food and Nutrition Service (FNS) is provided with greater authority and flexibility when sanctioning retail or wholesale food stores that violate Supplemental Nutrition Assistance Program (SNAP) rules.

Specifically, the Department is authorized to assess a civil penalty and to disqualify a retail or wholesale food

Page 79481

store authorized to participate in SNAP. Previously, the Department could assess a civil penalty or disqualification, but not both. Section 4132 also eliminates the minimum disqualification period which was previously set at 6 months.

In addition to implementing statutory provisions, this rule proposes to provide a clear administrative penalty when an authorized retailer or wholesale food store redeems a SNAP participant's Program benefits without the knowledge of the participant. All Program benefits are issued through the Electronic Benefits Transfer (EBT) system. The EBT system establishes data that may be used to identify fraud committed by retail food stores. While stealing Program benefits could be prosecuted under current statute, Program regulations do not provide a clear penalty for these thefts. The proposed rule would establish an administrative penalty for such thefts equivalent to the penalty for trafficking in Program benefits, which is the permanent disqualification of a retailer or wholesale food store from SNAP participation.

Finally, the Department proposes to identify additional administrative retail violations and the associated sanction that would be imposed against the retail food store for committing the violation. For instance, to maintain integrity, FNS requires retail and wholesale food stores to key enter EBT card data in the presence of the actual EBT card.

The proposed rule would codify this requirement and identify the specific sanction that would be imposed if retail food stores are found to be in violation (08-007).

Statement of Need:

This proposed rule would implement provisions under section 4132 of the

Food, Conservation, and Energy Act of 2008, also referred to as the

Farm Bill of 2008. Under section 4132, the Department of Agriculture's

Specifically, the Department is authorized to assess a civil penalty and to disqualify a retail or wholesale food store authorized to participate in SNAP. Previously, the Department could assess a civil penalty or disqualification, but not both. Section 4132 also eliminates the minimum disqualification period which was previously set at six months. In addition to implementing statutory provisions, this rule proposes to provide a clear administrative penalty when an authorized retailer or wholesale food store redeems a SNAP participant's Program benefits without the knowledge of the participant. All Program benefits are issued through the Electronic Benefits Transfer (EBT) system. The

EBT system establishes data that may be used to identify fraud committed by retail food stores. While stealing Program benefits could be prosecuted under current statute, Program regulations do not provide a clear penalty for these thefts. The proposed rule would establish an administrative penalty for such thefts equivalent to the penalty for trafficking in Program benefits, which is the permanent disqualification of a retailer or wholesale food store from SNAP participation. Finally, the Department proposes to identify additional administrative retail violations and the associated sanction that would be imposed against the retail food store for committing the violation.

For instance, to maintain integrity, FNS requires retail and wholesale food stores to key enter EBT card data in the presence of the actual

EBT card. The proposed rule would codify this requirement and identify the specific sanction that would be imposed if retail food stores are found to be in violation.

Summary of Legal Basis:

Section 4132, Food, Conservation, and Energy Act of 2008 (Pub. L. 110- 246).

Alternatives:

Because this proposed rule is under development alternatives are not yet articulated.

Anticipated Cost and Benefits:

Because this proposed rule is under development anticipated costs and benefits have not yet been articulated.

Risks:

The risk that retail or wholesale food stores will violate SNAP rules, or continue to violate SNAP rules, is expected to be reduced by refining program sanctions for participating retailers and wholesalers.

Timetable:

Action

Date

FR Cite

NPRM

09/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Additional Information:

Note: This RIN replaces the previously issued RIN 0584-AD78.

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service 10th Floor 3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: james.herbert@fns.usda.gov

RIN: 0584-AD88

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 12. FRESH FRUIT AND VEGETABLE PROGRAM

Priority:

Other Significant

Legal Authority:

Food, Conservation, and Energy Act of 2008; National School Lunch Act

(NSLA); 42 USC 1769(a)

CFR Citation: 7 CFR 211

Legal Deadline:

None

Abstract:

The Food, Conservation, and Energy Act of 2008 amended the National

School Lunch Act (NSLA) to add section 19, the Fresh Fruit and

Vegetable Program (FFVP). Section 19 establishes the FFVP as a permanent national program in a select number of schools in each State, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands.

Schools in all States must apply annually for FFVP funding.

This proposed rule would implement statutory requirements currently established through program policy and guidance for operators at the

State and local level. The proposed rule would set forth requirements detailed in the statute for school selection and participation, State agency outreach to needy schools, the yearly application process, and the funding and allocation processes for schools and States. The proposed rule would also include the statutory per student funding range and the requirement for a program evaluation.

Page 79482

In addition, the proposed rule would establish oversight activity and reporting and recordkeeping requirements that are not included in FFVP statutory requirements. Implementation of this rule is not expected to result in expenses for program operators because they receive funding to cover food purchases and administrative costs (09-007).

Statement of Need:

The Food, Conservation, and Energy Act of 2008 amended the National

School Lunch Act (NSLA) to add section 19, the Fresh Fruit and

Schools in all States must apply annually for FFVP funding. This proposed rule would implement statutory requirements currently established through program policy and guidance for operators at the

Summary of Legal Basis:

Section 19, Food, Conservation, and Energy Act of 2008. National School

Lunch Act (NSLA). 42 U.S.C. 1769(a).

Alternatives:

Because this proposed rule is under development, alternatives are not yet articulated. The rule would implement statutory requirements set forth by the Food, Conservation, and Energy Act of 2008 by adding section 19, the Fresh Fruit and Vegetable Program (FFVP), to the

National School Lunch Act. Alternatives to this process are not known or being pursued at this time.

Anticipated Cost and Benefits:

Implementation of this rule is not expected to result in expenses for program operators because they receive funding to cover food purchases and administrative costs.

Risks:

No risks by implementing this proposed rule have been identified at this time.

Timetable:

Action

Date

FR Cite

NPRM

02/00/11

NPRM Comment Period End

04/00/11

Final Action

08/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service 10th Floor 3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: james.herbert@fns.usda.gov

RIN: 0584-AD96

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--FNS

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 13. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM

INTEGRITY

Priority:

Other Significant

Legal Authority: 42 USC 1766; PL 103-448; PL 104-193; PL 105-336

CFR Citation: 7 CFR 226

Legal Deadline:

None

Abstract:

This rule amends the Child and Adult Care Food Program (CACFP) regulations. The changes in this rule result from the findings of State and Federal program reviews and from audits and investigations conducted by the Office of Inspector General. This rule revises: State agency criteria for approving and renewing institution applications; program training and other operating requirements for child care institutions and facilities; and State and institution-level monitoring requirements. This rule also includes changes that are required by the

Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the

Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition

Reauthorization Act of 1998 (Pub. L. 105-336).

The changes are designed to improve program operations and monitoring at the State and institution levels and, where possible, to streamline and simplify program requirements for State agencies and institutions

(95-024).

Statement of Need:

In recent years, State and Federal program reviews have found numerous cases of mismanagement, abuse, and, in some instances, fraud by child care institutions and facilities in the CACFP. These reviews revealed weaknesses in management controls over program operations and examples of regulatory noncompliance by institutions, including failure to pay facilities or failure to pay them in a timely manner; improper use of program funds for non-program expenditures; and improper meal reimbursements due to incorrect meal counts or to mis-characterized or incomplete income eligibility statements. In addition, audits and investigations conducted by the Office of Inspector General (OIG) have raised serious concerns regarding the adequacy of financial and administrative controls in CACFP. Based on its findings, the OIG recommended changes to CACFP review requirements and management controls.

Summary of Legal Basis:

Some of the changes proposed in the rule are discretionary changes being made in response to deficiencies found in program reviews and OIG audits. Other changes codify statutory changes made by the Healthy

Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal

Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub.

L. 104-193), and the William F. Goodling Child Nutrition

Reauthorization Act of 1998 (Pub. L. 105-336).

Alternatives:

This proposed interim final rule is under development and alternatives are not yet articulated. FNS is working with State agencies to identify reasonable alternatives to implement the changes mandated by law. FNS will be developing extensive guidance materials in conjunction with agency

Page 79483

cooperators to meet the objectives of the statute.

Anticipated Cost and Benefits:

This rule contains changes designed to improve management and financial integrity in the CACFP. When implemented, these changes would affect all entities in CACFP, from USDA to participating children and children's households. These changes will primarily affect the procedures used by State agencies in reviewing applications submitted by, and monitoring the performance of, institutions which are participating or wish to participate in the CACFP. Those changes which would affect institutions and facilities will not, in the aggregate, have a significant economic impact.

Data on CACFP integrity is limited, despite numerous OIG reports on individual institutions and facilities that have been deficient in

CACFP management. While program reviews and OIG reports clearly illustrate that there are weaknesses in parts of the program regulations and that there have been weaknesses in oversight, neither program reviews, OIG reports, nor any other data sources illustrate the prevalence and magnitude of CACFP fraud and abuse. This lack of information precludes USDA from estimating the amount of money lost due to fraud and abuse or the reduction in fraud and abuse the changes in this rule will realize.

Risks:

With the interim final rule in place and operational, risk of integrity problems is reduced. The final rule will use comments from stakeholders to further improve the rule.

Timetable:

Action

Date

FR Cite

NPRM

09/12/00

65 FR 55103

NPRM Comment Period End

12/11/00

Interim Final Rule

06/27/02

67 FR 43448

Interim Final Rule

Effective

07/29/02

Interim Final Rule

Comment Period End

12/24/02

Interim Final Rule

09/01/04

69 FR 53502

Interim Final Rule

Effective

10/01/04

Interim Final Rule

Comment Period End

09/01/05

Final Action

02/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

Local, State

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service 10th Floor 3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: james.herbert@fns.usda.gov

Related RIN: Merged with 0584-AC94

RIN: 0584-AC24

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 14. DIRECT CERTIFICATION OF CHILDREN IN FOOD STAMP HOUSEHOLDS AND

CERTIFICATION OF HOMELESS, MIGRANT, AND RUNAWAY CHILDREN FOR FREE MEALS

IN THE NSLP, SBP, AND SMP

Priority:

Other Significant

Legal Authority:

PL 108-265, sec 104

CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 245

Legal Deadline:

None

Abstract:

In response to Public Law 108-265, which amended the Richard B. Russell

National School Lunch Act, 7 CFR 245, Determining Eligibility for Free and Reduced Price Meals and Free Milk in Schools, will be amended to establish categorical (automatic) eligibility for free meals and free milk upon documentation that a child is (1) homeless as defined by the

McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant programs under the Runaway and Homeless Youth Act; or (3) migratory as defined in section 1309(2) of the Elementary and Secondary Education

Act. The rule also requires phase-in of mandatory direct certification for children who are members of households receiving food stamps and continues discretionary direct certification for other categorically eligible children (04-018).

Statement of Need:

The changes made to the Richard B. Russell National School Lunch Act concerning direct certification are intended to improve program access, reduce paperwork, and improve the accuracy of the delivery of free meal benefits. This regulation will implement the statutory changes and provide State agencies and local educational agencies with the policies and procedures to conduct mandatory and discretionary direct certification.

Summary of Legal Basis:

These changes are being made in response to provisions in Public Law 108-265.

Anticipated Cost and Benefits:

This regulation will reduce paperwork, target benefits more precisely, and will improve program access of eligible school children.

Risks:

This regulation may require adjustments to existing computer systems to more readily share information between schools, food stamp offices, and other agencies.

Timetable:

Action

Date

FR Cite

Interim Final Rule

02/00/11

Interim Final Rule

Comment Period End

05/00/11

Final Action

10/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service 10th Floor 3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: james.herbert@fns.usda.gov

Related RIN: Merged with 0584-AD62

RIN: 0584-AD60

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 15. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND

CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1786

CFR Citation: 7 CFR 246

Legal Deadline:

Final, Statutory, November 2006.

CN and WIC Reauthorization Act of 2004 (Pub. L. 108-265) requires issuance of a final rule within 18 months of release of IOM Report.

Abstract:

This final rule will affirm and address comments from stakeholders on the interim final rule that went into effect October 1, 2009, and for which the comment period ended February 1, 2010. Significant changes to the rule are not anticipated. The rule amended regulations governing the WIC food packages to align them more closely with updated nutrition science and the infant feeding practice guidelines of the American

Academy of Pediatrics, promote and support more effectively the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. The final rule considers public comments submitted on the impacts of the changes and how they might be refined to assist State agencies and recipients.

Statement of Need:

As the population served by WIC has grown and become more diverse over the past 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. A rule is needed to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science.

Summary of Legal Basis:

The Child Nutrition and WIC Reauthorization Act of 2004, enacted on

June 30, 2004, requires the Department to issue a final rule within 18 months of receiving the Institute of Medicine's report on revisions to the WIC food packages. This report was published and released to the public on April 27, 2005.

Alternatives:

FNS developed a regulatory impact analysis that addressed a variety of alternatives that were considered in the interim final rulemaking. The regulatory impact analysis was published as an appendix to the interim rule. FNS developed a regulatory impact analysis that addressed a variety of alternatives that were considered in the interim final rulemaking. That regulatory impact analysis was published as an appendix to the interim rule.

Anticipated Cost and Benefits:

The regulatory impact analysis for this rule provided a reasonable estimate of the anticipated effects of the rule. This analysis estimated that the provisions of the rule would have a minimal impact on the costs of overall operations of the WIC Program over 5 years. The regulatory impact analysis was published as an appendix to the interim rule.

Risks:

This rule applies to WIC State agencies with respect to their selection of foods to be included on their food lists. As a result, vendors will be indirectly affected and the food industry will realize increased sales of some foods and decreases in other foods, with an overall neutral effect on sales nationally. The rule may have an indirect economic affect on certain small businesses because they may have to carry a larger variety of certain foods to be eligible for authorization as a WIC vendor. With the high degree of State flexibility allowable under this final rule, small vendors will be impacted differently in each State depending upon how that State chooses to meet the new requirements. It is, therefore, not feasible to accurately estimate the rule's impact on small vendors. Since neither

FNS nor the State agencies regulate food producers under the WIC

Program, it is not known how many small entities within that industry may be indirectly affected by the rule. FNS has, however, modified the new food provision in an effort to mitigate the impact on small entities. This rule adds new food items, such as fruits and vegetables and whole grain breads, which may require some WIC vendors, particularly smaller stores, to expand the types and quantities of food items stocked in order to maintain their WIC authorization. In addition, vendors also have to make available more than one food type from each WIC food category, except for the categories of peanut butter and eggs, which may be a change for some vendors. To mitigate the impact of the fruit and vegetable requirement, the rule allows canned, frozen, and dried fruits and vegetables to be substituted for fresh produce. Opportunities for training on and discussion of the revised

WIC food packages will be offered to State agencies and other entities as necessary.

Timetable:

Action

Date

FR Cite

NPRM

08/07/06

71 FR 44784

NPRM Comment Period End

11/06/06

Interim Final Rule

12/06/07

72 FR 68966

Interim Final Rule

Effective

02/04/08

Interim Final Rule

Comment Period End

02/01/10

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses, Governmental Jurisdictions

Government Levels Affected:

Federal, Local, State, Tribal

URL For More Information: www.fns.usda.gov/wic

URL For Public Comments: www.fns.usda.gov/wic

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service 10th Floor 3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: james.herbert@fns.usda.gov

RIN: 0584-AD77

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Food Safety and Inspection Service (FSIS)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 16. EGG PRODUCTS INSPECTION REGULATIONS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 21 USC 1031 to 1056

CFR Citation: 9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . .

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) is proposing to require egg products plants and establishments that pasteurize shell eggs to develop and implement Hazard Analysis and Critical Control Points

(HACCP) systems and Sanitation (SOPs). FSIS also is proposing pathogen reduction performance standards that would be applicable to egg products and pasteurized shell eggs. FSIS is proposing to amend the

Federal egg products inspection regulations by removing current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to their use in official plants.

The Agency also plans to eliminate the prior label approval system for egg products. This proposal will not encompass shell egg packers. In the near future, FSIS will initiate non-regulatory outreach efforts for shell egg packers that will provide information intended to help them safely process shell eggs intended for human consumption or further processing.

Statement of Need:

The actions being proposed are part of FSIS' regulatory reform effort to improve FSIS' shell egg and egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg products regulations as consistent as possible with the Agency's meat and poultry products regulations. FSIS also is taking these actions in light of changing inspection priorities and recent findings of

Salmonella in pasteurized egg products.

This proposal is directly related to FSIS' PR/HACCP initiative.

Summary of Legal Basis:

This proposed rule is authorized under the Egg Products Inspection Act

(21 U.S.C. 1031 to 1056). It is not the result of any specific mandate by the Congress or a Federal court.

Alternatives:

A team of FSIS economists and food technologists is conducting a cost- benefit analysis to evaluate the potential economic impacts of several alternatives on the public, egg products industry, and FSIS. These alternatives include: (1) Taking no regulatory action; (2) requiring all inspected egg products plants to develop, adopt, and implement written sanitation SOPs and HACCP plans; and (3) converting to a lethality-based pathogen reduction performance standard many of the current highly prescriptive egg products processing requirements. The team will consider the effects of a uniform, across-the-board standard for all egg products; a performance standard based on the relative risk of different classes of egg products; and a performance standard based on the relative risks to public health of different production processes.

Anticipated Cost and Benefits:

FSIS is analyzing the potential costs of this proposed rulemaking to industry, FSIS, and other Federal agencies, State and local governments, small entities, and foreign countries. The expected costs to industry will depend on a number of factors. These costs include the required lethality, or level of pathogen reduction, and the cost of

HACCP plan and sanitation SOP development, implementation, and associated employee training. The pathogen reduction costs will depend on the amount of reduction sought and on the classes of product, product formulations, or processes.

Relative enforcement costs to FSIS and Food and Drug Administration may change because the two agencies share responsibility for inspection and oversight of the egg industry and a common farm-to-table approach for shell egg and egg products food safety. Other Federal agencies and local governments are not likely to be affected.

Egg product inspection systems of foreign countries wishing to export egg products to the U.S. must be equivalent to the U.S. system. FSIS will consult with these countries, as needed, if and when this proposal becomes effective.

This proposal is not likely to have a significant impact on small entities. The entities that would be directly affected by this proposal would be the approximately 80 federally inspected egg products plants, most of which are small businesses, according to Small Business

Administration criteria. If necessary, FSIS will develop compliance guides to assist these small firms in implementing the proposed requirements.

Potential benefits associated with this rulemaking include:

Improvements in human health due to pathogen reduction; improved utilization of FSIS inspection program resources; and cost savings resulting from the flexibility of egg products plants in achieving a lethality-based pathogen reduction performance standard. Once specific alternatives are identified, economic analysis will identify the quantitative and qualitative benefits associated with each alternative.

Human health benefits from this rulemaking are likely to be small because of the low level of (chiefly post-processing) contamination of pasteurized egg products. In light of recent scientific studies that raise questions about the efficacy of current regulations, however, it is likely that measurable reductions will be achieved in the risk of foodborne illness.

The preliminary anticipated annualized costs of the proposed action are approximately $7 million. The preliminary anticipated benefits of the proposed action are approximately $90 million per year.

Risks:

FSIS believes that this regulatory action may result in a further reduction in the risks associated with egg products. The development of a lethality-based pathogen reduction performance standard for egg products, replacing command-and-control regulations, will remove unnecessary regulatory obstacles to, and provide incentives for, innovation to improve the safety of egg products.

To assess the potential risk-reduction impacts of this rulemaking on the

Page 79486

public, an intra-Agency group of scientific and technical experts is conducting a risk management analysis. The group has been charged with identifying the lethality requirement sufficient to ensure the safety of egg products and the alternative methods for implementing the requirement. FSIS has developed new risk assessments for Salmonella

Enteritidis in eggs and for Salmonella spp. in liquid egg products to evaluate the risk associated with the regulatory alternatives.

Timetable:

Action

Date

FR Cite

NPRM

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses, Governmental Jurisdictions

Government Levels Affected:

None

Agency Contact:

Victoria Levine

Program Analyst, Policy Issuances Division

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-5627

Fax: 202 690-0486

Email: victoria.levine@fsis.usda.gov

RIN: 0583-AC58

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 17. NEW POULTRY SLAUGHTER INSPECTION

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 451 et seq

CFR Citation: 9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR 381.83; 9 CFR 381.91; 9

CFR 381.94

Legal Deadline:

None

Abstract:

FSIS is proposing a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection.

This new system would be available initially only to young chicken slaughter establishments. Establishments that slaughter broilers, fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170) would be considered as ``young chicken establishments.'' FSIS is also proposing to revoke the provisions that allow young chicken slaughter establishments to operate under the current Streamlined Inspection

System (SIS) or the New Line Speed (NELS) Inspection System. The proposed rule would establish new performance standards to reduce pathogens. FSIS anticipates that this proposed rule would provide the framework for action to provide public health-based inspection in all establishments that slaughter amenable poultry species.

Under the proposed new system, young chicken slaughter establishments would be required to sort chicken carcasses and to conduct other activities to ensure that carcasses are not adulterated before they enter the chilling tank.

Statement of Need:

Because of the risk to the public health associated with pathogens on young chicken carcasses, FSIS is proposing a new inspection system that would allow for more effective inspection of young chicken carcasses, would allow the Agency to more effectively allocate its resources, would encourage industry to more readily use new technology, and would include new performance standards to reduce pathogens.

This proposed rule is an example of regulatory reform because it would facilitate technological innovation in young chicken slaughter establishments. It would likely result in more cost-effective dressing of young chickens that are ready to cook or ready for further processing. Similarly, it would likely result in more efficient and effective use of Agency resources.

Summary of Legal Basis:

The Secretary of Agriculture is charged by the Poultry Products

Inspection Act (PPIA--21 U.S.C. 451 et seq.) with carrying out a mandatory poultry products inspection program. The Act requires post- mortem inspection of all carcasses of slaughtered poultry subject to the Act and such reinspection as deemed necessary (21 U.S.C. 455(b)).

The Secretary is authorized to promulgate such rules and regulations as are necessary to carry out the provisions of the Act (21 U.S.C. 463(b)). The Agency has tentatively determined that this rule would facilitate FSIS post-mortem inspection of young chicken carcasses. The proposed new system would likely result in more efficient and effective use of Agency resources and in industry innovations.

Alternatives:

FSIS considered the following options in developing this proposal: 1) No action. 2) Propose to implement HACCP-Based Inspection Models Pilot in regulations. 3) Propose to establish a mandatory, rather than a voluntary, new inspection system for young chicken slaughter establishments. 4) Propose standards of identity regulations for young chickens that include trim and processing defect criteria and that take into account the intended use of the product. 5) Propose a voluntary new inspection system for young chicken slaughter establishments and propose standards of identity for whole chickens, regardless of the products' intended use.

Anticipated Cost and Benefits:

The proposed performance standards and the implementation of public health-based inspection would likely improve the public health. FSIS is conducting a risk assessment for this proposed rule to assess the likely public health benefits that the implementation of this rule may achieve.

Establishments that volunteer for this proposed new inspection system alternative would likely need to make capital investments in facilities and equipment. They may also need to add labor (trained employees).

However, one of the beneficial effects of these investments would likely be the lowering of the average cost per pound to dress poultry properly. Cost savings would likely result because of increased line speeds, increased productivity, and increased flexibility to industry.

The expected lower average unit cost for dressing poultry would likely give a marketing advantage to establishments under the new system.

Consumers would likely benefit from lower retail prices for high quality poultry products. The rule would also likely provide opportunities for the industry to innovate because of the increased flexibility it would allow poultry slaughter establishments. In addition, in the public sector, benefits would accrue to FSIS from the more effective deployment of FSIS inspection program personnel to verify process

Page 79487

control based on risk factors at each establishment.

Risks:

Salmonella and other pathogens are present on a substantial portion of poultry carcasses inspected by FSIS. Foodborne Salmonella cause a large number of human illnesses that at times lead to hospitalization and even death. There is an apparent relationship between human illness and prevalence levels for salmonella in young chicken carcasses. FSIS believes that through better allocation of inspection resources and the use of performance standards, it would be able to reduce the prevalence of salmonella and other pathogens in young chickens.

Timetable:

Action

Date

FR Cite

NPRM

10/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Dr. Daniel L. Engeljohn

Deputy Assistant Administrator, Office of Policy and Program

Development

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 205-0495

Fax: 202 401-1760

Email: daniel.engeljohn@fsis.usda.gov

RIN: 0583-AD32

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 18. MANDATORY INSPECTION OF CATFISH AND CATFISH PRODUCTS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 601 et seq; PL 110-249, sec 11016

CFR Citation: 9 CFR ch III, subchapter F (new)

Legal Deadline:

Final, Statutory, December 2009, Final regulations NLT 18 months after enactment of PL 110-246.

Abstract:

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11016), known as the 2008 Farm Bill, amended the Federal Meat

Inspection Act (FMIA) to make catfish an amenable species under the

FMIA. Amenable species must be inspected, so this rule will define inspection requirements for catfish. The regulations will define

``catfish'' and the scope of coverage of the regulations to apply to establishments that process farm-raised species of catfish and to catfish and catfish products. The regulations will take into account the conditions under which the catfish are raised and transported to a processing establishment.

Statement of Need:

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11016), known as the 2008 Farm Bill, amended the Federal Meat

Inspection Act (FMIA) to make catfish an amenable species under the

FMIA. The Farm Bill directs the Department to issue final regulations implementing the FMIA amendments not later than 18 months after the enactment date (June 18, 2008) of the legislation.

Summary of Legal Basis: 21 U.S.C. 601 to 695 and Public Law 110-246, section 11016

Alternatives:

The option of no rulemaking is unavailable. The Agency has considered alternative methods of implementation and levels of stringency, and the effects on foreign and domestic commerce and on small business associated with the alternatives.

Anticipated Cost and Benefits:

FSIS anticipates benefits from uniform standards and the more extensive and intensive inspection service that FSIS provides (compared with current voluntary inspection programs). FSIS would apply requirements for imported catfish that would be equivalent to those applying to catfish raised and processed in the United States.

Risks:

In preparing regulations on catfish and catfish products, the Agency will consider any risks to public health or other pertinent risks associated with the production, processing, and distribution of the products. FSIS will determine, through scientific risk assessment procedures, the magnitude of the risks associated with catfish and how they compare with those associated with other foods in FSIS's jurisdiction.

Timetable:

Action

Date

FR Cite

NPRM

12/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Quita Bowman Blackwell

Acting Assistant Administrator, Office of Catfish Inspection Program

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-5735

Fax: 202 690-1742

RIN: 0583-AD36

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 19. ELECTRONIC IMPORTED PRODUCT INSPECTION APPLICATIONS; ELECTRONIC

FOREIGN IMPORTED PRODUCT AND FOREIGN ESTABLISHMENT CERTIFICATIONS;

DELETION OF STREAMLINED INSPECTION PROCEDURES FOR CANADIAN PRODUCT

Priority:

Other Significant

Legal Authority:

Federal Meat Inspection Act (FMIA) (21 USC 601 to 695), the Poultry

Products Inspection Act (PPIA) (21 USC 451 to 470); Egg Products

Inspection Act (EPIA) (21 USC 1031 to 1056)

CFR Citation: 9 CFR 304.3; 9 CFR 327.2 and 327.4; 9 CFR 381.196 to 381.198; 9 CFR 590.915 and 590.920

Legal Deadline:

None

Abstract:

FSIS is proposing to amend the meat, poultry, and egg products import inspection regulations to provide for an electronic application, and electronic imported product and foreign establishment certification system. FSIS

Page 79488

is also proposing to delete the ``streamlined'' import inspection procedures for Canadian product. In addition, the Agency is proposing that official import inspection establishment must develop, implement, and maintain written Sanitation SOPs, as provided in 9 CFR 416.11 through 416.17.

Statement of Need:

FSIS is proposing these regulations to provide for the electronic import system, which will be available through the Agency's Public

Health Information System (PHIS), a computerized, Web-based inspection information system. The import system will enable applicants to electronically submit and track import inspection applications that are required for all commercial entries of FSIS regulated products imported in to the U.S. FSIS inspection program personnel will be able to access the PHIS system to assign appropriate imported product inspection activities. The electronic import system will also facilitate the foreign imported product and annual foreign establishment certifications by providing immediate and direct electronic government- to-government exchange of information. The Agency is proposing to delete the Canadian streamlined import inspection procedures because they have not been in use since 1990 and are obsolete. Sanitation SOPs are written procedures establishments develop, implement, and maintain to prevent direct contamination or adulteration of meat or poultry products. To ensure that imported meat and poultry products do not become contaminated while undergoing reinspection prior to entering the

U.S., FSIS is proposing to clarify that official import inspection establishments must develop written Sanitation SOPs.

Summary of Legal Basis:

The authorities for this proposed rule are: the Federal Meat Inspection

Act (FMIA) (21 U.S.C. 601 to 695), the Poultry Products Inspection Act

(PPIA) (21 U.S.C. 451 to 470), Egg Products Inspection Act (EPIA)(21

U.S.C. 1031 to 1056) and the regulations that implement these Acts.

Alternatives:

The use of the electronic import system is voluntary. The Agency will continue to accept and process paper import inspection applications, and foreign establishment and foreign imported product certificates.

The Canadian streamlined import inspection procedures are not currently in use. Proposing Sanitation SOPs in official import inspection establishments will prevent direct contamination or adulteration of product. Therefore, no alternatives were considered.

Anticipated Cost and Benefits:

Under this proposed rule, the industry will have the option of filing inspection applications electronically and submitting electronic foreign product and establishment certificates through the PHIS. Since the electronic option is voluntary; applicants and the foreign countries that choose to file electronically will do so only if the benefits outweigh the cost. Sanitation (SOPs) are a condition of approval for official import inspection establishments, and as a requirement for official import inspection establishments to continue to operate under Federal inspection. The proposed rule will clarify that official import inspection establishments must have developed written Sanitation SOPs before being granted approval and that existing official import inspection establishments must meet Sanitation SOP requirements. Since, in practice, FSIS has always expected official import inspection establishments to maintain Sanitation SOPs during the reinspection of imported products, the proposed amendment for these sanitation requirements will have little, if any, cost impact on the industry.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

12/00/10

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Mary Stanley

Director, International Policy Division Office of Policy and Program

Department of Agriculture

Food Safety and Inspection Service

Room 2125 1400 Independence Avenue SW.

Washington, DC 20250

Phone: 202 720-0287

RIN: 0583-AD39

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 20. ELECTRONIC EXPORT APPLICATION AND CERTIFICATION AS A REIMBURSABLE

SERVICE AND FLEXIBILITY IN THE REQUIREMENTS FOR OFFICIAL EXPORT

INSPECTION MARKS, DEVICES, AND CERTIFICATES

Priority:

Other Significant

Legal Authority:

Federal Meat Inspection Act (FMIA) (21 USC 601 to 695); Poultry

Products Inspection Act (PPIA) (21 USC 451 to 470); Egg Products

Inspection Act (EPIA) (21 USC 1031 to 1056)

CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9 CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and 592.500

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) is proposing to amend the meat, poultry, and egg product inspection regulations to provide an electronic export application and certification process. FSIS is proposing to charge users for the use of the proposed system. FSIS is also proposing to provide establishments that export meat, poultry, and egg products with flexibility in the official export inspection marks, devices, and certificates. In addition, FSIS is proposing egg product export regulations that parallel the meat and poultry export regulations.

Statement of Need:

FSIS is proposing these regulations to facilitate the electronic processing of export applications and certificates through the Public

Health Information System (PHIS), a computerized, Web-based inspection information system. The current export application and

Page 79489

certification regulations provide only for a paper-based process. This proposed rule will provide this electronic export system as a reimbursable certification service charged to the exporter.

Summary of Legal Basis:

The authorities for this proposed rule are: The Federal Meat Inspection

Act (FMIA) (21 U.S.C. 601 to 695), the Poultry Products Inspection Act

(PPIA) (21 U.S.C. 451 to 470), the Egg Products Inspection Act (EPIA)

(21 U.S.C. 1031 to 1056), and the regulations that implement these

Acts. FSIS is proposing to charge for the electronic export application and certification system under the Agricultural Marketing Act (7 U.S.C. 1622(h)) that provides the Secretary of Agriculture with the authority to: ``Inspect, certify, and identify the class, quality, quantity, and condition of agricultural products when shipped or received in interstate commerce, under such rules and regulations as the Secretary of Agriculture may prescribe, including assessment and collection of such fees as will be reasonable and as nearly as may be to cover the cost of the service rendered, to the end that agricultural products may be marketed to the best advantage, that trading may be facilitated, and that consumers may be able to obtain the quality product which they desire.``

Alternatives:

The electronic export applications and certification system is being proposed as a voluntary service, therefore, exporters have the option of continuing to use the current paper-based system. Therefore, no alternatives were considered.

Anticipated Cost and Benefits:

FSIS is proposing to charge exporters that choose to utilize the system

$90.00 per application submitted. Automating the export application and certification process will facilitate the exportation of U.S. meat, poultry, and egg products by streamlining and automating the processes that are in use while ensuring that foreign regulatory requirements are met. The direct cost to exporters would be approximately $22.5 million to $31.5 million per year, if they choose to file electronically.

However, the total cost to an exporter would depend on the number of electronic applications processed. An exporter that processes only a few applications per year would not be likely to experience a significant economic impact. Under this proposal, inspection personnel workload is reduced through the elimination of the physical handling and processing of applications and certificates. When an electronic government-to-government system interface or data exchange is used, fraudulent transactions, such as false alterations and reproductions, will be significantly reduced, if not eliminated. The electronic export system is designed to ensure authenticity, integrity, and confidentiality. Exporters will be provided a more efficient and effective application and certification process. The proposed egg product export regulations provide the same export requirements across all products regulated by FSIS and consistency in the export application and certification process.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

12/00/10

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Dr. Ron Jones

Assistant Administrator, Office of International Affairs

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-3473

RIN: 0583-AD41

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--FSIS

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 21. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND

POULTRY PRODUCTS; CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT

MEAT AND POULTRY PRODUCTS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 451 et seq; 21 USC 601 et seq

CFR Citation: 9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR 325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431

Legal Deadline:

None

Abstract:

FSIS has proposed to establish pathogen reduction performance standards for all ready-to-eat (RTE) and partially heat-treated meat and poultry products, and measures, including testing, to control Listeria monocytogenes in RTE products. The performance standards spell out the objective level of pathogen reduction that establishments must meet during their operations in order to produce safe products, but allow the use of customized, plant-specific processing procedures other than those prescribed in the earlier regulations. With HACCP, food safety performance standards give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls, while providing objective, measurable standards that can be verified by Agency inspectional oversight. This set of performance standards will include and be consistent with standards already in place for certain ready-to-eat meat and poultry products.

Statement of Need:

Although FSIS routinely samples and tests some ready-to-eat products for the presence of pathogens prior to distribution, there are no specific regulatory pathogen reduction requirements for most of these products. The proposed performance standards are necessary to help ensure

Page 79490

the safety of these products; give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls; and provide objective, measurable standards that can be verified by Agency oversight.

Summary of Legal Basis:

Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the

Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues regulations governing the production of meat and poultry products prepared for distribution in commerce. The regulations, along with FSIS inspection programs, are designed to ensure that meat and poultry products are safe, not adulterated, and properly marked, labeled, and packaged.

Alternatives:

As an alternative to all of the proposed requirements, FSIS considered taking no action. As alternatives to the proposed performance standard requirements, FSIS considered end-product testing and requiring ``use- by'' date labeling on ready-to-eat products.

Anticipated Cost and Benefits:

Benefits are expected to result from fewer contaminated products entering commercial food distribution channels as a result of improved sanitation and process controls and in-plant verification. FSIS believes that the benefits of the rule would exceed the total costs of implementing its provisions. FSIS currently estimates net benefits from the 2003 interim final rule at $470 to $575 million, with annual recurring costs at $150.4 million, if FSIS discounts the capital cost at 7 percent. FSIS is continuing to analyze the potential impact of the other provisions of the proposal.

The other main provisions of the proposed rule are: Lethality performance standards for Salmonella and E. coli O157:H7 and stabilization performance standards for C. perfringens that firms must meet when producing RTE meat and poultry products. Most of the costs of these requirements would be associated with one-time process performance validation in the first year of implementation of the rule and with revision of HACCP plans. Benefits are expected to result from the entry into commercial food distribution channels of product with lower levels of contamination resulting from improved in-plant process verification and sanitation. Consequently, there will be fewer cases of foodborne illness.

Risks:

Before FSIS published the proposed rule, FDA and FSIS had estimated that each year L. monocytogenes caused 2,540 cases of foodborne illness, including 500 fatalities. The Agencies estimated that about 65.3 percent of these cases, or 1660 cases and 322 deaths per year, were attributable to RTE meat and poultry products. The analysis of the interim final rule on control of L. monocytogenes conservatively estimated that implementation of the rule would lead to an annual reduction of 27.3 deaths and 136.7 illnesses at the median. FSIS is continuing to analyze data on production volume and Listeria controls in the RTE meat and poultry products industry and is using the FSIS risk assessment model for L. monocytogenes to determine the likely risk reduction effects of the rule. Preliminary results indicate that the risk reductions being achieved are substantially greater than those estimated in the analysis of the interim rule.

FSIS is also analyzing the potential risk reductions that might be achieved by implementing the lethality and stabilization performance standards for products that would be subject to the proposed rule. The risk reductions to be achieved by the proposed rule and that are being achieved by the interim rule are intended to contribute to the Agency's public health protection effort.

Timetable:

Action

Date

FR Cite

NPRM

02/27/01

66 FR 12590

NPRM Comment Period End

05/29/01

NPRM Comment Period

Extended

07/03/01

66 FR 35112

NPRM Comment Period End

09/10/01

Interim Final Rule

06/06/03

68 FR 34208

Interim Final Rule

Effective

10/06/03

Interim Final Rule

Comment Period End

01/31/05

NPRM Comment Period

Reopened

03/24/05

70 FR 15017

NPRM Comment Period End

05/09/05

Affirmation of Interim

Final Rule

03/00/11

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Dr. Daniel L. Engeljohn

Deputy Assistant Administrator, Office of Policy and Program

Development

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 205-0495

Fax: 202 401-1760

Email: daniel.engeljohn@fsis.usda.gov

RIN: 0583-AC46

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 22. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR

CHOPPED MEAT AND POULTRY PRODUCTS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 601 et seq; 21 USC 451 et seq

CFR Citation: 9 CFR 317; 9 CFR 381

Legal Deadline:

None

Abstract:

FSIS has proposed to amend the Federal meat and poultry products inspection regulations to require nutrition labeling for the major cuts of single-ingredient, raw meat and poultry products, either on their label or at their point-of-purchase, unless an exemption applies. FSIS also proposed to require nutrition information on the label of ground or chopped meat and poultry products, unless an exemption applies. The requirements for ground or chopped products will be consistent with those for multi-ingredient products.

FSIS also proposed to amend the nutrition labeling regulations to provide that when a ground or chopped product does not meet the regulatory criteria to be labeled ``low fat,'' a lean percentage claim may be included on the label or in labeling, as long as a statement of the fat percentage also is displayed on the label or in labeling.

Statement of Need:

The Agency will require that nutrition information be provided for the major

Page 79491

cuts of single-ingredient, raw meat and poultry products, either on their label or at their point of purchase, because during the most recent surveys of retailer, the Agency did not find significant participation in the voluntary nutrition labeling program for single- ingredient, raw meat and poultry products. Ground or chopped products are similar to multi-ingredient products. This rule is necessary so that consumers can have the information they need to construct healthy diets.

Summary of Legal Basis:

This action is authorized under the Federal Meat Inspection Act (21

U.S.C. 601 to 695) and the Poultry Products Inspection Act (21 U.S.C. 451 to 470).

Alternatives:

No action; nutrition labels required on all single-ingredient, raw products (major cuts and non-major cuts) and all ground or chopped products; nutrition labels required on all major cuts of single- ingredient, raw products (but not non-major cuts) and all ground or chopped products; nutrition information at the point of purchase required for all single-ingredient, raw products (major and non-major cuts) and for all ground or chopped products.

Anticipated Cost and Benefits:

Cost will include the equipment for making labels, labor, and materials used for labels for ground or chopped products. The cost of providing nutrition labeling for the major cuts of single-ingredient, raw meat and poultry products should not be significant, because retail establishments would have the option of providing nutrition information through point-of-purchase materials.

Benefits of the nutrition labeling rule would result consumers modify their diets in response to new nutrition information concerning ground or chopped products and the major cuts of single-ingredient, raw products. Reductions in consumption of fat and cholesterol are associated with reduced incidence of cancer and coronary heart disease.

FSIS has concluded that the quantitative benefits will exceed the quantitative costs of the supplemental proposed rule. FSIS estimates that the annualized benefits of the proposed rule will range from approximately $185.6 to $230.8 million, using a 7 percent discount rate over 20 years. FSIS estimates that the annualized costs will range from approximately $26.7 to $44.8 million, using a 7 percent discount rate over 20 years.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

01/18/01

66 FR 4970

NPRM Comment Period End

04/18/01

Extension of Comment

Period

04/20/01

66 FR 20213

NPRM Comment Period End

07/17/01

Supplemental Proposed

Rule

12/18/09

74 FR 67736

Supplemental Proposed

Rule Comment Period

End

02/16/10

Final Action

12/00/10

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Rosalyn Murphy-Jenkins

Director, Labeling and Program Delivery Division

Department of Agriculture

Food Safety and Inspection Service 5601 Sunnyside Avenue

Beltsville, MD 20705-5000

Phone: 301 504-0878

Fax: 301 504-0872

Email: rosalyn.murphy-jenkins@fsis.usda.gov

RIN: 0583-AC60

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 23. NOTIFICATION, DOCUMENTATION, AND RECORDKEEPING REQUIREMENTS FOR

INSPECTED ESTABLISHMENTS

Priority:

Other Significant

Legal Authority: 21 USC 612 to 613; 21 USC 459

CFR Citation: 9 CFR 417.4; 9 CFR 418

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) has proposed to require establishments subject to inspection under the Federal Meat Inspection

Act and the Poultry Products Inspection Act to promptly notify the

Secretary of Agriculture that an adulterated or misbranded product received by or originating from the establishment has entered into commerce, if the establishment believes or has reason to believe that this has happened. FSIS has also proposed to require these establishments to: (1) Prepare and maintain current procedures for the recall of all products produced and shipped by the establishment and

(2) document each reassessment of the process control plans of the establishment.

Statement of Need:

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec. 11017), known as the 2008 Farm Bill, amended the Federal Meat

Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to require establishments subject to inspection under these Acts to promptly notify the Secretary that an adulterated or misbranded product received by or originating from the establishment has entered into commerce, if the establishment believes or has reason to believe that this has happened. Section 11017 also requires establishments subject to inspection under the FMIA and PPIA to: (1) Prepare and maintain current procedures for the recall of all products produced and shipped by the establishment; and (2) document each reassessment of the process control plans of the establishment.

Summary of Legal Basis: 21 U.S.C. 612 and 613; 21 U.S.C. 459, and Public Law 110-246, sec. 11017.

Alternatives:

The option of no rulemaking is unavailable.

Anticipated Cost and Benefits:

Approximate costs: $5.0 million for labor and costs; $5.2 million for first year costs; $0.7 million average costs adjusted with a 3.0 percent inflation rate for following years. Total approximate costs:

$10.2 million. The average cost of this final rule to small entities is expected to be less than one tenth of one cent of meat and poultry food products per annum. Therefore, FSIS has determined that this rule will not have a significant economic impact on a substantial number of small entities.

Approximate benefits: Benefits have not been monetized because quantified data

Page 79492

on benefits attributable to this final rule are not available. Non- monetary benefits include improved protection of the public health, improved HACCP plans, and improved recall effectiveness.

Risks:

In preparing regulations on the shipment of adulterated meat and poultry products by meat and poultry establishments, the preparation and maintenance of procedures for recalled products produced and shipped by establishments, and the documentation of each reassessment of the process control plans by the establishment, the Agency considered any risks to public health or other pertinent risks associated with these actions.

Timetable:

Action

Date

FR Cite

NPRM

03/25/10

75 FR 14361

NPRM Comment Period End

05/24/10

Final Action

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Victoria Levine

Program Analyst, Policy Issuances Division

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-5627

Fax: 202 690-0486

Email: victoria.levine@fsis.usda.gov

RIN: 0583-AD34

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 24. FEDERAL-STATE INTERSTATE SHIPMENT COOPERATIVE INSPECTION PROGRAM

Priority:

Other Significant

Legal Authority:

PL 110-246, sec 11015

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, December 18, 2009.

Abstract:

FSIS has proposed regulations to implement a new voluntary Federal-

State cooperative inspection program under which State-inspected establishments with 25 or fewer employees would be eligible to ship meat and poultry products in interstate commerce. State-inspected establishments selected to participate in this program would be required to comply with all Federal standards under the Federal Meat

Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).

These establishments would receive inspection services from State inspection personnel that have been trained and certified to assist with enforcement of the FMIA and PPIA. Meat and poultry products produced under the program that have been inspected and passed by selected State-inspection personnel would bear a Federal mark of inspection. FSIS is proposing these regulations in response to the

Food, Conservation, and Energy Act, enacted on June 18, 2008 (the 2008

Farm Bill). Section 11015 of 2008 Farm Bill provides for the interstate shipment of State-inspected meat and poultry product from selected establishments and requires that FSIS promulgate implementing regulations no later than 18 months from the date of its enactment.

Statement of Need:

This action is needed to implement a new Federal-State cooperative program that will permit certain State-inspected establishments to ship meat and poultry products in interstate commerce. Inspection services for establishments selected to participate in the program will be provided by State inspection personnel that have been trained and certified in the administration and enforcement of the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products

Inspection Act (PPIA) (21 U.S.C. 451 et seq.) Meat and poultry products produced by establishments selected to participate in the program will bear a Federal mark of inspection.

Summary of Legal Basis:

This action is authorized under section 11015 of the Food,

Conservation, and Energy Act of 2008 (the 2008 Farm Bill) (Pub. L. 110- 246). Section 11015 amends the Federal Meat Inspection Act (FMIA) (21

U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) to establish an optional Federal-State cooperative program under which State-inspected establishments would be permitted to ship meat and poultry products in interstate commerce. The law requires that FSIS promulgate implementing regulations no later than 18 months after the date of enactment.

Alternatives: 1. No action: FSIS did not consider the alternative of no action because section 11015 of the 2008 Farm Bill requires that it promulgate regulations to implement the new Federal-State cooperative program. The

Agency did consider alternatives on how to implement the new program. 2. Limit participation in the program to State-inspected establishments with 25 or fewer employees on average: Under the law, State-inspected establishments that have 25 or fewer employees on average are permitted to participate in the program. The law also provides that FSIS may select establishments that employ more than 25 but fewer than 35 employees on average as of June 18, 2008 (the date of enactment), to participate in the program. Under the law, if these establishments employ more than 25 employees on average 3 years after FSIS promulgates implementing regulations, they are required to transition to a Federal establishment. FSIS rejected the option of limiting the program to establishment that employ 25 or fewer employees on average to give additional small establishments the opportunity to participate in the program and ship their meat and poultry products in interstate commerce. 3. Permit establishments with 25 to 35 employees on average as of June 18, 2008, to participate in the program. FSIS chose the option of permitting these establishments to be selected to participate in the program to give additional small establishments the opportunity to ship their meat and poultry products in interstate commerce. Under this option, FSIS will develop a procedure to transition any establishment that employs more than 25 people on average to a Federal establishment.

Establishments that employee 24 to 35 employees on average as of June 18, 2008, would be subject to the transition procedure beginning on the date 3 years after the Agency promulgates implementing regulations.

Anticipated Cost and Benefits:

FSIS is analyzing the costs of this proposed rule to industry, FSIS,

State and local governments, small entities, and foreign countries.

Participation in

Page 79493

the new Federal-State cooperative program will be optional. Thus, the costs and benefits associated with the proposed rule will depend on the number of States and establishments that choose to participate. Very small and certain small establishments State-inspected establishments that are selected to participate in the program are likely to benefit from the program because they will be permitted sell their products to consumers in other States and foreign countries.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

09/16/09

74 FR 47648

NPRM Comment Period End

12/16/09

Final Action

05/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal, State

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Rachel Edelstein

Director, Policy Issuances Division

Department of Agriculture

Food Safety and Inspection Service 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-0399

Fax: 202 690-0486

Email: rachel.edelstein@fsis.usda.gov

RIN: 0583-AD37

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Rural Business-Cooperative Service (RBS)

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 25. VALUE-ADDED PRODUCER GRANT PROGRAM

Priority:

Other Significant

Legal Authority:

PL 110-246

CFR Citation: 7 CFR 1951, subpart E; 7 CFR 4284, subpart J

Legal Deadline:

None

Abstract:

The Agency proposes to modify 7 CFR part 4284, subpart J, to include the definitions for mid-tier value chain and value-added agricultural product to include an agricultural commodity or product that is aggregated and marketed as a locally produced agricultural food product. Additionally, the proposed rule will expand the grant term not to exceed 3 years; implement a simplified application process for project proposals less than $50,000; provide for priority to projects that increase opportunities for beginning farmers or ranchers, socially disadvantaged farmers or ranchers, and operators of small- and medium sized farms and ranches that are structured as a family farm; and implement a reservation of funds for projects to benefit beginning farmers or ranchers, socially disadvantaged farmers or ranchers, and mid-tier value chains.

The Agency is also proposing to amend 7 CFR part 1951, subpart E, to allow the delegation of the servicing of the program to USDA State

Office personnel.

Statement of Need:

The modifications to the Value Added Producer Grant program will streamline program regulations resulting in better quality applications. It is expected that all of the changes will result in time and resource savings to the applicant and the Agency. Publication of the final rule is crucial to program implementation. The program will directly create new businesses, assist with the expansion of existing businesses, create jobs, increase the flow of tax dollars to rural communities, and add lasting value in terms of rural community impact.

Summary of Legal Basis:

The program was authorized by the Agriculture Risk Protection Act of 2000, section 231 (Pub. L. 106-224). The purpose of the Value Added

Producer Grant (VAPG) program is to help eligible independent producers of agricultural commodities, agricultural producer groups, farmer and rancher cooperatives, and majority-owned, producer-based business ventures develop business plans for viable marketing opportunities and develop strategies to create marketing opportunities.

Alternatives:

An alternative is to continue under the interim rule. The interim rule is scheduled to be published and remain in effect until a final rule is adopted. A notice announcing FY 2010 funding will be published after the interim rule. FY 2010 funding will be expendable in FY 2011.

Anticipated Cost and Benefits:

Costs:

The anticipated costs associated with this process are contract services. An exact dollar amount cannot be determined at this time, but it will not have an annual effect on the economy of $100 million or more.

No change in FTE needs is anticipated.

Minimal automation changes are anticipated.

Benefits:

The intended action is to fine tune the program regulations, making them easier to use for the public and Agency staff, while incorporate changes designed to reduce the cost to the Government and the subsidy rate.

Risks:

Program risks include risk of loss in the loans guaranteed under this program. We anticipate mitigating these risks with improved regulatory and administrative guidance and appropriate training.

Timetable:

Action

Date

FR Cite

NPRM

05/28/10

75 FR 29920

NPRM Comment Period End

06/28/10

Interim Final Rule

12/00/10

Interim Final Rule

Effective

01/00/11

Interim Final Rule

Comment Period End

02/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

Page 79494

Agency Contact:

Jermolowicz Andrew

Assistant Deputy Administrator

Department of Agriculture

Rural Business-Cooperative Service

STOP 3250 1400 Independence Avenue SW.

Washington, DC 20250-3250

Phone: 202 720-8460

Fax: 202 720-4641

Email: andrew.jermolowicz@wdc.usda.gov

RIN: 0570-AA79

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA

USDA--Rural Utilities Service (RUS)

FINAL RULE STAGE

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Statement of Regulatory Priorities

USDA's regulatory efforts in the coming year will be focused on achieving the Department's goals identified in the Department's

Strategic Plan for 2010 to 2015. To assist the country in addressing today's challenges, USDA 26. RURAL BROADBAND ACCESS LOANS AND LOAN GUARANTEES

Priority:

Other Significant

Legal Authority:

PL 107-171; 7 USC 901 et seq

CFR Citation: 7 CFR 1738

Legal Deadline:

None

Abstract:

On February 17, 2009, President Obama signed the American Recovery and

Reinvestment Act of 2009 (Recovery Act) into law. The essential goal of the Recovery Act is to provide a ``direct fiscal boost to help lift our

Nation from the greatest economic crisis in our lifetimes and lay the foundation for future growth.'' The Recovery Act expanded Rural

Utilities Service's (RUS') existing authority to make loans and provides new authority to make grants to facilitate broadband deployment in rural areas. RUS has been tasked with the time-sensitive priority of developing the regulation for this new authority. The

Agency will, however, also continue to develop a final rule for the

Broadband Program as authorized by The Farm Security and Rural

Investment Act of 2002, Public Law 107-171 (2002 Farm Bill).

There has been more than $1.7 billion in loans for broadband deployment with more than 1,900 rural communities that will receive broadband services. Even with this level of success, the program needs to be adjusted to better serve unserved or underserved communities. In response, the RUS, an agency of the United States Department of

Agriculture, revised the broadband rule to address this and other critical issues, and further facilitate the deployment of broadband service in rural America as directed by Congress by: (1) Clearly defining served and underserved markets based on service availability and existing competitors and target unserved in underserved areas; (2) providing potential applicants with a clear definition of which communities are eligible for funding; (3) establishing a minimum data transmission rate that the facilities financed must be able to deliver to the consumer; (4) establishing equity requirements that mitigate risks; (5) modifying market survey requirements based on service territories and existing availability of service; and (6) imposing new time limits for build-out and deployment to ensure prudent use of loan funds and timely delivery services to rural customers. A proposed rule was published in May 2007 seeking comments from interested parties.

Subsequently, the rulemaking process was suspended in light of new statutory requirements provided in the 2008 Farm Bill, thus requiring further rulemaking activities.

Statement of Need:

Since the Broadband Loan Program's inception, the Agency has faced and continues to face significant challenges in administering the program, including the fierce competitive nature of the broadband market, the fact that many companies proposing to offer broadband service are start-up organizations with limited resources, continually evolving technology, and economic factors such as the higher cost of serving rural communities. Because of these challenges, the Agency has been reviewing the characteristics of the Broadband Loan Program and has determined that modifications are required to accelerate the deployment of broadband service to the rural areas of the country.

The Broadband Loan Program is important to the revitalization of our rural communities and their economies. A lack of private capital has been cited as a reason for slow broadband deployment. However, an adequate supply of investment capital alone may not be sufficient to universally deploy broadband facilities in rural America--primarily due to the high cost of deployment outside of more densely populated areas.

Due to market uncertainties and risks associated with startup ventures, non-Federal sources of funding are restricting and raising the cost of capital, particularly in costly rural markets. Better access to low- cost capital is a primary initiative of this program in facilitating an increase in the rate of rural broadband deployment.

Summary of Legal Basis:

On May 13, 2002, the Farm Security and Rural Investment Act of 2002,

Public Law 107-171 (``2002 Farm Bill''), was signed into law. Title VI of the Farm Bill authorized the Agency to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. On June 18, 2008, the Food, Conservation, and Energy Act of 2008 (``2008 Farm Bill'') became law, significantly changing the statutory requirements of the Broadband Loan Program. As such, the

Agency will be issuing a Interim Rule that implements the statutory changes and requests comment on sections of the rule that were not part of the Proposed Rule published in May 2007.

Anticipated Cost and Benefits:

The program costs associated with lending activity are relatively low.

The average subsidy rate since the program's inception is 2.4 percent, or $24,000 in appropriated budget authority for every $1 million in loans. The residents and businesses of rural communities are the beneficiaries. Rural Development is responsible for helping rural

America transition from an agricultural base economy to a platform for new business and economic opportunity. Rural Development seeks to leverage its financial resources with private investment to facilitate the development of the changing rural economy. The Broadband Loan

Program provides rural America with the platform on which to achieve these goals. With access to the same advanced telecommunications networks as its urban counterparts, especially broadband networks designed to accommodate distance learning, telework, and telemedicine, rural America will eventually see improving educational opportunities, health care, economies, safety and security, and ultimately higher employment. The Agency shares the assessment of Congress, State and local officials, industry representatives, and rural residents that broadband service is a critical component to the future of rural

America. The Agency is committed to ensuring that rural America will have access to affordable, reliable, broadband

Page 79495

services, and to provide a healthy, safe and prosperous place to live and work.

Risks:

Building broadband infrastructure in sparsely populated rural communities is very capital intensive. The Broadband Loan Program continues to face risk factors that pose challenges in ensuring that proposed projects can and do deliver robust, affordable broadband services to rural consumers. These factors include the competitive nature of the broadband market, the fact that many companies proposing to offer broadband service are start-up organizations with limited resources, rapidly evolving technology, and economic factors such as the higher cost of serving rural communities. While many of the smallest rural communities understand the importance of broadband infrastructure to their economic development, they often have difficulty attracting service providers to their communities.

Timetable:

Action

Date

FR Cite

NPRM

05/11/07

72 FR 26742

NPRM Comment Period End

07/10/07

Interim Final Rule

12/00/10

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Michele L. Brooks

Director, Program Development and Regulatory Analysis

Department of Agriculture

Rural Utilities Service

Room 5159 South Building

STOP 1522 1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 690-1078

Fax: 202 720-8435

Email: michele.brooks@usda.gov

RIN: 0572-AC06

BILLING CODE 3410-90-S

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Statement of Regulatory and Deregulatory Priorities

The President's fiscal year (FY) 2010 Budget details how this

Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of

Comme

DOC--National Oceanic and Atmospheric Administration (NOAA)

Page 79497

assessments, and forecasts of environmental phenomena on which resource management, adaptation, and other societal decisions can be made.

In the environmental stewardship area, NOAA's goals include: Rebuilding and maintaining strong U.S. fisheries by using market-based tools and ecosystem approaches to management; increasing the populations of depleted, threatened, or endangered species and marine mammals by implementing recovery plans that provide for their recovery while still allowing for economic and recreational opportunities; promoting healthy coastal ecosystems by ensuring that economic development is managed in ways that maintain biodiversity and long-term productivity for sustained use; and modernizing navigation and positioning services. In the environmental assessment and prediction area, goals include:

Understanding climate change science and impacts, and communicating that understanding to government and private sector stakeholders enabling them to adapt; continually improving the National Weather

Service; implementing reliable seasonal and interannual climate forecasts to guide economic planning; providing science-based policy advice on options to deal with very long-term (decadal to centennial) changes in the environment; and advancing and improving short-term warning and forecast services for the entire environment.

Magnuson-Stevens Fishery Conservation and Management Act

Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-

Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles). Among the several hundred rulemakings that NOAA plans to issue in fiscal year 2010, a number of the preregulatory and regulatory actions will be significant. The exact number of such rulemakings is unknown, since they are usually initiated by the actions of eight regional Fishery Management Councils (FMCs) that are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for drafting implementing regulations for each managed fishery. NOAA issues regulations to implement FMPs and FMP amendments.

Once a rulemaking is triggered by an FMC, the Magnuson-Stevens Act places stringent deadlines upon NOAA by which it must exercise its rulemaking responsibilities. FMPs and FMP amendments for Atlantic highly migratory species, such as bluefin tuna, swordfish, and sharks, are developed directly by NOAA, not by FMCs.

FMPs address a variety of issues including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. One of the problems that FMPs may address is preventing overcapitalization (preventing excess fishing capacity) of fisheries. This may be resolved by market-based systems such as catch shares, which permit shareholders to harvest a quantity of fish and which can be traded on the open market. Harvest limits based on the best available scientific information, whether as a total fishing limit for a species in a fishery or as a share assigned to each vessel participant, enable stressed stocks to rebuild. Other measures include staggering fishing seasons or limiting gear types to avoid gear conflicts on the fishing grounds and establishing seasonal and area closures to protect fishery stocks.

The FMCs provide a forum for public debate and, using the best scientific information available, make the judgments needed to determine optimum yield on a fishery-by-fishery basis. Optional management measures are examined and selected in accordance with the national standards set forth in the Magnuson-Stevens Act. This process, including the selection of the preferred management measures, constitutes the development, in simplified form, of an FMP. The FMP, together with draft implementing regulations and supporting documentation, is submitted to NMFS for review against the national standards set forth in the Magnuson-Stevens Act, in other provisions of the Act, and other applicable laws. The same process applies to amending an existing approved FMP.

Marine Mammal Protection Act

The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the take of marine mammals. Exceptions allow for permitting the collection of wild animals for scientific research or public display or to enhance the survival of a species or stock. NMFS initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries.

The Act also established the Marine Mammal Commission, which makes recommendations to the Secretaries of the Departments of Commerce and the Interior and other Federal officials on protecting and conserving marine mammals. The Act underwent significant changes in 1994 to allow for takings incidental to commercial fishing operations, to provide certain exemptions for subsistence and scientific uses, and to require the preparation of stock assessments for all marine mammal stocks in waters under U.S. jurisdiction.

Endangered Species Act

The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be ``endangered'' or ``threatened,'' and the conservation of the ecosystems on which these species depend.

The ESA authorizes both NMFS and the Fish and Wildlife Service (FWS) to jointly administer the provisions of the Act. NMFS manages marine and

``anadromous'' species, and FWS manages land and freshwater species.

Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the 1,310 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over approximately 60 species. NMFS' rulemaking actions are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing, and revising critical habitat for any listed species. In addition, under the ESA's procedural framework, Federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect one of the listed species or designated critical habitat, or is likely to jeopardize proposed species or adversely modify proposed critical habitat that is under

NMFS' jurisdiction.

NOAA's Regulatory Plan Actions

While most of the rulemakings undertaken by NOAA do not rise to the level necessary to be included in the Department's regulatory plan,

NMFS is undertaking four actions that rise to the level of ``most important'' of the Department's significant regulatory actions and thus are included in this year's regulatory plan. The four actions implement provisions of the Magnuson-Stevens Fishery Conservation and Management

Act, as reauthorized in 2006. The first action may be of

Page 79498

particular interest to international trading partners as it concerns the Certification of Nations Whose Fishing Vessels are Engaged in

Illegal, Unreported, or Unregulated Fishing or Bycatch of Protected

Living Marine Resources. A description of the four regulatory plan actions is provided below. 1. Certification of Nations Whose Fishing Vessels Are Engaged in

Illegal, Unreported, or Unregulated Fishing or Bycatch of

Protected Living Marine Resources (0648-AV51). NOAA's NMFS is establishing a process of identification and certification to address illegal, unreported, or unregulated (IUU) activities and bycatch of protected species in international fisheries. Nations whose fishing vessels engage, or have been engaged, in IUU fishing would be identified in a biennial report to Congress, as required under section 403 of the Magnuson-Stevens Fishery

Conservation and Management Act. NMFS would subsequently certify whether identified nations have taken appropriate corrective action with respect to the activities of its fishing vessels. 2. Pacific Coast Groundfish Trawl Rationalization Program--Program

Components Rulemaking (0648-AY68): Due to the complexity of the fishery management measures, NMFS is implementing the

Pacific Coast Groundfish Trawl Rationalization Program through multiple rulemakings. A previous rulemaking (i.e., the Initial Issuance rule) creates and issues quota shares to qualified participants and establishes an appeals process. The program components rulemaking would implement the second phase of the trawl rationalization program. In particular, this rulemaking includes requirements for observers and compliance monitors, retention requirements, coop permits and agreements, first receiver site licenses, vessel accounts and mandatory economic data collection. 3. Designation of Critical Habitat for Cook Inlet Beluga Whale (0648-

AX50): This rule would designate critical habitat in two areas of Cook Inlet totaling 3,016 square miles. Critical habitat would include intertidal and subtidal waters near high and medium flow anadromous fish streams. The deadline for publication is October 20, 2010. 4. Critical Habitat for North Atlantic Right Whales (0648-AY54):

Northern right whales have been listed as endangered since 1973. In 2008, NOAA removed Northern right whales from the list of endangered species and replaced it with two separate species (North Pacific and North Atlantic right whales). NOAA had designated critical habitat for Northern right whales but has not yet designated critical habitat for the new North Atlantic right whale species. Several environmental groups threaten litigation over the failure to designate critical habitat for the species listed in 2008. NOAA is discussing a possible schedule for critical habitat designation that would avoid litigation.

At this time, NOAA is unable to determine the aggregate cost of the identified Regulatory Plan actions as several of these actions are currently under development.

Bureau of Industry and Security

The Bureau of Industry and Security (BIS) advances U.S. national security, foreign policy, and economic objectives by maintaining and strengthening an adaptable, efficient, and effective export control and treaty compliance systems. BIS also administers programs to prioritize certain contracts to promote the national defense and to protect and enhance the defense industrial base.

In August 2009, the President directed a broad-based interagency review of the U.S. export control system with the goal of strengthening national security and the competitiveness of key U.S. manufacturing and technology sectors by focusing on the current threats and adapting to the changing economic and technological landscape. In August 2010, the

President outlined an approach under which agencies that administer export controls will apply new criteria for determining what items need to be controlled and a common set of policies for determining when an export license is required. The control list criteria are to be based on transparent rules, which will reduce the uncertainty faced by our

Allies, U.S. industry, and its foreign partners, and will allow the government to erect higher walls around the most sensitive items in order to enhance national security.

Under the President's approach, agencies will apply the criteria and revise the lists of munitions and dual use items that are controlled for export so that they:

Are ``tiered'' to distinguish the types of items that should be subject to stricter or more permissive levels of control for different destinations, end-uses, and end-users;

Create a ``bright line'' between the two current control lists to clarify jurisdictional determinations and reduce government and industry uncertainty about whether particular items are subject to the control of the State

Department or the Commerce Department; and

Are structurally aligned so that they potentially can be combined into a single list of controlled items.

BIS' current regulatory plan action is designed to implement the initial phase of the President's directive.

Major Programs and Activities

BIS administers four sets of regulations. The Export Administration

Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR also regulate participation of U.S. persons in certain boycotts administered by foreign governments. The National Defense Industrial Base

Regulations provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign government imposed offsets in defense sales, and address the effect of imports on the defense industrial base. The

Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under Chemical

Weapons Convention treaty. The Additional Protocol Regulations implement similar requirements with respect to an agreement between the

United States and the International Atomic Energy Agency.

BIS also has an enforcement component with eight field offices in the

United States. BIS export control officers are stationed at several

U.S. embassies and consulates abroad. BIS works with other U.S.

Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and to promote effective export controls through cooperation with other governments.

BIS' Regulatory Plan Actions

As the agency responsible for leading administration and enforcement of the

Page 79499

U.S. dual-use export control system, BIS is playing a central role in the Administration's efforts to fundamentally reform the export control system. Changing what we control, how we control it and how we enforce and manage our controls will help strengthen our national security by focusing our efforts on controlling the most critical products and technologies and by enhancing the competitiveness of key U.S. manufacturing and technology sectors. In accordance with the

President's directive to develop a system that is tiered to distinguish the types of items that should be subject to stricter or more permissive levels of control for different destinations, end-uses, and end-users, BIS is developing a rule to implement an Export Control Tier

Based License Exception. This rule would allow certain dual-use items to be exported and reexported with conditions to specific countries without a license that would otherwise be required.

BIS will also be developing other rules to implement additional aspects of the export control reform as those aspects are identified and decided.

International Trade Administration

The International Trade Administration (ITA) assists in the development of U.S. trade policy in the global economy; creates jobs and economic growth by promoting U.S. companies; strengthens American competitiveness across all industries; addresses market access and compliance issues; administers U.S. trade laws; and undertakes a range of trade promotion and trade advocacy efforts.

Import Administration

The Import Administration (IA) is the ITA's lead unit on enforcing trade laws and agreements to prevent unfairly traded imports and to safeguard jobs and the competitive strength of American industry. From working to resolve disputes to implementing measures when violations are found, we are there to protect U.S. companies from unfair trade practices.

The primary role of IA is to enforce effectively the U.S. unfair trade laws (i.e., the antidumping duty (AD) and countervailing duty (CVD) laws) and to develop and implement other policies and programs aimed at countering foreign unfair trade practices. IA also administers the

Foreign Trade Zones program, the Statutory Import Program and certain sector-specific agreements and programs, such as the Textiles and

Apparel Program and the Steel Import Monitoring and Analysis licensing system.

AD proceedings focus on whether foreign producers/exporters are selling their merchandise in the United States at less than fair value. CVD proceedings focus on whether foreign producers/exporters are benefitting from subsidies provided by their governments. Parties who participate in AD/CVD proceedings include U.S. manufacturers, U.S. importers, and foreign exporters and manufacturers, some of whom are affiliated with U.S. companies.

ITA's Regulatory Plan Actions

IA is developing a rule entitled, ``Antidumping and Countervailing Duty

Proceedings: Electronic Filing Procedures; Administrative Protective

Order Procedures'' to implement an electronic filing and records management system called IA's Antidumping and Countervailing Duty

Centralized Electronic Service System (IA ACCESS). The Department's regulations currently require parties to submit multiple copies of a public document, and additional copies if the document contains business proprietary information. Alternatively, under the current regulations, if a document contains business proprietary information, a party must submit one hard copy original and five hard copies of a business proprietary document and three copies of a public version. The proposed rule will require interested parties to use IA ACCESS to file submissions electronically, unless an exception for manual, hard copy filing is applicable. If a document must be filed manually, the proposed rule also reduces the required number of copies for manual submissions such that only one paper copy of the submission will need to be filed with the Department.

In addition to electronic filing, the goal of the IA ACCESS system is to expand the public's access to information in AD/CVD proceedings by making all publicly filed documents available on the internet. It will also allow interested parties to file all submissions (both public and business proprietary) with the Department using an internet connection.

The Department envisions that such a system will create efficiencies in both the process and costs associated with filing and maintaining the documents. The ease of document submission will increase accessibility of submission to the Department by interested parties located within and outside the Washington, DC area.

Foreign-Trade Zones Board

The Foreign-Trade Zones (FTZ) Board is an interagency board composed of the Secretary of Commerce and the Secretary of the Treasury. The

Secretary of Commerce is the chairman of the Board. The FTZ Board administers the Foreign-Trade Zones Act of 1934, as amended (19 U.S.C. section 81a et seq.) (FTZ Act).

Major Program and Activities

The FTZ Board administers the FTZ program of the United States, pursuant to the FTZ Act and the FTZ regulations, codified at 15 CFR part 400. FTZs are restricted-access sites in or near U.S. Customs and

Border Protection (CBP) ports of entry licensed by the FTZ Board and operated under the supervision of CBP. FTZs are locations into which foreign and domestic merchandise may be moved for operations involving storage, exhibition, assembly, manufacture, or other processing not prohibited by law. FTZs are considered outside of U.S. customs territory, which means that the usual customs entry procedures and payment of duties are not required on foreign merchandise admitted into an FTZ unless and until that merchandise enters U.S. customs territory for domestic consumption.

The fact that FTZs are considered outside of U.S. customs territory makes them a valuable resource for many businesses. An FTZ user can avoid payment of U.S. customs duties on foreign merchandise admitted into an FTZ and then re-exported after further processing or manufacturing. Further, in some circumstances an FTZ user can admit foreign merchandise into an FTZ for use in manufacturing, and then, upon entry of the manufactured product into the U.S. customs territory, pay customs duties at the rate for the manufactured product. This can result in significant duty savings. Therefore, the FTZ program encourages retention of employment in the United States and promotion of export activity.

The FTZ Board reviews and approves applications for authority to establish FTZs and to conduct certain activity within FTZs. It has the authority to restrict or prohibit activity in FTZs. Under the FTZ Act,

FTZs must be operated under public utility principles and provide uniform treatment to all that apply to use the FTZ. The FTZ Board ensures that FTZs are operated in the public interest.

Page 79500

The FTZ Board's Regulatory Plan Actions

The FTZ Board is in the process of revising its regulations, which have been in effect since 1990, in a proposed rule entitled, ``Foreign-Trade

Zones in the United States.'' The new proposed rule was sent to OMB for review on August 31, 2010 (RIN 0625-AA81). The proposed rule will streamline application procedures and improve access to FTZs. For example, the FTZ Board is proposing to eliminate the need for advance

Board approval of many types of manufacturing operations. This will allow businesses, including small businesses, to take advantage of manufacturing opportunities in FTZs more quickly and more in keeping with the pace of modern business, because they will not need to wait through the sometimes lengthy application process. Further, the proposed rule will provide guidance on the FTZ Act's requirements that

FTZs be operated as public utilities with uniform access to all users.

This aspect of the proposed rule will improve access to the job- retention and export-promotion benefits of FTZs. The proposed rule also will provide greater clarity on various other aspects of the FTZ program, such as the FTZ Board's statutory fining authority.

PROPOSED RULE STAGE

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Statement of Regulatory and Deregulatory Priorities

The President's fiscal year (FY) 2010 Budget details how this

Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of

Comme 27. DESIGNATION OF CRITICAL HABITAT FOR THE NORTH ATLANTIC RIGHT WHALE

Priority:

Other Significant

Legal Authority: 16 USC 1361 et seq; 16 USC 1531 to 1543

CFR Citation: 50 CFR 226; 50 CFR 229

Legal Deadline:

None

Abstract:

In June 1970, the Northern right whale was listed as endangered under the Endangered Species Conservation Act, the precursor to the

Endangered Species Act (ESA)(35 FR 8495; codified at 50 CFR 17.11).

Subsequently, right whales were listed as endangered under the ESA in 1973, and as depleted under the Marine Mammal Protection Act (MMPA) the same year. In 1994, NMFS designated critical habitat for the Northern right whale, a single species thought at the time to include right whales in both the North Atlantic and the North Pacific.

In 2006, NMFS published a comprehensive right whale status review that concluded that recent genetic data provided unequivocal support to distinguish three right whale lineages (including the southern right whale) as separate phylogenetic species (Rosenbaum et al. 2000).

Rosenbaum et al. (2000) concluded that the right whale should be regarded as the following three separate species: (1) The North

Atlantic right whale (Eubalaena glacialis) ranging in the North

Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica), ranging in the North Pacific Ocean; and (3) the southern right whale

(Eubalaena australis), historically ranging throughout the southern hemisphere's oceans.

Based on these findings, NMFS published a proposed and final determination listing right whales in the North Atlantic and North

Pacific as separate endangered species under the ESA (71 FR 77704,

December 27, 2006; 73 FR 12024, March 6, 2008). Based on the new listing determination, NMFS is required by the ESA to designate critical habitat separately for both the North Atlantic right whale and the North Pacific right whale.

In April 2008, a final critical habitat determination was published for the North Pacific right whale (73 FR 19000; April 8, 2008). At this time, NMFS is preparing a proposal to designate critical habitat for the North Atlantic right whale.

Statement of Need:

In June 1970, the Northern right whale was listed as endangered under the Endangered Species Conservation Act, the precursor to the

Endangered Species Act (ESA)(35 FR 8495; codified at 50 CFR 17.11).

Subsequently, right whales were listed as endangered under the ESA in 1973 and as depleted under the Marine Mammal Protection Act (MMPA) the same year. In 1994, NMFS designated critical habitat for the Northern right whale, a single species thought at the time to include right whales in both the North Atlantic and the North Pacific.

Rosenbaum et al. (2000) concluded that the right whale should be regarded as the following three separate species: (1) The North

Atlantic right whale (Eubalaena glacialis) ranging in the North

Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica), ranging in the North Pacific Ocean; and (3) the southern right whale

(Eubalaena australis), historically ranging throughout the southern hemisphere's oceans.

Based on these findings, NMFS published a proposed and final determination listing right whales in the North Atlantic and North

Pacific as separate endangered species under the ESA (71 FR 77704,

Summary of Legal Basis:

Endangered Species Act

Alternatives:

Because this rule is presently in the beginning stages of development, no alternatives have been formulated or analyzed at this time.

Anticipated Cost and Benefits:

Because this rule is presently in the beginning stages of development, no analysis has been completed at this time to assess costs and benefits.

Risks:

Loss of critical habitat for a species listed as protected under the

ESA and MMPA, as well as potential loss of right whales due to habitat loss.

Timetable:

Action

Date

FR Cite

NPRM

12/00/10

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Page 79501

Government Levels Affected:

None

Agency Contact:

Marta Nammack

Office of Protected Resources

Department of Commerce

National Oceanic and Atmospheric Administration 1315 East-West Highway

Silver Spring, MD 20910

Phone: 301 713-1401

Fax: 301 427-2523

Email: marta.nammack@noaa.gov

RIN: 0648-AY54

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Statement of Regulatory and Deregulatory Priorities

The President's fiscal year (FY) 2010 Budget details how this

Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of

Comme

DOC--NOAA

FINAL RULE STAGE

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Statement of Regulatory and Deregulatory Priorities

The President's fiscal year (FY) 2010 Budget details how this

Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of

Comme 28. CERTIFICATION OF NATIONS WHOSE FISHING VESSELS ARE ENGAGED IN

ILLEGAL, UNREPORTED, AND UNREGULATED FISHING OR BYCATCH OF PROTECTED

LIVING MARINE RESOURCES

Priority:

Other Significant

Legal Authority: 16 USC 1801 et seq; 16 USC 1826(d) to 1826(k)

CFR Citation: 50 CFR 300

Legal Deadline:

Final, Statutory, January 12, 2011, Report due to Congress 16 USC 1826h.

Report on countries identified as having vessels engaged in IUU fishing.

Abstract:

The National Marine Fisheries Service (NMFS) is establishing a process of identification and certification to address illegal, unreported, or unregulated (IUU) activities and bycatch of protected species in international fisheries. Nations whose fishing vessels engage, or have been engaged, in IUU fishing or bycatch of protected living marine resources would be identified in a biennial report to Congress, as required under section 403 of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA) of 2006. NMFS would subsequently certify whether identified nations have taken appropriate corrective action with respect to the activities of its fishing vessels, as required under section 403 of MSRA.

Statement of Need:

The National Oceanic and Atmospheric Administration (NOAA) National

Marine Fisheries Service (NMFS) proposes regulations to set forth identification and certification procedures for nations whose vessels engage in illegal, unregulated, and unreported (IUU) fishing activities or bycatch of protected living marine resources pursuant to the High

Seas Fishing Moratorium Protection Act (Moratorium Protection Act).

Specifically, the Moratorium Protection Act requires the Secretary of

Commerce to identify in a biennial report to Congress those foreign nations whose vessels are engaged in IUU fishing or fishing that results in bycatch of protected living marine resources. The Moratorium

Protection Act also requires the establishment of procedures to certify whether nations identified in the biennial report are taking appropriate corrective actions to address IUU fishing or bycatch of protected living marine resources by fishing vessels of that nation.

Based upon the outcome of the certification procedures developed in this rulemaking, nations could be subject to import prohibitions on certain fisheries products and other measures under the authority provided in the High Seas Driftnet Fisheries Enforcement Act if they are not positively certified by the Secretary of Commerce.

Summary of Legal Basis:

NOAA is proposing these regulations pursuant to its rulemaking authority under sections 609 and 610 of the High Seas Driftnet Fishing

Moratorium Protection Act (16 U.S.C. 1826j and k), as amended by the

Magnuson-Stevens Fishery Conservation and Management Reauthorization

Act.

Alternatives:

NMFS developed alternatives for the Secretary of Commerce to make a positive certification that a nation, once identified as having vessels engaged in illegal, unregulated, and unreported (IUU) fishing, has taken sufficient corrective action against those vessels or is a member of a regional fishery management organization that has adopted effective measures to address the IUU activities. NMFS also developed alternatives for the Secretary of Commerce to make a positive certification that a nation, once identified as having vessels engaged in bycatch of protected living marine resources (PLMR), has adopted a regulatory program to conserve those PLMR that is comparable in effectiveness to the United States and which collects data to support international assessment and conservation efforts.

Anticipated Cost and Benefits:

Because this rule is under development, NMFS does not currently have estimates of the amount of product that is imported into the United

States from other nations whose vessels are engaged in illegal, unreported, and unregulated (IUU) fishing or bycatch of protected living marine resources. Therefore, quantification of the economic impacts of this rulemaking is not possible at this time. This rulemaking has not been determined to be economically significant under

E.O. 12866; however, it is considered significant because it raises novel or legal or policy issues arising out of legal mandates, the

President's Priorities, and the principles set forth in the Executive order.

Risks:

The risks associated with not pursuing the proposed rulemaking include allowing IUU fishing activities and/or bycatch of protected living marine resources by foreign vessels to continue without an effective tool to aid in combating such activities.

Timetable:

Action

Date

FR Cite

ANPRM

06/11/07

72 FR 33436

ANPRM Comment Period End

07/05/07

NPRM

01/14/09

74 FR 2019

NPRM Comment Period End

05/14/09

Final Action

12/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Page 79502

Agency Contact:

Christopher Rogers

Division Chief

Department of Commerce

National Oceanic and Atmospheric Administration 1315 East-West Highway

Silver Spring, MD 20910

Phone: 301 713-9090

Fax: 301 713-9106

Email: christopher.rogers@noaa.gov

Related RIN: Related to 0648-AV23

RIN: 0648-AV51

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Statement of Regulatory and Deregulatory Priorities

The President's fiscal year (FY) 2010 Budget details how this

Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of

Comme 29. CRITICAL HABITAT DESIGNATION FOR COOK INLET BELUGA WHALE UNDER THE

ENDANGERED SPECIES ACT

Priority:

Other Significant

Legal Authority: 16 USC 1531 et seq

CFR Citation: 50 CFR 226

Legal Deadline:

None

Abstract:

The National Marine Fisheries Service (NMFS) listed the Cook Inlet beluga whale Distinct Population Segment as endangered under the

Endangered Species Act on October 17, 2009. NMFS is required to designate critical habitat no later than one year after the publication of a listing. NMFS intends to publish a proposed rule by October 17, 2009.

Statement of Need:

The National Marine Fisheries Service (NMFS) listed the Cook Inlet beluga whale Distinct Population Segment as endangered under the

Summary of Legal Basis:

Endangered Species Act

Alternatives:

Alternative 1. No action (status quo): NMFS would not designate critical habitat (CH) in Cook Inlet, Alaska, for the Cook Inlet beluga whale. Conservation and recovery of the listed species would depend exclusively upon the protections provided under the ``jeopardy'' provisions of Section 7 of the ESA.

Alternative 2. Designate Area 1 and Area 2, which encompass all of upper-Cook Inlet, north of a line at 60[deg] 25' north latitude, and portions of mid- and lower-Cook Inlet, extending south along the west side of the Cook Inlet, following the tidal flats into Kamishak Bay to

Douglas Reef, between MHHW and waters within two nautical miles of shore. It further includes all waters of Kachemak Bay, eastward of 151[deg] 30' west longitude and seaward of MHHW.

Anticipated Cost and Benefits:

The post-designation incremental costs are estimated to range from

$187,000 to $571,000, in present value terms, at a 3 percent discount rate, and from $157,000 to $472,000 at a 7 percent discount rate.

Approximately six Federal action agencies for section 7 consultations are anticipated to bear 70 percent ($398,000) of these costs, while 26 percent ($148,000) are expected to accrue to NMFS, as the consulting agency. The remaining four percent ($25,000) of these costs may be borne by third parties, during the consultations. Of the total costs to

Federal action agencies, the DOD is anticipated to bear approximately 76 percent ($302,000). This is followed by USACE (9 percent; $37,000),

NMFS (7 percent; $28,000), FERC (7 percent; $28,000), EPA (1 percent;

$3,000), and FHWA (less than 1 percent; less than $1,000).

Benefits are qualitative: Area more attractive to workers in various industrial sectors; anticipated conservation and recovery species; and the general stability in associated environs should provide increases in welfare to tourists, recreationists, wildlife watchers, Cook Inlet

Ferry passengers, and future cruise ship passengers. This should result in higher revenues for relevant businesses. Other wildlife and fish species will benefit, resulting in overall improvements in commercial, recreational, personal use, and subsistence uses. The increase in Cook

Inlet beluga whale populations, in the longer term, will provide more frequent subsistence harvest opportunities to the Alaska Natives and allow future generations to practice their traditional ways. It will enhance passive-use benefits among those who value this species and the myriad elements and aspects of the natural habitat that sustains it.

Finally, as the ESA is carried out, there are expected to be scientific and educational benefits to the Nation.

Risks:

Loss of critical habitat for the Cook Inlet beluga whale Distinct

Population Segment and connected loss of Cook Inlet beluga whale members.

Timetable:

Action

Date

FR Cite

ANPRM

04/14/09

74 FR 17131

ANPRM Comment Period End

05/14/09

NPRM

12/02/09

74 FR 63080

NPRM Comment Period

Extended

01/12/10

75 FR 1582

NPRM Comment Period End

02/01/10

Final Action

12/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected:

Federal, Local, State, Tribal

Agency Contact:

Marta Nammack

Office of Protected Resources

Department of Commerce

National Oceanic and Atmospheric Administration 1315 East-West Highway

Silver Spring, MD 20910

Phone: 301 713-1401

Fax: 301 427-2523

Email: marta.nammack@noaa.gov

RIN: 0648-AX50

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Statement of Regulatory and Deregulatory Priorities

The President's fiscal year (FY) 2010 Budget details how this

Administration plans to lift our economy out of recession and lay a new foundation for long-term growth and prosperity. The Department of

Comme 30. FISHERIES OFF WEST COAST STATES; PACIFIC COAST GROUNDFISH FISHERY;

AMENDMENTS 20 AND 21; TRAWL RATIONALIZATION PROGRAM

Priority:

Other Significant

Legal Authority: 16 USC 1801 et seq

CFR Citation: 50 CFR 660

Legal Deadline:

None

Abstract:

The trawl rationalization program creates an individual fishing quota

Page 79503

(IFQ) program for the shore-based trawl fleet; and cooperative (coop) programs for the at-sea trawl fleet in the Pacific Coast Groundfish

Fishery. This rulemaking includes regulations to implement Amendments 20 and 21 to the Pacific Coast Groundfish Fishery Management Plan

(FMP). Amendment 20 creates the structure and management details of the trawl rationalization program, which would be a limited access privilege program (LAPP) under the Magnuson-Stevens Fishery

Conservation and Management Act (MSA), as reauthorized in 2007.

Amendment 21, intersector allocation, allocates the groundfish stocks between trawl and non-trawl fisheries.

Statement of Need:

The trawl rationalization program is intended to increase net economic benefits, create individual economic stability, provide full utilization of the trawl sector allocation, consider environmental impacts, and achieve individual accountability of catch and bycatch.

This rule would establish the key components that would be necessary to implement the trawl rationalization program at the start of the 2011 fishery.

Summary of Legal Basis:

Section 303A of the Magnuson-Stevens Act.

Alternatives:

The Pacific Fishery Management Council (the Council) prepared two environmental impact statement (EIS) documents: Amendment 20--

Rationalization of the Pacific Coast Groundfish Limited Entry Trawl

Fishery, which would create the structure and management details of the trawl fishery rationalization program; and Amendment 21--Allocation of

Harvest Opportunity Between Sectors of the Pacific Coast Groundfish

Fishery, which would allocate the groundfish stocks between trawl and non-trawl fisheries. These EISs covered a range of alternatives. The

Regulatory Impact Review and Initial Regulatory Flexibility Analysis

(RIR/IRFA) for this rule focuses on the two key alternatives--the No-

Action Alternative and the Preferred Alternative. By focusing on the two key alternatives (no action and preferred) in the RIR/IRFA, it encompasses parts of the other alternatives and informs the reader of these proposed regulations. Under the no action alternative, the current, primary management tool used to control the Pacific coast groundfish trawl catch includes a system of two month cumulative landing limits for most species and season closures for Pacific whiting. This management program would continue under the no action alternative. The analysis of the preferred alternative describes what is likely to occur as a result of the proposed action. Under the preferred alternative, the existing shore-based whiting and shore-based non-whiting sectors of the Pacific Coast groundfish limited entry trawl fishery would be managed as one sector under a system of IFQs, and the at-sea whiting sectors of the fishery would be managed under a system of sector-specific harvesting cooperatives (coops).

Anticipated Cost and Benefits:

The RIR/IRFA reviewed and summarized the benefits and costs, and the economic effects of the Council's recommendations. The major conclusions of the economic model suggest that (with landings held at 2004 levels), the current groundfish fleet (non-whiting component), which consisted of 117 vessels in 2004, will be reduced by roughly 50 percent to 66 percent, or 40 to 60 vessels under an IFQ program. The reduction in fleet size implies cost savings of $18 to $22 million for the year 2004 (most recent year of the data). Vessels that remain active will, on average, be more cost efficient and will benefit from economies of scale that are currently unexploited under controlled access regulations in the fishery. The cost savings estimates are significant, amounting to approximately half of the costs incurred currently, suggesting that IFQ management may be an attractive option for the Pacific Coast Groundfish Fishery. The increase in profits that commercial harvesters are expected to experience under the preferred alternative may render them better able to sustain the costs of complying with the new reporting and monitoring requirements. The costs of at-sea observers may reduce profits by about $2.2 million, depending on the fee structure. However, the profits earned by the non-whiting sector would still be substantially higher under the preferred alternative than under the no action alternative.

Risks:

Under the no action alternative, cumulative landing limits for target species have to be set lower because the bycatch of overfished species cannot be directly controlled. Introducing accountability at the individual vessel level by means of IFQs provides a strong incentive for bycatch avoidance.

There will likely be a lower motivation to ``race for fish'' due to coop harvest privileges. This is expected to result in improved product quality, slower-paced harvest activity, increased yield (which should increase ex-vessel prices), and enhanced flexibility and ability for business planning.

Timetable:

Action

Date

FR Cite

Notice of Availability

05/12/10

75 FR 26702

First Proposed Rule

06/10/10

75 FR 32994

First Proposed Rule

Correction

06/30/10

75 FR 37744

First Proposed Rule

Comment Period End

07/12/10

Second Proposed Rule

08/31/10

75 FR 53379

Second Proposed Rule

Comment Period End

09/30/10

First Final Rule

10/01/10

75 FR 60868

Second Final Rule

12/00/10

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

None

Agency Contact:

Barry Thom

Regional Administrator, Northwest Region, NMFS

Department of Commerce

National Oceanic and Atmospheric Administration

Building 1, 7600 Sand Point Way NE.

Seattle, WA 48115-0070

Phone: 206 526-6150

Fax: 206 526-6426

Email: barry.thom@noaa.gov

Related RIN: Related to 0648-AX98

RIN: 0648-AY68

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Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department consisting of 3 Military departments (Army, Navy, and Air Force), 10

Unified Combatant Commands, 14 Defense agencies, and 10 DoD Field

Activities

DOD--Office of the Secretary (OS)

Page 79505

Consider revisions to the FAR to address the findings of the

Rothe case that Federal contracting programs for minority- owned and other small businesses that implement 10 U.S.C. 2323 are ``facially'' unconstitutional;

Establish a DoD program to enhance participation of

Historically Black Colleges and Universities and Minority-

Serving Institutions in defense research programs;

Conform the DFARS to the FAR with respect to the use of the

Electronic Subcontracting Reporting System; and

Require public disclosure of justification and approval documents for noncompetitive 8(a) contracts over $20 million. 4. Regulations with international effects or interest

Of international effect or interest are regulations to:

Implement in the FAR statutory certification requirement that each offeror does not engage in any activity for which sanctions may be imposed under section 5 of the Iran

Sanctions Act. Also implements a procurement prohibition relating to contracts with persons that export sensitive technology to Iran;

Establish in the FAR processes and criteria for waiver of the prohibition on contracting with entities that conduct restricted business operations in Sudan;

Implement in the DFARS the determinations regarding participation of South Caucasus/Central and South Asian states in acquisitions in support of operations in

Afghanistan;

Finalize the FAR rule that prohibits Government contracts with any foreign incorporated entity that is treated as an inverted domestic corporation under section 835(b) of the

Homeland Security Act of 2002 or any subsidiary of such entity;

Implement in the FAR and DFARS the annual consolidated appropriation act exemption from the Buy American Act/

Balance of Payments Program restrictions on the acquisition of foreign commercial information technology items as construction material; and

Finalize in the FAR and DFARS the rules that increase trade agreements thresholds, as specified by the United States

Trade Representative.

Specific DoD Priorities:

For this Regulatory Plan, there are seven specific DoD priorities, all of which reflect the established regulatory principles. In those areas where rulemaking or participation in the regulatory process is required, DoD has studied and developed policy and regulations that incorporate the provisions of the President's priorities and objectives under the Executive order.

DoD has focused its regulatory resources on the most serious environmental, health, and safety risks. Perhaps most significant is that each of the priorities described below promulgates regulations to offset the resource impacts of Federal decisions on the public or to improve the quality of public life, such as those regulations concerning acquisition, security, homeowners, education, and health affairs. 1. Regulatory Program of the U.S. Army Corps of Engineers

In 1988, the Army Corps of Engineers published as appendix B of 33 CFR part 325, a rule that governs compliance with the National

Environmental Policy Act (NEPA) for the Army's Regulatory Program. On

April 2, 2010, the Assistant Secretary of the Army for Civil Works announced that the Army Corps of Engineers would conduct rulemaking to modify appendix B to reflect a limited change in policy addressing permit applications for surface coal mining activities in Appalachia.

The modification of appendix B will focus on the NEPA scope of review for considering the effects of surface coal mining in Appalachia on the aquatic environment, to enhance protection of aquatic resources. 2. Defense Procurement and Acquisition Policy

The Department of Defense continuously reviews the DFARS and continues to lead Government efforts to:

Revise the DFARS to implement the Weapons System Acquisition

Reform Act of 2009 - including acquisition strategies to ensure competition throughout life-cycle of major defense acquisition programs and address organizational conflicts of interest in major defense acquisition programs;

Revise DFARS to ensure continuation of contractor services in support of mission essential functions during an emergency, such as an influenza pandemic;

Clarify DoD policy in the DFARS regarding the definition and administration of contractor business systems to improve the effectiveness of DCMA/DCAA oversight of contractor business systems;

Implement in the DFARS statutory requirement to inspect military facilities, infrastructure, and equipment for safety and habitability prior to use;

Revise the FAR to implement the Executive orders relating to allowability of labor relations costs, non-displacement of qualified workers, notification of employee rights under

Federal labor laws, and Federal leadership in environmental, energy, and economic performance;

Revise the FAR to adopt biobased procurement preferences and collect contractor information on use of biobased products;

Revise the FAR to address service contractor employee personal conflicts of interest and organizational conflicts of interest and limit contractor access to information; and

Provide enhanced competition for task- and delivery-order contracts and additional market research before awarding a task or delivery order in excess of the simplified acquisition threshold. 3. Logistics and Materiel Readiness, Department of Defense

The Department of Defense published or plans to publish rules on contractors supporting the military in contingency operations:

Final Rule: Private Security Contractors (PSCs) Operating in

Contingency Operations. In order to meet the mandate of section 862 of the 2008 National Defense Authorization Act, this rule establishes policy, assigns responsibilities and provides procedures for the regulation of the selection, accountability, training, equipping, and conduct of personnel performing private security functions under a covered contract during contingency operations. It also assigns responsibilities and establishes procedures for incident reporting, use of and accountability for equipment, rules for the use of force, and a process for administrative action or the removal, as appropriate, of

PSCs and PSC personnel. DoD published an interim final rule on July 17, 2009 (74 FR 34690 to 34694) with an effective date of July 17, 2009. The comment period ended August 31, 2009. DoD, in coordination with the Department of State and the United States Agency

Page 79506

for International Development, have prepared a final rule, which includes the responses to the public comments, and incorporates changes to the interim final rule, where appropriate. The final rule is expected to be published the first or second quarter of FY 2011.

Interim Final Rule: Operational Contract Support for

Contingency Operations. This rule will incorporate the latest changes and lessons learned into policy and procedures for program management for the preparation and execution of contracted support and the integration of DoD contractor personnel into military contingency operations outside the United States. DoD anticipates publishing the interim final rule in the first or second quarter of FY 2011. 4. Installations and Environment, Department of Defense

The Department of Defense published a rule to assist eligible military and civilian Federal employee homeowners:

Final Rule: This rule authorizes the Homeowners Assistance

Program (HAP) under section 3374 of title 42, United States

Code, to assist eligible military and civilian Federal employee homeowners when the real estate market is adversely affected by closure or reduction-in-scope of operations. In accordance with DoD Directive 5101.1, ``DoD

Executive Agent,'' designates the Secretary of the Army as the DoD Executive Agent for administering, managing, and executing the HAP. Additionally, this rule allows the

Department of Defense to temporarily expand the existing

HAP in compliance with section 1001 of the American

Recovery and Reinvestment Act of 2009. This temporary expansion covers certain persons affected by BRAC 2005, certain persons on permanent change of station orders, and certain wounded persons and surviving spouses. This rule updates policy, delegates authority, and assigns responsibilities for managing Expanded HAP. This is an economically significant rule. DoD published an interim final rule on September 30, 2009 (74 FR 50109-50115), with an effective date of September 30, 2009. The comment period ended October 30, 2009. The final rule published November 16, 2010 (75 FR 69871) with an effective date of January 18, 2011. 5. Military Personnel Policy, Department of Defense

The Department of Defense published or plans to publish a rule implementing the Post-9/11 Veterans Educational Assistance Act of 2008, title V, Public Law 110-252 (the ``Post-9/11 GI Bill''):

Interim Final Rule: This rule establishes policy, assigns responsibilities, and prescribes procedures for carrying out the Post-9/11 GI Bill. It establishes policy for the use of supplemental educational assistance ``kickers,'' for members with critical skills or specialties, or for members serving additional service; for authorizing the transferability of education benefits; and for the DoD

Education Benefits Fund Board of Actuaries. DoD published an interim final rule on June 25, 2009 (74 FR 30212 to 30220) with an effective date of June 25, 2009. The comment period ended July 27, 2009. DoD anticipates finalizing this rule in the spring of 2011. 6. Military Community and Family Policy, Department of Defense

The Department of Defense published or plans to publish a rule to implement policy, assign responsibilities, and prescribe procedures for the operation of voluntary education programs within DoD.

Proposed Rule: This rule implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD.

Included are: Procedures for Service members participating in education programs; guidelines for establishing, maintaining, and operating voluntary education programs; procedures for obtaining on-base voluntary education programs and services; minimum criteria for selecting institutions to deliver higher education programs and services on military installations; and the Memorandum of

Understanding between educational institutions and DoD prior to the disbursement of tuition assistance funds. This is an economically significant rule. The proposed rule published August 6, 2010 (75 FR 47504-47515). The comment period ends October 5, 2010. DoD anticipates finalizing this rule in the spring or fall of FY 2011. 7. Health Affairs, Department of Defense

The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care by operating an extensive network of medical treatment facilities. This network includes DoD's own military treatment facilities supplemented by civilian health care providers, facilities, and services under contract to DoD through the

TRICARE program. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system. The program's goal is to increase access to health care services, improve health care quality, and control health care costs.

The TRICARE Management Activity has published or plans to publish the following rules:

Final rule on CHAMPUS/TRICARE: Inclusion of TRICARE Retail

Pharmacy Program in Federal Procurement of Pharmaceuticals.

This rule provided an additional opportunity for comment on the final rule of March 17, 2009, implementing provisions of section 703 of the National Defense Authorization Act for Fiscal Year 2008. This statute extended pharmaceutical

Federal Ceiling Prices to TRICARE Retail Pharmacy Program prescriptions. The Department of Defense (DoD) issued a final rule on March 17, 2009, implementing the law. On

November 30, 2009, the U.S. District Court for the District of Columbia ``ordered that the final rule is remanded without vacatur for the Defense Department to consider in its discretion whether to readopt the current iteration of the rule or adopt another approach to implement 10 U.S.C. 1074g(f).'' As part of DoD's reconsideration, DoD solicited public comments on the implementation of the statute, DoD's resulting regulations, and the matters addressed for DoD's consideration in the Court's Memorandum Opinion. The proposed rule was published February 9, 2010 (75 FR 6335- 6336). The comment period ended on March 11, 2010. DoD anticipates publishing a second final rule in the first quarter of FY 2011.

Final rule on TRICARE: Relationship Between the TRICARE

Program and Employer-Sponsored Group Health Coverage. This rule implements section 1097c of title 10, United States

Code. This law prohibits employers from offering incentives to TRICARE-eligible employees to not enroll, or to terminate enrollment, in an employer-offered Group Health

Plan (GHP) that is or would be primary to TRICARE.

Cafeteria plans that comport with section 125 of the

Internal Revenue Code will be permissible so long as the plan treats all employees the same and does not illegally take TRICARE eligibility into account. The proposed rule was published March 28, 2008

Page 79507

(73 FR 16612). The comment period ended May 27, 2008. The final rule published April 9, 2010 (75 FR 18051 to 18055) with an effective date of June 18, 2010.

Proposed rule on TRICARE: Sole Community Hospital Payment

Reform. This rule implements the statutory provision in section 1079(j)(2) of title 10, United States Code that

TRICARE payment methods for institutional care shall be determined to the extent practicable in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for services provided by sole community hospitals. DoD anticipates publishing a proposed rule in the first or second quarter of FY 2011.

Proposed rule on TRICARE: Long Term Care Hospital Prospective

Payment System. This rule adopts a reimbursement methodology for Long Term Care Hospitals similar to

Medicare's Long Term Care Hospital Prospective Payment

System. DoD anticipates publishing a proposed rule in the spring of FY 2011. 8. Networks and Information Integration, Department of Defense

The Department of Defense will publish a rule regarding Defense

Industrial Base Voluntary Cyber Security and Information Assurance

Information Sharing:

Interim Final Rule: This rule establishes cyber threat information sharing, reporting, and analysis mechanisms between DoD and cleared Defense Industrial Base (DIB) contractors to enhance cyber threat situational awareness and threat response. The rule establishes a voluntary information sharing environment with DIB partners to address the unacceptable risk and imminent threat to national and economic security stemming from the unauthorized access by U.S. adversaries or business competitors to critical DoD unclassified information resident on, or transiting, DIB unclassified networks. The rule describes the collaborative DoD and DIB corporate- level partnership to enhance security of DIB networks; increase USG and industry knowledge of advanced cyber threats; provide near-real time cyber threat information sharing and understand the impact of data compromise on DoD operational activities. Participation in the DIB Cyber

Security/Information Assurance program is voluntary and open to all qualified cleared contractors. DoD anticipates publishing an interim final rule in the second quarter of

FY 2011.

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Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department consisting of 3 Military departments (Army, Navy, and Air Force), 10

Unified Combatant Commands, 14 Defense agencies, and 10 DoD Field

Activities 31. VOLUNTARY EDUCATION PROGRAMS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 10 USC 2005; 10 USC 2007

CFR Citation: 32 CFR 68

Legal Deadline:

None

Abstract:

This rule implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within

DoD. Included are: Procedures for Service members participating in education programs; guidelines for establishing, maintaining, and operating voluntary education programs, including but not limited to, instructor-led courses offered on-installation and off-installation, as well as via distance learning; procedures for obtaining on-base voluntary education programs and services; minimum criteria for selecting institutions to deliver higher education programs and services on military installations; the establishment of a DoD

Voluntary Education Partnership Memorandum of Understanding between DoD and educational institutions receiving tuition assistance payments; and procedures for other education programs for Service members and their adult family members.

Statement of Need:

This rule implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within

Summary of Legal Basis: sections 2005 and 2007 of title 10, United States Code

Alternatives:

None.

Anticipated Cost and Benefits:

Voluntary Education Programs include: High School Completion /Diploma;

Military Tuition Assistance (TA); Postsecondary Degree Programs;

Independent Study and Distance Learning Programs; College Credit

Examination Program; Academic Skills Program; and Certification/

Licensure Programs. Funding for Voluntary Education Programs during 2009 was $800 million, which included tuition assistance and operational costs. This funding provided more than 650,000 individuals

(Service members and their adult family members) the opportunity to participate in Voluntary Education Programs around the world.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

08/06/10

75 FR 47504

NPRM Comment Period End

10/05/10

Final Action

04/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Page 79508

Agency Contact:

Kerrie Tucker

Department of Defense

Office of the Secretary

Defense Pentagon

Washington, DC 20301

Phone: 703 602-4949

RIN: 0790-AI50

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Page 79508

Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department consisting of 3 Military departments (Army, Navy, and Air Force), 10

Unified Combatant Commands, 14 Defense agencies, and 10 DoD Field

Activities

DOD--Office of Assistant Secretary for Health Affairs (DODOASHA)

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Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department consisting of 3 Military departments (Army, Navy, and Air Force), 10

Unified Combatant Commands, 14 Defense agencies, and 10 DoD Field

Activities 32. TRICARE; REIMBURSEMENT OF SOLE COMMUNITY HOSPITALS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 5 USC 301; 10 USC ch 55

CFR Citation: 32 CFR 199

Legal Deadline:

None

Abstract:

This proposed rule is to implement the statutory provision at 10 U.S.C. 1079(j)(2) that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for inpatient services provided by Sole Community

Hospitals (SCHs). It will be phased in over a several-year period.

Statement of Need:

This rule is being published to implement the statutory provision in 10

U.S.C. 1079(j)(2), that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for inpatient services provided by Sole Community

Hospitals.

Summary of Legal Basis:

There is a statutory basis for this proposed rule: 10 U.S.C. 1079(j)(2).

Alternatives:

Alternatives were considered for phasing in the needed reform and an alternative was selected for a gradual, smooth transition.

Anticipated Cost and Benefits:

We estimate the total reduction (from the proposed changes in this rule) in hospital revenues under the SCH reform for its first year of implementation (assumed for purposes of this RIA to be FY 2011), compared to expenditures in that same period without the proposed SCH changes, to be approximately $190 million. The estimated impact for FYs 2012 through 2015 (in $ millions) is $208, $229, $252, and $278 respectively.

Risks:

Failure to publish this proposed rule would result in noncompliance with a statutory provision.

Timetable:

Action

Date

FR Cite

NPRM

12/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

None

Agency Contact:

Marty Maxey

Department of Defense

Office of Assistant Secretary for Health Affairs 1200 Defense Pentagon

Washington, DC 20301

Phone: 303 676-3627

RIN: 0720-AB41

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Statement of Regulatory Priorities

I. Introduction

The U.S. Department of Education (Department) supports States, local communities, institutions of higher education, and others in improving education nationwide and in helping to ensure that all Americans r

ED--Office of Postsecondary Education (OPE)

Page 79510

generally go through the negotiated rulemaking process.

D. Individuals with Disabilities Education Act

We plan to issue final regulations implementing changes to the part C program--the early intervention program for infants and toddlers with disabilities--under the IDEA.

E. Family Educational Rights and Privacy Act

Given the President's emphasis on improving the collection and use of data as a key element of educational reform, we intend to issue a notice of proposed rulemaking to amend our current regulations for the

Family Educational Rights and Privacy Act of 1974 (FERPA) to ensure that States are able to effectively establish and expand robust statewide longitudinal data systems while protecting student privacy.

F. Other Potential Regulatory Activities

Congress may legislate to reauthorize the Adult Education and Family

Literacy Act (AEFLA) (title II of the Workforce Investment Act of 1998) and the Rehabilitation Act of 1973, as amended. The Administration is working with Congress to ensure that any changes to these laws (1) improve the State grant and other programs providing assistance for adult basic education under the AEFLA and for vocational rehabilitation and independent living services for persons with disabilities under the

Rehabilitation Act of 1973 and (2) provide greater accountability in the administration of programs under both statutes. Changes to our regulations may be necessary as a result of the reauthorization of these two statutes.

III. Principles for Regulating

Over the next year, other regulations may be needed because of new legislation or programmatic changes. In developing and promulgating regulations, we follow our Principles for Regulating, which determine when and how we will regulate. Through consistent application of the following principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without regulations or with limited regulatory action.

In deciding when to regulate, we consider the following:

Whether regulations are essential to promote quality and equality of opportunity in education.

Whether a demonstrated problem cannot be resolved without regulation.

Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity.

Whether entities or situations subject to regulation are so diverse that a uniform approach through regulation does more harm than good.

Whether regulations are needed to protect the Federal interest; that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse.

In deciding how to regulate, we are mindful of the following principles:

Regulate no more than necessary.

Minimize burden to the extent possible and promote multiple approaches to meeting statutory requirements if possible.

Encourage coordination of federally funded activities with

State and local reform activities.

Ensure that the benefits justify the costs of regulation.

To the extent possible, establish performance objectives rather than specify compliance behavior.

Encourage flexibility, to the extent possible, so institutional forces and incentives achieve desired results.

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Statement of Regulatory Priorities

I. Introduction

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 20 USC title IV; PL 111-152

CFR Citation: 34 CFR ch VI

Legal Deadline:

None

Abstract:

The Secretary proposes to amend its title IV, HEA student assistance regulations, to (1) reflect the termination of the Federal Family

Education Loan Program pursuant to title II of the Health Care and

Education Reconciliation Act of 2010, which is the SAFRA Act, and (2) reflect other statutory changes resulting from the SAFRA Act.

Statement of Need:

These regulations are needed to reflect the provisions of the SAFRA Act

(title II of the Health Care and Education Reconciliation Act of 2010), which terminated the Federal Family Education Loan (FFEL) program, and to reflect other amendments to the HEA resulting from the SAFRA Act.

Summary of Legal Basis:

Health Care and Education Reconciliation Act of 2010, Public Law 111- 152.

Alternatives:

The Department is still developing these proposed regulations; our discussion of alternatives will be included in the notice of proposed rulemaking.

Anticipated Cost and Benefits:

Estimates of the costs and benefits are currently under development and will be published in the proposed regulations.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

05/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

None

URL For Public Comments: www.regulations.gov

Agency Contact:

David Bergeron

Department of Education

Office of Postsecondary Education

Room 8022 1990 K Street NW.

Washington, DC 20006

Phone: 202 502-7815

Email: david.bergeron@ed.gov

RIN: 1840-AD05

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Statement of Regulatory Priorities

I. Introduction

ED--OPE

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Statement of Regulatory Priorities

I. Introduction

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 20 USC 1001 to 1003; 20 USC 1070g; 20 USC 1085; 20 USC 1088; 20 USC 1091 to 1092; 20 USC 1094; 20 USC 1099c; 20 USC 1099c-1; . . .

CFR Citation: 34 CFR 668

Legal Deadline:

None

Abstract:

The Secretary amends the Student Assistance General Provisions to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in recognized occupations, and the conditions under which those educational programs remain eligible for the student financial assistance programs authorized under title IV of the Higher Education Act of 1965, as amended.

Statement of Need:

These regulations are needed to establish measures for determining whether certain postsecondary educational programs lead to gainful employment in a recognized occupation.

Summary of Legal Basis:

Title IV of the Higher Education Act of 1965, as amended.

Alternatives:

A discussion of alternatives was outlined in the Notice of Proposed

Rulemaking published on July 26, 2010.

Anticipated Cost and Benefits:

Estimates of anticipated costs and benefits are set forth in the Notice of Proposed Rulemaking published on July 26, 2010.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

07/26/10

75 FR 43616

NPRM Comment Period End

09/09/10

Final Action

02/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

None

URL For Public Comments: www.regulations.gov

Agency Contact:

John A. Kolotos

Department of Education

Office of Postsecondary Education

Room 8018 1990 K Street NW.

Washington, DC 20006-8502

Phone: 202 502-7762

Email: john.kolotos@ed.gov

Fred Sellers

Department of Education

Office of Postsecondary Education

Room 8021 1990 K Street NW.

Washington, DC 20006

Phone: 202 502-7502

Email: fred.sellers@ed.gov

Related RIN: Previously reported as 1840-AD04

RIN: 1840-AD06

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Statement of Regulatory and Deregulatory Priorities

The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental

DOE--Energy Efficiency and Renewable Energy (EE)

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Statement of Regulatory and Deregulatory Priorities

CONDITIONERS

Priority:

Economically Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 42 USC 6295(c) and (g)

CFR Citation: 10 CFR 430

Legal Deadline:

Final, Judicial, June 30, 2011.

Abstract:

The Energy Policy and Conservation Act, as amended, establishes initial energy efficiency standard levels for many types of major residential appliances and generally requires DOE to undertake two subsequent rulemakings, at specified times, to determine whether the existing standard for a covered product should be amended. This is the second review of the standards for clothes dryers and room air conditioners.

Page 79513

Statement of Need:

The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances from the market.

Summary of Legal Basis:

Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. EPCA covers consumer products and certain commercial equipment, including clothes dryers and room are conditioners that are the subject of the rulemaking (42 U.S.C. 6292(a)(2)-(8)). EPCA prescribes energy conservation standards for room air conditioners (42 U.S.C. 6295(c)) and directs DOE to conduct two cycles of rulemaking to determine whether to adopt amended standards

(42 U.S.C. 6295(c)(3)(A)). For clothes dryers, EPCA sets a prescriptive requirement (42 U.S.C. 6294(g)(3)) and directs DOE to conduct a cycle of rulemaking to determine whether to adopt amended standards (42

U.S.C. 6294(g)(4)). This rulemaking represents the second and first round of amendments to the standards for room air conditioners and dryers respectively.

Alternatives:

The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is a technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits:

Because DOE has not yet proposed candidate standard levels for these products, DOE cannot provide an estimate of combine aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasibly and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment.

Timetable:

Action

Date

FR Cite

Notice: Public Meeting,

Framework Document

Availability

10/09/07

72 FR 57254

Notice: Public Meeting,

Data Availability

02/23/10

75 FR 7987

Comment Period End

04/26/10

NPRM

03/00/11

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Local, State

Federalism:

Undetermined

Additional Information:

This rulemaking is the second of two rulemakings required for this equipment. Comments pertaining to this rule may be submitted electronically to aham2-2008-TP-0010@hq.doe.gov.

URL For More Information: www1.eere.energy.gov/buildings--standards/residential/clothes-- dryers.html

URL For Public Comments: www.regulations.gov

Agency Contact:

Stephen Witkowski

Office of Building Technologies Program, EE-2J

Department of Energy

Energy Efficiency and Renewable Energy 1000 Independence Avenue SW.

Washington, DC 20585

Phone: 202 586-7463

Email: stephen.witkowski@ee.doe.gov

Related RIN: Merged with 1904-AB51, Related to 1904-AB76, Related to 1904-AC02

RIN: 1904-AA89

December 20, 2010 (Volume 75, Number 243)

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Page 79513-79514

Statement of Regulatory and Deregulatory Priorities

CONDITIONERS AND HEAT PUMPS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 42 USC 6295(d)

CFR Citation: 10 CFR 430

Legal Deadline:

Final, Judicial, June 30, 2011.

Abstract:

DOE is reviewing and updating energy efficiency standards, as required by the Energy Policy and Conservation Act, to reflect technological advances. All amended standards must be technologically feasible and economically justified. This is the second review of the statutory standards for residential central air conditioners and air conditioning heat pumps.

Statement of Need:

The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis:

Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. Amendments expanded title III of EPCA to include certain commercial and industrial equipment. (42 U.S.C. 6292(3)) The National Appliance Energy Conservation Act of 1987

(NAECA), Pub. L. 100--12, established energy conservation standards for central air conditioners and heat pumps as well as requirements for determining whether these standards should be amended. NAECA also required that DOE conduct two cycles of rulemakings to determine if more stringent standards are economically justified and technologically feasible. (42 U.S.C. 6295(d)(3)) On January 22, 2001, DOE published a final rule in the Federal Register, which completed the first rulemaking cycle to amend energy conservation standards for residential central air conditioners and heat pumps. 66 FR 7170. This rulemaking encompasses DOE's second cycle of review to determine whether the standards in effect for residential central air conditioners and heat pumps should be amended.

Page 79514

Alternatives:

The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits:

Because DOE has not yet proposed candidate standard levels for this equipment, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified.

Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment.

Timetable:

Action

Date

FR Cite

Notice: Public Meeting,

Framework Document

Availability

06/06/08

73 FR 32243

Notice: Public Meetings,

Data Availability

03/25/10

75 FR 14368

NPRM

12/00/10

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Local, State

Federalism:

Undetermined

Additional Information:

This rulemaking is the second of two rulemakings required for this equipment. Comments pertaining to this rule may be submitted electronically to Res--Central--AC--HP@ee.doe.gov.

URL For More Information: www1.eere.energy.gov/buildings/appliance--standards/residential/ central--ac--hp.html

URL For Public Comments: www.regulations.gov

Agency Contact:

Wes Anderson

Mechanical Engineer, Office of Building Technologies Program, EE-2J

Department of Energy

Energy Efficiency and Renewable Energy 1000 Independence Avenue SW.

Washington, DC 20585

Phone: 202 586-7335

Email: wes.anderson@ee.doe.gov

Related RIN: Related to 1904-AB94

RIN: 1904-AB47

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Page 79514-79515

Statement of Regulatory and Deregulatory Priorities

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 42 USC 6295(g)

CFR Citation: 10 CFR 430

Legal Deadline:

Final, Judicial, June 30, 2011.

Abstract:

DOE is reviewing and updating energy efficiency standards, as required by the Energy Policy and Conservation Act, to reflect technological advances. All amended energy efficiency standards must be technologically feasible and economically justified. This is the second review of the statutory standards for fluorescent lamp ballasts.

Statement of Need:

The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis:

The Energy Policy and Conservation Act (EPCA) of 1975 (42 U.S.C. 6291 to 6309) established an energy conservation program for major household appliances. Amendments to EPCA in the National Appliance Energy

Conservation Amendments of 1988 (NAECA 1988) established energy conservation standards for fluorescent lamp ballasts. These amendments also required that DOE (1) conduct two rulemaking cycles to determine whether these standards should be amended and (2), for each rulemaking cycle, determine whether the standards in effect for fluorescent lamp ballasts should be amended to apply to additional fluorescent lamp ballasts. (42 U.S.C. 6295(g)(7)(A)--(B)). On September 19, 2000, DOE published a final rule in the Federal Register, which completed the first rulemaking cycle to amend energy conservation standards for fluorescent lamp ballasts. 65 FR 56740. This rulemaking encompasses

DOE's second cycle of review to determine whether the standards in effect for fluorescent lamp ballasts should be amended and whether the standards should be applicable to additional fluorescent lamp ballasts.

Alternatives:

The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits:

Because DOE has not yet proposed candidate standard levels for this equipment, however, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment.

Timetable:

Action

Date

FR Cite

Notice: Public Meeting,

Framework Document

Availability

01/22/08

73 FR 3653

Notice: Public Meetings,

Data Availability

03/24/10

75 FR 14319

NPRM

12/00/10

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Local, State

Page 79515

Federalism:

Undetermined

Additional Information:

This rulemaking is the second of two rulemakings required for this equipment. Comments pertaining to this rule may be submitted electronically to ballasts.rulemaking@ee.doe.gov.

URL For More Information: www1.eere.energy.gov/ buildings/appliance--standards/residential. fluorescent--lamp.ballasts.html

URL For Public Comments: www.regulations.gov

Agency Contact:

Linda Graves

Office of Building Technologies Program, EE-2J

Department of Energy

Energy Efficiency and Renewable Energy 1000 Independence Avenue SW.

Washington, DC 20585

Phone: 202 586-1851

Email: linda.graves@ee.doe.gov

Related RIN: Related to 1904-AB77, Related to 1904-AA99

RIN: 1904-AB50

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-58

Page 79515

Statement of Regulatory and Deregulatory Priorities

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 42 USC 6295(f) and (m)

CFR Citation: 10 CFR 430

Legal Deadline:

Final, Judicial, June 30, 2011.

Abstract:

DOE published an energy conservation standard final rule for residential furnaces and boilers in the Federal Register on November 19, 2007 (72 FR 65136). Petitioners challenged this final rule on several grounds. DOE filed a motion for voluntary remand to allow the agency to consider: 1) The application of regional standards in additional to national standards for furnaces, authorized by Energy

Independence and Security Act of 2007 (enacted Dec. 19, 2007) and 2) the effect of alternative standards on natural gas prices. This motion for voluntary remand was granted on April 21, 2009. DOE has initiated this rulemaking to consider amended energy conservation standards for residential furnaces.

Statement of Need:

The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis:

Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. The program covers certain commercial and industrial equipment, including residential furnaces. (42 U.S.C. 6292(a)(5)) EPCA prescribed the initial energy conservation standards for residential furnaces. (42 U.S.C. 6295(f)(1)--(2)) The statute further provides DOE with the authority to conduct rulemakings to determine whether to amend these standards. (42 U.S.C. 6295(f)(4)).

Alternatives:

The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits:

Estimates of energy savings will be provided when DOE issues the notices of proposed rulemaking for this equipment.

Timetable:

Action

Date

FR Cite

Notice: Public Meeting,

Rulemaking Analysis

Plan Availability

03/15/10

75 FR 12144

NPRM

12/00/10

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Undetermined

Federalism:

Undetermined

URL For More Information: http://www1.eere.energy.gov/buildings/appliance--standards/residential/ furnaces--boilers.html

URL For Public Comments: www.regulations.gov

Agency Contact:

Mohammed Khan

Office of Building Technologies Program, EE-2J

Department of Energy

Energy Efficiency and Renewable Energy 1000 Independence Avenue SW.

Washington, DC 20585

Phone: 202 586-7892

Email: mohammed.khan@ee.doe.gov

RIN: 1904-AC06

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-59

Page 79515-79516

Statement of Regulatory and Deregulatory Priorities

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 42 USC 17071

CFR Citation: 10 CFR 460

Legal Deadline:

Final, Statutory, December 19, 2011.

Abstract:

The rule would establish energy efficiency standards for manufactured housing and a system to ensure compliance with, and enforcement of, the standards.

Page 79516

Statement of Need:

The Energy Independence and Security Act requires increased energy efficiency standards for manufactured housing.

Summary of Legal Basis:

Section 413 of the Energy Independence and Security Act of 2007 (EISA), 42 U.S.C. 17071 directs DOE to develop and publish energy standards for manufactured housing.

Alternatives:

The statute requires DOE to conduct a rulemaking to establish standards to achieve the maximum improvement in energy efficiency that the

Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits:

Because DOE has not yet proposed candidate standard levels, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide the increased energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Timetable:

Action

Date

FR Cite

ANPRM

02/22/10

75 FR 7556

ANPRM Comment Period End

03/24/10

NPRM

04/00/11

Final Action

12/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

None

URL For Public Comments: www.regulations.gov

Agency Contact:

Jean J. Boulin

Project Manager, Office of Building Technologies Program, EE-2J

Department of Energy

Energy Efficiency and Renewable Energy 1000 Independence Avenue SW.

Washington, DC 20585

Phone: 202 586-9870

Email: jean.boulin@ee.doe.gov

RIN: 1904-AC11

December 20, 2010 (Volume 75, Number 243)

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From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:ua20de10_002-60

Page 79516

Statement of Regulatory and Deregulatory Priorities

DOE--EE

FINAL RULE STAGE

December 20, 2010 (Volume 75, Number 243)

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Page 79516-79517

Statement of Regulatory and Deregulatory Priorities

REFRIGERATOR-FREEZERS, AND FREEZERS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority: 42 USC 6295(b)(4)

CFR Citation: 10 CFR 430

Legal Deadline:

Final, Statutory, December 31, 2010.

Abstract:

The Energy Independence and Security Act of 2007 amended the Energy

Policy and Conservation Act and directed the Secretary to issue a final rule to determine whether to amend the standards for refrigerators, refrigerator-freezers, and freezers. The final rule will contain any amended standards.

Statement of Need:

The Energy Policy and Conservation Act requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis:

Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products other than Automobiles. EPCA covers consumer products and certain commercial equipment, including the types of refrigeration products that are the subject of this rulemaking. (42 U.S.C. 6292(a)(1)) EPCA prescribes energy conservation standards for these products (42 U.S.C. 6295(b)(1)-(2)) and directs DOE to conduct three cycles of rulemakings to determine whether to adopt amended standards. (42 U.S.C. 6295(b)(3)(A)(i), (b)(3)(B)-(C), and (b)(4)) This rulemaking represents the third round of amendments to the standards for refrigeration products.

Alternatives:

The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute

Anticipated Cost and Benefits:

DOE believes that the benefits to the Nation of the proposed energy standards for residential refrigerators and freezers (energy savings, consumer average lifecycle cost (LCC) savings, national net present value (NPV) increase, and emission reductions) outweigh the burdens

(loss of INPV and LCC increases for some small electric motor users).

DOE estimates that energy savings from electricity will be 4.5 quads over 30 years and the benefit to the Nation will be between $2.56 billion and $18.80 billion.

Timetable:

Action

Date

FR Cite

Notice: Public Meeting,

Framework Document

Availability

09/18/08

73 FR 54089

Notice: Public Meeting,

Data Availability

11/16/09

74 FR 58915

NPRM

09/27/10

75 FR 59470

NPRM Comment Period End

11/26/10

Final Action

12/00/10

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Local, State

Page 79517

Federalism:

This action may have federalism implications as defined in EO 13132.

Additional Information:

Comments pertaining to this rule may be submitted electronically to

ResRefFreez-2008-STD-0012@hq.doe.gov.

URL For More Information: www.eere.energy.gov/buildings/appliance--standards/residential/ refrigerators--freezer.html

URL For Public Comments: www.regulations.gov

Agency Contact:

Subid Wagley

Office of Building Technologies Program, EE-2J

Department of Energy

Energy Efficiency and Renewable Energy 1000 Independence Avenue SW.

Washington, DC 20585

Phone: 202 287-1414

Email: subid.wagley@ee.doe.gov

Related RIN: Related to 1904-AB92

RIN: 1904-AB79

BILLING CODE 6450-01-S

Page 79518

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DOCID:ua20de10_002-62

Page 79518-79521

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--Office of the Secretary (OS)

Page 79519

Additionally, there will be smaller ongoing FDA enforcement costs.

Two other key rules will implement provisions of the Affordable Care

Act that require certain chain restaurants and vending machine operators to disclose nutritional information about their offerings. In the case of chain restaurants, these businesses will bear the cost of analysis of their menu items for nutritional information where this analysis does not already exist, and the cost of revising existing menus and other displays to note the required information. In the case of vending machines, the bulk of the costs associated with this rule will be in managing the actual disclosure of calories at the machine.

Because almost all vending machines sell food that is previously manufactured and packaged, most vended foods are subject to the

Nutrition Labeling and Education Act, which means that calorie content is already collected. The requirements of these rules, specifically that calorie and other nutrition information appear at the point of purchase, solves the apparent market failure in information provision stemming from present-biased preferences. 3. Enhanced Insurance Appeal and External Review Processes Under the

Affordable Care Act

With a goal of empowering patient consumers, the Affordable Care Act provides individuals with the right to appeal decisions made by their private health insurer to an outside, independent decisionmaker, regardless of consumers' State of residence or type of health insurance. One rule to be promulgated by the Department in FY 2011 will ensure that non-grandfathered plans and issuers comply with State or

Federal external review processes. This rule will advance the

Administration's objective of transparency by making certain that all consumers--regardless of whether their plan has grandfather status--are afforded an opportunity to appeal the decisions of their health carrier before an independent body. HHS estimates the benefits of the regulation to come from the transformation of the current, highly variable health claims and appeals process into a more uniform and structured process. This will result in a reduction in the incidence of excessive delays and inappropriate denials, averting serious, avoidable lapses in health care quality and resultant injuries and losses to participants; enhance enrollees' level of confidence in and satisfaction with their health care benefits and improve plans' awareness of participant concerns, prompting plan responses that improve quality; helping ensure prompt and precise adherence to contract terms and improving the flow of information between plans and enrollees to bolster the efficiency of labor, health care, and insurance markets. It is not possible to quantify these benefits at this time. The primary sources of costs are those required to administer and conduct the internal and external review process, prepare and distribute required disclosures and notices, and bring plan and issuers' internal and external claims and appeals procedures into compliance with the new requirements. In addition, there are start-up costs for issuers in the individual market to bring themselves into compliance and the costs and transfers associated with the reversal of denied claims. These costs are estimated to total $50.4 million in 2011, $78.8 million in 2012, and $101.1 million in 2013. 4. Notification Requirements for Long-Term Care Facility Closures

A rule to be promulgated by CMS in the upcoming fiscal year will require that, in the case of a long-term care facility closure, the facility administrator provides written notification of closure and the plan for the relocation of residents at least 60 days prior to the impending closing. Such transparency will afford patients and family members a greater opportunity to meaningfully participate in decisions regarding relocation. The costs associated with the implementation of this rule are related to the efforts made by each facility to develop a plan for closure. The benefits would include the protection of residents' health and safety and a smooth transition for residents who need to be relocated, as well as their family members and facility staff.

In addition to the aforementioned rules, the Department's regulatory priorities in the upcoming fiscal year include:

Eliminating Insurance Company Abuses Under the Affordable Care Act

The Affordable Care Act made important changes that will improve the affordability and transparency of private health insurance in the

United States. Specifically, the law calls for the annual State review of unreasonable increases in health insurance premiums, which will help protect consumers from unjustified and/or excessive premium increases.

In developing a process for the review of rate increases, HHS will propose standards for when and how health insurance issuers will be required to report rate increases, as well as detail the relevant data and documentation that must be submitted in support of rate increases.

The proposed rule will detail criteria for how determinations of unreasonableness will be made by HHS and also sets forth the conditions under which HHS will adopt unreasonableness determinations made by

States. The rule will also propose standards for when and how health insurance issuers must provide justifications for rate increases determined to be unreasonable and when such justifications must be posted on the issuer's website. It will explain that HHS will post information regarding rate increases on its website to ensure the public disclosure of information on rate increases, including increases determined to be unreasonable. Finally, the proposed rule will address the development by HHS of annual summaries of data on rate trends.

The CLASS Act and Improving Long-Term Care

The Department will promulgate a significant rule in FY 2011 that will improve the quality of long-term care for affected Americans.

Implementation of the CLASS (Community Living Assistance Services and

Support) Act will provide a new opportunity for all Americans to prepare themselves financially to remain independent under a variety of future health circumstances as they age. While this program may help reduce spending down to Medicaid, costs to implement the proposed regulation have not yet been estimated.

Food Safety

The Department is committed to improvements in our food safety system guided in part by the findings of the President's Food Safety Working

Group, which adopted a public-health approach based on three core principles: Prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery if prevention fails.

The goal of this new agenda is to shift emphasis away from mitigating public health harm by removing unsafe products from the market place to a new overriding objective--preventing harm by keeping unsafe food from entering commerce in the first place. As such, an FDA regulation will aim squarely at protecting the youngest and most vulnerable Americans by finalizing a modernization of existing requirements

Page 79520

on current good manufacturing practices for infant formula.

Streamlining Drug and Device Requirements

Two Food and Drug Administration (FDA) final rules will standardize the electronic submission of registrations and listings for devices, data from studies evaluating drugs and biologics for humans, and data on adverse events involving medical devices. Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the Agency review process. FDA estimates that the costs resulting from the proposal would include substantial one-time costs, additional waves of one-time costs as standards mature, and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits associated with reduced time for preparing applications, including reduced preparation costs and faster time to market for beneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensive, and accurate data review, as well as enhanced communication among sponsors and clinicians.

Additionally, a new proposed rule will establish a unique identification system that will identify a device through distribution and use. FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a unique device identifier (UDI), costs to purchase equipment to print and verify the

UDI, and costs to purchase software, integrate and validate the UDI into existing IT systems. Certain entities would be required to submit information about each UDI and the relevant medical device into a database. FDA anticipates that implementation of a UDI system would help improve the efficiency of recalled medical devices and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors. Together, these rules will enable the FDA to more quickly and efficiently process and review information submitted on devices, drugs, and biologics, furthering their ability to both better protect the public safety and more rapidly advance innovations to the market.

Medicare Modernization

The Regulatory Plan highlights three final rules that would adjust payment amounts under Medicare for physicians' services, hospital inpatient, and hospital outpatient services for fiscal year 2012. These new payment rules reflect continuing experience with regulating these systems and will implement modernizations to ensure that the Medicare program best serves its beneficiaries, fairly compensates providers, and remains fiscally sound. Additionally, another rule promulgated under the Affordable Care Act will propose a Medicare shared savings program for provider groups to establish Accountable Care Organizations and share in savings generated for Medicare by meeting certain benchmarks.

Health Information Technology

The Department will issue a rule that will modify the existing HIPAA privacy and security enforcement regulations to comply with the provisions of the HITECH Act. This rule will ensure that Americans can be confident that their medical data is kept private as the country increasingly moves to electronic health records. These modifications to the HIPAA Privacy, Security, and Enforcement Rules will benefit health care consumers by strengthening the privacy and security protections afforded their health information by HIPAA covered entities and their business associates. The Agency believes the primary cost associated with this regulation will be for covered entities to revise and redistribute their notices of privacy practices to ensure health care consumers are informed of their new rights and protections. The Agency estimates the cost of revising and redistributing these notices to total approximately $166.1 million over the first year following the effective date of the regulation. Of this total, the cost to health care providers is estimated to be approximately $46 million and to health plans to be approximately $120.1 million. The Agency does not believe that the additional modifications to the Privacy, Security, or

Enforcement Rules required by this regulation will significantly increase covered entity or business associate costs. It is estimated that the changes to the HIPAA authorization and access requirements will impose little to no additional costs on covered entities and their business associates, and in some cases will reduce burden. Further, it is expected that the costs of modifying business associate contracts will be mitigated both by the additional one-year transition period which will allow the costs of modifying contracts to be incorporated into the normal renegotiation of contracts as the contracts expire, as well as sample business associate contract language to be provided by the Agency.

Head Start Program Integrity

The Department will finalize a rule in FY 2011 that will implement statutory requirements requiring a re-evaluation of Head Start grantees every 5 years to ensure that taxpayer dollars are spent in the most effective possible manner by this critical program. The Administration on Children and Families estimates the costs of implementing the new reporting requirements described in the rule will be approximately

$20,000 annually. In addition, at least 25 percent of grantees reviewed in a year will be required to submit a competitive application for a new 5-year grant, at an estimated cost of less than $1,500 for each grantee. In terms of benefits, the proposed system will fund only high- performing grantees in order to ensure the best services for Head Start children are provided and child outcomes are improved.

Small Business Impact

Finally, HHS actively seeks to minimize regulatory burdens on small business. Over 95 per cent of the entities that we regulate - hospitals, doctors' practices, social service providers, medical device firms, universities and many others - qualify as ``small entities'' under the Regulatory Flexibility Act (RFA). All of the aforementioned actions have been developed in light of and with serious consideration of the small-business impact analysis.

Page 79521

FINAL RULE STAGE

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Page 79521

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 41. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES

UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL

HEALTH ACT

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

PL 111-5, secs 13400 to 13410

CFR Citation: 45 CFR 160; 45 CFR 164

Legal Deadline:

NPRM, Statutory, February 17, 2010.

Abstract:

The Department of Health and Human Services Office for Civil Rights will issue rules to modify the HIPAA Privacy, Security, and Enforcement

Rules as necessary to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information

Technology for Economic and Clinical Health Act (title XIII of the

American Recovery and Reinvestment Act of 2009).

Statement of Need:

The Office for Civil Rights will issue rules to modify the HIPAA

Privacy, Security, and Enforcement Rules to implement the privacy and security provisions in sections 13400 to 13410 of the Health

Information Technology for Economic and Clinical Health Act (title XIII of Division A of the American Recovery and Reinvestment Act of 2009,

Pub. L. 111-5). These regulations will improve the privacy and security protection of health information.

Summary of Legal Basis:

Subtitle D of the Health Information Technology for Economic and

Clinical Health Act (title XIII of the American Recovery and

Reinvestment Act of 2009) requires the Office for Civil Rights to modify certain provisions of the HIPAA Privacy and Security Rules to implement sections 13400 to 13410 of the Act.

Alternatives:

The Office for Civil Rights is statutorily mandated to make modifications to the HIPAA Privacy and Security Rules to implement the privacy provisions at sections 13400 to 13410 of the Health Information

Technology for Economic and Clinical Health Act (title XIII of the

American Recovery and Reinvestment Act of 2009).

Anticipated Cost and Benefits:

These modifications to the HIPAA Privacy, Security, and Enforcement

Rules will benefit health care consumers by strengthening the privacy and security protections afforded their health information by HIPAA covered entities and their business associated. The Agency believe the primary cost associate with this regulation will be for covered entities to revise and redistribute their notices of privacy practices to ensure health care consumers are informed of their new rights and protections. The Agency estimates the cost of revising and redistributing these notices to total approximates $166.1 million over the first year following the effective date of the regulation. Of this total, the cost heal care providers is estimated to be approximately

$46 million and to health plans to be approximately $120.1 million. The

Agency does not believe that the additional modification to Privacy,

Security, or Enforcement Rules required by this regulation will significantly increase covered entity or business associates and in some cases will reduce burden. Further, it is expected that the costs of modifying business associate contracts will be mitigated both by the additional one-year transition period which will allow the costs of modifying contracts to be incorporated into the normal renegotiation of contracts as the contracts expire, as well as sample business associate contract language to be provided by the Agency.

Timetable:

Action

Date

FR Cite

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected:

Federal, Local, State, Tribal

Agency Contact:

Andra Wicks

Department of Health and Human Services 200 Independence Avenue SW.

Washington, DC 20201

Phone: 202 205-2292

Fax: 202 205-4786

Email: andra.wicks@hhs.gov

RIN: 0991-AB57

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--Office of Consumer Information and Insurance Oversight (OCIIO)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 42. TRANSPARENCY REPORTING

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 111-148, title I, subtitle A, sec 1001 PHS Act, sec 2715A

CFR Citation: 45 CFR 153, Insurance Rules (sec 2715A)

Legal Deadline:

None

Abstract:

The Affordable Care Act requires group health plans and health insurance issuers to submit specific information to the Secretary, the

State insurance commissioner, and to make the information available to the public. This includes information on claims payment policies, the number of claims denied, data on rating practices and other information as determined by the Secretary. The provision also requires plans and issuers to provide to individuals upon request the amount of cost sharing that the individual would be responsible for paying for a specific item or service provided by a participating provider. This interim final rule would implement information disclosure provisions in section 2715A of the Public Health Service Act, as added by the

Affordable Care Act.

Statement of Need:

The Department of Health and Human Services, along with the Department of Labor and the Treasury Department, will issue interim final rules to implement the information disclosure

Page 79522

provisions in section 2715A of the Public Health Service Act, as added by the Affordable Care Act. This regulation will improve the transparency of information about how health coverage works so consumers will have better information to use and assess the coverage they have now, and/or make choices among different coverage options.

Summary of Legal Basis:

Title I, subtitle A, section 1001 of the Affordable Care Act adds section 2715A to the Public Health Service Act that will require group health plans and health insurance issuers to make certain disclosures to the Secretary, the State insurance commissioner, the public, and in some cases, individuals.

Alternatives:

None--statutory requirement.

Anticipated Cost and Benefits:

HHS estimates the benefits of this regulation to come from improved information for consumers and regulators, which will in tern result in a more efficient insurance market. Improved information for consumers will allow them to make better health insurance choices -- to choose higher quality insurers and ones that more closely match their preferences with respect to plan design. This could result in increased satisfaction and decreased morbidity. In addition, consumers may be more likely to choose insurers with more efficient processes, which could result in a reduction in administrative costs. Improved information for regulators will allow for monitoring of the markets to track current industry practices, which will allow for better enforcement of current market regulations through more targeted audits that are based upon insurer responses. Additionally, reporting requirements and the threat of targeted audit will likely influence issuer behavior to motivate compliance. I is not possible to quantify the benefits at this time.

The direct costs imposed by the regulation are reporting requirements.

These requirements are still being developed, and will be quantified in the regulation.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Kaye L. Pestaina

Office of Consumer Support

Department of Health and Human Services

Office of Consumer Information and Insurance Oversight 200 Independence Avenue SW.

Washington, DC 20201

Phone: 301 492-4227

Email: kaye.pestaina@hhs.gov

RIN: 0950-AA07

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Page 79522

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--OCIIO

FINAL RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 43. RATE REVIEW

Priority:

Other Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 111-148

CFR Citation: 45 CFR 154

Legal Deadline:

None

Abstract:

The Affordable Care Act requires the Secretary to work with states to establish an annual review of unreasonable rate increases, to monitor premium increases and to award grants to states to carry out their rate review process. This interim final rule would implement the rate review process.

Statement of Need:

The Affordable Care Act requires standards to be set for the review of rate increases. The proposed rule will detail standards for when and how health insurance issuers will be required to report rate increases, as well as detail the relevant data and documentation that must be submitted in support of the rate increases. The proposed rule will detail criteria for how determinations of unreasonableness will be made by HHS, and also sets forth the conditions under which HHS will adopt unreasonableness determinations made by States. This regulation is part of the health insurance market reform and will increase affordability of health insurance for all Americans.

Summary of Legal Basis:

The Affordable Care Act.

Alternatives:

There are no alternatives, as this rulemaking is a matter of law based on the Affordable Care Act.

Anticipated Cost and Benefits:

HHS expects that costs associated with this rulemaking will be minimal as insurers routinely report to States on rate increases. Insurers may experience slight additional costs in connection with completion of policy rate data collection forms and any necessary submission of justification forms for rates that trigger unreasonable designations.

The benefits of these requirements include increased consumer protections around unsubstantiated premium rate increases, reduced health insurance rate increases, increased transparency and consumer confidence in the products they buy, and ensuring financially solvent companies that can pay promised benefits.

Timetable:

Action

Date

FR Cite

Interim Final Rule

07/03/10

75 FR 45014

Interim Final Rule

Comment Period End

09/28/10

Final Action

12/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

James Mayhew

Department of Health and Human Services

Office of Consumer Information and Insurance Oversight

Mail Stop C2-12016 7500 Security Boulevard

Baltimore, MD 21244

Phone: 410 786-9244

Email: james.mayhew@cms.hhs.gov

RIN: 0950-AA03

Page 79523

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 44. UNIFORM EXPLANATION OF BENEFITS, COVERAGE FACTS, AND

STANDARDIZED DEFINITIONS

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 111-148, title I, subtitle A, sec 1001 (Public Health Service Act, sec 2715)

CFR Citation: 45 CFR 153, Insurance Rules (sec 2715)

Legal Deadline:

None

Abstract:

The Affordable Care Act requires the Secretary to develop standards for use by group health plans and health insurance issuers in compiling and providing a summary of benefits and coverage explanation that accurately describes benefits and coverage. The Secretary must also set standards for the definitions of terms used in health insurance coverage, including specific terms set out in the statute. Plans and issuers must provide information according to these standards no later than 24 months after enactment. This interim final rule would implement the information disclosure provisions in section 2715 of PHSA , as added by the Affordable Care Act.

Statement of Need:

The Department of Health and Human Services, along with the Departments of Labor and the Treasury, will issue interim final rules to implement the information disclosure provisions in section 2715 of PHSA, as added by the Affordable Care Act. This regulation will provide consumers with a simplified and uniform overview of their benefits, specific

``Coverage Facts'' or scenarios for the costs of coverage for specific episodes of care, and standardized consumer-friendly health coverage definitions. This will allow consumers to better understand the coverage that they have and allow consumers choosing coverage to better compare coverage options.

Summary of Legal Basis:

Title I, subtitle A, section 1001, of the Affordable Care Act adds section 2715 to the Public Health Service Act that will require group health plans and health insurance issuers to provide a summary of benefits and coverage explanations and standardized definitions to applicants, enrollees, and policyholders.

Alternatives:

None--statutory requirement.

Anticipated Cost and Benefits:

HHS estimates the benefits of this regulation to come from improved information for consumers and regulators, which will in turn result in a more efficient insurance market. Improved information for consumers will allow them to make better health insurance choices--to chose higher quality insurers and ones that more closely match their preference with respect to plan design. This could result in increased satisfaction and decreased morbidity. It is not possible to quantify the benefits at this time.

The direct costs imposed by the regulation are the creation and provision of summary documents to consumers at the time of application, prior to enrollment and at re-enrollment. There will also be costs imposed by the creation of the coverage facts label section of the summary documents. These requirements are still being developed and will be quantified in the regulation.

Timetable:

Action

Date

FR Cite

Interim Final Rule

03/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Kaye L. Pestaina

Office of Consumer Support

Department of Health and Human Services

Office of Consumer Information and Insurance Oversight 200 Independence Avenue SW.

Washington, DC 20201

Phone: 301 492-4227

Email: kaye.pestaina@hhs.gov

RIN: 0950-AA08

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--Food and Drug Administration (FDA)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 45. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS

AND BIOLOGICS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96

Legal Deadline:

None

Abstract:

The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that

FDA can process, review, and archive.

Statement of Need:

Before a drug is approved for marketing, FDA must determine that the drug is safe and effective for its intended use. This determination is based in part on clinical study data and bioequivalence data that are submitted as part of the marketing application. Study data submitted to

FDA in electronic format have generally been more efficient to process and review.

FDA's proposed rule would address the submission of study data in a standardized electronic format. Electronic submission of study data would improve patient safety and enhance health care delivery by enabling FDA to process, review, and archive data more efficiently.

Standardization would also enhance the ability to share study data and communicate results. Investigators and industry would benefit from the use of

Page 79524

standards throughout the lifecycle of a study--in data collection, reporting, and analysis. The proposal would work in concert with ongoing Agency and national initiatives to support increased use of electronic technology as a means to improve patient safety and enhance health care delivery.

Summary of Legal Basis:

Our legal authority to amend our regulations governing the submission and format of clinical study data and bioequivalence data for human drugs and biologics derives from sections 505 and 701 of the Act

(U.S.C. 355 and 371) and section 351 of the Public Health Service Act

(42 U.S.C. 262).

Alternatives:

FDA considered issuing a guidance document outlining the electronic submission and the standardization of study data, but not requiring electronic submission of the data in the standardized format. This alternative was rejected because the Agency would not fully benefit from standardization until it became the industry standard, which could take up to 20 years.

We also considered a number of different implementation scenarios, from shorter to longer time-periods. The 2-year time-period was selected because the Agency believes it would provide ample time for applicants to comply without too long a delay in the effective date. A longer time-period would delay the benefit from the increased efficiencies, such as standardization of review tools across applications, and the incremental cost savings to industry would be small.

Anticipated Cost and Benefits:

Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the Agency review process. FDA estimates that the costs resulting from the proposal would include substantial one-time costs, additional waves of one-time costs as standards mature, and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data

(i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits associated with reduced time for preparing applications, including reduced preparation costs and faster time to market for beneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensive and accurate data review, as well as enhanced communication among sponsors and clinicians.

Risks:

None.

Timetable:

Action

Date

FR Cite

NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Martha Nguyen

Regulatory Counsel

Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research

WO 51, Room 6352 10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Phone: 301 796-3471

Fax: 301 847-8440

Email: martha.nguyen@fda.hhs.gov

RIN: 0910-AC52

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 46. UNIQUE DEVICE IDENTIFICATION

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 15 USC 1451 to 1461; 21 USC 141 to 149, 321 to 394, 467f, 679, 821, 1034; 28 USC 2112; 42 USC 201 to 262, 263a and 263b, 264, 271, 364

CFR Citation: 21 CFR 16, 801, 803, 806, 810, 814, 820, 821,

Legal Deadline:

None

Abstract:

The Food and Drug Administration Amendments Act of 2007, amended the

Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21

U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number.

Statement of Need:

A unique device identification system will help reduce medical errors; will allow FDA, the healthcare community, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); and thereby allow for more rapid, effective, corrective actions that focus sharply on the specific devices that are of concern.

Summary of Legal Basis:

This rule is provided for/mandated by FDAAA. Section 519(f) of the FD&C

Act (added by sec. 226 of the Food and Drug Administration Amendments

Act of 2007) directs the Secretary to promulgate regulations establishing a unique device identification (UDI) system for medical devices, requiring the label of devices to bear a unique identifier that will adequately identify the device through its distribution and use.

Alternatives:

FDA considered several alternatives that allow certain requirements of the proposed rule to vary, such as the required elements of a UDI and the scope of affected devices.

Anticipated Cost and Benefits:

FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a UDI, costs to purchase equipment to print and verify the UDI, and costs to purchase software, integrate and validate the UDI into existing IT systems. Certain entities would be required to submit information about each UDI and the relevant medical device into a database, FDA would incur costs to develop,

Page 79525

implement, and administer a database that would serve as a repository of information to facilitate the identification of medical devices through their distribution and use. FDA anticipates that implementation of a UDI system would help improve the efficiency of recalled medical devices and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors.

Risks:

This rule is intended to substantially eliminate existing obstacles to the adequate identification of medical devices used in the Unites

States. By providing the means to rapidly and definitely identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The rule will fulfill a statutory directive to establish a unique device identification system.

Timetable:

Action

Date

FR Cite

NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Undetermined

Federalism:

Undetermined

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

John J. Crowley

Senior Advisor for Patient Safety

Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

WO 66, Room 2315 10903 New Hampshire Avenue

Silver Spring, MD 20993

Phone: 301 980-1936

Email: jay.crowley@fda.hhs.gov

RIN: 0910-AG31

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 47. CIGARETTE WARNING LABEL STATEMENTS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority:

PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 201

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, June 22, 2011.

Section 4 of the Federal Cigarette Labeling and Advertising Act

(FCLAA), as amended by section 201 of the Family Smoking Prevention and

Tobacco Control Act (the Tobacco Control Act), requires FDA to issue regulations no later than 24 months after the date of enactment of the

Tobacco Control Act that require color graphics depicting the negative health consequences of smoking.

Abstract:

Section 4 of the FCLAA, as amended by section 201 of the Tobacco

Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements. FDA also may adjust the type size, text and format of the required label statements on product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area.

Statement of Need:

This proposed rule is necessary to amend FDA's regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements and to specify the color graphics that must accompany each textual warning statement.

Summary of Legal Basis:

The proposed rule would implement a provision of the Tobacco Control

Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the

Tobacco Control Act. The Tobacco Control Act amends the FCLAA to require each cigarette package and advertisement to bear one of nine new textual warning statements.

Alternatives:

The Agency will compare the proposed rule to two hypothetical alternatives: An otherwise identical rule with a 24-month compliance period and an otherwise identical rule with a 6-month compliance period. Although we will compare the rule to two hypothetical alternatives, they are not viable regulatory options as they are inconsistent with FDA's statutory mandate.

Anticipated Cost and Benefits:

The largest benefits of this proposed rule stem from increased life expectancies for individuals who are induced not to smoke. Other quantifiable benefits come from reductions in cases of non-fatal emphysema, reductions in fire losses, and reductions in medical expenditures. Unquantifiable benefits come from reductions in smokers' non-fatal illnesses other than emphysema, reductions in passive smoking, and reductions in infant and child health effects due to mothers' smoking during pregnancy.Large, one-time costs will arise from the need to change cigarette package labels and remove point-of-sale promotions that do not comply with the new advertising restrictions.

Additionally, there will be smaller ongoing FDA enforcement costs.

Risks:

This proposed rule would reduce the risk to the public by helping to clearly and effectively convey the negative health consequences of smoking on cigarette packages and in cigarette advertisements, which would help both to discourage non-smokers, including minor children, from initiating cigarette

Page 79526

use and to encourage current smokers to consider cessation.

Timetable:

Action

Date

FR Cite

NPRM

11/12/10

75 FR 69524

NPRM Comment Period End

01/11/11

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Undetermined

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Gerie Voss

Regulatory Counsel

Department of Health and Human Services

Food and Drug Administration 9200 Corporate Boulevard

Rockville, MD 20850

Phone: 877 287-1373

Fax: 240 276-4193

Email: gerie.voss@fda.hhs.gov

RIN: 0910-AG41

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 48. FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD IN VENDING

MACHINES

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 21 USC 343; 21 USC 371

CFR Citation:

Not Yet Determined

Legal Deadline:

NPRM, Statutory, March 23, 2011, Proposed rule to be published 1 year after enactment.

Abstract:

The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of food sold in vending machines. FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out the provisions of section 4205 of the Patient Protection and Affordable Care Act (``Affordable

Care Act'' or ``ACA''), which was signed into law on March 23, 2010.

Statement of Need:

This proposed rule was mandated by section 4205 of the Affordable Care

Act.

Summary of Legal Basis:

On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and

Cosmetic Act by creating new clause (H) to require that vending machine operators, who own or operate 20 or more machines, disclose calories for food items. FDA has the authority to issue this proposed rule under section 403(q)(5)(H) and 701(a) (21 U.S.C. 343(q)(5)(H), and 371(a)).

Section 701(a) of the act vests the Secretary (and, by delegation, the

FDA) with the authority to issue regulations for the efficient enforcement of the act.

Alternatives:

Section 4205 requires the Secretary (and, by delegation, the FDA) to establish, by regulation, requirements for calorie disclosure of food items for vending machine operators, who own or operate 20 or more machines. Therefore, there are no alternatives to rulemaking.

Anticipated Cost and Benefits:

The bulk of the costs associated with this rule will be in managing the actual disclosure of calories at the machine. Since almost all vending machines sell food that is previously manufactured and packaged, most vended foods are subject to the Nutrition Labeling Education Act, which means that calorie content is already collected. A likely scenario for response to vending machine labeling is that food manufacturers include a set of calorie label stickers in each case of product.

Since consumers of vended foods do not generally have access to nutrition information prior to purchase, requiring that operators make that information available should benefit consumers. Consumers may ignore future costs of overeating, relative to the current gains from eating, even when they understand the connection. Therefore, consumers do not generally demand calorie and other nutrition information for food away from home, even when they do, given a wider frame of reference, value that information. Given the costs and the uncertain reception for calorie information that many consumers appear not to care about, most vending machine operators have chosen not to display calorie information. The requirements of the proposed rule, specifically, that calorie and other nutrition information appear at the point of purchase, solves the apparent market failure in providing information provision stemming from present-biased preferences.

Risks:

For some vending machine foods, consumers cannot view the nutrition facts panel or otherwise see nutrition information prior to purchasing the item. Completion of this rulemaking will provide consumers information about the nutritional content of food to empower them to make healthier food choices from vending machines.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

NPRM Comment Period End

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Governmental Jurisdictions

Government Levels Affected:

Federal, Local, State

Federalism:

Undetermined

Agency Contact:

Geraldine A. June

Supervisor, Product Evaluation and Labeling Team

Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition

(HFS-820) 5100 Paint Branch Parkway

College Park, MD 20740

Phone: 301 436-1802

Fax: 301 436-2636

Email: geraldine.june@fda.hhs.gov

RIN: 0910-AG56

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 49. FOOD LABELING: NUTRITION LABELING OF STANDARD MENU ITEMS

IN CHAIN RESTAURANTS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 21 USC 343; 21 USC 371

CFR Citation:

Not Yet Determined

Legal Deadline:

NPRM, Statutory, March 23, 2011, Proposed rule to be published 1 year after enactment.

Abstract:

The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of standard menu items for chain restaurants and similar retail food establishments. FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out the provisions of section 4205 of the Patient

Protection and Affordable Care Act (``Affordable Care Act'' or

``ACA''), which was signed into law on March 23, 2010.

Statement of Need:

This proposed rule was mandated by section 4205 of the Affordable Care

Act.

Summary of Legal Basis:

On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and

Cosmetic Act by creating new clause (H) to require that chain restaurants, with 20 or more locations, require certain nutrient disclosure. Specifically, section 4205 required the Secretary of Health and Human Services to issue a proposed regulation to carry out clause

(H) of the ACA no later than 1 year of enactment of this clause (i.e.,

Mar. 23, 2011). FDA has the authority to issue this proposed rule under section 403(q)(5)(H) and 701(a) (21 U.S.C. 343(q)(5)(H), and 371(a)).

Section 701(a) of the act vests the Secretary (and, by delegation, the

FDA) with the authority to issue regulations for the efficient enforcement of the act.

As directed by section 4205, FDA is proposing requirements for menu calorie declaration, as well as other nutrition information declaration to implement the provisions of 403(q)(5)(H). FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205.

Alternatives:

Section 4205 requires the Secretary (and, by delegation, the FDA) to establish, by regulation, requirements for nutrition labeling of standard menu items for chain restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking.

Anticipated Cost and Benefits:

Chain restaurants operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant, with fewer than 20 locations, may opt in to the national standard to receive this benefit.

Many chain restaurants, with 20 or more locations, will bear costs for adding nutrition information to menus and menu boards. Consumers will benefit from having important nutrition information for the approximately 30 per cent of calories consumed away from home.

Risks:

Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information. Completion of this rulemaking will provide consumers information about the nutritional content of food to empower them to make healthier food choices.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

NPRM Comment Period End

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Governmental Jurisdictions

Government Levels Affected:

Federal, Local, State

Federalism:

Undetermined

Agency Contact:

Geraldine A. June

Supervisor, Product Evaluation and Labeling Team

Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition

(HFS-820) 5100 Paint Branch Parkway

College Park, MD 20740

Phone: 301 436-1802

Fax: 301 436-2636

Email: geraldine.june@fda.hhs.gov

RIN: 0910-AG57

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Page 79527

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--FDA

FINAL RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 50. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY

CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND

QUALITY FACTORS

Priority:

Other Significant

Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . .

CFR Citation: 21 CFR 106 and 107

Legal Deadline:

None

Abstract:

The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.

Statement of Need:

The agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, records and reports for the production of infant formula. This proposal was issued in response to the

Page 79528

1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003,

FDA reopened the comment period to update comments on the proposal. The comment was extended on June 27, 2003 and ended on August 26, 2003. The comment period was reopened on August 1, 2006 and ended on September 15, 2006.

Summary of Legal Basis:

The Infant Formula Act of 1980 (the 1980 Act) (Pub. L. 96-359) amended the Federal Food, Drug, and Cosmetic Act (the Act) to include section 412 (21 U.S.C. 350a). This law is intended to improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula. In 1982, FDA adopted infant formula recall procedures in subpart D of 21 CFR part 107 of its regulations (47 FR 18832, Apr. 30, 1982), and infant formula quality control procedures in subpart B of 21

CFR part 106 (47 FR 17016, Apr. 20, 1982). In 1985, FDA further implemented the 1980 Act by establishing subparts B, C, and D in 21 CFR part 107 regarding the labeling of infant formula, exempt infant formulas, and nutrient requirements for infant formula, respectively

(50 FR 1833, Jan. 14, 1985; 50 FR 48183, Nov. 22, 1985; and 50 FR 45106, Oct. 30, 1985).

In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (Pub. L. 99-570) (the 1986 amendments), amended section 412 of the act to address concerns that had been expressed by Congress and consumers about the 1980 Act and its implementation related to the sufficiency of quality control testing, CGMP, recordkeeping, and recall requirements.

The 1986 amendments: (1) State that an infant formula is deemed to be adulterated if it fails to provide certain required nutrients, fails to meet quality factor requirements established by the Secretary (and, by delegation, FDA), or if it is not processed in compliance with the CGMP and quality control procedures established by the Secretary; (2) require that the Secretary issue regulations establishing requirements for quality factors and CGMP, including quality control procedures; (3) require that infant formula manufacturers regularly audit their operations to ensure that those operations comply with CGMP and quality control procedure regulations; (4) expand the circumstances in which firms must make a submission to the Agency to include when there is a major change in an infant formula or a change that may affect whether the formula is adulterated; (5) specify the nutrient quality control testing that must be done on each batch of infant formula; (6) modify the infant formula recall requirements; and (7) give the Secretary authority to establish requirements for retention of records, including records necessary to demonstrate compliance with CGMP and quality control procedures. In 1989, the Agency implemented the provisions on recalls (secs. 412(f) and (g) of the act) by establishing subpart E in 21 CFR part 107 (54 FR 4006, Jan. 27, 1989). In 1991, the Agency implemented the provisions on record and record retention requirements by revising 21 CFR 106.100 (56 FR 66566, Dec. 24, 1991).

The Agency has already promulgated regulations that respond to a number of the provisions of the 1986 amendments. The final rule would address additional provisions of these amendments.

Alternatives:

The 1986 amendments require the Secretary (and, by delegation, FDA) to establish, by regulation, requirements for quality factors and CGMPs, including quality control procedures. Therefore, there are no alternatives to rulemaking.

Anticipated Cost and Benefits:

FDA estimates that the costs from the final rule to producers of infant formula would include first year and recurring costs (e.g., administrative costs, implementation of quality controls, records, audit plans and assurances of quality factors in new infant formulas).

FDA anticipates that the primary benefits would be a reduced risk of illness due to Cronobacter sakazakii and Salmonella spp in infant formula. Additional benefits stem from the quality factors requirements that would assure the healthy growth of infants consuming infant formula. Monetized estimates of costs and benefits for this final rule are not available at this time. The analysis for the proposed rule estimated costs of less than $1 million per year. FDA was not able to quantify benefits in the analysis for the proposed rule.

Risks:

Special controls for infant formula manufacturing are especially important because infant formula, particularly powdered infant formula, is an ideal medium for bacterial growth and because infants are at high risk of foodborne illness because of their immature immune systems. In addition, quality factors are of critical need to assure that the infant formula supports healthy growth in the first months of life when infant formula may be an infant's sole source of nutrition. The provisions of this rule will address weaknesses in production that may allow contamination of infant formula, including, contamination with C. sakazakii and Salmonella spp which can lead to serious illness with devastating sequelae and/or death. The provisions would also assure that new infant formulas support healthy growth in infants.

Timetable:

Action

Date

FR Cite

NPRM

07/09/96

61 FR 36154

NPRM Comment Period End

12/06/96

NPRM Comment Period

Reopened

04/28/03

68 FR 22341

NPRM Comment Period

Extended

06/27/03

68 FR 38247

NPRM Comment Period End

08/26/03

NPRM Comment Period

Reopened

08/01/06

71 FR 43392

NPRM Comment Period End

09/15/06

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Benson Silverman

Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition (HFS-850) 5100 Paint Branch Parkway

College Park, MD 20740

Phone: 301 436-1459

Email: benson.silverman@fda.hhs.gov

Related RIN: Split from 0910-AA04

RIN: 0910-AF27

Page 79529

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Page 79529

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 51. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 321, 331, 351, 352, 360c, 360e, 360i to 360j, 371, 374, 381, 393; 42 USC 264, 271

CFR Citation: 21 CFR 803

Legal Deadline:

None

Abstract:

The Food and Drug Administration (FDA) is amending its postmarket medical device reporting (MDR) regulations to require that manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to the Agency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues.

Statement of Need:

The final rule would require user facilities and medical device manufacturers and importers to submit medical device adverse event reports in electronic format instead of using a paper form. FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports.

Summary of Legal Basis:

The Agency has legal authority under section 519 of the Federal Food,

Drug, and Cosmetic Act to require adverse event reports. The final rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to

FDA in electronic format instead of using a hard copy form.

Alternatives:

There are two alternatives. The first alternative is to allow the voluntary submission of electronic MDRs. If a substantial number of reporters fail to voluntarily submit electronic MDRs, FDA will not obtain the benefits of standardized formats and quicker access to medical device adverse event data. The second alternative is to allow small entities more time to comply. Because so many device companies are small entities, this would significantly postpone the benefits of the rule.

Anticipated Cost and Benefits:

The principal benefit would be to public health because the increased speed in the processing and analysis of 173,000 medical device reports currently submitted annually on paper. In addition, requiring electronic submission would reduce FDA annual operating costs by $1.9 million and generate industry savings of about $9.8 million.

The total one-time cost for modifying SOPs and establishing electronic submission capabilities is estimated to range from $81.4 million to

$101.0 million. Annually recurring costs totaled $8.8 million and included maintenance of electronic submission capabilities, including renewing the electronic certificate, and for some firms, the incremental cost to maintain high-speed Internet access.

Risks:

None

Timetable:

Action

Date

FR Cite

NPRM

08/21/09

74 FR 42310

NPRM Comment Period End

11/19/09

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Nancy Pirt

Regulatory Counsel

Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

WO 66 Room 4438 10903 New Hampshire Avenue

Silver Spring, MD 20993

Phone: 301 796-6248

Fax: 301 847-8145

Email: nancy.pirt@fda.hhs.gov

RIN: 0910-AF86

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 52. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES

Priority:

Other Significant

Legal Authority:

PL 110-85; PL 107-188, sec 321; PL 107-250, sec 207; 21 USC 360(a) through 360(j); 21 USC 360(p)

CFR Citation: 21 CFR 807

Legal Deadline:

None

Abstract:

This rule will convert registration and listing to a paperless process.

However, for those companies that do not have access to the Web, FDA will offer an avenue by which they can register, list, and update information with a paper submission. The rule also will amend part 807 to reflect the timeframes for device establishment registration and listing established by sections 222 and 223 of Food and Drug

Administration Amendment Act (FDAAA) and to reflect the requirement in section 510(i) of the Act, as amended by section 321 of the Public

Health Security and Bioterrorism Preparedness and Response Act (BT

Act), that foreign establishments provide FDA with additional pieces of information as part of their registration.

Statement of Need:

FDA is amending the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the electronic submission requirements in section 510(p) of the Act, which was added by section 207 of MDUFMA and later amended by section 224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect

Page 79530

the requirements in section 321 of the BT Act for foreign establishments to furnish additional information as part of their registration. This rule will improve FDA's device establishment registration and listing system and utilize the latest technology in the collection of this information.

Summary of Legal Basis:

The statutory basis for our authority includes sections 510(a) through

(j), 510(p), 701, 801, and 903 of the Act.

Alternatives:

The alternatives to this rulemaking include not updating the registration and listing regulations. Because of the new FDAAA statutory requirements and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative.

Anticipated Cost and Benefits:

The Agency believes that there may be some one-time costs associated with the rulemaking, which involve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information by domestic firms would probably remain the same or decrease because a paper submission and postage is not required. There might be some increase in the financial burden on foreign firms since they will have to supply additional registration information as required by section 321 of the BT Act.

Risks:

None

Timetable:

Action

Date

FR Cite

NPRM

03/26/10

75 FR 14510

NPRM Comment Period End

06/24/10

Final Rule

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Nancy Pirt

Regulatory Counsel

Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

WO 66 Room 4438 10903 New Hampshire Avenue

Silver Spring, MD 20993

Phone: 301 796-6248

Fax: 301 847-8145

Email: nancy.pirt@fda.hhs.gov

RIN: 0910-AF88

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Page 79530

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--Centers for Medicare & Medicaid Services (CMS)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 53. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: NOTIFICATION

OF FACILITY CLOSURE (CMS-3230-IFC)

Priority:

Other Significant

Legal Authority:

PL 111-148, sec 6113

CFR Citation: 42 CFR 483; 42 CFR 488; 42 CFR 489

Legal Deadline:

Final, Statutory, March 23, 2011.

Abstract:

This rule would ensure that, in the case of a facility closure, any individual who is the administrator of the facility provides written notification of closure and the plan for the relocation of residents at least 60 days prior to the impending closure, or if the facility's participation in Medicare or Medicaid is terminated, not later than the date the HHS Secretary determines appropriate.

Statement of Need:

Section 6113 of the Affordable Care Act of 2010 (ACA) amends the Act by setting forth certain requirements for LTC facility closures to ensure that, among other things, in the case of a facility closure, any individual who is the administrator of the facility provides written notification of the closure and a plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate.

Summary of Legal Basis:

Sections 1819(b)(1)(A) of the Social Security Act (the Act) for NFs and 1919 (b)(1)(A) for SNFs state that a skilled nursing facility must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident. Sections 1819(c)(2)(A) and 1919 (c)(2)(A) of the Act state that, in general, with certain specified exceptions, a nursing facility must permit each resident to remain in the facility and must not transfer or discharge the resident from the facility. Section 6113 of

ACA amends section 1128I of the Act by setting forth certain requirements for LTC facility closures.

Alternatives:

None. This implements a statutory requirement.

Anticipated Cost and Benefits:

The costs associated with the implementation of this rule are related to the efforts made by each facility to develop a plan for closure. The benefits would include the protection of residents' health and safety and a smooth transition for residents who need to be relocated, as well as their family members and facility staff.

Risks:

LTC facility closures have implications related to access, the quality of care, availability of services, and the overall health of residents.

Without an organized process for facilities to follow in the event of a nursing home closure, there is a risk to the health and safety of residents.

Timetable:

Action

Date

FR Cite

NPRM

02/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

Page 79531

Agency Contact:

Patricia Brooks

Health Insurance Specialist

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Office of Clinical Standards and Quality

Mailstop S3-02-01 7500 Security Boulevard

Baltimore, MD 21244

Phone: 410 786-4561

Email: patricia.brooks@cms.hhs.gov

RIN: 0938-AQ09

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Page 79531

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 54. MEDICARE SHARED SAVINGS PROGRAM: ACCOUNTABLE CARE

ORGANIZATIONS (CMS-1345-P)

Priority:

Other Significant

Legal Authority:

PL 111-148, sec 3022

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, January 1, 2012.

Abstract:

This rule would propose a shared savings program for provider groups to establish Accountable Care Organizations, agree to meet quality measures, and share in savings generated for Medicare by meeting certain benchmarks. Consistent with section 3022 of the Affordable Care

Act of 2010, the shared savings program must be established by January 1, 2012.

Statement of Need:

This rule would propose a shared savings program for provider groups to establish Accountable Care Organizations (ACOs), agree to meet quality measures, and share in savings generated for Medicare by meeting certain cost and quality benchmarks beginning January 1, 2012. This rule is aimed at improving quality and Medicare expenditures for

Medicare beneficiaries and the Medicare program.

Summary of Legal Basis:

Section 3022 of the Affordable Care Act of 2010 requires the Secretary to establish a shared savings program by January 1, 2012.

Alternatives:

None. This is a statutory requirement.

Anticipated Cost and Benefits:

Medicare expenditures will be adjusted beginning January 1, 2012.

Risks:

If this regulation is not published, the shared savings program will not be established by January 1, 2012, as required by ACA, thereby violating the statute.

Timetable:

Action

Date

FR Cite

NPRM

01/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

Agency Contact:

Terri Postma

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mail Stop C5-01-14 7500 Seurity Boulevard

Baltimore, MD 21244

Phone: 410 786-4169

Email: terri.postma@cms.hhs.gov

RIN: 0938-AQ22

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 55. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE

PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2012 RATES AND TO THE

LONG-TERM CARE HOSPITAL PPS AND RY 2012 RATES (CMS-1518-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: sec 1886(d) of the Social Security Act

CFR Citation: 42 CFR 412

Legal Deadline:

NPRM, Statutory, April 1, 2011.

Final, Statutory, August 1, 2011.

Abstract:

This annual major proposed rule would revise the Medicare hospital inpatient and long-term care prospective payment systems (IPPS) for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems.

Statement of Need:

CMS annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed rule solicits comments on the proposed

IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing the payment rates for the FY 2012 IPPS and LTCHs at least 60 days before October 1, 2011.

Summary of Legal Basis:

The Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under

Medicare Part A (Hospital Insurance) based on prospectively set rates.

The Act requires the Secretary to pay for the capital-related costs of hospital inpatient and Long-Term Care stays under a PPS. Under these

PPSs, Medicare payment for hospital inpatient and Long-Term Care operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. These changes would be applicable to services furnished on or after October 1, 2011.

Alternatives:

None. This implements a statutory requirement.

Anticipated Cost and Benefits:

Total expenditures will be adjusted for FY 2012.

Risks:

If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2011.

Timetable:

Action

Date

FR Cite

NPRM

04/00/11

Regulatory Flexibility Analysis Required:

Yes

Page 79532

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Tiffany Swygert

Health Insurance Specialist, Division of Acute Care, Hospital and

Ambulatory Policy Group

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mailstop C4-25-11 7500 Security Boulevard

Baltimore, MD 21244

Phone: 410 786-4642

Email: tiffany.swygert@cms.hhs.gov

RIN: 0938-AQ24

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Page 79532

Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 56. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE

SCHEDULE AND PART B FOR CY 2012 (CMS-1524-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

Social security Act, sec 1102; Social Security Act, sec 1871

CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426

Legal Deadline:

Final, Statutory, November 1, 2011.

The statute requires that the final rule be issued by November.

Abstract:

This proposed rule would revise payment polices under the physician fee schedule, as well as other policy changes to payment under Part B.

These changes would be applicable to services furnished on or after

January 1, annually.

Statement of Need:

The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This major proposed rule would make changes affecting

Medicare Part B payment to physicians and other Part B suppliers.

The final rule has a statutory publication date of November 1, 2011, and an implementation date of January 1, 2012.

Summary of Legal Basis:

Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes a deadline of no later than November 1 for publication of the final physician fee schedule rule.

Alternatives:

None. This implements a statutory requirement.

Anticipated Cost and Benefits:

Total expenditures will be adjusted for CY 2012.

Risks:

If this regulation is not published timely, physician services will not be paid appropriately.

Timetable:

Action

Date

FR Cite

NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Carol Bazell

Director, Division of Practitioner Services

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mail Stop C4-03-06 7500 Security Boulevard

Baltimore, MD 21244

Phone: 410 786-6960

Email: carol.bazell@cms.hhs gov

RIN: 0938-AQ25

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 57. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT

SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2012 (CMS- 1525-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: sec 1833 of the Social Security Act

CFR Citation: 42 CFR 410; 42 CFR 416 ; 42 CFR 419

Legal Deadline:

Final, Statutory, November 1, 2011.

Abstract:

This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the Ambulatory Surgical Center Payment

System list of services and rates.

Statement of Need:

Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The

OPPS is based on groups of clinically similar services called ambulatory payment classification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposes new payment policies, and updates the payments for inflation using the hospital operating market basket. The proposed rule solicits comments on the proposed OPPS payment rates and new policies. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposes new policies, and updates payments for inflation using the

Consumer Price Index for All Urban Consumers (CPI-U). CMS will issue a final rule containing the payment rates for the 2012 OPPS and ASC payment system at least 60 days before January 1, 2012.

Summary of Legal Basis:

Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The final rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the proposed and final rules describe changes to the outpatient APC system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the

Page 79533

prospective payment system as well as changes to the rates and services paid under the ASC payment system. These changes would be applicable to services furnished on or after January 1, 2012.

Alternatives:

None. This is a statutory requirement.

Anticipated Cost and Benefits:

Total expenditures will be adjusted for CY 2012.

Risks:

If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2012.

Timetable:

Action

Date

FR Cite

NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal

Federalism:

Undetermined

Agency Contact:

Alberta Dwivedi

Health Insurance Specialist

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mailstop C5-01-26 7500 Security Boulevard

Baltimore, MD 21244

Phone: 410 786-0763

Email: alberta.dwivedi@cms.hhs.gov

RIN: 0938-AQ26

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--CMS

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 58. CIVIL MONEY PENALTIES FOR NURSING HOMES (CMS-2435-F)

Priority:

Other Significant

Legal Authority: 42 USC 1302 and 1395 (hh)

CFR Citation: 42 CFR 488

Legal Deadline:

Final, Statutory, March 23, 2011, 1 year after enactment of PPACA.

Abstract:

This rule revises and expands current Medicare and Medicaid regulations regarding the imposition of civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements.

Statement of Need:

The intent of this final rule is to improve the efficiency and effectiveness of the nursing home enforcement process, particularly as it relates to civil money penalties imposed by CMS. The new provisions will reduce the delay between the identification of problems with noncompliance and the effect of certain penalties that are intended to motivate a nursing home to maintain continuous compliance with basic expectations regarding the provision of quality care. The new provisions also eliminate a facility's ability to significantly defer the direct financial effect of an applicable civil monetary penalty until after an often long litigation process. Specifically, this rule would allow for civil money penalty reductions when facilities self- report and promptly correct their noncompliance; offer, in cases where civil money penalties are imposed, an independent informal dispute resolution process where interests of both facilities and residents are represented and balanced; provide for the establishment of an escrow account where civil money penalties may be placed until any applicable administrative appeal processes have been completed; and improve the extent to which civil money penalties collected from Medicare facilities can benefit nursing home residents. Through the proposed revisions, we intend to directly promote and improve the health, safety, and overall well-being of residents.

Summary of Legal Basis:

Section 6111 of the Affordable Care Act of 2010 amended the Act to incorporate specific provisions pertaining to the imposition and collection of civil money penalties when facilities do not meet

Medicare and Medicaid participation requirements.

Alternatives:

None. This rule implements a statutory requirement. The proposed rule was published on July 12, 2010. Alternatives proposed by commenters will be considered in the preparation of the final rule.

Anticipated Cost and Benefits:

The regulatory impact statement provides that these regulatory proposals would have no consequential effect on State, local, or tribal governments or on the private sector. The anticipated benefits of this regulation include stronger protections for nursing home residents, improved due process for nursing homes, incentives for prompt self- correction of deficiencies, and increased quality improvement.

Risks:

CMS does not expect any additional risks to providers and/or States as a result of the implementation of this rule.

Timetable:

Action

Date

FR Cite

NPRM

07/12/10

75 FR 39641

NPRM Comment Period End

08/11/10

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

State

Agency Contact:

Dr. Lori Chapman

Acting Director, Division of State Demonstrations and Waivers

Department of Health and Human Services

Centers for Medicare & Medicaid Services 7500 Security Boulevard

Baltimore, MD 21220

Phone: 410 786-9254

Email: lori.chapman@cms.hhs.gov

RIN: 0938-AQ02

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--Administration for Children and Families (ACF)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 59. DESIGNATION RENEWAL OF HEAD START GRANTEES

Priority:

Other Significant

Legal Authority:

Improving Head Start for School Readiness Act of 2007, PL 110-134

CFR Citation:

Not Yet Determined

Page 79534

Legal Deadline:

None

Abstract:

This rule would implement provisions of the Improving Head Start for

School Readiness Act of 2007 (Pub. L. 110-134), requiring the Secretary to develop a system that will evaluate each grantee's performance every 5 years to determine which grantees are providing services of such high quality that they should be given another 5-year grant without needing to recompete for the grant.

Statement of Need:

The Administration for Children and Families will issue rules to amend 45 CFR chapter XIII by adding a new part 1307, Policies and Procedures for Designation Renewal of Head Start and Early Head Start Grantees, in order to respond to the statutory requirements of The Improving Head

Start for School Readiness Act of 2007, which establishes that Head

Start grantees will be awarded grants for a 5-year period and only grantees delivering high quality services will be given another 5-year grant non-competitively. These regulations will describe the proposed system for designation renewal, including a proposal to transition all current continuous grants into 5-year grants over a 3-year period.

These regulations will encourage excellence, establish accountability for poor performance, and open up Head Start to new energetic organizations that may have great capacity to run high quality programs.

Summary of Legal Basis:

Section 641 of the Head Start Act requires the Secretary of HHS to develop and implement a system for designation renewal (e.g.,

Designation Renewal System (DRS)) to determine if a Head Start agency is delivering a high-quality and comprehensive Head Start program that meets the educational, health, nutritional, and social needs of the children and families it serves and publish a notice in the Federal

Alternatives:

The Administration for Children and Families is statutorily mandated to develop and implement a system for designation renewal. As a precursor to developing the system, the Head Start Act required the Secretary to establish an Advisory Committee to inform the development of a DRS and make recommendations to the Secretary. We are proposing to adopt the majority of the Advisory Committee's recommendations in whole or with minor modifications. In addition, we are considering additional and alternative criteria to be incorporated into the system for designation renewal, and ask for public comments regarding numerous provisions of the rule, as described in the preamble.

Anticipated Cost and Benefits:

The Agency estimates the costs of implementing the new reporting requirements described in the rule will be approximately $20,000 annually. In addition, at least 25 percent of grantees reviewed in a year will be required to submit a competitive application for a new 5- year grant, at an estimated cost of less than $1,500 for each grantee.

In terms of benefits, the proposed system will fund only high- performing grantees in order to ensure the best services for Head Start children are provided and child outcomes are improved.

Timetable:

Action

Date

FR Cite

NPRM

09/22/10

75 FR 57704

NPRM Comment Period End

12/21/10

Final Action

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Collen Rathgeb

Department of Health and Human Services

Administration for Children and Families 1250 Maryland Avenue SW.

Washington, DC 20447

Phone: 202 205-7378

Email: crathgeb@acf.hhs.gov

RIN: 0970-AC44

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i

HHS--Administration on Aging (AOA)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities for FY 2011

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS' responsibilities i 60. COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS

ENROLLMENT AND ELIGIBILITY RULES UNDER THE AFFORDABLE CARE ACT

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 111-148, sec 8002

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Abstract:

The Department of Health and Human Services will issue rules to implement the Community Living Assistance Services and Supports (CLASS) program included in the Affordable Care Act. Specifically, the rules will define the enrollment and eligibility criteria for the program.

Participation in the program is voluntary.

Statement of Need:

About 14 million people spend more than $230 billion a year on long- term services and supports to assist them with daily living. Four times that many rely solely on unpaid care provided by family and friends.

Medicare does not pay for long-term care, and while Medicaid is the largest public payer of these services, it is only available for people with few other resources. The CLASS program represents a significant new opportunity for all Americans to prepare themselves financially to remain as independent as possible under a variety of future health circumstances.

Summary of Legal Basis:

Section 8002 of Public Law 111-148 (Affordable Care Act) requires the promulgation of regulations to implement the CLASS program.

Specifically, the law states, ``[t]he Secretary shall promulgate such regulations as are necessary to carry out the CLASS program in accordance with this title. Such regulations shall include provisions to prevent fraud and abuse under the program.''

Page 79535

Alternatives:

Under the law, the Secretary, in consultation with appropriate actuaries and other experts, will develop at least three actuarially sound benefit plans as alternatives for consideration for designation by the Secretary as the CLASS Independence Benefit Plan. Under the law, the Secretary will designate the final benefit plan by October 1, 2012.

Anticipated Cost and Benefits:

The program will help Americans prepare themselves financially to remain as independent as possible under a variety of future health circumstances and their financial independence may help reduce spending down to Medicaid. Costs to implement the proposed regulation have not yet been estimated.

Timetable:

Action

Date

FR Cite

NPRM

09/00/11

Final Action

10/00/12

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Agency Contact:

Laura Lawrence

Department of Health and Human Services

Administration on Aging

Phone: 202 357-3469

RIN: 0985-AA07

BILLING CODE 4150-24-S

Page 79536

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Statement of Regulatory Priorities

The Department of Homeland Security (DHS) was created in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-296. DHS has a vital mission: To secure the nation from the many threats we face. This requires th

DHS--Office of the Secretary (OS)

Page 79537

rule would eliminate the need for petitioning employers to prepare and file complete H-1B petitions before knowing whether a prospective worker has ``won'' the H-1B lottery. The rule would also reduce the costs incurred by USCIS in entering data and subsequently returning non-selected petitions to employers once the cap is reached.

Regulatory Changes Involving Humanitarian Benefits

USCIS offers protection to individuals who face persecution by adjudicating applications for refugees and asylees. Other humanitarian benefits are available to individuals who have been victims of severe forms of trafficking or criminal activity.

Asylum and Withholding Definitions

USCIS plans a regulatory proposal to amend the regulations that govern asylum eligibility. The amendments are expected to focus on portions of the regulations that deal with determinations of whether persecution is inflicted on account of a protected ground, the requirements for establishing the failure of State protection, and the definition of membership in a particular social group. This effort should provide greater stability and clarity in this important area of the law.

Exception to the Persecution Bar for Asylum, Refugee, or Temporary

Protected Status, and Withholding of Removal

DHS, in a joint rulemaking with DOJ, will propose amendments to existing DHS and DOJ regulations to resolve ambiguity in the statutory language precluding eligibility for asylum, refugee resettlement, temporary protected status, and withholding of removal of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed rule would provide a limited exception for persecutory actions taken by the applicant under duress and clarify the required levels of the applicant's knowledge of the persecution.

``T'' and ``U'' Nonimmigrants

USCIS plans additional regulatory initiatives related to T nonimmigrants (victims of trafficking), U nonimmigrants (victims of criminal activity), and Adjustment of Status for T and U status holders. By promulgating additional regulations related to these victims of specified crimes or severe forms of human trafficking, USCIS hopes to provide greater stability for these vulnerable groups, their advocates, and the community. These rulemakings will contain provisions that seek to ease documentary requirements for this vulnerable population and provisions that provide greater clarity to the law enforcement community. In addition, publication of these rules will inform the community about how their petitions are adjudicated.

United States Coast Guard

The U.S. Coast Guard (Coast Guard) is a military, multi-mission, maritime service of the United States and the only military organization within DHS. It is the principal Federal agency responsible for maritime safety, security, and stewardship and delivers daily value to the Nation through multi-mission resources, authorities, and capabilities.

Effective governance in the maritime domain hinges upon an integrated approach to safety, security, and stewardship. The Coast Guard's policies and capabilities are integrated and interdependent, delivering results through a network of enduring partnerships. The Coast Guard's ability to field versatile capabilities and highly-trained personnel is one of the U.S. Government's most significant and important strengths in the maritime environment.

America is a maritime nation, and our security, resilience, and economic prosperity are intrinsically linked to the oceans. Safety, efficient waterways, and freedom of transit on the high seas are essential to our well-being. The Coast Guard is leaning forward, poised to meet the demands of the new millennium. The Coast Guard creates value for the public through solid prevention and response efforts.

Activities involving oversight and regulation, enforcement, maritime presence, and public and private partnership foster increased maritime safety, security, and stewardship.

The statutory responsibilities of the Coast Guard include ensuring marine safety and security, preserving maritime mobility, protecting the marine environment, enforcing U.S. laws and international treaties, and performing search and rescue. The Coast Guard supports the

Department's overarching goals of mobilizing and organizing our Nation to secure the homeland from terrorist attacks, natural disasters, and other emergencies. The rulemaking projects identified for the Coast

Guard in the Unified Agenda, and the rules appearing in the fall 2010

Regulatory Plan below, contribute to the fulfillment of those responsibilities and reflect our regulatory policies. The Coast Guard's rulemaking projects support maritime safety, security, and environmental protection as indicated by the wide range of topics covered in its rulemaking projects in this Unified Agenda.

Inspection of Towing Vessels

In 2004, Congress amended U.S. law by adding towing vessels to the types of commercial vessels that must be inspected by the Coast Guard.

Congress also provided guidance relevant to the use of a safety management system as part of the inspection regime. The intent of the proposed rule is to promote safer work practices and reduce casualties on towing vessels by ensuring that towing vessels adhere to prescribed safety standards and safety management systems. The proposed rule was developed in cooperation with the Towing Vessel Safety Advisory

Committee (TSAC). It would establish a new subchapter dedicated to towing vessels and covering vessel equipment, systems, operational standards, and inspection requirements. To implement this change, the

Coast Guard is developing regulations to prescribe standards, procedures, tests, and inspections for towing vessels. This rulemaking supports maritime safety and maritime stewardship.

Standards for Living Organisms in Ships' Ballast Water Discharged in

U.S. Waters

This rule would set performance standards for the quality of ballast water discharged in U.S. waters and require that all vessels that operate in U.S. waters and are bound for ports or places in the U.S. and are equipped with ballast tanks, install and operate a Coast Guard approved Ballast Water Management System (BWMS) before discharging ballast water into U.S. waters. This would include vessels bound for offshore ports or places. As the effectiveness of ballast water exchange varies from vessel to vessel, the Coast Guard believes that setting performance standards would be the most effective way for approving BWMS that are environmentally protective and scientifically sound. Ultimately, the approval of BWMS would require procedures similar to those located in title 46, subchapter Q, of the Code of

Federal Regulations, to ensure that the BWMS works, not only in the laboratory, but also under shipboard conditions. These would include:

Pre-approval requirements, application requirements, land-based/ shipboard

Page 79538

testing requirements, design and construction requirements, electrical requirements, engineering requirements, and piping requirements. This requirement is intended to meet the requirements of the National

Invasive Species Act (NISA). Ballast water discharged from ships is a significant pathway for the introduction and spread of non-indigenous aquatic nuisance species. These organisms, which may be plants, animals, bacteria, or pathogens, have the potential to displace native species, degrade native habitats, spread disease, and disrupt human economic and social activities that depend on water resources. This rulemaking supports maritime stewardship.

Outer Continental Shelf Activities

The Coast Guard is revising regulations to address new developments in the offshore industry, to fully address existing legislation, to effectively implement interagency agreements, to respond to comments received from the notice of proposed rulemaking (Outer Continental

Shelf Activities, 64 FR 68416 (Dec. 7, 1999), and to update security requirements and procedures. This proposed rule would improve the level of safety in the workplace and security for personnel and units engaged in Outer Continental Shelf (OCS) activities. The Coast Guard is the lead Federal agency for OCS workplace safety and health--other than for matters generally related to drilling and production that are regulated by the Bureau of Ocean Energy Management, Regulation, and Enforcement-- on facilities and vessels engaged in the exploration for, or development or production of, minerals on the OCS. The last major revision of the Coast Guard's OCS regulations occurred in 1982. At that time, the offshore industry was not as technologically advanced as it is today. Offshore activities were in relatively shallow water near land, where help was readily available during emergency situations. The regulations required only basic equipment, primarily for lifesaving appliances and hand-held portable fire extinguishers. Since 1982, the requirements in 33 CFR chapter I, subchapter N, have not kept pace with the changing offshore technology or the safety problems it creates as

OCS activities extend to deeper water (10,000 feet) and move farther offshore (150 miles). This rulemaking would reassess all of the Coast

Guard's current OCS regulations in order to help make the OCS a safer workplace, and it supports the Commandant's strategic goals of marine safety and environmental stewardship.

Updates to 33 CFR Subchapter H--Maritime Security.

The intent of this rulemaking is to strengthen security of our Nation's ports, vessels, facilities, and Outer Continental Shelf facilities by incorporating clarifications realized since the original Maritime

Transportation Security Act (MTSA) regulations of 2003, Security and

Accountability for Every Port Act of 2006 (SAFE Port Act) requirements, and the Coast Guard and Maritime Transportation Act of 2006.This proposed rule would incorporate feedback received from industry stakeholders, Coast Guard field units, and the public since the original MTSA regulations came into effect in 2003. The proposed rule would also consolidate into regulation appropriate actions promulgated in a series of Policy Advisory Council (PAC) papers, Navigation and

Inspection Circulars (NVICs), and MTSA Help Desk responses; address screening standards for port facilities and vessels; establish security training standards that will be modeled after the courses developed by the Maritime Administration (MARAD); and the training standards

(mandatory and non-mandatory) and courses developed by the

International Maritime Organization (IMO). It would also update existing regulations regarding the areas of maritime security plans, facility and vessel security plans, and facility exercise requirements in the SAFE Port Act of 2006. This rulemaking supports the Commandant's strategic goal of maritime security.

Assessment Framework and Organizational Restatement Regarding

Preemption for Certain Regulations Issued by the Coast Guard

This rule would restate the preemptive effect of existing Coast Guard regulations and articulate the assessment framework for evaluating the preemptive effect of future regulations. This rule would not alter the preemptive effect of any regulation: It would merely restate the existing law. By clarifying the preemptive effect of Coast Guard regulations, the Coast Guard intends to increase transparency, encourage appropriate State regulation, and avoid or reduce litigation related to State and local attempts to regulate in preempted areas. In doing so, the Coast Guard intends to comply with the May 2009 presidential memoranda on preemption, and on transparency and open government, and also intends to reinforce a uniform maritime regulatory regime that is predictable and useful for maritime interests. The Coast

Guard expects no additional cost impacts to the industry from this rule, because it only restates and clarifies the status of Federal and

State law as it exists.

The following Coast Guard rulemakings may be of particular interest to small entities:

Inspection of Towing Vessels

Based on preliminary analysis, the Coast Guard determined 1,059 operators of 5,208 uninspected towing vessels would incur additional costs from this rulemaking and over 92 percent of these entities are small businesses. This rulemaking would require operators of previously uninspected towing vessels to incur the costs of becoming regulated under a new inspection regime.

Standards for Living Organisms in Ships' Ballast Water Discharged in

U.S. Waters

Based on preliminary analysis in the notice of proposed rulemaking (74

FR 44632), the Coast Guard determined 850 U.S. operators of 2,616 vessels would incur additional costs from this rulemaking and over 57 percent of these entities are small businesses. This rulemaking would require operators to purchase and install ballast water management systems costing between $258,000 and $419,000 per vessel, depending vessel and technology type.

Updates to 33 CFR Subchapter H--Maritime Security

Based on preliminary analysis, the Coast Guard determined that 55 percent of operators affected by this rulemaking are small entities.

This rulemaking would require operators to incur additional costs for training and exercise provisions.

United States Customs and Border Protection

U.S. Customs and Border Protection (CBP) is the Federal agency principally responsible for the security of our Nation's borders, both at and between the ports of entry and at official crossings into the

United States. CBP must accomplish its border security and enforcement mission without stifling the flow of legitimate trade and travel. The primary mission of CBP is its homeland security mission, that is, to prevent terrorists and terrorist weapons from entering the United

States. An important aspect of this priority mission involves improving security at our borders and ports of entry, but it also means extending our zone of security beyond our physical borders.

CBP is also responsible for administering laws concerning the

Page 79539

importation into the United States of goods and enforcing the laws concerning the entry of persons into the United States. This includes regulating and facilitating international trade; collecting import duties; enforcing U.S. trade, immigration, and other laws of the United

States at our borders; inspecting imports, overseeing the activities of persons and businesses engaged in importing; enforcing the laws concerning smuggling and trafficking in contraband; apprehending individuals attempting to enter the United States illegally; protecting our agriculture and economic interests from harmful pests and diseases; servicing all people, vehicles, and cargo entering the United States; maintaining export controls; and protecting U.S. businesses from theft of their intellectual property.

In carrying out its priority mission, CBP's goal is to facilitate the processing of legitimate trade and people efficiently without compromising security. Consistent with its primary mission of homeland security, CBP intends to finalize several rules during the next fiscal year that are intended to improve security at our borders and ports of entry. We have highlighted some of these rules below.

Electronic System for Travel Authorization (ESTA).

On June 9, 2008, CBP published an interim final rule amending DHS regulations to implement the Electronic System for Travel Authorization

(ESTA) for aliens who wish to enter the United States under the Visa

Waiver Program (VWP) at air or sea ports of entry. This rule is intended to fulfill the requirements of section 711 of the Implementing

Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). The rule establishes ESTA and delineates the data field DHS has determined will be collected by the system. The rule requires that each alien traveling to the United States under the VWP must obtain electronic travel authorization via the ESTA System in advance of such travel. VWP travelers may obtain the required ESTA authorization by electronically submitting to CBP biographic and other information as currently required by the I-94W Nonimmigrant Alien Arrival/Departure Form (I- 94W). By Federal Register notice dated November 13, 2008, the Secretary of Homeland Security informed the public that ESTA would become mandatory beginning January 12, 2009. This means that all VWP travelers must either obtain travel authorization in advance of travel under ESTA or obtain a visa prior to traveling to the United States.

By shifting from a paper to an electronic form and requiring the data in advance of travel, CBP will be able to determine before the alien departs for the U.S., the eligibility of nationals from VWP countries to travel to the United States and to determine whether such travel poses a law enforcement or security risk. By modernizing the VWP, the

ESTA is intended to increase national security and provide for greater efficiencies in the screening of international travelers by allowing for vetting of subjects of potential interest well before boarding, thereby reducing traveler delays based on lengthy processes at ports of entry. CBP intends to issue a final rule during the next fiscal year.

On August 9, 2010, CBP published an interim final rule amending the

ESTA regulations to require ESTA applicants to pay a congressionally mandated fee which is the sum of two amounts: a $10 travel promotion fee for an approved ESTA and a $4 operational fee for the use of ESTA set by the Secretary of Homeland Security to, at a minimum, ensure the recovery of the full costs of providing and administering the ESTA. CBP is working to finalize the 2008 and 2010 interim final rules during fiscal year 2011.

Importer Security Filing and Additional Carrier Requirements

The Security and Accountability for Every Port Act of 2006 (SAFE Port

Act) calls for CBP to promulgate regulations to require the electronic transmission of additional data elements for improved high-risk targeting. See Public Law No. 109-347, section 203 (Oct. 13, 2006).

This includes appropriate security elements of entry data for cargo destined for the United States by vessel prior to loading of such cargo on vessels at foreign seaports. The SAFE Port Act requires that the information collected reasonably improve CBP's ability to identify high-risk shipments to prevent smuggling and ensure cargo safety and security.

On November 25, 2008, CBP published an interim final rule ``Importer

Security Filing and Additional Carrier Requirements,'' amending CBP regulations to require carriers and importers to provide to CBP, via a

CBP-approved electronic data interchange system, information necessary to enable CBP to identify high-risk shipments to prevent smuggling and ensure cargo safety and security. This rule, which became effective on

January 26, 2009, improves CBP risk assessment and targeting capabilities, facilitates the prompt release of legitimate cargo following its arrival in the United States, and assists CBP in increasing the security of the global trading system. The comment period for the interim final rule concluded on June 1, 2009. CBP is analyzing comments and conducting a structured review of certain flexibility provided in the interim final rule. CBP intends to publish a final rule during fiscal year 2011.

Implementation of the Guam-CNMI Visa Waiver Program

CBP published an interim final rule in November 2008 amending the DHS regulations to replace the current Guam Visa Waiver Program with a new

Guam-CNMI Visa Waiver program. This rule implements portions of the

Consolidated National Resources Act of 2008 (CNRA), which extends the immigration laws of the United States to the Commonwealth of the

Northern Mariana Islands (CNMI) and, among others things, provides for a visa waiver program for travel to Guam and the CNMI. The amended regulations set forth the requirements for nonimmigrant visitors who seek admission for business or pleasure and solely for entry into and stay on Guam or the CNMI without a visa. The rule also establishes six ports of entry in the CNMI for purposes of administering and enforcing the Guam-CNMI Visa Waiver program. CBP intends to issue a final rule during fiscal year 2011.

Global Entry Program

Pursuant to section 7208(k) of the Intelligence Reform and Terrorism

Prevention Act of 2004, as amended, CBP issued a notice of proposed rulemaking (NPRM) in the fall of 2009, proposing to establish an international trusted traveler program called Global Entry. This voluntary program would allow CBP to expedite clearance of pre- approved, low-risk air travelers into the United States. CBP has been operating the Global Entry program as a pilot at several airports since

June 6, 2008. Based on the successful operation of the pilot, CBP proposed to establish Global Entry as a permanent voluntary regulatory program. CBP will evaluate the public comments received in response to the NPRM, in order to develop a final rule. CBP intends to issue a final rule during fiscal year 2011.

The rules discussed above foster DHS' mission. Under section 403(1) of the Homeland Security Act of 2002, the former-U.S. Customs Service, including

Page 79540

functions of the Secretary of the Treasury relating thereto, transferred to the Secretary of Homeland Security. As part of the initial organization of DHS, the Customs Service inspection and trade functions were combined with the immigration and agricultural inspection functions of the Border Patrol and transferred into CBP. It is noted that certain regulatory authority of the United States Customs

Service relating to customs revenue function was retained by the

Department of the Treasury (see the Department of the Treasury

Regulatory Plan). In addition to its plans to continue issuing regulations to enhance border security, CBP, during fiscal year 2011, expects to continue to issue regulatory documents that will facilitate legitimate trade and implement trade benefit program. CBP regulations regarding the customs revenue function are discussed in the regulatory plan of the Department of the Treasury.

Federal Emergency Management Agency

The mission of the Federal Emergency Management Agency (FEMA) is to support our citizens and first responders to ensure that, as a Nation, we work together to build, sustain, and improve our capability to prepare for, protect against, respond to, recover from, and mitigate all hazards. In fiscal year 2011, FEMA will continue to serve that mission and promote the Department of Homeland Security's goals. In furtherance of the Department and Agency's goals, in the upcoming fiscal year, FEMA will be working on regulations to implement provisions of the Post-Katrina Emergency Management Reform Act of 2006

(PKEMRA) (Pub. L. 109-295, Oct. 4, 2006), and to implement lessons learned from past events.

Public Assistance Program regulations

FEMA will work to revise the Public Assistance Program regulations in 44 CFR part 206 to reflect changes made to the Robert T. Stafford

Disaster Relief and Emergency Assistance Act by PKEMRA, the Pets

Evacuation and Transportation Standards Act of 2006 (PETS Act) (Pub. L.

No. 109-308, Oct. 6, 2006), the Local Community Recovery Act of 2006

(Pub. L. No. 109-218, Apr. 20, 2006), and the Security and

Accountability for Every Port Act of 2006 (SAFE Port Act) (Pub. L. No. 109-347, Oct. 13, 2006), and to make other substantive and nonsubstantive clarifications and corrections to the Public Assistance regulations. The proposed changes would expand eligibility to include performing arts facilities and community arts centers pursuant to section 688 of PKEMRA; include education in the list of critical services pursuant to section 689(h) of PKEMRA, thus allowing private nonprofit educational facilities to be eligible for restoration funding; add accelerated Federal assistance to available assistance pursuant to section 681 of PKEMRA; include household pets and service animals in essential assistance pursuant to section 689 of PKEMRA and section 4 of the PETS Act; provide for expedited payments of grant assistance for the removal of debris pursuant to section 610 of the

SAFE Port Act; and allow for a contract to be set aside for award based on a specific geographic area pursuant to section 2 of the Local

Community Recovery Act of 2006. Other changes would include adding or changing requirements to improve and streamline the Public Assistance grant application process.

Federal Law Enforcement Training Center

The Federal Law Enforcement Training Center (FLETC) does not have any significant regulatory actions planned for fiscal year 2011.

United States Immigration and Customs Enforcement

U.S. Immigration and Customs Enforcement (ICE) is the principal criminal investigative arm of the Department of Homeland Security and one of the three Department components charged with the civil enforcement of the Nation's immigration laws. ICE's primary mission is to protect national security, public safety, and the integrity of our borders through the criminal and civil enforcement of Federal law governing border control, customs, trade, and immigration.

During fiscal year 2011, ICE will pursue rulemaking actions that improve two critical subject areas: The detention of aliens who are subject to final orders of removal and the processes for the Student and Exchange Visitor Program (SEVP).

Continued Detention of Aliens Subject to Final Orders of Removal

ICE will improve the post order custody review process in a final rule related to the continued detention of aliens subject to final orders of removal in light of the U.S. Supreme Court's decisions in Zadvydas v.

Davis, 533 U.S. 678 (2001) and Clark v. Martinez, 543 U.S. 371 (2005), as well as make changes pursuant to the enactment of the Homeland

Security Act of 2002. During fiscal year 2011, ICE will also issue a companion notice of proposed rulemaking that will allow the public an opportunity to comment on new sections of the custody determination process not previously published for comment.

Processes for the Student and Exchange Visitor Program

ICE will improve SEVP processes by publishing a final Optional

Practical Training (OPT) rule, which will respond to comments on the

OPT Interim Final Rule (IFR) published on June 9, 2008. The IFR increased the maximum period of OPT from 12 months to 29 months for nonimmigrant students who have completed a science, technology, engineering, or mathematics degree and who accept employment with employers who participate in USCIS' E-Verify employment verification program.

National Protection and Programs Directorate

The goal of the National Protection and Programs Directorate (NPPD) is to advance the Department's risk-reduction mission. Reducing risk requires an integrated approach that encompasses both physical and virtual threats and their associated human elements.

Secure Handling of Ammonium Nitrate Program

The Secure Handling of Ammonium Nitrate Act, section 563 of the Fiscal

Year 2008 Department of Homeland Security Appropriations Act, Public

Law No. 110-161, amended the Homeland Security Act of 2002 to provide

DHS with the authority to ``regulate the sale and transfer of ammonium nitrate by an ammonium nitrate facility . . . to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.''

The Secure Handling of Ammonium Nitrate Act directs DHS to promulgate regulations requiring potential buyers and sellers of ammonium nitrate to register with DHS. As part of the registration process, the statute directs DHS to screen registration applicants against the Federal

Government's Terrorist Screening Database. The statute also requires sellers of ammonium nitrate to verify the identities of those seeking to purchase it; to record certain information about each sale or transfer of ammonium nitrate; and to report thefts and losses of ammonium nitrate to DHS.

The rule would aid the Federal Government in its efforts to prevent the

Page 79541

misappropriation of ammonium nitrate for use in acts of terrorism. By preventing such misappropriation, this rule will limit terrorists' abilities to threaten the public and to threaten the Nation's critical infrastructure and key resources. By securing the Nation's supply of ammonium nitrate, it will be more difficult for terrorists to obtain ammonium nitrate materials for use in terrorist acts.

DHS published an advance notice of proposed rulemaking (ANPRM) for the

Secure Handling of Ammonium Nitrate Program on October 29, 2008, and has received a number of public comments on that ANPRM. DHS is presently reviewing those comments and is in the process of developing a notice of proposed rulemaking, which the Department hopes to issue during fiscal year 2011.

Collection of Alien Biometric Data Upon Exit From the United States at

Air and Sea Ports of Departure; United States Visitor and Immigrant

Status Indicator Technology Program

The U.S. Visitor and Immigrant Status Indicator Technology (US-VISIT) is an integrated, automated entry-exit system that records the arrival and departure of aliens, verifies aliens' identities, and verifies aliens' travel documents by comparison of biometric identifiers. The goals of US-VISIT are to enhance the security of U.S. citizens and visitors to the United States, facilitate legitimate travel and trade, ensure the integrity of the U.S. immigration system, and protect the privacy of visitors to the United States.

The US-VISIT program, through CBP officers or Department of State (DOS) consular offices, collects biometrics (digital fingerprints and photographs) from aliens seeking to enter the United States. DHS checks that information against government databases to identify suspected terrorists, known criminals, or individuals who have previously violated U.S. immigration laws. This system assists DHS and DOS in determining whether an alien seeking to enter the United States is, in fact, admissible to the United States under existing law. No biometric exit system currently exists, however, to assist DHS or DOS in determining whether an alien has overstayed the terms of his or her visa or other authorization to be present in the United States.

NPPD published a notice of proposed rulemaking on April 24, 2008, proposing to establish an exit program at all air and sea ports of departure in the United States. Congress subsequently enacted the

Consolidated Security, Disaster Assistance, and Continuing

Appropriations Act of 2009, Public Law No.110-329 (Sep. 30, 2008), requiring DHS to delay issuance of a final rule until the conclusion of pilot tests to analyze the collection of biometrics from at least two air exit scenarios. DHS currently is reviewing the results of those tests. DHS continues to work to ensure that the final air/sea exit rule will be issued as soon as practicable.

Transportation Security Administration

The Transportation Security Administration (TSA) protects the Nation's transportation systems to ensure freedom of movement for people and commerce. TSA is committed to continuously setting the standard for excellence in transportation security through its people, processes, and technology as we work to meet the immediate and long-term needs of the transportation sector.

In fiscal year 2011, TSA will promote the DHS mission by emphasizing regulatory efforts that allow TSA to better identify, detect, and protect against threats against various modes of the transportation system, while facilitating the efficient movement of the traveling public, transportation workers, and cargo.

Screening of Air Cargo

TSA will finalize an interim final rule that codifies a statutory requirement of the Implementing Recommendations of the 9/11 Commission

Act of 2008 (9/11 Act), Public Law 110-53 (Aug. 3, 2007) that TSA establish a system to screen 100 percent of cargo transported on passenger aircraft by August 3, 2010. To assist in carrying out this mandate, TSA has established a voluntary program under which it certifies cargo screening facilities to screen cargo according to TSA standards prior to its being tendered to aircraft operators for carriage on passenger aircraft.

Large Aircraft Security Program (General Aviation)

TSA plans to issue a supplemental notice of proposed rulemaking (SNPRM) to propose amendments to current aviation transportation security regulations to enhance the security of general aviation (GA) by expanding the scope of current requirements and by adding new requirements for certain GA aircraft operators. To date, the

Government's focus with regard to aviation security generally has been on air carriers and commercial operators. As vulnerabilities and risks associated with air carriers and commercial operators have been reduced or mitigated, terrorists may perceive that GA aircraft are more vulnerable and may view them as attractive targets. This rule would enhance aviation security of certain GA aircraft to undertake other security measures. TSA published a notice of proposed rulemaking on

October 30, 2008, and received over 7,000 public comments, generally urging significant changes to the proposal. The SNPRM will respond to the comments and contain proposals on addressing security in the GA sector.

Security Training for Surface Mode Employees

TSA will propose regulations to enhance the security of several non- aviation modes of transportation. In particular, TSA will propose regulations requiring freight railroad carriers, public transportation agencies (including rail mass transit and bus systems), passenger railroad carriers, over-the-road bus operators, and motor carriers transporting certain hazardous materials to conduct security training for front line employees. This regulation would implement sections 1408

(Public Transportation), 1517 (Freight Railroads), and 1534(a) (Over the Road (OTR) Buses) of the 9/11 Act. The NPRM will define which employees must be trained under these provisions, in compliance with the definitions of frontline employees in the pertinent provisions of the 9/11 Act. Some parts of the proposed rule would extend beyond the requirements of the 9/11 Act; those portions are authorized by the

Aviation and Transportation Security Act.

Aircraft Repair Station Security.

TSA will finalize a rule requiring repair stations that are certificated by the Federal Aviation Administration under 14 CFR part 145 to adopt and implement standard security programs and to comply with security directives issued by TSA. TSA issued a notice of proposed rulemaking on November 18, 2009. The final rule will also codify the scope of TSA's existing inspection program and require regulated parties to allow DHS officials to enter, inspect, and test property, facilities, and records relevant to repair stations. This rulemaking action implements section 1616 of the 9/11 Act.

Standardized Vetting, Adjudication, and Redress Process and Fees

TSA is developing a proposed rule to revise and standardize the procedures, adjudication criteria, and fees for most

Page 79542

of the security threat assessments (STA) of individuals that TSA conducts. The scope of the rulemaking will include transportation workers from almost all modes of transportation who are required to undergo an STA by a regulatory program and new programs, including those covered under the 9/11 Act. In addition, TSA will propose equitable fees to cover the cost of the STAs and credentials for some personnel. TSA plans to identify new efficiencies in processing STAs and ways to streamline existing regulations by simplifying language and removing redundancies.

United States Secret Service

The United States Secret Service does not have any significant regulatory actions planned for fiscal year 2011.

DHS Regulatory Plan for Fiscal Year 2011

A more detailed description of the priority regulations that comprise

DHS' fall 2010 regulatory plan follows.

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: sec 563 of the 2008 Consolidated Appropriations Act, subtitle J--Secure

Handling of Ammonium Nitrate, PL 110-161

CFR Citation: 6 CFR 31

Legal Deadline:

NPRM, Statutory, May 26, 2008, Publication of Notice of Proposed

Rulemaking.

Abstract:

This rulemaking will implement the December 2007 amendment to the

Homeland Security Act entitled ``Secure Handling of Ammonium Nitrate.''

The amendment requires the Department of Homeland Security to

``regulate the sale and transfer of ammonium nitrate by an ammonium nitrate facility. . .to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.''

Statement of Need:

Pursuant to section 563 of the 2008 Consolidated Appropriations Act, the Secure Handling of Ammonium Nitrate Act, Public Law 110-161, the

Department of Homeland Security is required to promulgate a rulemaking to create a registration regime for certain buyers and sellers of ammonium nitrate. The rule, as proposed by this NPRM, would create that regime, and will aid the Federal Government in its efforts to prevent the misappropriation of ammonium nitrate for use in acts of terrorism.

By preventing such misappropriation, this rule would limit terrorists' abilities to threaten the public and to threaten the Nation's critical infrastructure and key resources. By securing the Nation's supply of ammonium nitrate, it would be much more difficult for terrorists to obtain ammonium nitrate materials for use in improvised explosive devices. As a result, there is a direct value in the deterrence of a catastrophic terrorist attack using ammonium nitrate, such as the

Oklahoma City attack that killed over 160, injured 853 people, and is estimated to have caused $652 million in damages ($921 million in 2009).

Summary of Legal Basis:

Section 563 of the 2008 Consolidated Appropriations Act, subtitle J--

Secure Handling of Ammonium Nitrate, Public Law 110-161, authorizes and requires this rulemaking.

Alternatives:

The Department of Homeland Security is required by statute to publish regulations implementing the Secure Handling of Ammonium Nitrate Act.

As part of its notice of proposed rulemaking, the Department will seek public comment on the numerous alternative ways in which the final

Secure Handling of Ammonium Nitrate Program could carry out the requirements of the Secure Handling of Ammonium Nitrate Act.

Anticipated Cost and Benefits:

A proposed rule registering certain buyers and sellers of ammonium nitrate would have costs to ammonium nitrate (AN) purchasers, including farms, fertilizer mixers, farm supply wholesalers and coops, golf courses, landscaping services, explosives distributors, mines, retail garden centers, and lab supply wholesalers. There would also be costs to AN sellers, such as ammonium nitrate fertilizer and explosive manufacturers, fertilizer mixers, farm supply wholesalers and coops, retail garden center, explosives distributors, fertilizer applicator services, and lab supply wholesalers. Costs will relate to the point of sale requirements, registration activities, recordkeeping, inspections/ audits, and reporting of theft or loss.

Because the value of the benefits of reducing risk of a terrorist attack is a function of both the probability of an attack and the value of the consequence, it is difficult to identify the particular risk reduction associated with the implementation of this rule. When the proposed rule is published, DHS will provide a break even analysis. The program elements that would help achieve the risk reductions will be discussed in the break even analysis. These elements and related qualitative benefits include point of sale identification requirements and requiring individuals to be screened against the TSDB resulting in known bad actors being denied the ability to purchase ammonium nitrate.

Risks:

Explosives containing ammonium nitrate are commonly used in terrorist attacks. Such attacks have been carried out both domestically and internationally. The 1995 Murrah Federal Building attack in Oklahoma

City claimed the lives of 167 individuals and demonstrated firsthand to

America how ammonium nitrate could be misused by terrorists. In addition to the Murrah Building attack, the Provisional Irish

Republican Army used ammonium nitrate as part of its London, England bombing campaign in the early 1980s. More recently, ammonium nitrate was used in the 1998 East African Embassy bombings and in November 2003 bombings in Istanbul, Turkey. Additionally, since the events of 9/11, stores of ammonium nitrate have been confiscated during raids on terrorist sites around the world, including sites in Canada, England,

India, and the Philippines.

The Department of Homeland Security aims to prevent terrorist attacks within the United States and to reduce the vulnerability of the United

States to terrorism. By preventing the misappropriation or use of ammonium nitrate in acts of terrorism, this rulemaking will support the

Department's efforts to prevent terrorist attacks and to reduce the

Nation's vulnerability to terrorist attacks. This rulemaking is complementary to other Department programs seeking to reduce the risks posed by terrorism, including the Chemical Facility Anti-Terrorism

Page 79543

Standards program (which seeks in part to prevent terrorists from gaining access to dangerous chemicals) and the Transportation Worker

Identification Credential program (which seeks in part to prevent terrorists from gaining access to certain critical infrastructure), among other programs.

Timetable:

Action

Date

FR Cite

ANPRM

10/29/08

73 FR 64280

Correction

11/05/08

73 FR 65783

ANPRM Comment Period End

12/29/08

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Federal

Federalism:

This action may have federalism implications as defined in EO 13132.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Todd Klessman

Acting Deputy Director, Infrastructure Security Compliance Division

Department of Homeland Security

Ballston 1 - 5th floor

Room 5030

Arlington, VA 22201

Phone: 703 235-4921

Email: todd.klessman@dhs.gov

RIN: 1601-AA52

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Statement of Regulatory Priorities

DHS--OS

FINAL RULE STAGE

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Statement of Regulatory Priorities

AT AIR AND SEA PORTS OF DEPARTURE; UNITED STATES VISITOR AND IMMIGRANT

STATUS INDICATOR TECHNOLOGY PROGRAM (US-VISIT)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority: 8 USC 1101 to 1104; 8 USC 1182; 8 USC 1184 to 1185 (pursuant to EO 13323); 8 USC 1221; 8 USC 1365a, 1365b; 8 USC 1379; 8 USC 1731 to 1732

CFR Citation: 8 CFR 215.1; 8 CFR 215.8

Legal Deadline:

None

Abstract:

DHS established the United States Visitor and Immigrant Status

Indicator Technology Program (US-VISIT) in accordance with a series of legislative mandates requiring that DHS create an integrated automated entry-exit system that records the arrival and departure of aliens; verifies aliens' identities; and authenticates travel documents. This rule requires aliens to provide biometric identifiers at entry and upon departure at any air and sea port of entry at which facilities exist to collect such information.

Statement of Need:

This rule establishes an exit system at all air and sea ports of departure in the United States. This rule requires aliens subject to

United States Visitor and Immigrant Status Indicator Technology Program biometric requirements upon entering the United States to also provide biometric identifiers prior to departing the United States from air or sea ports of departure.

Alternatives:

The proposed rule would require aliens who are subject to US-VISIT biometric requirements upon entering the United States to provide biometric information before departing from the United States at air and sea ports of entry. The rule proposed a performance standard for commercial air and vessel carriers to collect the biometric information and to submit this information to DHS no later than 24 hours after air carrier staff secure the aircraft doors on an international departure, or for sea travel, no later than 24 hours after the vessel's departure from a U.S. port. DHS is considering numerous alternatives based upon public comment on the alternatives in the NPRM. Alternatives included various points in the process, kiosks, and varying levels of responsibility for the carriers and government. DHS may select another variation between the outer bounds of the alternatives presented or another alternative if subsequent analysis warrants.

Anticipated Cost and Benefits:

The proposed rule expenditure and delay costs for a 10-year period are estimated at $3.5 billion. Alternative costs range from $3.1 billion to

$6.4 billion. US-VISIT assessed seven categories of economic impacts other than direct expenditures. Of these, two are economic costs:

Social costs resulting from increased traveler queue and processing time; and social costs resulting from increased flight delays. Ten-year benefits are estimated at $1.1 billion. US-VISIT assessed seven categories of economic impacts other than direct expenditures. Of these, five are benefits, which include costs that could be avoided for each alternative: Cost avoidance resulting from improved detection of aliens overstaying visas; cost avoidance resulting from improved U.S.

Immigrations and Customs Enforcement (ICE) efficiency attempting apprehension of overstays; cost avoidance resulting from improved efficiency processing exit/entry data; improved compliance with NSEERS requirements due to the improvement in ease of compliance; and improved national security environment. These benefits are measured quantitatively or qualitatively.

Timetable:

Action

Date

FR Cite

NPRM

04/24/08

73 FR 22065

NPRM Comment Period End

06/23/08

Final Rule

04/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Page 79544

Agency Contact:

Long D. Kaiser

Policy Analyst, National Protection and Programs Directorate (NPPD),

US-VISIT

Department of Homeland Security

Washington, DC 20528

Phone: 202 295-0735

Email: long.d.kaiser@dhs.gov

Related RIN: Previously reported as 1650-AA04

RIN: 1601-AA34

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Statement of Regulatory Priorities

DHS--U.S. Citizenship and Immigration Services (USCIS)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

Priority:

Other Significant

Legal Authority: 8 USC 1103; 8 USC 1158; 8 USC 1226; 8 USC 1252; 8 USC 1282; 8 CFR 2

CFR Citation: 8 CFR 208

Legal Deadline:

None

Abstract:

This rule proposes to amend Department of Homeland Security regulations that govern asylum eligibility. The amendments focus on portions of the regulations that deal with the definitions of membership in a particular social group, the requirements for failure of State protection, and determinations about whether persecution is inflicted on account of a protected ground. This rule codifies long-standing concepts of the definitions. It clarifies that gender can be a basis for membership in a particular social group. It also clarifies that a person who has suffered or fears domestic violence may under certain circumstances be eligible for asylum on that basis. After the Board of

Immigration Appeals published a decision on this issue in 1999, Matter of R-A-, Int. Dec. 3403 (BIA 1999), it became clear that the governing regulatory standards required clarification. The Department of Justice began this regulatory initiative by publishing a proposed rule addressing these issues in 2000.

Statement of Need:

This rule provides guidance on a number of key interpretive issues of the refugee definition used by adjudicators deciding asylum and withholding of removal (withholding) claims. The interpretive issues include whether persecution is inflicted on account of a protected ground, the requirements for establishing the failure of State protection, and the parameters for defining membership in a particular social group. This rule will aid in the adjudication of claims made by applicants whose claims fall outside of the rubric of the protected grounds of race, religion, nationality, or political opinion. One example of such claims which often fall within the particular social group ground concerns people who have suffered or fear domestic violence. This rule is expected to consolidate issues raised in a proposed rule in 2000, and to address issues that have developed since the publication of the proposed rule. This should provide greater stability and clarity in this important area of the law.

Summary of Legal Basis:

The purpose of this rule is to provide guidance on certain issues that have arisen in the context of asylum and withholding adjudications. The 1951 Geneva Convention relating to the Status of Refugees (1951

Convention) contains the internationally accepted definition of a refugee. United States immigration law incorporates an almost identical definition of a refugee as a person outside his or her country of origin ``who is unable or unwilling to return to, and is unable or unwilling to avail himself or herself of the protection of, that country because of persecution or a well-founded fear of persecution on account of race, religion, nationality, membership in a particular social group, or political opinion.`` Section 101(a)(42) of the

Immigration and Nationality Act.

Alternatives:

A sizable body of interpretive case law has developed around the meaning of the refugee definition. Historically, much of this case law has addressed more traditional asylum and withholding claims based on the protected grounds of race, religion, nationality, or political opinion. In recent years, however, the United States increasingly has encountered asylum and withholding applications with more varied bases, related, for example, to an applicant's gender or sexual orientation.

Many of these new types of claims are based on the ground of

``membership in a particular social group,'' which is the least well- defined of the five protected grounds within the refugee definition.

On December 7, 2000, a proposed rule was published in the Federal

``membership in a particular social group.'' Prior to publishing a final rule, the Department will be considering how the nexus between persecution and a protected ground might be further conceptualized; how membership in a particular social group might be defined and evaluated; and what constitutes a State's inability or unwillingness to protect the applicant where the persecution arises from a non-State actor. This rule will provide guidance to the following adjudicators: USCIS asylum officers, Department of Justice Executive Office for Immigration Review

(EOIR) immigration judges, and members of the EOIR Board of Immigration

Appeals. The alternative to publishing this rule would be to allow the standards governing this area of law to continue to develop piecemeal through administrative and judicial precedent. This approach has resulted in inconsistent and confusing standards, and the Department has therefore determined that promulgation of the final rule is necessary.

Anticipated Cost and Benefits:

By providing a clear framework for key asylum and withholding issues, we anticipate that adjudicators will have clear guidance, increasing administrative efficiency, and consistency in adjudicating these cases.

The rule will also promote a more consistent and predictable body of administrative and judicial precedent governing these types of cases.

We anticipate that this will enable applicants to better assess their potential eligibility for asylum, and to present their claims more efficiently when they believe that they may qualify, thus reducing the resources spent on adjudicating claims that do not qualify. In addition, a more consistent and predictable body of law on these issues will likely result in fewer appeals, both administrative and judicial, and reduce the associated litigation costs. The Department has no way of accurately predicting how this rule will impact the number of asylum applications filed in the United States. Based on anecdotal evidence and on the reported experience of other nations that have adopted standards under which the results are similar to those we anticipate from this rule, we do not

Page 79545

believe this rule will cause a large change in the number of asylum applications filed.

Risks:

The failure to promulgate a final rule in this area presents significant risks of further inconsistency and confusion in the law.

The Government's interests in fair, efficient and consistent adjudications would be compromised.

Timetable:

Action

Date

FR Cite

NPRM

12/07/00

65 FR 76588

NPRM Comment Period End

01/22/01

NPRM

03/00/11

NPRM Comment Period End

05/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Additional Information:

CIS No. 2092-00

Transferred from RIN 1115-AF92

Agency Contact:

Jedidah Hussey

Deputy Chief, Asylum Division

Department of Homeland Security

U.S. Citizenship and Immigration Services

Suite 3300, 20 Massachusetts Avenue NW.

Washington, DC 20529

Phone: 202 272-1663

Email: jedidah.m.hussey@dhs.gov

RIN: 1615-AA41

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Statement of Regulatory Priorities

PETITIONS ON BEHALF OF ALIENS SUBJECT TO NUMERICAL LIMITATIONS

Priority:

Other Significant

Legal Authority: 8 USC 1184(g)

CFR Citation: 8 CFR 103; 8 CFR 299

Legal Deadline:

None

Abstract:

The Department of Homeland Security is proposing to amend its regulations governing petitions filed on behalf of alien workers subject to annual numerical limitations. This rule proposes an electronic registration program for petitions subject to numerical limitations contained in the Immigration and Nationality Act (the Act).

Initially, the program would be for the H-1B nonimmigrant classification; however, other nonimmigrant classifications will be added as needed. This action is necessary because the demand for H-1B specialty occupation workers by U.S. companies generally exceeds the numerical limitation. This rule is intended to allow USCIS to more efficiently manage the intake and lottery process for these H-1B petitions.

Statement of Need:

U.S. Citizenship and Immigration Services (USCIS) proposes to establish a mandatory Internet-based electronic registration process for U.S. employers seeking to file H-1B petitions for alien workers subject to either the 65,000 or 20,000 caps. This registration process would allow

U.S. employers to electronically register for consideration of available H-1B cap numbers. The mandatory proposed registration process will alleviate administrative burdens on USCIS service centers and eliminate the need for U.S. employers to needlessly prepare and file H- 1B petitions without any certainty that an H-1B cap number will ultimately be allocated to the beneficiary named on that petition.

Summary of Legal Basis:

Section 214(g) of the Immigration and Nationality Act provides limits on the number of alien temporary workers who may be granted H-1B nonimmigrant status each fiscal year (commonly known as the ``cap'').

USCIS has responsibility for monitoring the requests for H-1B workers and administers the distribution of available H-1B cap numbers in light of these limits.

Alternatives:

To ensure a fair and orderly distribution of H-1B cap numbers, USCIS evaluated its current random selection process, and has found that when it receives a significant number of H-1B petitions within the first few days of the H-1B filing period, it is extremely difficult to handle the volume of petitions received in advance of the H-1B random selection process. Further, the current petition process of preparing and mailing

H-1B petitions, with the required filing fee, can be burdensome and costly for employers, if the petition is returned because the cap was reached and the petition was not selected in the random selection process.

Accordingly, this rule proposes to implement a new process to allow

U.S. employers to electronically register for consideration of available H-1B cap numbers without having to first prepare and submit the petition.

Anticipated Cost and Benefits:

USCIS estimates that this rule will result in a net benefit to society.

Currently, employers submit a petition, at great expense, without any certainty that an H-1B cap number will ultimately be allocated to the beneficiary named on the petition. The new mandatory, Internet-based registration system allows employers to complete a much shorter and less expensive registration process for consideration of available H-1B cap numbers. The new system will also relieve a significant administrative burden and expense from USCIS.

This rule will reduce costs for some employers and increase them for others. For employers that are not allocated a cap number and therefore do not ultimately file a petition, there will be a significant cost savings. Employers that are allocated a cap number and ultimately file a petition will experience the new and additional cost of filing the registration. Additionally, USCIS will incur additional costs to implement and maintain the registration system. USCIS has weighed the benefits and costs associated with this rule and determined that the benefits to society outweigh the costs.

Risks:

There is a risk that a petitioner will submit multiple petitions for the same H-1B beneficiary so that the U.S. employer will have a better chance of his or her petition being selected. Accordingly, should USCIS receive multiple petitions for the same H-1B beneficiary by the same petitioner, the system will only accept the first petition and reject the duplicate petitions.

Timetable:

Action

Date

FR Cite

NPRM

01/00/11

NPRM Comment Period End

03/00/11

Page 79546

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Additional Information:

USCIS 2443-08

Agency Contact:

Claudia F. Young

Department of Homeland Security

U.S. Citizenship and Immigration Services

Service Center Operations 20 Massachusetts Avenue NW.

Washington, DC 20529

Phone: 202 272-8163

Email: cf1young@dhs.gov

RIN: 1615-AB71

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Statement of Regulatory Priorities

TEMPORARY PROTECTED STATUS, AND WITHHOLDING OF REMOVAL

Priority:

Other Significant

Legal Authority: 8 USC 1101; 8 USC 1103; 8 USC 1158; 8 USC 1226; PL 107-26; PL 110-229;

. . .

CFR Citation: 8 CFR 1; 8 CFR 208; 8 CFR 244; 8 CFR 1244; . . .

Legal Deadline:

None

Abstract:

This joint rule proposes amendments to Department of Homeland Security

(DHS) and Department of Justice (DOJ) regulations to describe the circumstances under which an applicant will continue to be eligible for asylum, refugee, or temporary protected status, special rule cancellation of removal under the Nicaraguan Adjustment and Central

American Relief Act, and withholding of removal, even if DHS or DOJ has determined that the applicant's actions contributed, in some way, to the persecution of others. The purpose of this rule is to resolve ambiguity in the statutory language precluding eligibility for asylum, refugee, and temporary protected status of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed amendment would provide a limited exception for actions taken by the applicant under duress and clarify the required levels of the applicant's knowledge of the persecution.

Statement of Need:

This rule resolves ambiguity in the statutory language precluding eligibility for asylum, refugee, and temporary protected status of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed amendment would provide a limited exception for actions taken by the applicant under duress and clarify the required levels of the applicant's knowledge of the persecution.

Summary of Legal Basis:

In Negusie v. Holder, 129 S. Ct. 1159 (2009), the Supreme Court addressed whether the persecutor bar should apply where an alien's actions were taken under duress. DHS believe that this is an appropriate subject for rulemaking and propose to amend the applicable regulations to set out their interpretation of the statute. In developing this regulatory initiative, DHS has carefully considered the purpose and history behind enactment of the persecutor bar, including its international law origins and the criminal law concepts upon which they are based.

Alternatives:

DHS did consider the alternative of not publishing a rulemaking on these issues. To leave this important area of the law without an administrative interpretation, however, would confuse adjudicators and the public.

Anticipated Cost and Benefits:

The programs affected by this rule exist so that the United States may respond effectively to global humanitarian situations and assist people who are in need. USCIS provides a number of humanitarian programs and protection to assist individuals in need of shelter or aid from disasters, oppression, emergency medical issues, and other urgent circumstances. This rule will advance the humanitarian goals of the asylum/refugee program, and other specialized programs. The main benefits of such tend to be intangible and difficult to quantify in economic and monetary terms. These forms of relief have not been available to certain persecutors. This rule will allow an exception to this bar from protection for applicants who can meet the appropriate evidentiary standard. Consequently, this rule may result in a small increase in the number of applicants for humanitarian programs. To the extent a small increase in applicants occurs, there could be additional fee costs incurred by these applicants.

Risks:

If DHS were not to publish a regulation, the public would face a lengthy period of confusion on these issues. There could also be inconsistent interpretations of the statutory language, leading to significant litigation and delay for the affected public.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Molly Groom

Office of the Chief Counsel

Department of Homeland Security

U.S. Citizenship and Immigration Services 20 Massachusetts Avenue NW.

Washington, DC 20259

Phone: 202 272-1400

Fax: 202 272-1408

Email: molly.groom@dhs.gov

RIN: 1615-AB89

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Statement of Regulatory Priorities

DHS--USCIS

FINAL RULE STAGE

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Statement of Regulatory Priorities

PERSONS; ELIGIBILITY FOR T NONIMMIGRANT STATUS

Priority:

Other Significant

Legal Authority: 5 USC 552; 5 USC 552a; 8 USC 1101 to 1104; 8 USC 1182; 8 USC 1184; 8

Page 79547

USC 1187; 8 USC 1201; 8 USC 1224 to 1227; 8 USC 1252 to 1252a; 22 USC 7101; 22 USC 7105; . . .

CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 274a; 8 CFR 299

Legal Deadline:

None

Abstract:

T classification was created by 107(e) of the Victims of Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law 106-386. The T nonimmigrant classification was designed for eligible victims of severe forms of trafficking in persons who aid law enforcement with their investigation or prosecution of the traffickers, and who can establish that they would suffer extreme hardship involving unusual and severe harm if they were removed from the United States. The rule establishes application procedures and responsibilities for the Department of

Homeland Security and provides guidance to the public on how to meet certain requirements to obtain T nonimmigrant status. The Trafficking

Victims Protection Reauthorization Act of 2008, Public Law 110-457, made amendments to the T nonimmigrant status provisions of the

Immigration and Naturalization Act. The Department will issue another interim final rule to make the changes required by recent legislation and to provide the opportunity for notice and comment.

Statement of Need:

T nonimmigrant status is available to eligible victims of severe forms of trafficking in persons who have complied with any reasonable request for assistance in the investigation or prosecution of acts of trafficking in persons, and who can demonstrate that they would suffer extreme hardship involving unusual and severe harm if removed from the

United States. This rule addresses the essential elements that must be demonstrated for classification as a T nonimmigrant alien; the procedures to be followed by applicants to apply for T nonimmigrant status; and evidentiary guidance to assist in the application process.

Summary of Legal Basis:

Section 107(e) of the Trafficking Victims Protection Act (TVPA), Public

Law 106-386, as amended, established the T classification to create a safe haven for certain eligible victims of severe forms of trafficking in persons, who assist law enforcement authorities in investigating and prosecuting the perpetrators of these crimes.

Alternatives:

To develop a comprehensive Federal approach to identifying victims of severe forms of trafficking in persons, to provide them with benefits and services, and to enhance the Department of Justice's ability to prosecute traffickers and prevent trafficking in persons in the first place, a series of meetings with stakeholders were conducted with representatives from key Federal agencies; national, State, and local law enforcement associations; non-profit, community-based victim rights organizations; and other groups. Suggestions from these stakeholders were used in the drafting of this regulation.

Anticipated Cost and Benefits:

There is no cost to applicants associated with this regulation.

Applicants for T nonimmigrant status do not pay application or biometric fees.

The anticipated benefits of these expenditures include: Assistance to trafficked victims and their families, prosecution of traffickers in persons, and the elimination of abuses caused by trafficking activities.

Benefits which may be attributed to the implementation of this rule are expected to be: 1. An increase in the number of cases brought forward for investigation and/or prosecution; 2. Heightened awareness by the law enforcement community of trafficking in persons; 3. Enhanced ability to develop and work cases in trafficking in persons cross-organizationally and multi-jurisdictionally, which may begin to influence changes in trafficking patterns.

Risks:

There is a 5,000-person limit to the number of individuals who can be granted T-1 status per fiscal year. Eligible applicants who are not granted T-1 status due solely to the numerical limit will be placed on a waiting list to be maintained by U.S. Citizenship and Immigration

Services (USCIS).

To protect T-1 applicants and their families, USCIS will use various means to prevent the removal of T-1 applicants on the waiting list, and their family members who are eligible for derivative T status, including its existing authority to grant deferred action, parole, and stays of removal.

Timetable:

Action

Date

FR Cite

Interim Final Rule

01/31/02

67 FR 4784

Interim Final Rule

Effective

03/04/02

Interim Final Rule

Comment Period End

04/01/02

Interim Final Rule

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected:

Federal, Local, State

Additional Information:

CIS No. 2132-01; AG Order No. 2554-2002

There is a related rulemaking, CIS No. 2170-01, the new U nonimmigrant status (RIN 1615-AA67).

Transferred from RIN 1115-AG19

Agency Contact:

Laura M. Dawkins

Chief, Family Immigration and Victim Protection Division

Department of Homeland Security

U.S. Citizenship and Immigration Services 20 Massachusetts Avenue NW.

Suite 1200

Washington, DC 20529

Phone: 202 272-1470

Fax: 202 272-1480

Email: laura.dawkins@dhs.gov

RIN: 1615-AA59

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Statement of Regulatory Priorities

AND U NONIMMIGRANT STATUS

Priority:

Other Significant

Legal Authority: 5 USC 552; 5 USC 552a; 8 USC 1101 to 1104; 8 USC 1182; 8 USC 1184; 8

USC 1187; 8 USC 1201; 8 USC 1224 to 1227; 8 USC 1252 to 1252a; 8 USC 1255; 22 USC 7101; 22 USC 7105

CFR Citation: 8 CFR 204; 8 CFR 214; 8 CFR 245

Page 79548

Legal Deadline:

None

Abstract:

This rule sets forth measures by which certain victims of severe forms of trafficking who have been granted T nonimmigrant status and victims of certain criminal activity who have been granted U nonimmigrant status may apply for adjustment to permanent resident status in accordance with Public Law 106-386, Victims of Trafficking and Violence

Protection Act of 2000; and Public Law 109-162, Violence Against Women and Department of Justice Reauthorization Act of 2005. The Trafficking

Victims Protection Reauthorization Act of 2008, Public Law 110-457, made amendments to the T nonimmigrant status provisions of the

Immigration and Naturalization Act. The Department will issue another interim final rule to make the changes required by recent legislation and to provide the opportunity for notice and comment.

Statement of Need:

This regulation is necessary to permit aliens in lawful T or U nonimmigrant status to apply for adjustment of status to that of lawful permanent residents. T nonimmigrant status is available to aliens who are victims of a severe form of trafficking in persons and who are assisting law enforcement in the investigation or prosecution of the acts of trafficking. U nonimmigrant status is available to aliens who are victims of certain crimes and are being helpful to the investigation or prosecution of those crimes.

Summary of Legal Basis:

This rule implements the Victims of Trafficking and Violence Protection

Act of 2000 (VTVPA), Public Law 106-386, 114 Stat. 1464 (Oct. 28, 2000), as amended, to permit aliens in lawful T or U nonimmigrant status to apply for adjustment of status to that of lawful permanent residents.

Alternatives:

USCIS did not consider alternatives to managing T and U applications for adjustment of status. Ease of administration dictates that adjustment of status applications from T and U nonimmigrants would be best handled on a first in, first out basis, because that is the way applications for T and U status are currently handled.

Anticipated Cost and Benefits:

USCIS uses fees to fund the cost of processing applications and associated support benefits. The fees to be collected resulting from this rule will be approximately $3 million in the first year, $1.9 million in the second year, and an average about $32 million in the third and subsequent years. To estimate the new fee collections to be generated by this rule, USCIS estimated the fees to be collected for new applications for adjustment of status from T and U nonimmigrants and their eligible family members. After that, USCIS estimated fees from associated applications that are required such as biometrics, and others that are likely to occur in direct connection with applications for adjustment, such as employment authorization or travel authorization.

The anticipated benefits of these expenditures include: Continued assistance to trafficked victims and their families, increased investigation and prosecution of traffickers in persons, and the elimination of abuses caused by trafficking activities.

Benefits that may be attributed to the implementation of this rule are expected to be: 1. An increase in the number of cases brought forward for investigation and/or prosecution; 2. Heightened awareness of trafficking-in-persons issues by the law enforcement community; and 3. Enhanced ability to develop and work cases in trafficking in persons cross-organizationally and multi-jurisdictionally, which may begin to influence changes in trafficking patterns.

Risks:

Congress created the U nonimmigrant status (``U visa'') to provide immigration protection to crime victims who assist in the investigation and prosecution of those crimes. Although there are no specific data on alien crime victims, statistics maintained by the Department of Justice have shown that aliens, especially those aliens without legal status, are often reluctant to help in the investigation or prosecution of crimes. U visas are intended to help overcome this reluctance and aid law enforcement accordingly.

Timetable:

Action

Date

FR Cite

Interim Final Rule

12/12/08

73 FR 75540

Interim Final Rule

Effective

01/12/09

Interim Final Rule

Comment Period End

02/10/09

Interim Final Rule

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

Federal, Local, State

Additional Information:

CIS No. 2134-01

Transferred from RIN 1115-AG21

Agency Contact:

Laura M. Dawkins

Chief, Family Immigration and Victim Protection Division

Department of Homeland Security

U.S. Citizenship and Immigration Services 20 Massachusetts Avenue NW.

Suite 1200

Washington, DC 20529

Phone: 202 272-1470

Fax: 202 272-1480

Email: laura.dawkins@dhs.gov

RIN: 1615-AA60

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Statement of Regulatory Priorities

FOR THE ``U'' NONIMMIGRANT STATUS

Priority:

Other Significant

Legal Authority: 5 USC 552; 5 USC 552a; 8 USC 1101; 8 USC 1101 note; 8 USC 1102

CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 212; 8 CFR 214; 8 CFR 299

Legal Deadline:

None

Abstract:

This rule sets forth application requirements for a new nonimmigrant status. The U classification is for non-U.S. Citizen/Lawful Permanent

Resident victims of certain crimes who cooperate with an investigation or prosecution of those crimes. There is a limit of 10,000 principals per year.

This rule establishes the procedures to be followed in order to petition for the

Page 79549

U nonimmigrant classifications. Specifically, the rule addresses the essential elements that must be demonstrated to receive the nonimmigrant classification, procedures that must be followed to make an application, and evidentiary guidance to assist in the petitioning process. Eligible victims will be allowed to remain in the United

States. The Trafficking Victims Protection Reauthorization Act of 2008,

Public Law 110-457, made amendments to the T nonimmigrant status provisions of the Immigration and Naturalization Act. The Department will issue another interim final rule to make the changes required by recent legislation and to provide the opportunity for notice and comment.

Statement of Need:

This rule provides requirements and procedures for aliens seeking U nonimmigrant status. U nonimmigrant classification is available to alien victims of certain criminal activity who assist government officials in the investigation or prosecution of that criminal activity. The purpose of the U nonimmigrant classification is to strengthen the ability of law enforcement agencies to investigate and prosecute such crimes as domestic violence, sexual assault, and trafficking in persons, while offering protection to alien crime victims in keeping with the humanitarian interests of the United

States.

Summary of Legal Basis:

Congress created the U nonimmigrant classification in the Battered

Immigrant Women Protection Act of 2000 (BIWPA). Congress intended to strengthen the ability of law enforcement agencies to investigate and prosecute cases of domestic violence, sexual assault, trafficking of aliens, and other crimes, while offering protection to victims of such crimes. Congress also sought to encourage law enforcement officials to better serve immigrant crime victims.

Alternatives:

USCIS has identified four alternatives, the first being chosen for the rule: 1. USCIS would adjudicate petitions on a first in, first out basis.

Petitions received after the limit has been reached would be reviewed to determine whether or not they are approvable, but for the numerical cap. Approvable petitions that are reviewed after the numerical cap has been reached would be placed on a waiting list and written notice sent to the petitioner. Priority on the waiting list would be based upon the date on which the petition is filed. USCIS would provide petitioners on the waiting list with interim relief until the start of the next fiscal year in the form of deferred action, parole, or a stay of removal. 2. USCIS would adjudicate petitions on a first in, first out basis, establishing a waiting list for petitions that are pending or received after the numerical cap has been reached. Priority on the waiting list would be based upon the date on which the petition was filed. USCIS would not provide interim relief to petitioners whose petitions are placed on the waiting list. 3. USCIS would adjudicate petitions on a first in, first out basis.

However, new filings would be reviewed to identify particularly compelling cases for adjudication. New filings would be rejected once the numerical cap is reached. No official waiting list would be established; however, interim relief until the start of the next fiscal year would be provided for some compelling cases. If a case was not particularly compelling, the filing would be denied or rejected. 4. USCIS would adjudicate petitions on a first in, first out basis.

However, new filings would be rejected once the numerical cap is reached. No waiting list would be established, nor would interim relief be granted.

Anticipated Cost and Benefits:

USCIS estimates the total annual cost of this interim rule to applicants to be $6.2 million. This cost includes the biometric services fee that petitioners must pay to USCIS, the opportunity cost of time needed to submit the required forms, the opportunity cost of time required for a visit to an Application Support Center, and the cost of traveling to an Application Support Center.

This rule will strengthen the ability of law enforcement agencies to investigate and prosecute such crimes as domestic violence, sexual assault, and trafficking in persons, while offering protection to alien crime victims in keeping with the humanitarian interests of the United

States.

Risks:

In the case of witness tampering, obstruction of justice, or perjury, the interpretive challenge for USCIS was to determine whom the BIWPA was meant to protect, given that these criminal activities are not targeted against a person. Accordingly it was determined that a victim of witness tampering, obstruction of justice, or perjury is an alien who has been directly and proximately harmed by the perpetrator of one of these three crimes, where there are reasonable grounds to conclude that the perpetrator principally committed the offense as a means: (1) to avoid or frustrate efforts to investigate, arrest, prosecute, or otherwise bring him or her to justice for other criminal activity; or

(2) to further his or her abuse or exploitation of, or undue control over, the alien through manipulation of the legal system.

Timetable:

Action

Date

FR Cite

Interim Final Rule

09/17/07

72 FR 53013

Interim Final Rule

Effective

10/17/07

Interim Final Rule

Comment Period End

11/17/07

Interim Final Rule

09/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

Federal, Local, State

Additional Information:

Transferred from RIN 1115-AG39

Agency Contact:

Laura M. Dawkins

Chief, Family Immigration and Victim Protection Division

Department of Homeland Security

U.S. Citizenship and Immigration Services 20 Massachusetts Avenue NW.

Suite 1200

Washington, DC 20529

Phone: 202 272-1470

Fax: 202 272-1480

Email: laura.dawkins@dhs.gov

RIN: 1615-AA67

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Statement of Regulatory Priorities

NORTHERN MARIANA ISLANDS WITH LONG-TERM INVESTOR STATUS

Priority:

Other Significant

Legal Authority: 8 USC 1101 to 1103; 8 USC 1182; 8 USC 1184; 8 USC 1186a

Page 79550

CFR Citation: 8 CFR 214

Legal Deadline:

None

Abstract:

This final rule amends Department of Homeland Security regulations governing E-2 nonimmigrant treaty investors to establish procedures for classifying long-term investors in the Commonwealth of the Northern

Mariana Islands (CNMI) as E-2 nonimmigrants. This final rule implements the CNMI nonimmigrant investor visa provisions of the Consolidated

Natural Resources Act of 2008, extending the immigration laws of the

United States to the CNMI.

Statement of Need:

This final rule responds to a congressional mandate that requires the

Federal Government to assume responsibility for visas for entry to CNMI by foreign investors.

Anticipated Cost and Benefits:

Public Costs: This rule reduces the employer's annual cost by $200 per year ($500-$300), plus any further reduction caused by eliminating the paperwork burden associated with the CNMI's process. In 2006 to 2007, there were 464 long-term business entry permit holders and 20 perpetual foreign investor entry permit holders and retiree investor permit holders, totaling 484, or approximately 500 foreign registered investors. The total savings to employers from this rule is thus expected to be $100,000 per year ($500 x $200). Cost to the Federal

Government: The yearly Federal Government cost is estimated at $42,310.

Benefits: The potential abuse of the visa system by those seeking to illegally emigrate from the CNMI to Guam or elsewhere in the United

States reduces the integrity of the United States immigration system by increasing the ease by which aliens may unlawfully enter the United

States through the CNMI. Federal oversight and regulations of CNMI foreign investors should help reduce abuse by foreign employees in the

CNMI, and should help reduce the opportunity for aliens to use the CNMI as an entry point into the United States.

Timetable:

Action

Date

FR Cite

NPRM

09/14/09

74 FR 46938

NPRM Comment Period End

10/14/09

Final Action

12/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Local, State

Additional Information:

CIS No. 2458-08

Agency Contact:

Kevin J. Cummings

Chief of Business and Foreign Workers Division

Department of Homeland Security

U.S. Citizenship and Immigration Services

Office of Policy and Strategy 20 Massachusetts Avenue NW.

Washington, DC 20529-2140

Phone: 202 272-8410

Fax: 202 272-1542

Email: kevin.cummings@dhs.gov

RIN: 1615-AB75

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Statement of Regulatory Priorities

CLASSIFICATION

Priority:

Other Significant

Legal Authority:

PL 110-229

CFR Citation: 8 CFR 214.2

Legal Deadline:

None

Abstract:

The Department of Homeland Security (DHS) is creating a new, temporary,

Commonwealth of the Northern Mariana Islands (CNMI)-only transitional worker classification (CW classification) in accordance with title VII of the Consolidated Natural Resources Act of 2008 (CNRA). The transitional worker program is intended to provide for an orderly transition from the CNMI permit system to the U.S. Federal immigration system under the Immigration and Nationality Act (INA). A CW transitional worker is an alien worker who is ineligible for another classification under the INA and who performs services or labor for an employer in the CNMI. The CNRA imposes a 5-year transition period before the INA requirements become fully applicable in the CNMI. The new CW classification will be in effect for the duration of that transition period, unless extended by the Secretary of Labor. The rule also establishes employment authorization incident to CW status.

Statement of Need:

Title VII of the Consolidated Natural Resources Act of 2008 (CNRA) created a new, temporary, Commonwealth of the Northern Mariana Islands

(CNMI)-only transitional worker classification. The transitional worker program is intended to provide for an orderly transition from the CNMI permit system to the U.S. Federal immigration system under the

Immigration and Nationality Act.

Anticipated Cost and Benefits:

Each of the estimated 22,000 CNMI transitional workers will be required to pay a $320 fee per year, for an annualized cost to the affected public of $7 million. However, since these workers will not have to pay

CNMI fees, the total present value costs of this rule are a net cost savings ranging from $9.8 million to $13.4 million depending on the validity period of CW status (1 or 2 years), whether out-of-status aliens present in the CNMI are eligible for CW status, and the discount rate applied. The intended benefits of the rule include improvements in national and homeland security and protection of human rights.

Timetable:

Action

Date

FR Cite

Interim Final Rule

10/27/09

74 FR 55094

Interim Final Rule

Comment Period End

11/27/09

Interim Final Rule

Comment Period End

Extended

12/09/09

74 FR 64997

Interim Final Rule

Comment Period End

01/08/10

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

State

Page 79551

Agency Contact:

Kevin J. Cummings

Chief of Business and Foreign Workers Division

Department of Homeland Security

U.S. Citizenship and Immigration Services

Office of Policy and Strategy 20 Massachusetts Avenue NW.

Washington, DC 20529-2140

Phone: 202 272-8410

Fax: 202 272-1542

Email: kevin.cummings@dhs.gov

RIN: 1615-AB76

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Statement of Regulatory Priorities

NORTHERN MARIANA ISLANDS

Priority:

Other Significant

Legal Authority:

PL 110-229

CFR Citation: 8 CFR 208 and 209; 8 CFR 214 and 215; 8 CFR 217; 8 CFR 235; 8 CFR 248; 8 CFR 264; 8 CFR 274a

Legal Deadline:

Final, Statutory, November 28, 2009, Consolidated Natural Resources Act

(CNRA) of 2008.

Abstract:

On October 28, 2009, the Department of Homeland Security (DHS) and the

Department of Justice (DOJ) published a joint interim final rule in the

Federal Register implementing conforming amendments to their respective regulations to comply with the Consolidated Natural Resources Act of 2008 (CNRA). The CNRA extends the immigration laws of the United States to the Commonwealth of the Northern Mariana Islands (CNMI). This rule finalizes the interim rule with additional changes to provisions concerning adjustment of status and change of status of aliens in the

CNMI, immigrant petitions for multinational executives, acceptable documents for employment eligibility verification (Form I-9), and the

Northern Marianas identification card. It is intended that such changes will ameliorate any adverse impact that implementation of the CNRA may have on CNMI employers and alien workers.

Statement of Need:

The Department of Homeland Security (DHS) and the Department of Justice

(DOJ) are implementing conforming amendments to their respective regulations to comply with the Consolidated Natural Resources Act of 2008 (CNRA). The CNRA extends the immigration laws of the United States to the Commonwealth of the Northern Mariana Islands (CNMI). This rule amends the regulations governing: Asylum and credible fear of persecution determinations; references to the geographical ``United

States'' and its territories and possessions; alien classifications authorized for employment; documentation acceptable for Employment

Eligibility Verification; employment of unauthorized aliens; and adjustment of status of immediate relatives admitted under the Guam-

CNMI Visa Waiver Program. Additionally, this rule makes a technical change to correct a citation error in the regulations governing the

Visa Waiver Program and the regulations governing asylum and withholding of removal.

Anticipated Cost and Benefits:

The stated goals of the CNRA are to ensure effective border control procedures, to properly address national security and homeland security concerns by extending U.S. immigration law to the CNMI, and to maximize the CNMI's potential for future economic and business growth. While those goals are expected to be partly facilitated by the changes made in this rule, they are general and qualitative in nature. There are no specific changes made by this rule with sufficiently identifiable direct or indirect economic impacts so as to be quantified.

Timetable:

Action

Date

FR Cite

Interim Final Rule

10/28/09

74 FR 55725

Interim Final Rule

Comment Period End

11/27/09

Correction

12/22/09

74 FR 67969

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Additional Information:

CIS 2460-08

Agency Contact:

Kevin Cummings

Branch Chief, Business and Trade Services

Department of Homeland Security

U.S. Citizenship and Immigration Services

Second Floor

Office of Program and Regulations Development 20 Massachusetts Avenue NW.

Washington, DC 20529

Phone: 202 272-8412

Fax: 202 272-1452

Email: kevin.cummings@dhs.gov

RIN: 1615-AB77

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Statement of Regulatory Priorities

DHS--U.S. Coast Guard (USCG)

PROPOSED RULE STAGE

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Priority:

Other Significant

Legal Authority: 43 USC 1333(d)(1); 43 USC 1348(c); 43 USC 1356; DHS Delegation No 0170.1

CFR Citation: 33 CFR 140 to 147

Legal Deadline:

None

Abstract:

The Coast Guard is the lead Federal agency for workplace safety and health, other than for matters generally related to drilling and production that are regulated by the Bureau of Ocean Energy Management,

Regulation and Enforcement (BOEMRE) on facilities and vessels engaged in the exploration for, or development or production of, minerals on the OCS. This project would revise the regulations on Outer Continental

Shelf (OCS) activities to: 1) Add new requirements for fixed OCS facilities for lifesaving, fire protection, training, hazardous materials used as stores and accommodation spaces; and 2) address foreign vessels engaged in OCS activities to comply with requirements similar to those imposed on U.S. vessels similarly engaged. This project would affect the owners and operators of facilities and vessels engaged in offshore activities.

Statement of Need:

The last major revision of Coast Guard OCS regulations occurred in 1982. At

Page 79552

that time, the offshore industry was not as technologically advanced as it is today. Offshore activities were in relatively shallow water near land, where help was readily available during emergency situations. The equipment regulations required only basic equipment, primarily for lifesaving appliances and hand-held portable fire extinguishers. Since 1982, the requirements in 33 CFR chapter I, subchapter N, have not kept pace with the changing offshore technology or the safety problems created as OCS activities extend to deeper water (10,000 feet) and move farther offshore (150 miles). This rulemaking reassesses all of our current OCS regulations in order to help make the OCS a safer workplace.

Summary of Legal Basis:

The authority for the Coast Guard to prescribe, change, revise, or amend these regulations is provided under 14 U.S.C. 85; 43 U.S.C. 1333(d)(1), 1347(c), 1348(c), 1356; and Department of Homeland Security

Delegation No. 0170.1. Section 145.100 also issued under 14 U.S.C. 664 and 31 U.S.C. 9701.

Alternatives:

The Coast Guard considered filling the shortfall in existing OCS regulations by extending the current vessel and Mobile Offshore

Drilling Unit regulations. This approach was rejected after concluding that the differences between fixed and floating units made this approach impractical. We also considered requiring compliance with industry standards. Those standards, though, do not cover all of the areas needing regulation. The new rule would adopt available consensus standards where appropriate.

Nonregulatory alternatives, such as agency policy documents and voluntary acceptance of industry standards were also considered. They were also rejected because enforceable regulations are necessary in order to carry out the relevant statutes.

Anticipated Cost and Benefits:

The Coast Guard is currently estimating the costs and benefits associated with this rulemaking. Industry would incur additional costs as a result of provisions for training, firefighting, lifesaving, and monitoring of unsafe conditions. This proposed rule supports the

Commandant's strategic goals of marine safety and environmental stewardship and is designed to help make the OCS a safer workplace by preventing accidents or reducing the consequences of accidents on the

OCS. In addition, the proposed rule will include measures that meet the changing offshore technology and the safety problems it creates as OCS activities extend to deeper water and move farther offshore.

Risks:

The extensive revisions to health and safety requirements for OCS units in this rule would substantially reduce the risk of injury or illness on those units.

Timetable:

Action

Date

FR Cite

Request for Comments

06/27/95

60 FR 33185

Comment Period End

09/25/95

NPRM

12/07/99

64 FR 68416

NPRM Correction

02/22/00

65 FR 8671

NPRM Comment Period

Extended

03/16/00

65 FR 14226

NPRM Comment Period

Extended

06/30/00

65 FR 40559

NPRM Comment Period End

11/30/00

Supplemental NPRM

08/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

Additional Information:

Docket Numbers: The notice of request for comments published June 27, 1995, was assigned Coast Guard docket number 95-016. Following the request for comments, that docket was terminated. This project continues under Docket No. USCG-1998-3868 and RIN 1625-AA18. This docket may be viewed online by going to www.regulations.gov.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Kevin Y. Pekarek

Program Manager

Department of Homeland Security

U.S. Coast Guard

Commandant, CG-5222 2100 2nd Street SW., STOP 7126

Washington, DC 20593-7126

Phone: 202 372-1386

Email: kevin.y.pekarek2@uscg.mil

RIN: 1625-AA18

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Statement of Regulatory Priorities

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 46 USC 3103; 46 USC 3301; 46 USC 3306; 46 USC 3308; 46 USC 3316; 46 USC 3703; 46 USC 8104; 46 USC 8904; DHS Delegation No 0170.1

CFR Citation: 46 CFR 2; 46 CFR 15; 46 CFR 136 to 144

Legal Deadline:

NPRM, Statutory, January 13, 2011.

On October 15, 2010, the Coast Guard Authorization Act of 2010 was enacted as Public Law 111-281. It requires that a proposed rule be issued within 90 days after enactment and that a final rule be issued within 1 year of enactment.

Abstract:

This rulemaking would implement a program of inspection for certification of towing vessels, which were previously uninspected. It would prescribe standards for safety management systems and third-party auditors and surveyors, along with standards for construction, operation, vessel systems, safety equipment, and recordkeeping.

Statement of Need:

This rulemaking would implement sections 409 and 415 of the Coast Guard and Maritime Transportation Act of 2004. The intent of the proposed rule is to promote safer work practices and reduce casualties on towing vessels by ensuring that towing vessels adhere to prescribed safety standards and safety management systems. This proposed rule was developed in cooperation with the Towing Vessel Safety Advisory

Committee. It would establish a new subchapter dedicated to towing vessels; covering vessel equipment, systems, operational standards, and inspection requirements.

Summary of Legal Basis:

Proposed new subchapter authority: 46 U.S.C. 3103, 3301, 3306, 3308, 3316, 8104, 8904; 33 CFR 1.05; DHS Delegation 0170.1.

The Coast Guard and Maritime Transportation Act of 2004 (CGMTA 2004),

Public Law 108-293, 118 Stat. 1028, (Aug. 9, 2004), established new

Page 79553

authorities for towing vessels as follows:

Section 415 added towing vessels, as defined in section 2101 of title 46, United States Code (U.S.C.), as a class of vessels that are subject to safety inspections under chapter 33 of that title (Id. at 1047).

Section 415 also added new section 3306(j) of title 46, authorizing the

Secretary of Homeland Security to establish, by regulation, a safety management system appropriate for the characteristics, methods of operation, and nature of service of towing vessels (Id.).

Section 409 added new section 8904(c) of title 46, U.S.C., authorizing the Secretary to establish, by regulation, ``maximum hours of service

(including recording and recordkeeping of that service) of individuals engaged on a towing vessel that is at least 26 feet in length measured from end to end over the deck (excluding the sheer).`` (Id. at 1044- 45).

Alternatives:

We considered the following alternatives for the notice of proposed rulemaking (NPRM):

One regulatory alternative would be the addition of towing vessels to one or more existing subchapters that deal with other inspected vessels, such as cargo and miscellaneous vessels (subchapter I), offshore supply vessels (subchapter L), or small passenger vessels

(subchapter T). We do not believe, however, that this approach would recognize the often ``unique'' nature and characteristics of the towing industry in general and towing vessels in particular.

In addition to inclusion in a particular existing subchapter (or subchapters) for equipment-related concerns, the same approach could be adopted for use of a safety management system by requiring compliance with title 33, Code of Federal Regulations, part 96 (Rules for the Safe

Operation of Vessels and Safety Management Systems). Adoption of these requirements, without an alternative safety management system, would also not be ``appropriate for the characteristics, methods of operation, and nature of service of towing vessels.``

The Coast Guard has had extensive public involvement (four public meetings, over 100 separate comments submitted to the docket, as well as extensive ongoing dialogue with members of the Towing Safety

Advisory Committee (TSAC)) regarding development of these regulations.

Adoption of one of the alternatives discussed above would likely receive little public or industry support, especially considering the

TSAC efforts toward development of standards to be incorporated into a separate subchapter dealing specifically with the inspection of towing vessels.

An approach that would seem to be more in keeping with the intent of

Congress would be the adoption of certain existing standards from those applied to other inspected vessels. In some cases, these existing standards would be appropriately modified and tailored to the nature and operation of certain categories of towing vessels. The adopted standards would come from inspected vessels that have demonstrated

``good marine practice'' within the maritime community. These regulations would be incorporated into a subchapter specifically addressing the inspection for certification of towing vessels. The law requiring the inspection for certification of towing vessels is a statutory mandate, compelling the Coast Guard to develop regulations appropriate for the nature of towing vessels and their specific industry.

Anticipated Cost and Benefits:

We estimate that owners and operators of towing vessels would incur additional costs from this rulemaking. The cost of this rulemaking would involve provisions for safety management systems, standards for construction, operation, vessel systems, safety equipment, and recordkeeping. Our cost assessment includes existing and new vessels.

We are currently developing cost estimates for the proposed rule.

The Coast Guard developed the requirements in the proposed rule by researching both the human factors and equipment failures that caused towing vessel accidents. We believe that the proposed rule would address a wide range of causes of towing vessel accidents and supports the main goal of improving safety in the towing industry. The primary benefit of the proposed rule is an increase in vessel safety and a resulting decrease in the risk of towing vessel accidents and their consequences.

Risks:

This regulatory action would reduce the risk of towing vessel accidents and their consequences. Towing vessel accidents result in fatalities, injuries, property damage, pollution, and delays.

Timetable:

Action

Date

FR Cite

NPRM

01/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected:

State

Additional Information:

The Regulations.gov docket number is USCG-2006-24412.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Michael Harmon

Program Manager, CG-5222

Department of Homeland Security

U.S. Coast Guard 2100 2nd Street SW., STOP 7126

Washington, DC 20593-7126

Phone: 202 372-1427

Email: michael.j.harmon@uscg.mil

RIN: 1625-AB06

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Statement of Regulatory Priorities

PREEMPTION FOR CERTAIN REGULATIONS ISSUED BY THE COAST GUARD

Priority:

Other Significant

Legal Authority: 14 USC 2; 14 USC 91; 33 USC 1223; 33 USC 1231; 33 USC 1903(b); 46 USC 3203; 46 USC 3306; 46 USC 3703; 46 USC 3717; 46 USC 4302; 46 USC 6101;

DHS Delegation No 0170.1

CFR Citation: 33 CFR 1.06

Legal Deadline:

None

Abstract:

The proposed rule will operate in two ways. First, it will describe the

Coast Guard's interpretation of the preemptive effect of certain current Coast Guard regulations. This analysis will apply to previously promulgated

Page 79554

regulations even if a complete description of federalism implications was clearly articulated in the development of the regulation. Second, the rule will set forth criteria and a process that the Coast Guard will undertake in future regulatory projects for evaluating the preemptive impact of those regulations. This part of the analysis is prospective in nature and will lay out a roadmap for future regulatory projects regarding federalism and preemption principles. This rulemaking will support the Coast Guard's broad role and responsibility of further enhancing maritime stewardship by reinforcing a uniform maritime regulatory regime that is predictable and useful for maritime interests.

Statement of Need:

In light of recent Federal court cases and the President's May 20, 2009, memorandum regarding preemption, the Coast Guard believes that a clear agency statement of the preemptive impact of our regulations, particularly those regulations issued prior to the promulgation of E.O. 13132, can be of great benefit to State and local governments, the public, and regulated entities. Therefore, the Coast Guard intends to issue a general statement of preemption policy, coupled with specific statements of policy regarding regulations issued under the authority of statutes with preemptive effect, including, among others, the Ports and Waterways Safety Act (PWSA) of 1972, as amended (33 U.S.C. 1221 et. seq.). The Coast Guard proposes to publish these policies in a new section 1.06 of title 33 of the Code of Federal Regulations, to allow for easy access by interested persons and parties.

Summary of Legal Basis:

The statutory authorities for the Coast Guard to prescribe, change, revise, or amend these regulations are provided under 14 U.S.C. 2 and 91; 33 U.S.C. 1223, 1231, and 1903(b); 46 U.S.C. 3203, 3306, 3703, 3717, 4302, and 6101; and Department of Homeland Security Delegation

No. 0170.1.

Alternatives:

The Coast Guard considered alternative mechanisms for restating the preemptive effect of regulations, including the use of a notice of policy. These methods would not provide the same level of transparency as codification in the Code of Federal Regulations, however, because they would not be as readily located by State and local government or other members of the public. They also would not satisfy the

President's May 20, 2009, memorandum regarding preemption, which directs agencies to include preemption provisions in the codified regulation.

Anticipated Cost and Benefits:

We expect no additional cost impacts to the industry from this proposed rule, because it only restates and clarifies the status of Federal and

State law as it exists.

Risks:

Not applicable to this rulemaking.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Additional Information:

The docket number for this rulemaking is USCG-2008-1259. The docket can be found at www.regulations.gov.

URL For More Information: http://www.regulations.gov

URL For Public Comments: http://www.regulations.gov

Agency Contact:

LCDR Stephen DaPonte

Program Manager

Department of Homeland Security

U.S. Coast Guard

Commandant (CG-0941) 2100 2nd Street SW., STOP 7121

Washington, DC 20593-7121

Phone: 202 372-3865

Email: stephen.daponte@uscg.mil

RIN: 1625-AB32

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Statement of Regulatory Priorities

Priority:

Economically Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 33 USC 1226; 33 USC 1231; 46 USC ch 701; 50 USC 191 and 192; EO 12656; 3 CFR 1988 Comp, p 585; 33 CFR 1.05-1; 33 CFR 6.04-11; 33 CFR 6.14; 33

CFR 6.16; 33 CFR 6.19; DHS Delegation No 0170.1

CFR Citation: 33 CFR subchapter H

Legal Deadline:

None

Abstract:

The Coast Guard proposes certain additions, changes, and amendments to 33 CFR, subchapter H. Subchapter H is comprised of parts 101 thru 106.

Subchapter H implements the major provisions of the Maritime

Transportation Security Act of 2002. This rulemaking is the first major revision to subchapter H. The proposed changes would further enhance the security of our Nation's ports, vessels, facilities, and Outer

Continental Shelf facilities and incorporate requirements from legislation implemented since the original publication of these regulations in 2003. This rulemaking has international interest because of the close relationship between subchapter H and the International

Ship and Port Security Code (ISPS).

Statement of Need:

This rulemaking is needed to incorporate Coast Guard Policy Advisory

Council (PAC) decisions on the interpretation of regulations, guidance provided in response to questions to the Maritime Transportation

Security Act of 2002 (MTSA) hotline, and to implement various requirements found in the Security and Accountability for Every Port

Act of 2006 and the Coast Guard and Maritime Transportation Act of 2006. In addition, this rulemaking is needed to incorporate recommendations from the Merchant Marine Personnel Advisory Committee.

It also incorporates various U.S. Maritime Administration and

International Maritime Organization voluntary consensus standards related to maritime security training.

Summary of Legal Basis:

The fundamental legal basis for subchapter H remains the Maritime

Transportation Security Act of 2002 as amended by the Security and

Accountability for Every Port Act of 2006 and the Coast Guard and

Maritime Transportation Act of 2006.

Alternatives:

The Coast Guard is currently evaluating a number of alternatives based on applicability and risk (threat,

Page 79555

vulnerability, and consequence). However, an overall update to make necessary changes to subchapter H and address improvements resulting from our experience since 2003 is prudent.

Anticipated Cost and Benefits:

The Coast Guard is currently estimating the costs associated with this rulemaking. Industry would incur additional costs as a result of provisions for standardized training requirements, updates to security plans and other documentation, and full-scale exercises requirements for high-risk facilities. The potential benefit from these provisions is reduction in risk of security incidents. This rulemaking expands and improves competencies associated with Maritime Domain Awareness (MDA).

MDA is the effective understanding of anything associated with the global maritime domain that could impact the United States' security, safety, economy, or environment. The proposed rule would improve MDA through training, exercise, and security plan enhancements. As a result, the primary benefit of the proposed rule would result from reducing the risk of a Transportation Security Incident (TSI) and therefore averting or mitigating the economic and environmental consequences of a TSI.

Risks:

With this rulemaking, the Coast Guard seeks to maintain the risk reduction goals established with the promulgation of the original MTSA regulations and further reduce risks by incorporating provisions related to more recent legislation and warranted by our experience with subchapter H since 2003.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information:

The Regulations.gov docket number for this rulemaking is USCG-2007- 0009.

URL For More Information: http://www.regulations.gov

URL For Public Comments: http://www.regulations.gov

Agency Contact:

LCDR Loan O'Brien

Project Manager

Department of Homeland Security

U.S. Coast Guard

Commandant, (CG-5442) 2100 2nd Street SW., STOP 7581

Washington, DC 20593-7581

Phone: 877 687-2243

Fax: 202 372-1906

Email: loan.t.o'brien@uscg.mil

RIN: 1625-AB38

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Statement of Regulatory Priorities

DHS--USCG

FINAL RULE STAGE

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Statement of Regulatory Priorities

IN U.S. WATERS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority: 16 USC 4711

CFR Citation: 33 CFR 151

Legal Deadline:

None

Abstract:

This rulemaking adds performance standards to 33 CFR part 151, subparts

C and D, for discharges of ballast water. It supports the Coast Guard's broad roles and responsibilities of maritime safety and maritime stewardship. This project is economically significant.

Statement of Need:

The unintentional introduction of nonindigenous species into U.S. waters via the discharge of vessels' ballast water has had significant impacts to the Nation's aquatic resources, biological diversity, and coastal infrastructures. This rulemaking would amend the ballast water management requirements (33 CFR part 151, subparts C and D) and establish standards that specify the level of biological treatment that must be achieved by a ballast water treatment system before ballast water can be discharged into U.S. waters. This would increase the Coast

Guard's ability to protect U.S. waters against the introduction of nonindigenous species via ballast water discharges.

Summary of Legal Basis:

Congress has directed the Coast Guard to develop ballast water regulations to prevent the introduction of nonindigenous species into

U.S. waters under the Nonindigenous Aquatic Nuisance Prevention and

Control Act of 1990 and reauthorized and amended it with the National

Invasive Species Act of 1996. This rulemaking does not have a statutory deadline.

Alternatives:

The Coast Guard would use the standard rulemaking process to develop regulations for ballast water discharge standards. Nonregulatory alternatives such as navigation and vessel inspection circulars and the

Marine Safety Manual have been considered and may be used for the development of policy and directives to provide the maritime industry and our field offices guidelines for implementation of the regulations.

Nonregulatory alternatives cannot be substituted for the standards we would develop with this rule. Congress has directed the Coast Guard to review and revise its BWM regulations not less than every 3 years based on the best scientific information available to the Coast Guard at the time of that review.

On August 28, 2009, the Coast Guard published the Notice of Proposed

Rulemaking (NPRM) entitled Standards for Living Organisms in Ships'

Ballast Water Discharged in U.S. Waters in the Federal Register (74 FR 44632). The proposed rule included a phase-in schedule (phase-one and phase-two) for the implementation of ballast water discharge standards based on vessel's ballast water capacity and build date (one that is one thousand times more stringent). The proposed phase-one standard is the same standard adopted by the International Maritime Organization

(IMO) for concentration of living organisms in ballast water discharges. For phase-two, we propose incorporating a practicability review to determine whether technology to achieve a more stringent standard than

Page 79556

the IMO standard can practicably be implemented.

Based on the comments received, we plan to move forward swiftly with a final rule.

Anticipated Cost and Benefits:

This rulemaking would affect certain vessels operating in U.S. waters seeking to discharge ballast water into waters of the United States.

Owners and operators of these vessels would be required to install and operate Coast Guard approved ballast water management systems before discharging ballast water into U.S. waters. Cost estimates for individual vessels vary due to the vessel class, type and size, and the particular technology of the ballast water management system installed.

We expect the highest annual costs of this rulemaking during the periods of installation as the bulk of the existing fleet of vessels must meet the standards according to proposed phase-in schedules. The primary cost driver of this rulemaking is the installation costs for existing vessels. Operating and maintenance costs are substantially less than the installation costs.

We evaluated the benefits of this rulemaking by researching the impact of aquatic nonindigenous species (NIS) invasions in the U.S. waters, since ballast water discharge is one of the main vectors of NIS introductions in the marine environment. The primary benefit of this rulemaking would be the economic and environmental damages avoided from the reduction in the number of new invasions as a result of the reduction in concentration of organisms in discharged ballast water. We expect that the benefits of this rulemaking would increase as the technology is developed to achieve more stringent ballast water discharge standards.

The Coast Guard issued a preliminary regulatory analysis of the costs, benefits, and other impacts of the 2009 NPRM. In this preliminary analysis, we estimated the total phase-one costs to be about $1.18 billion over a 10-year period of analysis (this and other values below at a 7 percent discount rate). As previously described, the implementation costs vary by year. We estimated the annualized cost over the same period to be approximately $168 million per year. We did not provide cost estimates for the phase-two costs in this preliminary analysis since data and information was not available at that time for technology that would meet the anticipated phase-two standard (1,000 x the IMO standard). In the same preliminary analysis, we estimated annualized benefits (damages avoided) for phase one are potentially as high as $553 million, with a mid-range estimate of $165 million to $282 million per year. We estimated total phase-one benefits to be as high as $3.88 billion, with a mid-range estimate of $1.16 billion to $1.98 billion over a 10-year period of analysis.

The Coast Guard has received public comments on the impacts of the NPRM and will be incorporating these comments into a revised Regulatory

Analysis for the next rulemaking publication.

Risks:

Ballast water discharged from ships is a significant pathway for the introduction and spread of non-indigenous aquatic nuisance species.

These organisms, which may be plants, animals, bacteria or pathogens, have the potential to displace native species, degrade native habitats, spread disease and disrupt human economic and social activities that depend on water resources. It is estimated that for areas such as the

Great Lakes, San Francisco Bay, and Chesapeake Bay, one nonindigenous species becomes established per year. At this time, it is difficult to estimate the reduction of risk that would be accomplished by promulgating this rulemaking; however, it is expected a major reduction will occur. We are currently requesting information on costs and benefits of more stringent ballast water discharge standards.

Timetable:

Action

Date

FR Cite

ANPRM

03/04/02

67 FR 9632

ANPRM Comment Period End

06/03/02

NPRM

08/28/09

74 FR 44632

Public Meeting

09/14/09

74 FR 46964

Public Meeting

09/22/09

74 FR 48190

Public Meeting

09/28/09

74 FR 49355

Notice--Extension of

Comment Period

10/15/09

74 FR 52941

Public Meeting

10/22/09

74 FR 54533

Public Meeting Correction

10/26/09

74 FR 54944

NPRM Comment Period End

12/04/09

74 FR 52941

Final Rule

04/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

State

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information:

The Regulations.gov docket number for this rulemaking is USCG-2001- 10486.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Mr. John C Morris

Project Manager

Department of Homeland Security

U.S. Coast Guard 2100 Second Street SW., STOP 7126

Washington, DC 20593-7126

Phone: 202 372-1433

Email: john.c.morris@uscg.mil

RIN: 1625-AA32

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Statement of Regulatory Priorities

DHS--U.S. Customs and Border Protection (USCBP)

FINAL RULE STAGE

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Statement of Regulatory Priorities

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority:

PL 109-347, sec 203; 5 USC 301; 19 USC 66; 19 USC 1431; 19 USC 1433 to 1434; 19 USC 1624; 19 USC 2071 note; 46 USC 60105

CFR Citation: 19 CFR 4; 19 CFR 12.3; 19 CFR 18.5; 19 CFR 103.31a; 19 CFR 113; 19 CFR 123.92; 19 CFR 141.113; 19 CFR 146.32; 19 CFR 149; 19 CFR 192.14

Legal Deadline:

None

Abstract:

This interim final rule implements the provisions of section 203 of the

Page 79557

Security and Accountability for Every Port Act of 2006. It amends CBP

Regulations to require carriers and importers to provide to CBP, via a

CBP-approved electronic data interchange system, information necessary to enable CBP to identify high-risk shipments to prevent smuggling and insure cargo safety and security. Under the rule, importers and carriers must submit specified information to CBP before the cargo is brought into the United States by vessel. This advance information will improve CBP's risk assessment and targeting capabilities, assist CBP in increasing the security of the global trading system, and facilitate the prompt release of legitimate cargo following its arrival in the

United States.

Statement of Need:

Vessel carriers are currently required to transmit certain manifest information by way of the CBP Vessel Automated Manifest System (AMS) 24 hours prior to lading of containerized and non-exempt break bulk cargo at a foreign port. For the most part, this is the ocean carrier's or non-vessel operating common carrier (NVOCC)'s cargo declaration. CBP analyzes this information to generate its risk assessment for targeting purposes.

Internal and external government reviews have concluded that more complete advance shipment data would produce even more effective and vigorous cargo risk assessments. In addition, pursuant to section 203 of the Security and Accountability for Every Port Act of 2006 (Pub. L. 109-347, 6 U.S.C. 943) (SAFE Port Act), the Secretary of Homeland

Security, acting through the Commissioner of CBP, must promulgate regulations to require the electronic transmission of additional data elements for improved high-risk targeting, including appropriate security elements of entry data for cargo destined to the United States by vessel prior to loading of such cargo on vessels at foreign seaports.

Based upon its analysis, as well as the requirements under the SAFE

Port Act, CBP is requiring the electronic transmission of additional data for improved high-risk targeting. Some of these data elements are being required from carriers (Container Status Messages and Vessel Stow

Plan) and others are being required from ``importers,'' as that term is defined for purposes of the regulations.

This rule intends to improve CBP's risk assessment and targeting capabilities and enables the agency to facilitate the prompt release of legitimate cargo following its arrival in the United States. The information will assist CBP in increasing the security of the global trading system and, thereby, reducing the threat to the United States and world economy.

Summary of Legal Basis:

Pursuant to section 203 of the Security and Accountability for Every

Port Act of 2006 (Pub. L. 109-347, 6 U.S.C. 943) (SAFE Port Act), the

Secretary of Homeland Security, acting through the Commissioner of CBP, must promulgate regulations to require the electronic transmission of additional data elements for improved high-risk targeting, including appropriate security elements of entry data for cargo destined to the

United States by vessel prior to loading of such cargo on vessels at foreign seaports.

Alternatives:

CBP considered and evaluated the following four alternatives:

Alternative 1 (the chosen alternative): Importer Security Filings and

Additional Carrier Requirements are required. Bulk cargo is exempt from the Importer Security Filing requirements;

Alternative 2: Importer Security Filings and Additional Carrier

Requirements are required. Bulk cargo is not exempt from the Importer

Security Filing requirements;

Alternative 3: Only Importer Security Filings are required. Bulk cargo is exempt from the Importer Security Filing requirements; and

Alternative 4: Only the Additional Carrier Requirements are required.

Anticipated Cost and Benefits:

When the NPRM was published, CBP estimated that approximately 11 million import shipments conveyed by 1,000 different carrier companies operating 37,000 unique voyages or vessel-trips to the United States will be subject to the rule. Annualized costs range from $890 million to $7.0 billion (7 percent discount rate over 10 years).

The annualized cost range results from varying assumptions about the importers' estimated security filing transaction costs or fees charged to the importers by the filing parties, the potential for supply chain delays, and the estimated costs to carriers for transmitting additional data to CBP.

The regulation may increase the time shipments are in transit, particularly for shipments consolidated in containers. For such shipments, the supply chain is generally more complex and the importer has less control of the flow of goods and associated security filing information. Foreign cargo consolidators may be consolidating multiple shipments from one or more shippers in a container destined for one or more buyers or consignees. In order to ensure that the security filing data is provided by the shippers to the importers (or their designated agents) and is then transmitted to and accepted by CBP in advance of the 24-hour deadline, consolidators may advance their cut-off times for receipt of shipments and associated security filing data.

These advanced cut-off times would help prevent a consolidator or carrier from having to unpack or unload a container in the event the security filing for one of the shipments contained in the container is inadequate or not accepted by CBP. For example, consolidators may require shippers to submit, transmit, or obtain CBP approval of their security filing data before their shipments are stuffed in the container, before the container is sealed, or before the container is delivered to the port for lading. In such cases, importers would likely have to increase the times they hold their goods as inventory, and thus incur additional inventory carrying costs to sufficiently meet these advanced cut-off times imposed by their foreign consolidators. The high end of the cost ranges presented assumes an initial supply chain delay of 2 days for the first year of implementation (2008) and a delay of 1 day for years 2 through 10 (2009 to 2017).

Ideally, the quantification and monetization of the benefits of this regulation would involve estimating the current level of risk of a successful terrorist attack, absent this regulation, and the incremental reduction in risk resulting from implementation of the regulation. CBP would then multiply the change by an estimate of the value individuals place on such a risk reduction to produce a monetary estimate of direct benefits. However, existing data limitations and a lack of complete understanding of the true risks posed by terrorists prevent us from establishing the incremental risk reduction attributable to this rule. As a result, CBP has undertaken a ``break- even'' analysis to inform decisionmakers of the necessary incremental change in the probability of such an event occurring that would result in direct benefits equal to the costs of the proposed rule. CBP's

Page 79558

analysis finds that the incremental costs of this regulation are relatively small compared to the median value of a shipment of goods, despite the rather large absolute estimate of present value cost.

The benefit of this rule is the improvement of CBP's risk assessment and targeting capabilities, while at the same time, enabling CBP to facilitate the prompt release of legitimate cargo following its arrival in the United States. The information will assist CBP in increasing the security of the global trading system, and thereby reducing the threat to the United States and the world economy.

Timetable:

Action

Date

FR Cite

NPRM

01/02/08

73 FR 90

NPRM Comment Period End

03/03/08

NPRM Comment Period

Extended

02/01/08

73 FR 6061

NPRM Comment Period End

03/18/08

Interim Final Rule

11/25/08

73 FR 71730

Interim Final Rule

Effective

01/26/09

Interim Final Rule

Comment Period End

06/01/09

Correction

07/14/09

74 FR 33920

Correction

12/24/09

74 FR 68376

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Richard DiNucci

Department of Homeland Security

U.S. Customs and Border Protection

Office of Field Operations 1300 Pennsylvania Avenue NW.

Washington, DC 20229

Phone: 202 344-2513

Email: richard.dinucci@dhs.gov

RIN: 1651-AA70

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Statement of Regulatory Priorities

SYSTEM FOR TRAVEL AUTHORIZATION (ESTA) PROGRAM

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 8 USC 1103; 8 USC 1187; 8 CFR 2

CFR Citation: 8 CFR 217.5

Legal Deadline:

None

Abstract:

This rule implements the Electronic System for Travel Authorization

(ESTA) for aliens who travel to the United States under the Visa Waiver

Program (VWP) at air or sea ports of entry. Under the rule, VWP travelers are required to provide certain biographical information to

CBP electronically before departing for the United States. This allows

CBP to determine before their departure whether these travelers are eligible to travel to the United States under the VWP and whether such travel poses a security risk. The rule is intended to fulfill the requirements of section 711 of the Implementing recommendations of the 9/11 Commission Act of 2007 (9/11 Act). In addition to fulfilling a statutory mandate, the rule serves the twin goals of promoting border security and legitimate travel to the United States. By modernizing the

VWP, the ESTA is intended to increase national security and to provide for greater efficiencies in the screening of international travelers by allowing for vetting of subjects of potential interest well before boarding, thereby reducing traveler delays at the ports of entry.

Statement of Need:

Section 711 of the 9/11 Act requires the Secretary of Homeland

Security, in consultation with the Secretary of State, to develop and implement a fully automated electronic travel authorization system that will collect biographical and other information in advance of travel to determine the eligibility of the alien to travel to the United States, and to determine whether such travel poses a law enforcement or security risk. ESTA is intended to fulfill these statutory requirements.

Under this rule, VWP travelers provide certain information to CBP electronically before departing for the United States. VWP travelers who receive travel authorization under ESTA are not required to complete the paper Form I-94W when arriving on a carrier that is capable of receiving and validating messages pertaining to the traveler's ESTA status as part of the traveler's boarding status. By automating the I-94W process and establishing a system to provide VWP traveler data in advance of travel, CBP is able to determine the eligibility of citizens and eligible nationals from VWP countries to travel to the United States and to determine whether such travel poses a law enforcement or security risk, before such individuals begin travel to the United States. ESTA provides for greater efficiencies in the screening of international travelers by allowing CBP to identify subjects of potential interest before they depart for the United

States, thereby increasing security and reducing traveler delays upon arrival at U.S. ports of entry.

Summary of Legal Basis:

The ESTA program is based on congressional authority provided under section 711 of the Implementing Recommendations of the 9/11 Commission

Act of 2007 and section 217 of the Immigration and Nationality Act

(INA).

Alternatives:

CBP considered three alternatives to this rule: 1. The ESTA requirements in the rule, but with a $1.50 fee per each travel authorization (more costly) 2. The ESTA requirements in the rule, but with only the name of the passenger and the admissibility questions on the I-94W form (less burdensome) 3. The ESTA requirements in the rule, but only for the countries entering the VWP after 2009 (no new requirements for VWP, reduced burden for newly entering countries)

CBP determined that the rule provides the greatest level of enhanced security and efficiency at an acceptable cost to traveling public and potentially affected air carriers.

Anticipated Cost and Benefits:

The purpose of ESTA is to allow DHS and CBP to establish the eligibility of certain foreign travelers to travel to the United States under the VWP, and whether the alien's proposed travel to the United

States poses a law enforcement or security risk. Upon review of such information, DHS will

Page 79559

determine whether the alien is eligible to travel to the United States under the VWP.

Costs to Air & Sea Carriers

CBP estimated that eight U.S.-based air carriers and eleven sea carriers will be affected by the rule. An additional 35 foreign-based air carriers and five sea carriers will be affected. CBP concluded that costs to air and sea carriers to support the requirements of the ESTA program could cost $137 million to $1.1 billion over the next 10 years depending on the level of effort required to integrate their systems with ESTA, how many passengers they need to assist in applying for travel authorizations, and the discount rate applied to annual costs.

Costs to Travelers

ESTA will present new costs and burdens to travelers in VWP countries who were not previously required to submit any information to the U.S.

Government in advance of travel to the United States. Travelers from

Roadmap countries who become VWP countries will also incur costs and burdens, though these are much less than obtaining a nonimmigrant visa

(category B1/B2), which is currently required for short-term pleasure or business to travel to the United States. CBP estimated that the total quantified costs to travelers will range from $1.1 billion to

$3.5 billion depending on the number of travelers, the value of time, and the discount rate. Annualized costs are estimated to range from

$133 million to $366 million.

Benefits

As set forth in section 711 of the 9/11 Act, it was the intent of

Congress to modernize and strengthen the security of the Visa Waiver

Program under section 217 of the Immigration and Nationality Act (INA, 8 U.S.C. 1187) by simultaneously enhancing program security requirements and extending visa-free travel privileges to citizens and eligible nationals of eligible foreign countries that are partners in the war on terrorism.

By requiring passenger data in advance of travel, CBP may be able to determine, before the alien departs for the United States, the eligibility of citizens and eligible nationals from VWP countries to travel to the United States under the VWP, and whether such travel poses a law enforcement or security risk. In addition to fulfilling a statutory mandate, the rule serves the twin goals of promoting border security and legitimate travel to the United States. By modernizing the

VWP, ESTA is intended to both increase national security and provide for greater efficiencies in the screening of international travelers by allowing for the screening of subjects of potential interest well before boarding, thereby reducing traveler delays based on potentially lengthy processes at U.S. ports of entry.

CBP concluded that the total benefits to travelers could total $1.1 billion to $3.3 billion over the period of analysis. Annualized benefits could range from $134 million to $345 million.

In addition to these benefits to travelers, CBP and the carriers should also experience the benefit of not having to administer the I-94W except in limited situations. While CBP has not conducted an analysis of the potential savings, it should accrue benefits from not having to produce, ship, and store blank forms. CBP should also be able to accrue savings related to data entry and archiving. Carriers should realize some savings as well, though carriers will still have to administer the

I-94 for those passengers not traveling under the VWP and the Customs

Declaration forms for all passengers aboard the aircraft and vessel.

Timetable:

Action

Date

FR Cite

Interim Final Action

06/09/08

73 FR 32440

Interim Final Rule

Effective

08/08/08

Interim Final Rule

Comment Period End

08/08/08

Notice - Announcing Date

Rule Becomes

Mandatory

11/13/08

73 FR 67354

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: http://www.cbp.gov/xp/cgov/travel/id--visa/esta/

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Suzanne Shepherd

Director, Electronic System for Travel Authorization

Department of Homeland Security

U.S. Customs and Border Protection 1300 Pennsylvania Avenue NW.

Washington, DC 20229

Phone: 202 344-2073

Email: cbp.esta@dhs.gov

Related RIN: Related to 1651-AA83

RIN: 1651-AA72

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Statement of Regulatory Priorities

Priority:

Other Significant

Legal Authority: 8 USC 1365b(k)(1); 8 USC 1365b(k)(3); 8 USC 1225; 8 USC 1185(b)

CFR Citation: 8 CFR 235; 8 CFR 103

Legal Deadline:

None

Abstract:

CBP already operates several regulatory and non-regulatory international registered traveler programs, also known as trusted traveler programs. In order to comply with the Intelligence Reform

Terrorism Prevention Act of 2004 (IRPTA), CBP is proposing to amend its regulations to establish another international registered traveler program called Global Entry. The Global Entry program would expedite the movement of low-risk, frequent international air travelers by providing an expedited inspection process for pre-approved, pre- screened travelers. These travelers would proceed directly to automated

Global Entry kiosks upon their arrival in the United States. This

Global Entry Program, along with the other programs that have already been established, are consistent with CBP's strategic goal of facilitating legitimate trade and travel while securing the homeland. A pilot of Global Entry has been operating since June 6, 2008.

Statement of Need:

CBP has been operating the Global Entry program as a pilot at several airports since June 6, 2008, and the pilot has been very successful. As a result, there is a desire on the part of

Page 79560

the public that the program be established as a permanent program, and expanded, if possible. By establishing this program, CBP will make great strides toward facilitating the movement of people in a more efficient manner, thereby accomplishing our strategic goal of balancing legitimate travel with security. Through the use of biometric and recordkeeping technologies, the risk of terrorists entering the United

States would be reduced. Improving security and facilitating travel at the border, both of which are accomplished by Global Entry, are primary concerns within CBP jurisdiction.

Summary of Legal Basis:

The Global Entry program is based on section 7208(k) of the

Intelligence Reform and Terrorism Prevention Act of 2004 (IRTPA), as amended by section 565 of the Consolidated Appropriations Act, which requires the Secretary of Homeland Security to create a program to expedite the screening and processing of pre-approved low risk air travelers into the United States.

Anticipated Cost and Benefits:

Global Entry is a voluntary program that provides a benefit to the public by speeding the CBP processing time for participating travelers.

Travelers who are otherwise admissible to the United States will be able to enter or exit the country regardless of whether they participate in Global Entry. CBP estimates that over a 5-year period, 250,000 enrollees will be processed (an annual average of 50,000 individuals). CBP will charge a fee of $100 per applicant and estimates that each application will require 40 minutes (0.67 hours) of the enrollee's time to search existing data resources, gather the data needed, and complete and review the application form. Additionally, an enrollee will experience an ``opportunity cost of time'' to travel to an Enrollment Center upon acceptance of the initial application. We assume that 1 hour will be required for this time spent at the

Enrollment Center and travel to and from the Center, though we note that during the pilot program, many applicants coordinated their trip to an Enrollment Center with their travel at the airport. We have used one hour of travel time so as not to underestimate potential opportunity costs for enrolling in the program. We use a value of

$28.60 for the opportunity cost for this time, which is taken from the

Federal Aviation Administration's ``Economic Values for FAA Investment and Regulatory Decisions, A Guide.'' (July 3, 2007). This value is the weighted average for U.S. business and leisure travelers. For this evaluation, we assume that all enrollees will be U.S. citizens, U.S. nationals, or Lawful Permanent Residents.

Timetable:

Action

Date

FR Cite

NPRM

11/19/09

74 FR 59932

NPRM Comment Period End

01/19/10

Final Rule

02/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

URL For More Information: www.globalentry.gov

Agency Contact:

John P. Wagner

Director, Trusted Traveler Programs

Department of Homeland Security

U.S. Customs and Border Protection

Office of Field Operations 1300 Pennsylvania Avenue NW.

Washington, DC 20229

Phone: 202 344-2118

RIN: 1651-AA73

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Statement of Regulatory Priorities

Priority:

Other Significant. Major under 5 USC 801.

Legal Authority:

PL 110-229, sec 702

CFR Citation: 8 CFR 100.4; 8 CFR 212.1; 8 CFR 233.5; 8 CFR 235.5; 19 CFR 4.7b; 19 CFR 122.49a

Legal Deadline:

Final, Statutory, November 4, 2008, PL 110-229.

Abstract:

This rule amends Department of Homeland Security (DHS) regulations to implement section 702 of the Consolidated Natural Resources Act of 2008

(CNRA). This law extends the immigration laws of the United States to the Commonwealth of the Northern Mariana Islands (CNMI) and provides for a joint visa waiver program for travel to Guam and the CNMI. This rule implements section 702 of the CNRA by amending the regulations to replace the current Guam Visa Waiver Program with a new Guam-CNMI Visa

Waiver Program. The amended regulations set forth the requirements for nonimmigrant visitors who seek admission for business or pleasure and solely for entry into and stay on Guam or the CNMI without a visa. This rule also establishes six ports of entry in the CNMI for purposes of administering and enforcing the Guam-CNMI Visa Waiver Program.

Statement of Need:

Currently, aliens who are citizens of eligible countries may apply for admission to Guam at a Guam port of entry as nonimmigrant visitors for a period of fifteen (15) days or less, for business or pleasure, without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission. Section 702(b) of the Consolidated

Natural Resources Act of 2008 (CNRA), supersedes the Guam visa waiver program by providing for a visa waiver program for Guam and the

Commonwealth of the Northern Mariana Islands (Guam-CNMI Visa Waiver

Program). Section 702(b) requires DHS to promulgate regulations within 180 days of enactment of the CNRA to allow nonimmigrant visitors from eligible countries to apply for admission into Guam and the CNMI, for business or pleasure, without a visa, for a period of authorized stay of no longer than forty-five (45) days.

Summary of Legal Basis:

The Guam-CNMI Visa Waiver Program is based on congressional authority provided under 702(b) of the Consolidated Natural Resources Act of 2008

(CNRA).

Alternatives:

None

Anticipated Cost and Benefits:

The most significant change for admission to the CNMI as a result of the rule will be for visitors from those countries who are not included in either the existing U.S. Visa Waiver Program or the Guam-CNMI Visa

Waiver Program established by the rule. These visitors must apply for

U.S. visas, which require in-person interviews at U.S. embassies or consulates and higher fees than the CNMI currently assesses for its visitor

Page 79561

entry permits. CBP anticipates that the annual cost to the CNMI will be

$6 million. These are losses associated with the reduced visits from foreign travelers who may no longer visit the CNMI upon implementation of this rule.

The anticipated benefits of the rule are enhanced security that will result from the federalization of the immigration functions in the

CNMI.

Timetable:

Action

Date

FR Cite

Interim Final Rule

01/16/09

74 FR 2824

Interim Final Rule

Effective

01/16/09

Interim Final Rule

Comment Period End

03/17/09

Technical Amendment;

Change of

Implementation Date

05/28/09

74 FR 25387

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact:

Cheryl C. Peters

Department of Homeland Security

U.S. Customs and Border Protection 1300 Pennsylvania Avenue NW.

Washington, DC 20229

Phone: 202 344-1707

Email: cheryl.c.peters@dhs.gov

Related RIN: Related to 1651-AA81

RIN: 1651-AA77

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Statement of Regulatory Priorities

DHS--Transportation Security Administration (TSA)

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

PROGRAM, AND AIRPORT OPERATOR SECURITY PROGRAM

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority: 6 USC 469; 18 USC 842; 18 USC 845; 46 USC 70102 to 70106; 46 USC 70117; 49 USC 114; 49 USC114(f)(3); 49 USC 5103; 49 USC 5103a; 49 USC 40113; 49 USC 44901 to 44907; 49 USC 44913 to 44914; 49 USC 44916 to 44918; 49

USC 44932; 49 USC 44935 to 44936; 49 USC 44942; 49 USC 46105

CFR Citation: 49 CFR 1515; 49 CFR 1520; 49 CFR 1522; 49 CFR 1540; 49 CFR 1542; 49 CFR 1544; 49 CFR 1550

Legal Deadline:

None

Abstract:

On October 30, 2008, the Transportation Security Administration (TSA) issued a Notice of Proposed Rulemaking (NPRM), proposing to amend current aviation transportation security regulations to enhance the security of general aviation by expanding the scope of current requirements, and by adding new requirements for certain large aircraft operators and airports serving those aircraft. TSA also proposed that all aircraft operations, including corporate and private charter operations, with aircraft having a maximum certificated takeoff weight

(MTOW) above 12,500 pounds (``large aircraft'') be required to adopt a large aircraft security program. TSA also proposed to require certain airports that serve large aircraft to adopt security programs. TSA is preparing a supplemental NPRM (SNPRM), which will include a comment period for public comments.

After considering comments received on the NPRM and meeting with stakeholders, TSA decided to revise the original proposal to tailor security requirements to the general aviation industry. TSA is considering alternatives to the following proposed provisions in the

SNPRM: (1) The type of aircraft subject to TSA regulation; (2) compliance oversight; (3) watch list matching of passengers; (4) prohibited items; (5) scope of the background check requirements and the procedures used to implement the requirement; and (6) other issues.

Additionally, in the SNPRM, TSA plans to propose security measures for foreign aircraft operators. U.S. and foreign operators would implement commensurate measures under the proposed rule.

Statement of Need:

This rule would enhance current security measures and might apply security measures currently in place for operators of certain types of aircraft to operators of other aircraft, including general aviation operators. While the focus of TSA's existing aviation security programs has been on air carriers and commercial operators, TSA is aware that general aviation aircraft of sufficient size and weight may inflict significant damage and loss of lives if they are hijacked and used as missiles. TSA has current regulations that apply to large aircraft operated by air carriers and commercial operators, including the twelve-five program, the partial program, and the private charter program. However, the current regulations in 49 CFR part 1544 do not cover all general aviation operations, such as those operated by corporations and individuals, and such operations do not have the features that are necessary to enhance security. Therefore, TSA is preparing a SNPRM which proposes to establish new security measures for operators, including general aviation operators, that are not covered under TSA's current regulations.

Summary of Legal Basis: 49 U.S.C. 114, 40113, 44903.

Alternatives:

DHS considered continuing to use voluntary guidance to secure general aviation, but determined that to ensure that each aircraft operator maintains an appropriate level of security, these security measures would need to be mandatory requirements.

Anticipated Cost and Benefits:

This proposed rule would yield benefits in the areas of security and quality governance. The rule would enhance security by expanding the mandatory use of security measures to certain operators of large aircraft that are not currently required to have a security plan. These measures would deter malicious individuals from perpetrating acts that might compromise transportation or national security by using large aircraft for these purposes.

As stated above, TSA is revising this proposed rule and preparing a

SNPRM. Aircraft operators, passengers, and TSA would incur costs to comply with the requirements of the proposed rule. TSA is currently evaluating the costs of the revised rule which will be published in the

SNPRM.

Page 79562

Risks:

This rulemaking addresses the national security risk of general aviation aircraft being used as a weapon or as a means to transport persons or weapons that could pose a threat to the United States.

Timetable:

Action

Date

FR Cite

NPRM

10/30/08

73 FR 64790

NPRM Comment Period End

12/29/08

Notice--NPRM Comment

Period Extended

11/25/08

73 FR 71590

NPRM Extended Comment

Period End

02/27/09

Notice--Public Meetings;

Requests for Comments

12/28/08

73 FR 77045

Supplemental NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Local

International Impacts:

This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information:

Public Meetings held on: Jan. 6, 2009, at White Plains, NY; Jan. 8, 2009, at Atlanta, GA; Jan 16, 2009, at Chicago, IL; Jan. 23, 2009, at

Burbank, CA; and Jan. 28, 2009, at Houston, TX.

Additional Comment Sessions held in Arlington, VA, on April 16, 2009,

May 6, 2009, and June 15, 2009.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact:

Erik Jensen

Assistant General Manager, General Aviation Security

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-132S 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-2154

Fax: 571 227-1923

Email: erik.jensen@dhs.gov

Holly Merwin

Economist, Regulatory Development and Economic Analysis

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-343N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-4656

Fax: 571 227-1362

Email: holly.merwin@dhs.gov

Mai Dinh

Assistant Chief Counsel, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, HQ, E12-309N 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-2725

Fax: 571 227-1378

Email: mai.dinh@dhs.gov

Kiersten Ols

Attorney, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, HQ, E12-316N 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-2403

Fax: 571 227-1378

Email: kiersten.ols@dhs.gov

Related RIN: Related to 1652-AA03, Related to 1652-AA04

RIN: 1652-AA53

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Statement of Regulatory Priorities

EMPLOYEES

Priority:

Other Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority: 49 USC 114; PL 110-53, secs 1408 and 1517

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, November 1, 2007, Interim Rule for public transportation agencies is due 90 days after date of enactment.

Final, Statutory, February 3, 2008, Rule for railroads is due 6 months after date of enactment.

Final, Statutory, August 3, 2008, Rule for public transportation agencies is due 1 year after date of enactment.

According to section 1408 of Public Law 110-53, Implementing

Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121

Stat. 266), interim final regulations for public transportation agencies are due 90 days after the date of enactment (Nov. 1, 2007), and final regulations are due 1 year after the date of enactment of this Act.According to section 1517 of the same Act, final regulations for railroads are due no later than 6 months after the date of enactment of this Act.

Abstract:

The Transportation Security Administration (TSA) will propose a new regulation to improve the security of public transportation and passenger railroads in accordance with the Implementing Recommendations of the 9/11 Commission Act of 2007. This rulemaking will propose general requirements for a public transportation security training program and a passenger railroad training program to prepare public transportation and passenger railroad employees, including frontline employees, for potential security threats and conditions.

Statement of Need:

A security training program for public transportation agencies and for passenger railroads is proposed to prepare public transportation and passenger railroad employees, including frontline employees, for potential security threats and conditions.

Summary of Legal Basis: 49 U.S.C. 114; sections 1408 and 1517 of Public Law 110-53,

Implementing

Page 79563

Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121

Stat. 266).

Alternatives:

TSA is required by statute to publish regulations requiring security programs for these operators. As part of its notice of proposed rulemaking, TSA will seek public comment on the numerous ways in which the final rule could carry out the requirements of the statute.

Anticipated Cost and Benefits:

TSA will estimate the costs that the public transportation agencies and passenger railroads covered by this proposed rule would incur following its implementation. These costs will include estimates for the following elements: 1) creating or modifying a security training program and submitting it to TSA; 2) training (initial and recurrent) all security-sensitive employees; 3) maintaining records of employee training; 4) being available for inspections; 5) providing information on security coordinators and alternates; and 6) reporting security concerns. TSA will also estimate the costs TSA itself would expect to incur with the implementation of this rule.

The primary benefit of the Security Training NPRM will be to enhance

United States surface transportation security by reducing the vulnerability of public transportation agencies and passenger railroads to terrorist activity through the training of security-sensitive employees. TSA uses a break-even analysis to assess the trade-off between the beneficial effects of the Security Training NPRM and the costs of implementing the rulemaking. This break-even analysis uses scenarios extracted from the TSA Transportation Sector Security Risk

Assessment (TSSRA) to determine the degree to which the Security

Training NPRM must reduce the overall risk of a terrorist attack in order for the expected benefits of the NPRM to justify the estimated costs. For its analyses, TSA uses scenarios with varying levels of risk, but only details the consequence estimates. To maintain consistency, TSA developed the analyses with a method similar to that used for the break-even analyses conducted in earlier DHS rules.

After estimating the total consequence of each scenario by monetizing lives lost, injuries incurred, capital replacement and clean-up, and lost revenue, TSA will use this figure and the annualized cost of the

NPRM for public transportation and passenger rail to calculate a breakeven annual likelihood of attack.

Risks:

The Department of Homeland Security aims to prevent terrorist attacks within the United States and to reduce the vulnerability of the United

States to terrorism. By providing for security training for personnel,

TSA intends in this rulemaking to reduce the risk of a terrorist attack on this transportation sector.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Morvarid Zolghadr

Branch Chief, Policy and Plans, Mass Transit and Passenger Rail

Security

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, E10-113S 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-2957

Fax: 571 227-0729

Email: morvarid.zolghadr@dhs.gov

Nicholas (Nick) Acheson

Sr. Economist, Regulatory Development and Economic Analysis

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-341N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-5474

Fax: 703 603-0302

Email: nicholas.acheson@dhs.gov

David Kasminoff

Sr. Counsel, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, HQ, E12-310N 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-3583

Fax: 571 227-1378

Email: david.kasminoff@dhs.gov

Related RIN: Related to 1652-AA57, Related to 1652-AA59

RIN: 1652-AA55

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DOCID:ua20de10_002-121

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Statement of Regulatory Priorities

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 49 USC 114; PL 110-53, sec 1517

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, February 3, 2008, Rule is due 6 months after date of enactment.

Page 79564

According to section 1517 of Public Law 110-53, Implementing

Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121

Stat. 266), TSA must issue a regulation no later than 6 months after the date of enactment of this Act.

Abstract:

The Transportation Security Administration (TSA) will propose new regulations to improve the security of freight railroads in accordance with the Implementing Recommendations of the 9/11 Commission Act of 2007. The rulemaking will propose general requirements for a security training program to prepare freight railroad employees, including frontline employees, for potential security threats and conditions. The regulations will take into consideration any current security training requirements or best practices.

Statement of Need:

The rulemaking will propose general requirements for a security training program to prepare freight railroad employees, including frontline employees, for potential security threats and conditions.

Summary of Legal Basis: 49 U.S.C. 114; section 1517 of Public Law 110-53, Implementing

Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121

Stat. 266).

Alternatives:

Anticipated Cost and Benefits:

TSA will estimate the costs that the freight rail systems covered by this proposed rule would incur following its implementation. These costs will include estimates for the following elements: 1) Creating or modifying a security training program and submitting it to TSA; 2) training (initial and recurrent) all security-sensitive employees; 3) maintaining records of employee training; 4) being available for inspections; 5) providing information on security coordinators and alternates; and 6) reporting security concerns. TSA will also estimate the costs TSA itself would expect to incur with the implementation of this rule.

The primary benefit of the Security Training NPRM will be to enhance

United States surface transportation security by reducing the vulnerability of freight railroad systems to terrorist activity through the training of security-sensitive employees. TSA uses a break-even analysis to assess the trade-off between the beneficial effects of the

Security Training NPRM and the costs of implementing the rulemaking.

This break-even analysis uses scenarios extracted from the TSA

Transportation Sector Security Risk Assessment (TSSRA) to determine the degree to which the Security Training NPRM must reduce the overall risk of a terrorist attack in order for the expected benefits of the NPRM to justify the estimated costs. For its analyses, TSA uses scenarios with varying levels of risk, but only details the consequence estimates. To maintain consistency, TSA developed the analyses with a method similar to that used for the break-even analyses conducted in earlier DHS rules.

After estimating the consequence of each scenario by monetizing lives lost, injuries incurred, capital replacement and clean-up, and lost revenue, TSA will use this figure and the annualized cost of the NPRM for freight rail to calculate a breakeven annual likelihood of attack.

Risks:

The Department of Homeland Security aims to prevent terrorist attacks within the United States and to reduce the vulnerability of the United

States to terrorism. By providing for security training for personnel,

TSA intends in this rulemaking to reduce the risk of a terrorist attack on this transportation sector.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Scott Gorton

Policy and Plans Branch Chief for Freight Rail

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-423N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-1251

Fax: 571 227-2930

Email: scott.gorton@dhs.gov

Nicholas (Nick) Acheson

Sr. Economist, Regulatory Development and Economic Analysis

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-341N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-5474

Fax: 703 603-0302

Email: nicholas.acheson@dhs.gov

David Kasminoff

Sr. Counsel, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, HQ, E12-310N 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-3583

Fax: 571 227-1378

Email: david.kasminoff@dhs.gov

Related RIN: Related to 1652-AA55, Related to 1652-AA59

RIN: 1652-AA57

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DOCID:ua20de10_002-122

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Statement of Regulatory Priorities

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 49 USC 114; PL 110-53, sec 1534

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, February 3, 2008, Rule due 6 months after date of enactment.

According to section 1534 of Public Law 110-53, Implementing

Page 79565

Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007); 121

Stat. 266), TSA must issue a regulation no later than 6 months after date of enactment of this Act.

Abstract:

The Transportation Security Administration (TSA) will propose new regulations to improve the security of over-the-road buses in accordance with the Implementing Recommendations of the 9/11 Commission

Act of 2007. The rulemaking will propose an over-the-road bus security training program to prepare over-the-road bus frontline employees for potential security threats and conditions. The regulations will take into consideration any current security training requirements or best practices.

Statement of Need:

The rulemaking will propose an over-the-road bus security training program to prepare over-the-road bus frontline employees for potential security threats and conditions.

Summary of Legal Basis: 49 U.S.C. 114; section 1534 of Public Law 110-53, Implementing

Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121

Stat. 266).

Alternatives:

Anticipated Cost and Benefits:

TSA will estimate the costs that the commercial over-the-road bus

(OTRB) entities covered by this proposed rule would incur following its implementation. These costs will include estimates for the following elements: 1) Creating or modifying a security training program and submitting it to TSA; 2) training (initial and recurrent) all security- sensitive employees; 3) maintaining records of employee training; 4) being available for inspections; 5) providing information on security coordinators and alternates; and 6) reporting security concerns. TSA will also estimate the costs TSA itself would expect to incur with the implementation of this rule.

The primary benefit of the Security Training NPRM will be to enhance

United States surface transportation security by reducing the vulnerability of commercial OTRB operators to terrorist activity through the training of security-sensitive employees. TSA uses a break- even analysis to assess the trade-off between the beneficial effects of the Security Training NPRM and the costs of implementing the rulemaking. This break-even analysis uses scenarios extracted from the

TSA Transportation Sector Security Risk Assessment (TSSRA) to determine the degree to which the Security Training NPRM must reduce the overall risk of a terrorist attack in order for the expected benefits of the

NPRM to justify the estimated costs. For its analyses, TSA uses scenarios with varying levels of risk, but only details the consequence estimates. To maintain consistency, TSA developed the analyses with a method similar to that used for the break-even analyses conducted in earlier DHS rules.

After estimating the consequence of each scenario by monetizing lives lost, injuries incurred, capital replacement and clean-up, and lost revenue, TSA will use this figure and the annualized cost of the NPRM for OTRB operators to calculate a breakeven annual likelihood of attack.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Steve Sprague

Highway Passenger, Infrastructure and Licensing Branch Chief; Highway and Motor Carrier Programs

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-1468

Email: steve.sprague@dhs.gov

Shaina Pereira

Economist, Regulatory Development and Economic Analysis

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-339N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-5138

Fax: 571 227-1362

Email: shaina.pereira@dhs.gov

Traci Klemm

Attorney, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, E12-335N 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-3596

Email: traci.klemm@dhs.gov

Related RIN: Related to 1652-AA55, Related to 1652-AA57

RIN: 1652-AA59

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-123

Page 79565

Statement of Regulatory Priorities

DHS--TSA

FINAL RULE STAGE

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-124

Page 79565-79567

Statement of Regulatory Priorities

Priority:

Other Significant. Major under 5 USC 801.

Legal Authority: 49 USC 114; 49 USC 44924

CFR Citation: 49 CFR 1554

Legal Deadline:

Final, Statutory, August 8, 2004, Rule within 240 days of the date of enactment of Vision 100.

Page 79566

Final, Statutory, August 3, 2008, Rule within 1 year after the date of enactment of 9/11 Commission Act.

Section 611(b)(1) of Vision 100--Century of Aviation Reauthorization

Act (Pub. L. 108-176; Dec. 12, 2003; 117 Stat. 2490), codified at 49

U.S.C. 44924, requires TSA issue ``final regulations to ensure the security of foreign and domestic aircraft repair stations.'' Section 1616 of the Implementing Recommendations of the 9/11 Commission Act of 2007 (Pub. L. 110--531; Aug. 3, 2007; 21 Stat. 266) requires TSA issue a final rule on foreign repair station security.

Abstract:

The Transportation Security Administration (TSA) proposed to add a new regulation to improve the security of domestic and foreign aircraft repair stations, as required by the section 611 of Vision 100--Century of Aviation Reauthorization Act and section 1616 of the 9/11 Commission

Act of 2007. The regulation proposed general requirements for security programs to be adopted and implemented by repair stations certificated by the Federal Aviation Administration (FAA). A notice of proposed rulemaking (NPRM) was published in the Federal Register on November 18, 2009, requesting public comments to be submitted by January 19, 2010.

The comment period was extended to February 19, 2010, on request of the stakeholders to allow the aviation industry and other interested entities and individuals additional time to complete their comments.

Statement of Need:

The Transportation Security Administration (TSA) is proposing regulations to improve the security of domestic and foreign aircraft repair stations. The NPRM proposed to require repair stations that are certificated by the Federal Aviation Administration to adopt and carry out a security program. The proposal will codify the scope of TSA's existing inspection program. The proposal also provides procedures for repair stations to seek review of any TSA determination that security measures are deficient.

Summary of Legal Basis:

Section 611(b)(1) of Vision 100--Century of Aviation Reauthorization

Act (Pub. L. 108-176; Dec. 12, 2003; 117 Stat. 2490), codified at 49

U.S.C. 44924, requires TSA to issue ``final regulations to ensure the security of foreign and domestic aircraft repair stations'' within 240 days from date of enactment of Vision 100. Section 1616 of Public Law 110-53, Implementing Recommendations of the 9/11 Commission Act of 2007

(Aug. 3, 2007; 121 Stat. 266) requires that the FAA may not certify any foreign repair stations if the regulations are not issued within 1 year after the date of enactment of the 9/11 Commission

Act unless the repair station was previously certificated or is in the process of certification.

Alternatives:

TSA is required by statute to publish regulations requiring security programs for aircraft repair stations. As part of its notice of proposed rulemaking, TSA sought public comment on the numerous alternative ways in which the final rule could carry out the requirements of the statute.

Anticipated Cost and Benefits:

TSA anticipates costs to aircraft repair stations mainly related to the establishment of security programs, which may include adding such measures as access controls, a personnel identification system, security awareness training, the designation of a security coordinator, employee background verification, and contingency plan. The total 10- year undiscounted cost of the program is $344 million. The discounted at 7 percent, 10-year cost of the program is $241 million. Security coordinator costs of $132 million and training costs of $132 million represent the largest portions of the program.

A major line of defense against an aviation-related terrorist act is the prevention of explosives, weapons, and/or incendiary devices from getting on board a plane. To date, efforts have been primarily related to inspection of baggage, passengers, and cargo, and security measures at airports that serve air carriers. With this rule, attention is given to aircraft that are located at repair stations, and to aircraft parts that are at repair stations, themselves to reduce the likelihood of an attack against aviation and the country. Since repair station personnel have direct access to all parts of an aircraft, the potential exists for a terrorist to seek to commandeer or compromise an aircraft when the aircraft is at one of these facilities. Moreover, as TSA tightens security in other areas of aviation, repair stations increasingly may become attractive targets for terrorist organizations attempting to evade aviation security protections currently in place.

Risks:

The Department of Homeland Security aims to prevent terrorist attacks within the United States and to reduce the vulnerability of the United

States to terrorism. By requiring security programs for aircraft repair stations, TSA will focus on preventing unauthorized access to repair work and to aircraft to prevent sabotage or hijacking.

Timetable:

Action

Date

FR Cite

Notice--Public Meeting;

Request for Comments

02/24/04

69 FR 8357

Report to Congress

08/24/04

NPRM

11/18/09

74 FR 59873

NPRM Comment Period End

01/19/10

NPRM Comment Period

Extended

12/29/09

74 FR 68774

NPRM Extended Comment

Period End

02/19/10

Final Rule

05/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Page 79567

Agency Contact:

Celio Young

Program Manager, Repair Stations

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management, General Aviation

Division

TSA-28, HQ, E5 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-3580

Fax: 571 227-1362

Email: celio.young@dhs.gov

Thomas (Tom) Philson

Manager, Economic Analysis

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-411N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-3236

Fax: 571 227-1362

Email: thomas.philson@dhs.gov

Linda L. Kent

Assistant Chief Counsel, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, HQ, E12-126S 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-2675

Fax: 571 227-1381

Email: linda.kent@dhs.gov

RIN: 1652-AA38

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DOCID:ua20de10_002-125

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Statement of Regulatory Priorities

Priority:

Other Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority:

PL 110-53, sec 1602; 49 USC 114; 49 USC 40113; 49 USC 44901 to 44905; 49 USC 44913 to 44914; 49 USC 44916; 49 USC 44935 to 44936; 49 USC 46105

CFR Citation: 49 CFR 1520; 49 CFR 1522; 49 CFR 1540; 49 CFR 1544; 49 CFR 1548; 49 CFR 1549

Legal Deadline:

Other, Statutory, February 3, 2009, Screen 50 percent of cargo on passenger aircraft.

Other, Statutory, August 3, 2010, Screen 100 percent of cargo on passenger aircraft.

Final, Statutory, November 3, 2010, 1 year after effective date of the interim final rule.

Section 1602 of the Implementing Recommendations of the 9/11 Commission

Act of 2007 (Pub. L. 110-53, 121 Stat. 266, 478, Aug. 3, 2007) requires that the Secretary of Homeland Security establish a system to screen 50 percent of cargo on passenger aircraft NLT 18 months after the date of enactment and 100 percent of such cargo NLT 3 years after the date of enactment. The 9/11 Act also requires that TSA issue a final rule NLT 1 year after the effective date of the interim final rule (Nov. 2010).

Abstract:

On September 16, 2009, the Transportation Security Administration (TSA) issued an Interim Final Rule (IFR) that established the Certified Cargo

Screening Program (CCSP) that certifies shippers, manufacturers, and other entities to screen air cargo intended for transport on a passenger aircraft. This is the primary means through which TSA will meet the requirements of section 1602 of the Implementing

Recommendations of the 9/11 Commission Act of 2007 that mandates that 100 percent of air cargo transported on passenger aircraft, operated by an air carrier or foreign air carrier in air transportation or intrastate air transportation, be screened by August 2010, to ensure the security of all such passenger aircraft carrying cargo.

Under this rulemaking, each certified cargo screening facility (CCSF) and its employees and authorized representatives that will be screening cargo must successfully complete a security threat assessment. The CCSF must also submit to an assessment of their security measures by TSA- approved validators, screen cargo using TSA-approved methods, and initiate strict chain of custody measures to ensure the security of the cargo throughout the supply chain prior to tendering it for transport on passenger aircraft.

TSA will issue a final rule responding to public comments from the IFR.

Statement of Need:

TSA is establishing a system to screen 100 percent of cargo transported on passenger aircraft operated by an air carrier or foreign air carrier in air transportation or intrastate air transportation to ensure the security of all such passenger aircraft carrying cargo.

The system shall require, at a minimum, that equipment, technology, procedures, personnel, or other methods approved by the Administrator of TSA, used to screen cargo carried on passenger aircraft, provide a level of security commensurate with the level of security for the screening of passenger checked baggage.

Summary of Legal Basis: 49 U.S.C. 114; section 1602 of the Implementing Recommendations of the 9/11 Commission Act of 2007 (Pub. L. 110-53, 121 Stat. 266, 478, 10/3/ 2007), codified at 49 U.S.C. 44901(g).

Alternatives:

The Interim Final Rule (IFR) states that as an alternative to establishing the CCSP, TSA considered meeting the statutory requirements by having aircraft operators screen cargo intended for transportation on passenger aircraft--that is, continuing the current cargo screening program but expanding it to 85 percent of air cargo on passenger aircraft, with the remaining 15 percent assumed to be shipped via other modes. Under this alternative, the cost drivers are screening equipment, personnel for screening, training of personnel, and delays.

Delays are the largest cost component, totaling $7.0 billion over 10 years, undiscounted. In summary, the undiscounted 10 year cost of the alternative is $11.1 billion, and discounted at 7 percent, the cost is $7.7 billion.

Anticipated Cost and Benefits:

TSA estimates the cost of the rule will be $1.9 billion (discounted at 7 percent) over 10 years. TSA analyzed the alternative of not establishing the Certified Cargo Screening Program (CCSP) and, instead, having aircraft operators and air carriers perform screening of all cargo transported on passenger aircraft. Absent the CCSP, the estimated cost to aircraft operators and air carriers is $7.7 billion (discounted at 7 percent) over 10 years.

The bulk of the costs for both the CCSP and the alternative are attributed to personnel and the impact of cargo delays resulting from the addition of a new operational process.

The benefits of the FR are five-fold. First, passenger air carriers will be more firmly protected against an act of terrorism or other malicious behaviors by the screening of 100 percent of cargo

Page 79568

shipped on passenger aircraft. Second, allowing the screening process to occur throughout the supply chain via the Certified Cargo Screening

Program will reduce potential bottlenecks and delays at the airports.

Third, the FR will allow market forces to identify the most efficient venue for screening along the supply chain, as entities upstream from the aircraft operator may apply to become CCSFs and screen cargo.

Fourth, the CCSP enables members to screen valuable cargo earlier in the supply chain and avoid any potentially invasive screening that may occur at the aircraft operator level.

Finally, validation firms will perform assessments of the entities that become CCSFs, allowing TSA to set priorities for compliance inspections.

Timetable:

Action

Date

FR Cite

Interim Final Rule

09/16/09

74 FR 47672

Interim Final Rule

Comment Period End

11/16/09

Interim Final Rule

Effective

11/16/09

Final Rule

03/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Federal

Agency Contact:

Victor Parker

Branch Chief, Air Cargo Policy & Plans

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-3664

Email: victor.parker@dhs.gov

Adam Sicking

Economist, Regulatory Development and Economic Analysis

Department of Homeland Security

Transportation Security Administration

Office of Transportation Sector Network Management

TSA-28, HQ, E10-345N 601 South 12th Street

Arlington, VA 20598-6028

Phone: 571 227-2304

Fax: 571 227-1362

Email: adam.sicking@dhs.gov

Alice Crowe

Sr. Attorney, Regulations and Security Standards Division

Department of Homeland Security

Transportation Security Administration

Office of the Chief Counsel

TSA-2, HQ, E12-320N 601 South 12th Street

Arlington, VA 20598-6002

Phone: 571 227-2652

Fax: 571 227-1379

Email: alice.crowe@dhs.gov

RIN: 1652-AA64

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-126

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Statement of Regulatory Priorities

DHS--U.S. Immigration and Customs Enforcement (USICE)

PROPOSED RULE STAGE

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-127

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Statement of Regulatory Priorities

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 8 USC 1103; 8 USC 1223; 8 USC 1227; 8 USC 1231; 8 USC 1253

CFR Citation: 8 CFR 241

Legal Deadline:

None

Abstract:

This notice of proposed rulemaking (NPRM) is proposing to amend the

Department of Homeland Security (DHS) regulatory provisions for custody determinations for aliens in immigration detention who are subject to an administratively final order of removal. The proposed amendment would add a paragraph to 8 CFR 241.4(g) providing that U.S. Immigration and Customs Enforcement (ICE) shall have a reasonable period of time to effectuate an alien's removal where the alien is not in immigration custody when the order of removal becomes administratively final. The proposed rule would also clarify the removal period time frame afforded to the agency following an alien's compliance with his or her obligations regarding removal subsequent to a period of obstruction or failure to cooperate. The rule proposes to make conforming changes to 241.13(b)(2). Lastly, the rule proposes to add a paragraph to 8 CFR 241.13(b)(3) to make clear that aliens certified by the Secretary under section 236A of the Immigration and Nationality Act, 8 U.S.C. 1226a, are not subject to the provisions of 8 CFR 241.13, in accordance with the separate detention standard provided under the Act.

Statement of Need:

The companion final rule will improve the post order custody review process in the final rule related to the Detention of Aliens Subject to

Final Orders of Removal in light of the U.S. Supreme Court's decisions in Zadvydas v. Davis, 533 U.S. 678 (2001), Clark v. Martinez, 543 U.S. 371 (2005) and conforming changes as required by the enactment of the

Homeland Security Act of 2002 (HSA). This notice of proposed rulemaking

(NPRM) will propose to amend 8 CFR 241.1(g) to provide for a new 90-day removal period once an alien comes into compliance with his or her obligation to make timely application in good faith for travel or other documents and not conspire or act to prevent removal.

Anticipated Cost and Benefits:

This proposed rule will clarify the regulatory provisions concerning the removal of aliens that are subject to an administratively final order of removal. DHS does not anticipate there will be cost impacts to the public as a result of the rule.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Page 79569

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Jason Johnsen

Department of Homeland Security

U.S. Immigration and Customs Enforcement 500 12th Street SW.

Washington, DC 20024

Phone: 202 732-4245

Email: jason.johnsen@dhs.gov

Related RIN: Related to 1653-AA13

RIN: 1653-AA60

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-128

Page 79569

Statement of Regulatory Priorities

DHS--USICE

FINAL RULE STAGE

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-129

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Statement of Regulatory Priorities

Priority:

Other Significant

Legal Authority: 8 USC 1103; 8 USC 1223; 8 USC 1227; 8 USC 1231; 8 USC 1253; . . .

CFR Citation: 8 CFR 241

Legal Deadline:

None

Abstract:

The U.S. Department of Homeland Security is finalizing, with amendments, the interim rule that was published on November 14, 2001, by the former Immigration and Naturalization Service (Service). The interim rule included procedures for conducting custody determinations in light of the U.S. Supreme Court's decision in Zadvydas v. Davis, 533

U.S. 678 (2001), which held that the detention period of certain aliens who are subject to a final administrative order of removal is limited under section 241(a)(6) of the Immigration and Nationality Act (Act) to the period reasonably necessary to effect their removal. The interim rule amended section 241.4 of title 8, Code of Federal Regulations

(CFR), in addition to creating two new sections: 8 CFR 241.13

(establishing custody review procedures based on the significant likelihood of the alien's removal in the reasonably foreseeable future) and 241.14 (establishing custody review procedures for special circumstances cases). Subsequently, in the case of Clark v. Martinez, 543 U.S. 371 (2005), the Supreme Court clarified a question left open in Zadvydas, and held that section 241(a)(6) of the Act applies equally to all aliens described in that section. This rule amends the interim rule to conform to the requirements of Martinez. Further, the procedures for custody determinations for post-removal period aliens who are subject to an administratively final order of removal, and who have not been released from detention or repatriated, have been revised in response to comments received and experience gained from administration of the interim rule published in 2001. This final rule also makes conforming changes as required by the enactment of the

Homeland Security Act of 2002 (HSA). Additionally, certain portions of the final rule were determined to require public comment and, for this reason, have been developed into a separate/companion notice of proposed rulemaking; RIN 1653-AA60.

Statement of Need:

This rule will improve the post order custody review process in the final rule related to the Detention of Aliens Subject to Final Orders of Removal in light of the U.S. Supreme Court's decisions in Zadvydas v. Davis, 533 U.S. 678 (2001), Clark v. Martinez, 543 U.S. 371 (2005) and conforming changes as required by the enactment of the Homeland

Security Act of 2002 (HSA). A companion notice of proposed rulemaking

Anticipated Cost and Benefits:

The changes are administrative and procedural in nature, and will not result in cost impacts to the public. The benefits of making these changes to the regulations will allow for expedited review of the post- order custody review process.

Timetable:

Action

Date

FR Cite

Interim Final Rule

11/14/01

66 FR 56967

Interim Final Rule

Comment Period End

01/14/02

Final Action

03/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Additional Information:

INS No. 2156-01

Transferred from RIN 1115-AG29

Agency Contact:

Jason Johnsen

Department of Homeland Security

U.S. Immigration and Customs Enforcement 500 12th Street SW.

Washington, DC 20024

Phone: 202 732-4245

Email: jason.johnsen@dhs.gov

RIN: 1653-AA13

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Statement of Regulatory Priorities

F-1 NONIMMIGRANT STUDENTS WITH STEM DEGREES AND EXPANDING THE CAP-GAP

RELIEF FOR ALL F-1 STUDENTS WITH PENDING H-1B PETITIONS

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 8 USC 1101 to 1103; 8 USC 1182; 8 USC 1184 to 1187; 8 USC 1221; 8 USC 1281 and 1282; 8 USC 1301 to 1305

CFR Citation: 8 CFR 214

Legal Deadline:

None

Abstract:

Currently, foreign students in F-1 nonimmigrant status who have been enrolled on a full-time basis for at least one full academic year in a college, university, conservatory, or seminary certified by U.S.

Immigration and Custom Enforcement's (ICE) Student and Exchange Visitor

Program (SEVP) are eligible for 12 months of optional practical training (OPT) to work for a

Page 79570

U.S. employer in a job directly related to the student's major area of study. The maximum period of OPT is 29 months for F-1 students who have completed a science, technology, engineering, or mathematics (STEM) degree and accept employment with employers enrolled in U.S.

Citizenship and Immigration Services' (USCIS') E-Verify employment verification program. Employers of F-1 students with an extension of post-completion OPT authorization must report to the student's designated school official (DSO) within 48 hours after the OPT student has been terminated from, or otherwise leaves, his or her employment with that employer prior to end of the authorized period of OPT.

The final rule will respond to public comments and may make adjustments to the regulations.

Statement of Need:

ICE will improve SEVP processes by publishing the Final Optional

Practical Training (OPT) rule, which will respond to comments on the

OPT interim final rule (IFR). The IFR increased the maximum period of

OPT from 12 months to 29 months for nonimmigrant students who have completed a science, technology, engineering, or mathematics (STEM) degree and who accept employment with employers who participate in the

U.S. Citizenship and Immigration Services' (USCIS') E-Verify employment verification program.

Alternatives:

DHS is considering several alternatives to the 17-month extension of

OPT and cap-gap extension, ranging from taking no action to further extension for a larger populace. The interim final rule addressed an immediate competitive disadvantage faced by U.S. industries and ameliorated some of the adverse impacts on the U.S. economy. DHS continues to evaluate both quantitative and qualitative alternatives.

Anticipated Cost and Benefits:

Based on an estimated 12,000 students per year that will receive an OPT extension and an estimated 5,300 employers that will need to enroll in

E-verify, DHS projects that this rule will cost students approximately

$1.49 million per year in additional information collection burdens,

$4,080,000 in fees, and cost employers $1,240,000 to enroll in E-Verify and $168,540 per year thereafter to verify the status of new hires.

However, this rule will increase the availability of qualified workers in science, technology, engineering, and mathematical fields; reduce delays that place U.S. employers at a disadvantage when recruiting foreign job candidates, thereby improving strategic and resource planning capabilities; increase the quality of life for participating students, and increase the integrity of the student visa program.

Timetable:

Action

Date

FR Cite

Interim Final Rule

04/08/08

73 FR 18944

Interim Final Rule

Comment Period End

06/09/08

Final Rule

03/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

URL For More Information: www.dhs.gov/sevis/

Agency Contact:

Sharon Snyder

Acting Branch Chief, SEVP Policy, Student and Exchange Visitor Program

Department of Homeland Security

U.S. Immigration and Customs Enforcement

Potomac Center North 500 12th Street SW.

Washington, DC 20024-6121

Phone: 703 603-3415

RIN: 1653-AA56

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Statement of Regulatory Priorities

DHS--Federal Emergency Management Agency (FEMA)

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Statement of Regulatory Priorities

Priority:

Other Significant

Legal Authority: 42 USC 5121 to 5207

CFR Citation: 44 CFR 206

Legal Deadline:

None

Abstract:

This proposed rule would revise the Federal Emergency Management

Agency's Public Assistance program regulations. Many of these changes reflect amendments made to the Robert T. Stafford Disaster Relief and

Emergency Assistance Act by the Post-Katrina Emergency Management

Reform Act of 2006 and the Security and Accountability For Every Port

Act of 2006. The proposed rule also proposes to reflect lessons learned from recent events, and propose further substantive and non-substantive clarifications and corrections to improve upon the Public Assistance regulations. This proposed rule is intended to improve the efficiency and consistency of the Public Assistance program, as well as implement new statutory authority by expanding Federal assistance, improving the

Project Worksheet process, empowering grantees, and improving State

Administrative Plans.

Statement of Need:

The proposed changes implement new statutory authorities and incorporate necessary clarifications and corrections to streamline and improve the Public Assistance program. Portions of FEMA's Public

Assistance regulations have become out of date and do not implement all of FEMA's available statutory authorities. The current regulations inhibit FEMA's ability to clearly articulate its regulatory requirements, and the Public Assistance applicants' understanding of the program. The proposed changes are intended to improve the efficiency and consistency of the Public Assistance program.

Summary of Legal Basis:

The legal authority for the changes in this proposed rule is contained in the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 to 5207, as amended by the Post-Katrina Emergency

Management Reform Act of 2006, 6 U.S.C. 701 et seq, the Security and

Accountability For Every Port Act of 2006, 6 U.S.C. 901 note, the Local

Community Recovery Act of 2006, Public Law 109-218, 120 Stat. 333, and the Pets Evacuation and Transportation Standards Act of 2006, Public

Law 109-308, 120 Stat. 1725.

Alternatives:

One alternative is to revise some of the current regulatory requirements (such as application deadlines) in addition to implementing the amendments made to the Stafford Act by (1) the Post-

Katrina Emergency Management Reform Act of 2006 (PKEMRA), Public Law 109-295, 120 Stat. 1394; 2) the Security and Accountability For Every

Port Act of 2006 (SAFE Port Act), Public Law 109-

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347, 120 Stat. 1884; 3) the Local Community Recovery Act of 2006,

Public Law 109-218, 120 Stat. 333; and 4) the Pets Evacuation and

Transportation Standards Act of 2006 (PETS Act), Public Law 109-308, 120 Stat. 1725. Another alternative is to expand funding by expanding force account labor cost eligibility to Category A Projects (debris removal).

Anticipated Cost and Benefits:

The proposed rule is expected to have economic impacts on the public, grantees, subgrantees, and FEMA. The expected benefits are a reduction in property damages, societal losses, and losses to local businesses, as well as improved efficiency and consistency of the Public Assistance program. The total economic impact of the proposed rule is estimated to be approximately $50 million per year (in 2010 dollars). The primary economic impact of the proposed rule is the additional transfer of funding from FEMA through the Public Assistance program to grantees and subgrantees that is effectuated by this rulemaking. The proposed rule will also incur additional administrative costs to grantees and FEMA, which is estimated to be approximately $230,000, and $20,000 per year, respectively. However, most of the proposed changes are not expected to result in any additional cost to FEMA or any changes in the eligibility of assistance.

Risks:

This action does not adversely affect public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

04/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Federal, Local, State, Tribal

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Tod Wells

Recovery Directorate

Department of Homeland Security

Federal Emergency Management Agency 500 C Street SW.

Washington, DC 20472-3100

Phone: 202 646-3936

Fax: 202 646-3363

Email: tod.wells@dhs.gov

RIN: 1660-AA51

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Statement of Regulatory Priorities

The Regulatory Plan for the Department of Housing and Urban Development

(HUD) for Fiscal Year (FY) 2011 highlights the most significant regulatory initiatives that HUD seeks to complete during the upcoming fiscal year. As

HUD--Office of Housing (OH)

Page 79573

and nonprofit organizations) to receive HUD housing counseling grants; establish standards for materials and forms to be used, as appropriate, by organizations providing homeownership counseling services; provide for the certification of various computer software programs for consumers to use in evaluating different residential mortgage loan proposals; and ensure that counselors receiving funding under HUD's housing counseling grant program are properly certified, in accordance with standards established by HUD.

Priority: Improving Energy Efficiency in Housing

Despite significant improvements in housing quality in recent decades, much of the Nation's housing stock is not energy efficient. Increasing the Nation's affordable housing stock must also include establishing or improving energy efficiency in such housing. HUD initiated new energy efficiency programs through the American Recovery and Reinvestment Act of 2009 (Recovery Act). These included: A $250 million Green Retrofit

Program for assisted multifamily buildings; $600 million for high performing energy retrofit and green projects in public housing; and additional formula and competitive programs that either contained incentives for energy efficiency and green, or could be utilized for that purpose. HUD estimates that up to 88,000 units may be retrofitted through these programs, for an estimated energy savings of $21 million.

While HUD's programs and initiatives under the Recovery Act focused on public and assisted multifamily housing, HUD's FY 2011 regulatory plan focuses on establishing a regulatory foundation to improve energy efficiency in FHA's title I Property Improvement Loan Insurance program

(Title I program). Through the Title I program, FHA makes it easier for consumers to obtain affordable home improvement loans by insuring loans made by private lenders to improve properties that meet certain requirements. Title I program loans may be used to finance permanent property improvements that protect or improve the basic livability or utility of the property. HUD's FY 2011 rulemaking for the Title I program will provide for qualified borrowers to obtain low cost loans for specified energy improvements.

Regulatory Action: Title I Energy Retrofit Property Improvement Loans

HUD's rule amending the Title I program to provide for low cost loans for energy improvements has its foundation in the Recovery through

Retrofit Report (Report), issued on October 19, 2009, by the Vice

President and the White House Middle Class Task Force. The Report builds on the foundation laid out in the Recovery Act to expand green job opportunities in the United States and boost energy savings for middle class Americans by retrofitting homes for energy efficiency. The

Report recognizes that making American homes and buildings more energy efficient presents an unprecedented opportunity for communities throughout the country. Home retrofits can potentially help people earn money, as home retrofit workers, while also helping them save money, by lowering their utility bills. The regulatory amendments to be addressed by this rulemaking will take into consideration the experience of HUD,

Title I lenders, and consumers participating in HUD's Title I program

Energy Retrofit Loan Demonstration to be launched late 2010. The demonstration will allow HUD to assess the success of the proposed modifications to its existing Title I program and address any programmatic concerns before undertaking final codification of regulatory amendments.

Aggregate Costs and Benefits

Executive Order 12866, as amended, requires the agency to provide its best estimate of the combined aggregate costs and benefits of all regulations included in the agency's regulatory plan that will be made effective in calendar year 2011. HUD expects that the neither the total economic costs nor the total efficiency gains will exceed $100 million.

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Statement of Regulatory Priorities

The Regulatory Plan for the Department of Housing and Urban Development

(HUD) for Fiscal Year (FY) 2011 highlights the most significant regulatory initiatives that HUD seeks to complete during the upcoming fiscal year. As 91. TITLE I ENERGY RETROFIT PROPERTY IMPROVEMENT LOANS (FR- 5445)

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 12 USC 1703; 42 USC 3535(d)

CFR Citation: 24 CFR 201

Legal Deadline:

None

Abstract:

This proposed rule would amend HUD's regulations for the title I

Property Improvement Loan Insurance program (Title I program) to better assist qualified borrowers obtain low-cost loans for specified energy improvements. Through the Title I program, FHA makes it easier for consumers to obtain affordable home improvement loans by insuring loans made by private lenders to improve properties that meet certain requirements. Title I program loans may be used to finance permanent property improvements that protect or improve the basic livability or utility of the property. The proposed rule is being issued in response to the Recovery through Retrofit Report (Report), issued on October 19, 2009, by the Vice President and the White House Middle Class Task

Force. The Report builds on the foundation laid out in the American

Recovery and Reinvestment Act (Pub. L. 111-5; approved February 17, 2009) to expand green job opportunities in the United States and boost energy savings for middle class Americans by retrofitting homes for energy efficiency. The Report recognizes that making American homes and buildings more energy efficient presents an unprecedented opportunity for communities throughout the country. Home retrofits can potentially help people earn money, as home retrofit workers, while also helping them save money, by lowering their utility bills. By encouraging nationwide weatherization of homes, workers of all skill levels will be trained, engaged, and will participate in ramping up a national home retrofit market.

The proposed regulatory amendments build upon the experience of HUD, title I lenders and consumers participating in the Department's Title I program Energy Retrofit Loan Demonstration. Before undertaking rulemaking to codify the regulatory amendments on a permanent, nationwide basis, HUD decided to conduct a demonstration involving a limited number of lenders and areas of the country. The demonstration will allow HUD to assess the success of the proposed modifications to the existing program and to address any programmatic concerns before authorizing its use throughout the country.

Page 79574

Statement of Need:

The Report identified several barriers that have prevented a self- sustaining retrofit market from forming. Among other barriers, the

Report found that homeowners face high upfront costs and many are concerned that they will be prevented from recouping the value of their investment if they choose to sell their home. The upfront costs of home retrofit projects are often beyond the average homeowner's budget. The report found that the solution to the lack of home energy retrofit financing is to make such financing more accessible and more consumer friendly. The proposed regulatory amendments will help to address these needs by enabling qualified borrowers obtain title I low cost loans for energy-related home improvements.

Summary of Legal Basis:

The Title I program is authorized under title I, section 2, of the

National Housing Act (12 U.S.C. 1703). Specifically, under section 2(a) of the National Housing Act, the Secretary of HUD is authorized to help homeowners finance alterations, repairs, and improvements in connection with existing structures or manufactured homes. HUD's implementing regulations are codified at 24 CFR part 201.

Alternatives:

The primary alternative HUD considered to amending the Title I regulations was use of the existing FHA Energy Efficient Mortgage (EEM) program. The FHA EEM program allows a borrower to finance and incremental amount on their first mortgage to invest in energy efficiency, with an additional appraisal or further credit qualification, provided that the benefit of projected energy savings exceed the cost of the improvements, as estimated by an energy audit,

HUD ultimately determined that the EEM was not an optimal vehicle for achieving the energy innovation goals of this rule. First the FHA EEM is, by definition, a negative equity instrument, and negative equity is extremely problematic in the current housing market. Another problematic feature of the EEM program is that the financing may exceed the benefit from and useful life of the measures, and result in a total net cost to the consumer that does not represent the optimal use of funds.

Anticipated Cost and Benefits:

The aggregate net benefits are obtained by multiplying the individual net benefits by the expected number of loans and adding the expected social benefits of reduced energy consumption. As a base case, HUD assumes a consumer household with annual savings of $1000, a zero percent price growth and a 7 percent discount rate. The present value of a technical retrofit for this base case scenario is $11,400.

Assuming a rebound effect of 30 percent yields a comfort benefit of

$3,400 and energy savings of $8,000 per participant (the ``rebound effect'' refers to the fact that the reaction of the consumer to the energy-saving technology will not necessarily reduce energy consumption by what is technically possible). Approximately 24,000 loans are expected over two years. For the base case scenario, this would equal

$41 million comfort benefits and $96 million in energy saving for each year of the program. The benefits of the FHA program may not equal the sum of the benefits of all retrofits financed through the program, but only reflect the benefits of the retrofits that would not have occurred without the program; however, the existence of significant market imperfections and the lack of affordable financing makes it reasonable to assume that a large proportion, if not all of the loans, will generate benefits. The cost of receiving the energy-savings is the upfront investment plus the costs of financing the investment. the cost per investment is thus equal to the size of the loan.

Risks:

This rule poses no risk to public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

04/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Karin Hill

Director, Office of Single Family Program Development

Department of Housing and Urban Development

Office of Housing 451 7th Street SW.

Washington, DC 20410

Phone: 202 708-4308

RIN: 2502-AI93

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Statement of Regulatory Priorities

The Regulatory Plan for the Department of Housing and Urban Development

(HUD) for Fiscal Year (FY) 2011 highlights the most significant regulatory initiatives that HUD seeks to complete during the upcoming fiscal year. As 92. HOUSING COUNSELING: NEW PROGRAM REQUIREMENTS (FR-5446)

Priority:

Other Significant

Legal Authority: 12 USC 1701x; 42 USC 3535(d)

CFR Citation: 24 CFR 214

Legal Deadline:

None

Abstract:

This proposed rule would amend HUD's regulations for the Housing

Counseling program to address the new program requirements and certification requirements for HUD approved housing counselors as provided by the Dodd-Frank Wall Street Reform and Consumer Protection

Act (Pub. L. 111-203, approved July 21, 2010). The proposed rule would also reflect the authority and responsibility of HUD's new Office of

Housing Counseling to coordinate and administer HUD's Housing

Counseling program.

HUD's Housing Counseling program is authorized by section 106 of the

Housing and Urban Development Act of 1968 (12 U.S.C. 1701x). Section 106 authorizes HUD to provide, make grants to, or contract with public or private organizations to provide a broad range of housing counseling services to homeowners and tenants to assist them in improving their housing conditions and in meeting the responsibilities of tenancy or homeownership. The regulations contained in this part prescribe the procedures and requirements by which the Housing Counseling program will be administered. These regulations apply to all agencies participating in HUD's Housing Counseling program.

The proposed regulatory amendments will implement the changes made to

Page 79575

section 106 of the Housing and Urban Development Act of 1968 by the

Dodd-Frank Wall Street Reform and Consumer Protection Act, which include directing that HUD-approved housing counseling agencies provide counseling that addresses the entire process of homeownership and that

HUD establish materials and forms to be used by HUD-approved housing counselors.

Statement of Need:

The rulemaking is needed because HUD's current regulations for the

Housing Counseling program do not reflect the changes made to section 106 of section 106 of the Housing and Urban Development Act of 1968 by the Dodd-Frank Wall Street Reform. The changes enhance the choices and protections afforded borrowers participating in HUD's single family mortgage insurance programs.

Summary of Legal Basis:

The Housing Counseling program is authorized by section 106 of the

Housing and Urban Development Act of 1968 (12 U.S.C. 1701x), as recently amended by subtitle D of title XIV of the Dodd-Frank Wall

Street Reform and Consumer Protection Act.

Alternatives:

As noted, the purpose of this rule is to update HUD's regulations that do not reflect current statutory requirements. While certain statutory changes may be implemented through HUD's annual competitive allocation of fund for the Housing Counseling program provided by appropriations acts, the regulation nevertheless needs to be amended to reflect the program changed made by changes to the underlying statutory authority.

Anticipated Cost and Benefits:

The benefit of the proposed regulatory amendments will be to strengthen the protection of consumers, primarily those who are prospective homeowners but also current homeowners through the enhanced counseling requirements provided by the Dodd-Frank Wall Street Reform and Consumer

Protection Act. The more comprehensive counseling services directed to be provided and the review of materials and forms by HUD designed to better educate consumers about homeownership are expected to produce homebuyers better educated about the homeownership process and less vulnerable to fraudulent mortgage practices. Costs are expected to minimal. The Dodd-Frank Wall Street Reform and Consumer Protection Act authorizes funding to help establish HUD's new Office of Housing

Counseling and the additional functions to be carried out by this office. The Dodd-Frank Wall Street Reform and Consumer Protection Act also authorizes additional funding for the expansion of services to be carried out by HUD-approved counseling agencies.

Risks:

This rule poses no risk to public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

03/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Ruth Roman

Director, Office of Housing Counseling

Department of Housing and Urban Development

Office of Housing 451 7th Street SW.

Washington, DC 20410-0001

Phone: 202 402-2112

RIN: 2502-AI94

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Statement of Regulatory Priorities

The Department of the Interior (DOI) is the principal Federal steward of our Nation's public lands and resources, including many of our cultural treasures. We serve as trustee to Native Americans and Alaska natives and are

Page 79577

there is no legal procedure to deaccession items in Federal collections that are of ``insufficient archaeological interest;'' i.e., they are of no further value to the science of archaeology or to the integrity of the collection in which they are contained. This rule would free up space in collections and allow custodians to allocate more time and effort to care of remaining items while ensuring proper disposition of those archaeological items.

The rule also requires assigning a specific individual to be accountable for proper disposition. This complicated rule is now undergoing final review and should be ready for publication in early 2011.

(2) Sustainably Using Energy, Water, and Natural Resources.

The Bureau of Land Management has identified a total of approximately 20.6 million acres of public land with wind energy potential in the 11 western states and approximately 29.5 million acres with solar energy potential in the six southwestern states. There are over 140 million acres of public land in western states and Alaska with geothermal resource potential. There is also significant wind and wave potential in our offshore waters. The National Renewable Energy Lab, a Department of Energy national laboratory, has identified more than 1,000 gigawatts of wind potential off the Atlantic coast--roughly equivalent to the

Nation's existing installed electric generating capacity--and more than 900 gigawatts of wind potential off the Pacific Coast. Because public lands are extensive and widely distributed, the Department has an important role, in consultation with Federal, State, regional, and local authorities, in siting new transmission lines needed to bring renewable energy assets to load centers.

Since the beginning of the Obama Administration, the Department has focused on renewable energy issues and has established priorities for environmentally responsible development of renewable energy on our public lands and the outer continental shelf. Industry has started to respond by investing in development of wind farms off the Atlantic seacoast and solar, wind, and geothermal energy facilities throughout the west. Power generation from these new energy sources produces virtually no greenhouse gases, and when done in an environmentally sensitive manner, harnesses with minimum impact abundant, renewable energy that nature itself provides. The Department will continue its intra- and inter-departmental efforts to move forward with the environmentally responsible review and permitting of renewable energy projects on public lands.

On March 11, 2009, the Secretary issued his first Secretarial Order that made facilitating production, development, and delivery of renewable energy on public lands and the OCS top priorities at the

Department. In accomplishing these goals, the Department will protect our signature landscapes, natural resources, wildlife, and cultural resources and will collaborate with relevant Federal, State, tribal, and other agencies. The Secretarial Order also established an energy and climate change task force that draws from the leadership of each of the bureaus and is responsible for:

Quantifying potential contributions of renewable energy resources on our public lands and the OCS; and

Identifying and prioritizing specific areas on public lands where the Department can facilitate a rapid and responsible increase in production of renewable energy.

On April 29, 2009, the former Minerals Management Service published a final rule to establish a program to grant leases, easements, and rights-of-way for renewable energy projects on the Outer Continental

Shelf (OCS). These regulations will ensure the orderly, safe, and environmentally responsible development of renewable energy sources on the OCS.

(3) Empowering People and Communities.

The Department encourages public participation in the regulatory process by seeking public input on a variety of regulatory issues. For example, every year the Fish and Wildlife Service (FWS) establishes migratory bird hunting seasons in partnership with flyway councils composed of State fish and wildlife agencies. FWS also holds a series of public meetings to give other interested parties, including hunters and other groups, opportunities to participate in establishing the upcoming season's regulations.

Similarly, the Bureau of Land Management uses Resource Advisory

Councils made up of affected parties to help prepare land management plans and regulations that it issues.

The National Park Service (NPS) has begun revising its rules on non-

Federal development of gas and oil in units of the National Park

System. Of the approximately 700 gas and oil wells in 13 NPS units, 55 per cent, or 385 wells, are exempt from current regulations. NPS is revising the regulations to improve protection of NPS resources and bring those 385 wells under the regulatory umbrella. NPS actively sought public input into designing the rule and published an Advance

Notice of Proposed Rulemaking with a comment period from November 15, 2009, through January 25, 2010. Interested members of the public were able to make suggestions on the content of the regulation, which NPS will consider in writing the proposed rule. After developing a proposed rule, NPS will solicit further public comment. NPS expects to publish a proposed rule in mid 2011.

Accountability and Sustainability Through Regulatory Efficiency

We are using the regulatory process to improve results while easing regulatory burdens. For instance, the Endangered Species Act (ESA) allows for delisting threatened and endangered species if they no longer need the protection of the ESA. We are working to identify species for which delisting or downlisting (reclassification from endangered to threatened) may be appropriate.

The Fish and Wildlife Service has found that making listing decisions under the Endangered Species Act in Hawaii on a traditional, species- by-species basis is inefficient, since very similar information and analysis would be repeated in each rule. To improve efficiency, FWS is making listing decisions for 48 species on the island of Kauai in one regulatory package. This allows the Service to address the existing backlog of candidate species more quickly.

Most candidate species on the Hawaiian Islands face nearly identical threats and are only found in the few remaining native-dominated ecological communities. The impacts of these threats are well understood at the community level, while their impacts to the individual candidate species are relatively less studied. Because this ecological community approach focuses on conserving the key physical and biological components of native communities and ecosystems, it may preclude the need to list additional species found in the same ecological communities. Recovery plans developed in response to the

Kauai listing will focus conservation efforts on protection and restoration of ecosystem processes, allowing us to more efficiently address

Page 79578

common threats in the most important areas.

DOI bureaus work to make our regulations easier to comply with and understand. Our regulatory process ensures that bureaus share ideas on how to reduce regulatory burdens while meeting the requirements of the laws they enforce and improving their stewardship of the environment and resources. Results include:

Effective stewardship of our Nation's resources in a way that is responsive to the needs of small businesses;

Increased benefits per dollars spent by carefully evaluating the economic effects of planned rules; and

Improved compliance and transparency by use of plain language in our regulations and guidance documents.

Bureaus and Offices Within DOI

The following brief descriptions summarize the regulatory functions of

DOI's major regulatory bureaus and offices.

Bureau of Indian Affairs

The Bureau of Indian Affairs (BIA) administers and manages 56 million acres of land held in trust by the United States for Indians and Indian tribes, providing services to approximately 1.9 million Indians and

Alaska Natives, and maintaining a government-to-government relationship with the 565 federally recognized Indian tribes. BIA's mission is to enhance the quality of life, to promote economic opportunity, and to carry out the responsibility to protect and improve the trust assets of

American Indians, Indian tribes, and Alaska Natives, as well as to provide quality education opportunities to students in Indian schools.

In the coming year, BIA will continue its regulatory focus on improved management of trust responsibilities and promotion of economic development in Indian communities. In addition, we will focus on updating Indian education regulations and on other regulatory changes to increase transparency in support of the President's Open Government

Initiative.

With the input of tribal leaders, individual Indian beneficiaries, and other subject matter experts, BIA has been examining ways to better serve its beneficiaries. The American Indian Probate Reform Act of 2004

(AIPRA) made clear that regulatory changes were necessary to update the manner in which we meet our trust management responsibilities. We have promulgated regulations implementing the probate-related provisions of

AIPRA and will now focus on regulations to implement other AIPRA provisions related to managing Indian land.

The focus on promoting economic development in Indian communities is a core component of BIA's mission. Economic development initiatives can attract businesses to Indian communities and fund services that support the health and well-being of tribal members.By providing the tools necessary to promote economic development, economic development can enable tribes to attain self-sufficiency, strengthen their governments, and reduce crime.

Indian education is a top priority of the Assistant Secretary--Indian

Affairs. For this reason, we will review Indian education regulations to ensure that they adequately support efforts to provide students of

BIA-funded schools with the best education possible.

Finally, BIA's regulatory focus on increasing transparency implements the President's Open Government Initiative. We will ensure that all regulations that we draft or revise meet high standards of readability and accurately and clearly describe BIA processes.

BIA's regulatory priorities are to:

Develop regulations to meet the Indian trust reform goals for land consolidation and land use management.

BIA is developing amendments to regulations in the areas of land title and records, conveyances of trust or restricted land, leasing, grazing, trespass, rights-of-way, and energy and minerals. Together, these regulatory changes will provide the Department with the tools it needs to better serve beneficiaries and will standardize procedures for consistent execution of fiduciary responsibilities across the BIA.

Revise loan guaranty regulations to promote private investment in Indian Country.

BIA plans to propose a rule that would address the chronic lack of business lending faced by Indian communities. While BIA currently operates a successful loan guaranty, insurance, and interest subsidy program, the program's current regulations are best suited to assisting for-profit businesses to secure loans in the $250,000 to $10 million range. Revisions to the rule would:

- Promote financing for smaller loans (under $250,000), which are important for sparking economic development, by allowing community development financial institutions to obtain program guarantees and insurance and by using fiscal transfer agents to encourage financing for small loans.

- Obtain funding for higher cost projects (above $10 million)-including infrastructure projects, energy projects, and other large projects requiring a longer repayment horizon-by offering a Federal Government guarantee for taxable tribal bonds. The guarantee would help ensure bond placement, decrease market rates charged for bonds, and help tribes become established in the bond market.

- Extend eligibility for the program to non-profit borrowers who make a significant economic contribution to the Indian reservation or tribal service area.

These changes are authorized by the Indian Financing Act, as amended by the Native American Technical Corrections Act of 2006.

Identify and develop regulatory changes necessary for improved

Indian education.

BIA is currently reviewing regulations addressing grants to tribally controlled community colleges and other Indian education regulations. The review will identify provisions that need to be updated to comply with applicable statutes and ensure that the proper regulatory framework is in place to support students of Bureau-funded schools.

Develop regulatory changes to reform the process for Federal acknowledgment of Indian tribes.

Over the years, BIA has received significant comments from American

Indian groups and members of Congress on the Federal acknowledgment process established by 25 CFR part 83. Most of these comments claim that the current process is cumbersome and overly restrictive. BIA is reviewing the current Federal acknowledgment regulation and will develop any necessary regulatory changes.

Revise regulations governing administrative appeals and other processes to increase transparency.

BIA is making a concentrated effort to improve the readability and precision of its regulations. Because trust beneficiaries often turn to the regulations for guidance on how a given

BIA process works, BIA is

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ensuring that each revised regulation is written as clearly as possible and accurately reflects the current organization of the Bureau. A few of the regulations BIA will be focusing this effort on include the regulation governing administrative appeals (25 CFR part 2), the land use management regulations mentioned above, and regulations addressing various Indian services.

The Bureau of Land Management

The Bureau of Land Management (BLM) manages the 245-million-acre

National System of Public Lands, located primarily in the western

States, including Alaska, and the 700-million-acre subsurface mineral estate located throughout the Nation. BLM's complex multiple-use mission affects the lives of a great number of Americans, including those who live near and visit the public lands, as well as millions of

Americans who benefit from commodities, such as minerals, energy, or timber, produced from the lands' rich resources.

BLM's multiple-use mission conserves the lands' natural and cultural resources and sustains the health and productivity of the public lands for the use and enjoyment of present and future generations. BLM manages such varied uses as energy and mineral development, outdoor recreation, livestock grazing, and forestry and woodlands products.

This year, BLM has celebrated the 10th anniversary of the National

Landscape Conservation System (NLCS), created in 2000 to highlight the conservation side of the Agency's multiple-use mandate. Last year,

Congress, through the passage of the Omnibus Public Land Management Act

(Pub. L. 111-11), affirmed its support of BLM-managed NLCS in statute and added 929,000 acres of wilderness, one national monument, four national conservation areas, 363 miles of wild and scenic rivers, and 40 miles of national scenic and historic trails to the NLCS. More than 880 NLCS treasured landscapes now span the Nation from Florida to

Alaska.

BLM is analyzing proposals for increasing renewable energy development on public lands. The quality of life that Americans enjoy today depends largely upon a stable and abundant supply of affordable energy. Because

BLM manages more Federal land than any other agency--more than 245 million surface acres and 700 million subsurface acres of mineral estate--it plays a key role in ensuring that the Nation's energy needs are met by managing both Federal renewable and non-renewable sources of energy. This is accomplished in an environmentally and fiscally sound way that protects our natural resources and critical wildlife habitat for such species as the sage-grouse and lynx. Although renewable energy can help reduce greenhouse gases, its development is not without environmental impacts. Large, commercial-scale solar energy plants, for example, can have long-term environmental impacts and may override other uses of the land.

Another BLM priority is siting and authorizing transmission corridors to assist the national effort to move renewable energy from production sites to market. BLM has already accomplished a significant step in this direction by designating more than 5,000 miles of energy transport corridors for the West-wide Energy Corridors. Development of actual transmission lines is done by authorizing rights-of-way across public lands.

In an effort to prioritize its complex, multiple-use responsibilities,

BLM has identified several emphasis areas to help explain its regulatory priorities. The following describes these programs and initiatives and reflects their interrelationship with the following priorities of the Secretary of the Interior:

Energy independence

Treasured landscapes

Native American Nations

Treasured landscapes

Protecting the landscapes of the National System of Public Lands involves numerous BLM programs as the Agency moves toward a holistic, landscape-level approach to managing multiple public land uses. BLM also engages partners interested in working on a broader scale across jurisdictional lines to achieve a common landscape vision. For the past several years, BLM, which manages the largest amount and the greatest diversity of fish and wildlife habitat of any Federal agency, has focused on restoring healthy landscapes in a number of ways, including:

Reducing the number of wild horses and burros on public lands, particularly in areas most affected by drought and wildfire. Maintaining the wild horse and burro population at appropriate management levels is critical in the effort to conserve forage resources that also sustain native wildlife and livestock.

Restoring habitat for sensitive, rare, threatened, and endangered species, such as sage-grouse, desert tortoise, and salmon.

Supporting greater biodiversity through noxious weed and invasive species treatments to bring back native plants.

Improving water quality by restoring riparian areas and protecting watersheds. Enhanced water quality aids in the restoration of habitat for fish and other aquatic and riparian species.

Conducting post-fire recovery efforts to promote healthy landscapes and discourage the spread of invasive species.

Native American Nations

BLM consults with Indian tribes on a government-to-government basis under multiple authorities and is continually working to assess and improve its tribal consultation practices. BLM held listening sessions throughout the West on this important issue in 2009 and 2010 and received many valuable comments. BLM has continued its efforts to improve its tribal consultation practices by participating with the

Department in multiple listening sessions with tribes throughout the country.

The Native American Graves Protection and Repatriation Act (NAGPRA), enacted in 1990, addresses the rights of lineal descendants, Indian tribes, and Native Hawaiian organizations to certain Native American human remains, funerary objects, associated funerary objects, sacred objects, and objects of cultural patrimony with which they are affiliated. The statute and implementing regulations represent a careful balance between the legitimate interests of lineal descendants,

Indian tribes, and Native Hawaiian organizations to control the remains of their ancestors and cultural property and the legitimate public interests in scientific and educational information associated with the human remains and cultural items.

BLM is complying with the new NAGPRA regulations, including inventorying and repatriating human remains and other cultural items that are in BLM museum collections. BLM also consults with Indian tribes on implementing appropriate actions when human remains and other cultural items subject to NAGPRA are inadvertently discovered or intentionally excavated on the public lands.

Additionally, BLM, in cooperation with the Bureau of Indian Affairs, helps tribes and individual Indian allottees

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develop their solid and fluid mineral resources. BLM is responsible for development, product measurement, and inspection and enforcement of extracting operations of the mineral estate on trust properties.

BLM's regulatory priorities

BLM's regulatory focus is directed primarily by the priorities of the

President and Congress, which include:

Facilitating domestic production of various sources of energy, including biomass, wind, solar, and other alternative sources.

Providing for a wide variety of public uses while maintaining the long-term health and diversity of the land.

Preserving significant natural, cultural, and historic resource values.

Understanding the arid, semi-arid, arctic, and other ecosystems that BLM manages.

Using the best scientific and technical information to make resource management decisions.

Understanding the needs of the people who use and enjoy BLM- managed public lands and providing them with quality service.

Securing the recovery of a fair return for using publicly owned resources and avoiding the creation of long-term liabilities for American taxpayers.

Resolving problems and implementing decisions in cooperation with other agencies, States, tribal governments, and the public.

In developing regulations, BLM recognizes the need to ensure communication, coordination, and consultation with the public, including affected interests, tribes, and other stakeholders. BLM also works to draft regulations that are easy for the public to understand and that provide clarity to those most affected by them.

BLM's specific regulatory priorities include:

Revising onshore oil and gas operating standards

BLM expects to publish rules to revise several existing onshore oil and gas operating orders and propose one new onshore order. Onshore orders establish requirements and minimum standards and provide standard operating procedures. The orders are binding on operating rights owners and operators of Federal and Indian (except the Osage Nation) oil and gas leases and on all wells and facilities on State or private lands committed to Federal agreements. BLM is responsible for ensuring that oil or gas produced and sold from Federal or Indian leases is accurately measured for quantity and quality. The volume and quality of oil or gas sold from leases is key to determining the proper royalty to be paid by the lessee to the Office of Natural Resources Revenue.

Existing Onshore Orders Number 3, 4, and 5 would be revised to use new industry standards so that they reflect current operating procedures and to require that proper verification and accounting practices are used consistently. New Onshore Order Number 9 would cover waste prevention and beneficial use. The revisions would ensure that proper royalties are paid on oil and gas removed from Federal and Trust lands.

Revising coal-management regulations

BLM plans to publish a proposed rule to amend the coal-management regulations that pertain to the administration of Federal coal leases and logical mining units. The rule would primarily implement provisions of the Energy Policy Act of 2005 that pertain to administering coal leases. The rule also would clarify the royalty rate applicable to continuous highwall mining, a new coal-mining method in use on some

Federal coal leases.

Publishing rules on paleontological resources preservation

The 2009 omnibus public lands law included provisions on permitting for the collection of paleontological resources. BLM and the National Park

Service are co-leads of a team with the U. S. Forest Service that will be drafting a paleontological resources rule. The rule would address the protection of paleontological resources and how BLM would permit the collection of these resources. The rule would also address other issues such as administering permits, casual collection of rocks and minerals, hobby collection of common invertebrate plants and fossils, and civil and criminal penalties for violation of these rules.

Revising the timber sale contract extension regulations

BLM regulations currently allow timber sale contract extensions under very limited circumstances and specifically do not allow extensions for

``market fluctuations.'' Nor do the regulations allow any reduction of contract value due to declines in the lumber market. BLM plans to publish a rule that would amend the forest product disposal regulations that pertain to the administration of forest product contracts. The recent decline in the housing industry has resulted in a more severe decline in the timber market than historically experienced, leaving many purchasers of BLM timber sale contracts without a reasonable market in which to sell harvested timber. The revised rule would allow

BLM to extend contracts under specified circumstances. Regulatory changes would provide BLM more options to help maintain the logging and sawmilling infrastructure needed to manage the 66 million acres of timber and woodland resources on the public lands.

The Bureau of Ocean Energy Management, Regulation and Enforcement

On April 20, 2010, an explosion and fire erupted on an offshore drilling rig in the Gulf of Mexico called the Deepwater Horizon. As a result, the Secretary recommended a series of steps to immediately improve the safety of offshore oil and gas drilling operations in

Federal waters and a suspension of certain permitting and drilling activities until the safety measures can be implemented and further analysis completed. Recommended actions include prescriptive near-term requirements, longer-term performance-based safety measures, and one or more Department-led working groups to evaluate longer-term safety issues.

The Bureau of Ocean Energy Management, Regulation and Enforcement

(BOEM) replaced the former Minerals Management Service (MMS) and will strengthen oversight and policing of offshore oil and gas development.

The program is national in scope and has two major program offices: 1) The Bureau of Ocean Energy Management will function as the resource manager for the conventional and renewable energy and mineral resources on the outer continental shelf (OCS). It will foster environmentally responsible and appropriate development of the OCS for both conventional and renewable energy and mineral resources in an efficient and effective manner that ensures fair market value for the rights conveyed. 2) The Bureau of Safety and Environmental Enforcement will apply independent regulation, oversight, and enforcement powers to promote and enforce safety in offshore energy exploration and production operations and ensure that potentially negative environmental impacts on marine ecosystems and coastal

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communities are appropriately considered and mitigated.

In 2009, MMS completed a major milestone by developing and codifying the regulatory framework for renewable energy projects on the OCS. We are continuing to implement the regulatory provisions for developing the Nation's offshore wind, wave, and ocean current resources in a safe and environmentally sound manner.

Our regulatory focus for fiscal year 2011 is directed by Presidential and legislative priorities that emphasize contributing to America's energy supply, protecting the environment, and ensuring a fair return for taxpayers for energy production from Federal and Indian lands.

Our regulatory priorities are to:

Establish New Requirements for Safety Measures for Oil and Gas

Operations.

This interim final rule published on October 15, 2010 (74 FR 63610).

It implements certain safety measures outlined in a Safety

Measures Report to the President dated May 27, 2010, which was prepared in response to the Deepwater Horizon event.

The recommendations implemented in this interim rule revise regulations related to subsea and surface blowout preventers, well casing and cementing, secondary intervention, unplanned disconnects, recordkeeping, well completion, and well plugging.

Develop a Comprehensive Safety and Environmental Management

Program for Offshore Operations and Facilities.

Promulgate a final rule for all OCS oil and gas operations and facilities under BOEM's jurisdiction including, but not limited to, drilling, production, construction, well workover, well completion, pipelines, fixed and floating facilities, mobile offshore drilling units, and lifting activities. This rule adds requirements for recordkeeping and documentation, hazards analysis, and job safety analysis for activities identified or discussed in the

Safety and Environmental Management System program. It published on October 14, 2010 (74 FR 63346).

Develop additional rules and regulations as a result of ongoing reviews of BOEMRE's offshore regulatory regime.

Several investigations and reviews of BOEMRE are being conducted by various agencies and entities--including the Safety

Oversight Board, the Office of Inspector General, the

President's Deepwater Horizon Commission, the National

Academy of Engineering, and the joint BOEMRE/USCG investigation of Deepwater Horizon. Some of these investigations and reviews focus narrowly on the Deepwater

Horizon explosion; others are broader in focus and include many aspects of BOEMRE's current regulatory system. We expect that recommendations for regulatory changes--both substantive and procedural--will be generated by these investigations and reviews, and will need to be reviewed, analyzed, and potentially incorporated in new or modified regulations.

Determine the proper value of coal for advanced royalty purposes.

Implementing requirements in the Energy Policy Act of 2005, these regulations will provide clarification by re-designating and amending a BLM coal valuation directive. The rule will provide a needed alternative method to determine the value of coal for advanced royalty purposes.

Office of Natural Resource Revenue

The revenue responsibilities of the former MMS will now be located in the Office of Natural Resource Revenue (ONRR), which will continue to collect, account for, and disburse more than $13 billion per year in revenues from Federal offshore energy and mineral leases and from onshore mineral leases on Federal and Indian lands. The program will operate Nationwide and will be primarily responsible for timely and accurate collection, distribution, and accounting for revenues associated with mineral and energy production. The regulatory program of ONRR will seek to:

Simplify valuation regulations.

ONRR plans to simplify the regulations at 30 CFR part 206 for establishing the value for royalty purposes of oil, natural gas, coal, and geothermal produced from Federal and Indian leases. Additionally, the proposed rule would consolidate sections of the regulations common to all minerals such as definitions and instructions regarding how a payor should request a valuation determination.

Finalize debt collection regulations.

ONRR is preparing regulations governing collection of delinquent royalties, rentals, bonuses, and other amounts due under

Federal and Indian oil, gas, and other mineral leases. The regulations would include provisions for administrative offset and would clarify and codify the provisions of the

Debt Collection Act of 1982 and the Debt Collection

Improvement Act of 1996.

Continue to meet Indian trust responsibilities.

ONRR has a trust responsibility to accurately collect and disburse oil and gas royalties on Indian lands. ONRR will increase royalty certainty by addressing oil valuation for Indian lands through a rulemaking process involving key stakeholders.

U.S. Fish and Wildlife Service

The mission of the U.S. Fish and Wildlife Service (FWS) is to work with others to conserve, protect, and enhance fish, wildlife, and plants and their habitats for the continuing benefit of the American people. FWS also helps ensure a healthy environment for people by providing opportunities for Americans to enjoy the outdoors and our shared natural heritage.

FWS fulfills its responsibilities through a diverse array of programs that:

Protect and recover threatened and endangered species;

Monitor and manage migratory birds;

Restore native aquatic populations and nationally significant fisheries;

Enforce Federal wildlife laws and regulate international trade;

Conserve and restore wildlife habitat such as wetlands;

Help foreign governments conserve wildlife through international conservation efforts;

Distribute Federal funds to States, territories, and tribes for fish and wildlife conservation projects; and

Manage the 96-million-acre National Wildlife Refuge System, which protects and conserves fish and wildlife and their habitats and allows the public to engage in outdoor recreational activities.

Critical challenges to the work of FWS include global climate change; shortages of clean water suitable for wildlife; invasive species that are harmful to our fish, wildlife, and plant resources and their habitats; and the alienation of children and adults from the natural world. To address these challenges, FWS has identified six priorities:

The National Wildlife Refuge System--conserving our lands and resources;

Landscape conservation--working with others;

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Migratory birds--conservation and management;

Threatened and endangered species--achieving recovery and preventing extinction;

Connecting people with nature--ensuring the future of conservation; and

Aquatic species--the National Fish Habitat Action Plan (a plan that brings public and private partners together to restore

U.S. waterways to sustainable health).

To carry out these priorities, FWS has a large regulatory agenda that will, among other things:

List, delist, and reclassify species on the Lists of

Endangered and Threatened Wildlife and Plants and designate critical habitat for certain listed species;

Update our regulations to carry out the Convention on

International Trade in Wild Fauna and Flora;

Manage migratory bird populations;

Administer the subsistence program for harvest of fish and wildlife in Alaska;

Update our regulations governing the Wildlife and Sport Fish

Restoration Program; and

Set forth hunting and sport fishing regulations for the

National Wildlife Refuge System.

National Park Service

In November 2006, the National Park Service completed a nearly 10-year public process to develop a management plan for the Colorado River in

Grand Canyon National Park. The Service is now implementing the plan by developing regulations that: Implement permit requirements for commercial river trips below a specified location in the canyon; update visitor use restrictions and camping closures; and eliminate unnecessary provisions in the current regulation. The proposed rule was published in the Federal Register on July13, 2009, and the public comment period ended on September 11, 2009. The Service hopes to complete and publish a final rule by the end of 2010.

The National Park Service is working with the Bureau of Land Management and the Fish and Wildlife Service to finalize rules implementing Public

Law 106-206, which directs the Secretary to establish a reasonable fee system (location fees) for commercial filming and still photography activities on public lands. Although commercial filming and still photography are generally allowed on Federal lands, it is in the public's interest to manage these activities through a permitting process. This will minimize the possibility of damage to the cultural or natural resources or interference with other visitors to the area.

This regulation would standardize the collection of location fees by

DOI agencies.

Bureau of Reclamation

The Bureau of Reclamation's mission is to manage, develop, and protect water and related resources in an environmentally and economically sound manner in the interest of the American public. To accomplish this mission, we employ management, engineering, and science to achieve effective and environmentally sensitive solutions.

Reclamation projects provide: Irrigation water service, municipal and industrial water supply, hydroelectric power generation, water quality improvement, groundwater management, fish and wildlife enhancement, outdoor recreation, flood control, navigation, river regulation and control, system optimization, and related uses. We have continued to focus on increased security at our facilities.

Our regulatory program focus in fiscal year 2011 is to ensure that our mission and laws that require regulatory actions are carried out expeditiously, efficiently, and with an emphasis on cooperative problem solving by implementing two newly authorized programs:

Title I of Public Law 109-451 authorizes establishment of a rural water supply program to enable the Bureau of

Reclamation to coordinate with rural communities throughout the Western United States to identify their potable water supply needs and evaluate options for meeting those needs.

Under the Act, we are finalizing a rule that will define how we will identify and work with eligible rural communities. We published an interim final rule on November 17, 2008, and expect to publish a final rule in 2011.

Title II of Public Law 109-451 authorizes the Secretary of the

Interior, through the Bureau of Reclamation, to issue loan guarantees to assist in financing: (a) rural water supply projects, (b) extraordinary maintenance and rehabilitation of Reclamation project facilities, and (c) improvements to infrastructure directly related to Reclamation projects.

This new program will provide an additional funding option to help western communities and water managers to cost effectively meet their water supply and maintenance needs.

Under the Act, we are working with the Office of Management and Budget to publish a rule that will establish criteria for administering the loan guarantee program. We published a proposed rule on October 6, 2008, and expect to publish a final rule in 2011.

BILLING CODE 4310-RK-S

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Statement of Regulatory Priorities

The Department of Justice's highest priority is to protect America against acts of terrorism, both foreign and domestic, within the letter and spirit of the Constitution. While vigorously pursuing the fight against terrori

DOJ--Legal Activities (LA)

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disabilities who experience barriers to their ability to travel or to leave their homes, the Internet may be their only way to access certain goods and services. Beyond goods and services, information available on the Internet has become a gateway to education, socializing, and entertainment.

The Internet is also dramatically changing the way that governmental entities serve the public. Public entities are increasingly providing their constituents access to government services and programs through their websites. Through government websites, the public can obtain information or correspond with local officials without having to wait in line or be placed on hold. They can also pay fines, apply for benefits, renew State-issued identification, register to vote, file taxes, request copies of vital records, and complete numerous other everyday tasks. The availability of these services and information online not only makes life easier for the public, but also enables governmental entities to operate more efficiently and at a lower cost.

The ADA's promise to provide an equal opportunity for individuals with disabilities to participate in and benefit from all aspects of American civic and economic life will be achieved in today's technologically advanced society only if it is clear to State and local governments, businesses, educators, and other public accommodations that their websites must be accessible. Consequently, the Department is considering amending its regulations implementing title II and title

III of the ADA to require public entities and public accommodations that provide products or services to the public through Internet websites make their sites accessible to and usable by individuals with disabilities.

Equipment and Furniture. Both title II and title III of the ADA require covered entities to make reasonable modifications in their programs or services to facilitate participation by persons with disabilities. In addition, covered entities are required to ensure that people are not excluded from participation because facilities are inaccessible or because the entity has failed to provide auxiliary aids. The use of accessible equipment and furniture is often critical to an entity's ability to provide a person with a disability equal access to its services. Changes in technology have resulted in the development and improved availability of accessible equipment and furniture that benefit individuals with disabilities. Consequently, it is easier now to specify appropriate accessibility standards for such equipment and furniture, as the 2010 ADA Standards will do for several types of fixed equipment and furniture, including ATMs, washing machines, dryers, tables, benches, and vending machines. To the extent that ADA standards apply requirements for fixed equipment and furniture, the Department will look to those standards for guidance on accessibility standards for equipment and furniture that are not fixed. The ANPRM seeks information about other categories of equipment--particularly medical equipment and exercise equipment. The public is invited to suggest other types of equipment that should be addressed.

Prison Rape Elimination

Pursuant to the Prison Rape Elimination Act of 2003 (PREA or the

``Act''), the Department is drafting regulations to adopt national standards for the detection, reduction, and punishment of prison rape.

PREA established the National Prison Rape Elimination Commission for the purpose of studying prison rape. The Commission issued a report that provided recommended national standards for reducing prison rape, which in turn, are to be reviewed by the Justice Department.

Specifically, PREA mandates that national standards issued pursuant to

PREA ``shall be based upon the independent judgment of the Attorney

General, after giving due consideration to the recommended national standards provided by the Commission... and being informed by such data, opinions, and proposals that the Attorney General determines to be appropriate to consider.'' The Act further provides that the

Department ``shall not establish a national standard... that would impose substantial additional costs compared to the costs presently expended by Federal, State, and local prison authorities.''

The Department is reviewing the Commission's recommendations and is drafting proposed regulations. In addition, the Department is reviewing a study by an independent contractor commissioned by the Department's

Office of Justice Programs to analyze the costs of the Commission's proposed recommendations. The Department is also reviewing extensive public comments on the Commission's proposed recommendations pursuant to an ANPRM that the Department issued while awaiting the completion of the cost analysis.

Federal Habeas Corpus Review Procedures in Capital Cases

Pursuant to the USA PATRIOT Improvement and Reauthorization Act of 2005, on December 11, 2008, the Department promulgated a final rule to implement certification procedures for States seeking to qualify for the expedited Federal habeas corpus review procedures in capital cases under chapter 154 of title 28 of the United States Code. On February 5, 2009, the Department published in the Federal Register a notice soliciting further public comment on all aspects of the December 2008 final rule. As the Department reviewed the comments submitted in response to the February 2009 notice, it considered further the statutory requirements governing the regulatory implementation of the chapter 154 certification procedures. The Attorney General has determined that chapter 154 reasonably could be construed to allow the

Attorney General greater discretion in making certification determinations than the December 2008 regulations allowed. Accordingly, a new rulemaking, and the removal of the entire December 2008 final rule, is warranted in order to articulate the standards the Attorney

General will apply in making chapter 154 certification decisions and to obtain public input concerning the formulation of such standards. As the first step of this process, the Department published a notice in the Federal Register on May 25, 2010, proposing to remove the December 2008 regulations pending the completion of a new rulemaking process.

The May 2010 rule will be finalized by a final rule to be published in the fall of 2010. The next step in the process will be the publication of a new proposed rule proposing new chapter 154 certification standards and seeking public input concerning the formulation of such standards.

Criminal Law Enforcement

For the most part, the Department's criminal law enforcement components do not rely on the rulemaking process to carry out their assigned missions. The Federal Bureau of Investigation (FBI), for example, is responsible for protecting and defending the United States against terrorist and foreign intelligence threats, upholding and enforcing the criminal laws of the United States, and providing leadership and criminal justice services to Federal, State, municipal, and international agencies and partners. Only in very limited contexts does the FBI rely on rulemaking. For example, the FBI is currently updating its National Instant

Page 79585

Criminal Background Check System regulations to allow criminal justice agencies to conduct background checks prior to the return of firearms.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) issues regulations to enforce the Federal laws relating to the manufacture and commerce of firearms and explosives. ATF's mission and regulations are designed to:

Curb illegal traffic in, and criminal use of, firearms, and to assist State, local, and other Federal law enforcement agencies in reducing crime and violence;

Facilitate investigations of violations of Federal explosives laws and arson-for-profit schemes;

Regulate the firearms and explosives industries, including systems for licenses and permits;

Assure the collection of all National Firearms Act (NFA) firearms taxes and obtain a high level of voluntary compliance with all laws governing the firearms industry; and

Assist the States in their efforts to eliminate interstate trafficking in, and the sale and distribution of, cigarettes and alcohol in avoidance of Federal and State taxes.

ATF will continue, as a priority during fiscal year 2011, to seek modifications to its regulations governing commerce in firearms and explosives. ATF plans to issue final regulations implementing the provisions of the Safe Explosives Act, title XI, subtitle C, of Public

Law 107-296, the Homeland Security Act of 2002 (enacted Nov. 25, 2002).

Electronic Prescriptions for Controlled Substances. Combating the proliferation of methamphetamine and preventing the diversion of prescription drugs for illicit purposes are among the Attorney

General's top drug enforcement priorities. The Drug Enforcement

Administration (DEA) is responsible for enforcing the Controlled

Substances Act and its implementing regulations to prevent the diversion of controlled substances, while ensuring adequate supplies for legitimate medical, scientific, and industrial purposes. DEA accomplishes its objectives through coordination with State, local, and other Federal officials in drug enforcement activities, development and maintenance of drug intelligence systems, regulation of legitimate controlled substances, and enforcement coordination and intelligence- gathering activities with foreign government agencies. DEA continues to develop and enhance regulatory controls relating to the diversion control requirements for controlled substances.

One of DEA's key regulatory initiatives is its Interim Final Rule with

Request for Comment ``Electronic Prescriptions for Controlled

Substances'' [RIN 1117-AA61]. This regulation provides practitioners with the option of writing prescriptions for controlled substances electronically and permits pharmacies to receive, dispense, and archive electronic prescriptions for controlled substances. This regulation provides pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances.

Bureau of Prisons Initiatives. The Federal Bureau of Prisons issues regulations to enforce the Federal laws relating to its mission: To protect society by confining offenders in the controlled environments of prisons and community-based facilities that are safe, humane, cost- efficient, and appropriately secure, and that provide work and other self-improvement opportunities to assist offenders in becoming law- abiding citizens. During the next 12 months, in addition to other regulatory objectives aimed at accomplishing its mission, the Bureau will continue its ongoing efforts to: Streamline regulations, eliminating unnecessary language and improving readability; improve disciplinary procedures through a revision of the subpart relating to the disciplinary process; reduce the introduction of contraband through various means, such as clarifying drug and alcohol surveillance testing programs; protect the public from continuing criminal activity committed within prison; and enhance the Bureau's ability to more closely monitor the communications of high-risk inmates.

Immigration Matters

On March 1, 2003, pursuant to the Homeland Security Act of 2002 (HSA), the responsibility for immigration enforcement and for providing immigration-related services and benefits such as naturalization and work authorization was transferred from the Justice Department's

Immigration and Naturalization Service (INS) to the Department of

Homeland Security (DHS). However, the immigration judges and the Board of Immigration Appeals in the Executive Office for Immigration Review

(EOIR)) remain part of the Department of Justice. The immigration judges adjudicate approximately 300,000 cases each year to determine whether the aliens should be ordered removed or should be granted some form of relief from removal, and the Board has jurisdiction over appeals from those decisions, as well as other matters. Accordingly, the Attorney General has a continuing role in the conduct of removal hearings, the granting of relief from removal, and the detention or release of aliens pending completion of removal proceedings. The

Attorney General also is responsible for civil litigation and criminal prosecutions relating to the immigration laws.

In several pending rulemaking actions, the Department is working to revise and update the regulations relating to removal proceedings in order to improve the efficiency and effectiveness of the hearings in resolving issues relating to removal of aliens and the granting of relief from removal.

On June 3, 2009, the Attorney General announced his intention to initiate a new rulemaking proceeding for regulations to govern claims of ineffective assistance of counsel in immigration proceedings. The

Department is currently drafting regulations to further this goal. The

Department is also drafting regulations pursuant to the William

Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 to take into account the specialized needs of unaccompanied alien children in removal proceedings.

PROPOSED RULE STAGE

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Statement of Regulatory Priorities

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 5 USC 301; 28 USC 509; 28 USC 510; 42 USC 15601

CFR Citation: 28 CFR 115

Legal Deadline:

Final, Statutory, June 23, 2010.

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Abstract:

The Department of Justice has under review national standards for enhancing the prevention, detection, and response to sexual abuse in confinement settings that were prepared by the National Commission on

Prison Rape Elimination pursuant to the Prison Rape Elimination Act of 2003 (PREA) and recommended by the Commission to the Attorney General.

Through an Advance Notice of Proposed Rulemaking (ANPRM), the

Department received public input on the Commission's proposed national standards and information useful to the Department in publishing a final rule adopting national standards for the detection, prevention, reduction and punishment of prison rape, as mandated by PREA.

Statement of Need:

Rape is violent, destructive, and a crime--no less so when the victim is incarcerated. Tolerance of sexual abuse of prisoners in the government's custody is incompatible with American values. Congress affirmed the duty to protect incarcerated individuals from sexual abuse by enacting the Prison Rape Elimination Act of 2003 (PREA), 42 U.S.C. section 15601 et seq.

Summary of Legal Basis:

PREA requires the Attorney General to promulgate regulations that adopt national standards for the detection, prevention, and punishment of prison rape. PREA established the Commission to carry out a comprehensive legal and factual study of a penological, physical, mental, medical, social, and economic impacts of prison rape in the

United States, and to recommend to the Attorney General national standard for the detection, prevention, reduction and punishment of prison rape. The Commission released its recommended national standards in a report dated June 23, 2009. Pursuant to PREA the final rule adopting national standards ``shall be based upon the independent judgment of the Attorney General, after giving due consideration to the recommended national standards provided by the Commission. . .and being informed by such data, opinions, and proposals that the Attorney

General determines to be appropriate to consider.'' 42 U.S.C. section 24607(a)(2). PREA expressly mandates that the Department shall not establish a national standard ``that would impose substantial additional costs compared to the costs presently expended by the

Federal, State, and local prison authorities.'' 42 U.S.C. section 24607(a)(3).

Alternatives:

Given the specific direction of Congress, the Department is obligated to issue a rule that promulgates regulations establishing national standards to combat prison rape. As discussed in the rule and in the

Regulatory Impact Analysis (RIA) the Department has received input from numerous stakeholders concerning the development of these regulations and, as part of the development process, considered a wide range of proposals in developing the content of such standards.

Anticipated Cost and Benefits:

In directing the Attorney General to promulgate national standards for enhancing the prevention, detection, reduction, and punishment of prison rape. Congress understood that such standards were likely to require federal, state, and local agencies (as well as private entities) that operate inmate confinement facilities to incur costs in implementing and complying with those standards. Given the statue's aspiration to ``eliminate'' prison rape in the United states, Congress recognized that costs would need to be expended. Indeed, the statute's findings (42 U.S.C. section 15601) suggest an assessment by Congress that the benefits to society of eliminating prison rape are likely to outweigh any anticipated costs of achieving that goal.

The Department's full discussion of the anticipated costs and benefits of this rule is included in the rule's Initial Regulatory Impact

Assessment.

Risks:

These regulations are intended to carry out the intent of Congress to eliminate prison rape. The risks from the failure to promulgate these regulations are primarily that inmates in Federal, State, and local facilities would be at higher risk of sexual assault than they would be if these regulations are promulgated.

Timetable:

Action

Date

FR Cite

ANPRM

03/10/10

75 FR 11077

ANPRM Comment Period End

05/10/10

NPRM

12/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Agency Contact:

Robert Hinchman

Senior Counsel, Office of Legal Policy

Department of Justice

Room 4252 950 Pennsylvania Avenue NW

Washington, DC 20530

Phone: 202 514-8059

Fax: 202 353-2371

Email: robert.hinchman@usdoj.gov

RIN: 1105-AB34

BILLING CODE 4410-BP-S

Page 79587

December 20, 2010 (Volume 75, Number 243)

Unified Agenda

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:ua20de10_002-139

Page 79587-79592

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Office of Federal Contract Compliance Programs (OFCCP)

Page 79588

Occupational Safety and Health Administration (OSHA)

OSHA's regulatory program is designed to help workers and employers identify hazards in the workplace, prevent the occurrence of injuries and adverse health effects, and communicate with the regulated community regarding hazards and how to effectively control them. Long- recognized health hazards such as silica, beryllium, and emerging hazards such as food flavorings containing diacetyl place American workers at risk of serious disease and death and are initiatives on

OSHA's regulatory agenda. In addition to targeting specific hazards,

OSHA is focusing on systematic processes that will modernize the culture of safety in America's workplaces.

Plan/Prevent/Protect

Infectious Diseases

OSHA is considering the need for regulatory action to address the risk to workers exposed to infectious diseases in healthcare and other related high-risk environments. The Agency is considering an approach that would combine elements of the Department's Plan/Prevent/Protect strategy with established infection control practices. The Agency received strong stakeholder participation in response to its May 2010 request for information on infectious diseases and is currently reviewing the docket.

In 2007, the healthcare and social assistance sector as a whole had 16.5 million employees. Healthcare workplaces can range from small, private practices of physicians to hospitals that employ thousands of workers. In addition, healthcare is increasingly being provided in other settings such as nursing homes, free-standing surgical and outpatient centers, emergency care clinics, patients' homes, and pre- hospitalization emergency care settings. OSHA is interested in all routes of infectious disease transmission in healthcare settings not already covered by its bloodborne pathogens standard (e.g., contact, droplet, and airborne). The Agency is particularly concerned by studies that indicate that transmission of infectious diseases to both patients and healthcare workers may be occurring as a result of incomplete adherence to recognized, but voluntary, infection control measures.

Another concern is the movement of healthcare delivery from the traditional hospital setting, with its greater infrastructure and resources to effectively implement infection control measures, into more diverse and smaller workplace setting with less infrastructure and fewer resources, but with an expanding worker population.

Injury and illness Prevention Program (12P2)

OSHA's I2P2 program is the prototype for the Department's Plan/Prevent/

Protect strategy. OSHA's first step in this important rulemaking was to hold stakeholder meetings. Stakeholder meetings were held in East

Brunswick, NJ; Dallas, Texas; Washington, DC; and Sacramento,

California, beginning in June 2010 and ending in August 2010. More than 200 stakeholders participated in these meetings, and in addition, nearly 300 stakeholders attended as observers. The proposed rule will explore requiring employers to provide their employees with opportunities to participate in the development and implementation of an injury and illness prevention program, including a systematic process to proactively and continuously address workplace safety and health hazards. This rule will involve planning, implementing, evaluating, and improving processes and activities that promote worker safety and health, and address the needs of special categories of workers (such as youth, aging, and immigrant workers). OSHA's efforts to protect workers under the age of 18 will be undertaken in cooperation with the Department's Wage and Hour Division, which has responsibility for enforcing the child labor provisions of the Fair

Labor Standards Act. OSHA has substantial evidence showing that employers that have implemented similar injury and illness prevention programs have significantly reduced injuries and illnesses in their workplaces. The new rule would build on OSHA's existing Safety and

Health Program Management Guidelines and lessons learned from successful approaches and best practices that have been applied by companies participating in OSHA's Voluntary Protection Program and

Safety and Health Achievement Recognition Program, and similar industry and international initiatives.

Addressing Targeted Hazards

Silica

In order to target one of the most serious hazards workers face, OSHA is proposing to address worker exposures to crystalline silica through the promulgation and enforcement of a comprehensive health standard.

Exposure to silica causes silicosis, a debilitating respiratory disease, and may cause cancer, other chronic respiratory diseases, and renal and autoimmune disease as well. Over 2 million workers are exposed to crystalline silica in general industry, construction, and maritime industries and workers are often exposed to levels that exceed current OSHA permissible limits, especially in the construction industry where workers are exposed at levels that exceed current limits by several fold. It has been estimated that between 3,500 and 7,000 new cases of silicosis arise each year in the U.S., and that 1,746 workers died of silicosis between 1996 and 2005. Reducing these hazardous exposures through promulgation and enforcement of a comprehensive health standard will contribute to OSHA's goal of reducing occupational fatalities and illnesses. As a part of the Secretary's strategy for securing safe and healthy workplaces, MSHA will also utilize information provided by OSHA to undertake regulatory action related to silica exposure in mines.

Backing Operations

In order to target one of most serious hazards that construction workers face, OSHA is proposing to address worker exposures to the dangers inherent in backing operations through the promulgation and enforcement of a revised construction standard. NIOSH reports that half of the fatalities involving construction equipment occur while the equipment is backing. Backing accidents cause 500 deaths and 15,000 injuries per year. Emerging technologies in the field of backing operations include after market devices, such as camera, radar, and sonar, to help monitor the presence of workers on foot in blind areas, and new monitoring technology, such as tag-based warning systems that use radio frequency (RFID) and magnetic field generators on equipment to detect electronic tags worn by workers. OSHA is developing this proposal in consultation with MSHA, which will issue an Emergency

Temporary Standard concerning Proximity Detection.

Openness and Transparency

Hazard Communication

Hearings on OSHA's proposal to modify its Hazard Communication standard have helped the agency to promote transparency in the communication of chemical hazard information. These hearings gathered information to assist OSHA in creating consistency between its current Hazard

Communication standard (HCS) and the United Nations' Globally

Harmonized System of Classification and Labeling of Chemicals (GHS).

This rulemaking

Page 79589

involves changing the criteria for classifying health and physical hazards to require information regarding the severity of the hazard, a standardized order of information for safety data sheets, and adopting standardized labeling requirements that would be understandable for low-literacy workers or those who do not speak English. The HCS covers over 945,000 hazardous chemical products in 7 million American workplaces and gives workers the ``right to know'' about chemical hazards to which they are exposed. OSHA and other Federal agencies have participated in long-term international negotiations to develop the

GHS. Revising the HCS to be consistent with the GHS is expected to significantly improve the communication of hazards to workers in

American workplaces, reducing exposures to hazardous chemicals, and reducing occupational illnesses and fatalities.

Modernizing Recordkeeping

In the first half of this year, OSHA held informal meetings to gather information from experts and stakeholders regarding the modification of its current injury and illness data collection system that will help the agency, employers, employees, researchers, and the public prevent workplace injuries and illnesses, as well as support President Obama's

Open Government Initiative. Under the proposed rule, OSFIA will explore increasing its legal authority to require employers to electronically submit to the Agency any data required by part 1904 (Recording and

Reporting Occupational Injuries). In addition it will set ongoing electronic submission requirements of data for a defined set of establishments. This two-part rule will give OSHA the flexibility to define the scope and frequency of data collection without having to undertake additional rulemakings. With OMB approval, OSHA will be able to conduct data collections ranging from the annual collection of data from a handful of employers to the real-time collection of all part 1904 data from all covered employers. In addition, OSHA will be able to request additional data elements that employers are not required to maintain, such as data on race and ethnicity, as a non-mandatory component of a given data collection. OSHA learned from stakeholders that most large employers already maintain their part 1904 data electronically; as a result, electronic submission will constitute a minimal burden on these employers, while providing a wealth of data to help OSHA, employers, employees, researchers, and the public prevent workplace injuries and illnesses.

Mine Safety and Health Administration (MSHA)

The Mine Safety and Health Administration is the worker protection agency focused on the prevention of death, disease, and injury from mining and the promotion of safe and healthful workplaces for the

Nation's miners. The Department believes that every worker has a right to a safe and healthy workplace. Workers should never have to sacrifice their lives for their livelihood, and all workers deserve to come home to their families at the end of their shift safe and whole. MSHA's approach to reducing workplace fatalities and injuries includes promulgating and enforcing mandatory health and safety standards.

Plan/Prevent/Protect

Safety and Health Management Programs for Mines

Year after year, many mines experience low injury and illness rates and low violation rates. For these mine operators, preventing harm to their miners is more than compliance with safety and health requirements; it reflects the embodiment of a culture of safety--from the CEO to the miner. This culture of safety derives from a commitment to an effective, comprehensive safety and health management program. Since compliance with safety and health standards is the responsibility of mine operators, MSHA plans to publish a proposed rule to require mine operators to develop comprehensive Safety and Health Management

Programs for Mines. MSHA believes that operators with effective safety and health management programs would identify and correct hazards in a more timely manner, resulting in fewer accidents, injuries and illnesses. To help develop the proposal, MSHA held public meetings and gathered information from worker organizations, industry, academia, government, and safety and health professionals about model safety and health programs.

Examinations of Work Areas in Underground Coal Mines for Violations of

Mandatory Health or Safety Standards

To complement the safety and health management programs proposed rule,

MSHA also plans to issue a proposed rule to address section 303(d) of the Federal Mine Safety and Health Act that requires mine operators to conduct examinations, in areas where miners work or travel, for violations of mandatory health or safety standards. The proposal would assure that underground coal mine operators find and fix violations of mandatory health or safety standards, thereby improving health and safety for miners.

Pattern of Violations

MSHA has determined that the existing pattern criteria and procedures contained in 30 CFR part 104 do not reflect the statutory intent for section 104(e) of the Federal Mine Safety and Health Act of 1977 (Mine

Act). The legislative history of the Mine Act explains that Congress intended the pattern of violations to be an enforcement tool for operators who have demonstrated a disregard for the health and safety of miners. These mine operators, who have a chronic history of persistent significant and substantial (S&S) violations, needlessly expose miners to the same hazards again and again. This indicates a serious safety and health management problem at a mine. The goal of the pattern of violations proposed rule is to compel operators to manage health and safety conditions so that the root causes of S&S violations are found and fixed before they become a hazard to miners. The proposal would reflect statutory intent, simplify the pattern of violations criteria, and improve consistency in applying the pattern of violations criteria.

Addressing Targeted Hazards

Maintenance of Incombustible Content of Rock Dust in Underground Coal

Mines

To help prevent explosion hazards, MSHA issued an emergency temporary standard (ETS) in response to the grave danger that miners in underground bituminous coal mines face when accumulations of coal dust are not made inert. MSHA concluded from investigations of mine explosions and other reports that immediate action was necessary to protect miners. Accumulations of coal dust can ignite, resulting in an explosion, or after an explosion, accumulations can propagate, increasing the severity of explosions. The ETS requires mine operators to increase the incombustible content of combined coal dust, rock dust, and other dust to at least 80 percent in underground bituminous coal mines. The ETS strengthens the protections for miners by reducing both the potential for and the severity of coal mine explosions.

Regulating Crystalline Silica Exposure

Page 79590

The Agency's regulatory actions also exemplify a commitment to protecting the most vulnerable populations while assuring broad-based compliance. Health hazards are pervasive in both coal and metal/ nonmetal mines (including surface and underground mines) and large and small mines. As mentioned previously, as part of the Secretary's strategy for securing safe and healthy workplaces, both MSHA and OSHA will be undertaking regulatory actions related to silica. Overexposure to crystalline silica can result in some miners developing silicosis, an irreversible but preventable lung disease, which ultimately may be fatal. In its proposed rule, MSHA plans to follow the recommendation of the Secretary of Labor's Advisory Committee on the Elimination of

Pneumoconiosis Among Coal Mine Workers, National Institute for

Occupational Safety and Health (NIOSH), and other groups to address the exposure limit for respirable crystalline silica. As another example of intra-departmental collaboration, MSHA intends to consider OSHA's work on the health effects of occupational exposure to silica and OSHA's risk assessment in developing the appropriate standard for the mining industry.

Lowering Miners' Exposure to Coal Mine Dust, including Continuous

Personal Dust Monitors

MSHA will continue its regulatory action related to preventing Black

Lung disease. Data from the NIOSH indicate increased prevalence of coal workers pneumoconiosis (CWP) ``clusters'' in several geographical areas, particularly in the Southern Appalachian Region. MSHA published a notice of proposed rulemaking to address continued risk to coal miners from exposure to respirable coal mine dust. This regulatory action is part of MSHA's Comprehensive Black Lung Reduction Strategy for reducing miners' exposure to respirable dust. This strategy includes enhanced enforcement, education and training, and health outreach and collaboration. The major provisions of the proposal would lower the existing exposure limit from 2.0 mg/m3 to 1.0 mg/m3 over a 2- year phase-in period, provide for single full-shift compliance sampling under both mine operator and MSHA inspector sampling programs, and establish sampling requirements for use of the continuous personal dust monitors.

Proximity Detection Systems

MSHA will issue an emergency temporary standard (ETS) to address the grave danger that miners face when working near mobile equipment in underground mines. MSHA has concluded, from investigations of accidents involving mobile equipment and other reports, that immediate action is necessary to protect miners. To date, in 2010, there have been 5 fatalities resulting from crushing and pinning accidents. Mobile equipment can pin, crush, or strike a miner working near the equipment.

Proximity detection technology can prevent these types of accidents.

Proximity detection systems can be installed on mining machinery to detect the presence of personnel or equipment within a certain distance of the machine. The ETS would strengthen the protection for underground miners by reducing the potential of pinning, crushing or striking hazards associated with working close to mobile equipment. As a part of the Secretary's strategy for securing safe and healthy workplaces, OSHA will also undertake regulatory action related to reducing injuries and fatalities to workers in close proximity to moving equipment and vehicles.

Wage and Hour Division (WHD)

The Wage and Hour Division is responsible for administering and enforcing a number of laws that establish the minimum standards for wages and working conditions in the United States. Collectively, these labor standards cover most private, state, and local government employment.

Plan/Prevent/Protect

Right To Know Under the Fair Labor Standards Act

WHD intends to publish a proposed rule updating the recordkeeping regulation issued under the Fair Labor Standards Act (FLSA) to assist employers in planning to protect workers' entitlement to wages that they have earned and bring greater transparency and openness to the workplace. The proposed rule would address notification of workers' status as employees or some other status such as independent contractors, and whether that worker is entitled to the protections of the FLSA. The proposed rulemaking would also explore requiring employers to provide a wage statement each pay period to their employees. This greater transparency will provide workers with essential information about their employment status and earnings, consistent with the Secretary's strategic vision. This greater transparency will in turn better ensure compliance by regulated entities and assist the Department with its enforcement efforts. This initiative contributes to the Department's efforts to prevent misclassification that denies workers employment law protections to which they are entitled.

As part of this Departmentwide initiative, OSHA's Injury and Illness

Prevention Program NPRM and OFCCP's NPRM on Construction Contractor

Affirmative Action Requirements, propose to also address employer analyses and worker notification as to whether an individual is an employee or is an independent business, volunteer, or trainee.

Office of Federal Contract Compliance Programs (OFCCP)

Through the work of the Office of Federal Contract Compliance Programs,

DOL ensures that the contractors and sub-contractors doing business at over 200,000 establishments provide equal employment opportunities--a fair and diverse workplace. OFCCP ensures workers are recruited, hired, trained, promoted, terminated, and compensated in a non-discriminatory manner by Federal contractors and helps workers in the Federal contractor sector by strengthening affirmative action and by combating discrimination on the basis of race, color, religion, sex, national origin, disability, or status as a protected veteran.

Construction Contractor Affirmative Action Requirements

OFCCP will publish a proposed rule that would enhance the effectiveness of the affirmative action program requirements for Federal and federally assisted construction contractors and subcontractors. The proposed rule would strengthen the regulations that set forth the actions construction contractors are required to take to implement their affirmative action programs particularly in the areas of recruitment, training, and apprenticeships. OFCCP is coordinating with the Employment and Training Administration (ETA), which is developing a proposed regulation revising the equal opportunity regulatory framework under the National Apprenticeship Act.

Employee Benefits Security Administration (EBSA)

The Employee Benefits Security Administration (EBSA) is responsible for administering and enforcing the fiduciary, reporting and disclosure, and health coverage provisions of title I of the Employee Retirement

Income Security Act of 1974 (ERISA). This includes recent amendments and additions to ERISA enacted in the

Page 79591

Pension Protection Act of 2006, as well as new health coverage provisions under the Patient Protection and Affordable Care Act of 2010

(the Affordable Care Act). EBSA's regulatory plan initiatives are intended to improve health benefits and retirement security for workers in every type of job at every income level. EBSA is charged with protecting approximately 150 million Americans covered by an estimated 708,000 private retirement plans, 2.6 million health plans, and similar numbers of other welfare benefit plans which together hold $5.2 trillion in assets.

EBSA will continue to issue guidance implementing the health reform provisions of the Affordable Care Act and other laws, such as the

Mental Health Parity and Addiction Equity Act, to help provide better quality health care for American workers and their families. EBSA's regulations reduce discrimination in health coverage, promote better access to quality coverage, and protect the ability of individuals and businesses to keep their current health coverage. Many regulations are joint rulemakings with the Departments of Health and Human Services and the Treasury.

Using regulatory changes to produce greater openness and transparency is an integral part of EBSA's contribution to a Departmentwide compliance strategy. These efforts will not only enhance EBSA's enforcement toolbox but will encourage greater levels of compliance by the regulated community and enhance awareness among workers of their rights and benefits. Several proposals from the EBSA agenda expand disclosure requirements, substantially enhancing the availability of information to employee benefit plan participants and beneficiaries and employers, and strengthening the retirement security of America's workers.

Health Reform Implementation

These regulations require better disclosure to participants and beneficiaries regarding their health plan coverage. These disclosures must now provide new and better descriptions regarding:

Certain enrollment opportunities and access to health coverage; rights to internal claims and appeals, and external review of health plan denials; access to providers; and a group health plan's status as a grandfathered health plan, which affects consumer protections under the

Patient Protection and Affordable Care Act.

Enhancing participant protections

EBSA recently proposed amendments to its regulations to clarify the circumstances under which a person will be considered a ``fiduciary'' when providing investment advice to employee benefit plans and their participants and beneficiaries of such plans. The amendments would take into account current practices of investment advisers and the expectations of plan officials and participants who receive investment advice. This initiative is intended to assure retirement security for workers in all jobs regardless of income level by ensuring that financial advisers and similar persons are required to meet ERISA's strict standards of fiduciary responsibility.

Lifetime Income Options

In February 2010, EBSA published a request for information concerning steps it can take by regulation, or otherwise, to encourage the offering of lifetime annuities or similar lifetime benefits distribution options for participants and beneficiaries of defined contribution plans. EBSA recently held a hearing with the Department of the Treasury and Internal Revenue Service to further explore these possibilities during the fall 2010 regulatory cycle. This initiative is intended to assure retirement security for workers in all jobs regardless of income level by helping to ensure that participants and beneficiaries have the benefit of their plan savings throughout retirement.

Promoting Openness and Transparency

In addition to its health care reform and participant protection initiatives, EBSA is pursuing a regulatory program that, as reflected in the Unified Agenda, is designed to encourage, foster, and promote openness, transparency, and communication with respect to the management and operations of pension plans, as well as participant rights and benefits under such plans. Among other things, EBSA will be issuing a final rule that will ensure that the participants and beneficiaries in participant-directed individual account plans are provided the information they need, including information about plan and investment-related fees and expenses, to make informed decisions about the management of their individual accounts and the investment of their retirement savings (RIN 1210-AB07); EBSA also will be issuing a proposed rule addressing the requirement that administrators of defined benefit pension plans annually disclose the funding status of their plan to the plan's participants and beneficiaries (RIN l210-AB18).

EBSA's Unified Agenda also includes the publication of a proposed rule requiring the automatic furnishing of a statement to pension plan participants informing them of their accrued and vested pension benefits, as well as other information pertinent to their retirement security (RIN 1210-AB20). In addition, EBSA will be amending the disclosure requirements applicable to plan investment options, including Qualified Default Investment Alternatives, to better ensure that participants understand the operations and risks associated with investments in target date funds (RIN 1210-AB38). A complete listing of

EBSA's regulatory initiatives (both Plan and non-Plan items) is provided in the Unified Agenda portion of this document.

Office of Labor-Management Standards (OLMS)

The Office of Labor-Management Standards (OLMS) administers and enforces most provisions of the Labor-Management Reporting and

Disclosure Act of 1959 (LMRDA). The LMRDA promotes labor-management transparency by requiring unions, employers, labor-relations consultants, and others to file reports that are publicly available.

The LMRDA includes provisions protecting union member rights to participate in their union's governance, to run for office and fully exercise their union citizenship, as well as procedural safeguards to ensure free and fair union elections. Besides enforcing these provisions, OLMS also ensures the financial accountability of unions, their officers and employees, through enforcement and voluntary compliance efforts. Because of these activities, OLMS better ensures that workers have a more effective voice in the governance of their unions, which in turn affords them a more effective voice in their workplaces. OLMS also administers certain provisions of Executive Order 13496 that require Federal contractors to notify their employees concerning their rights under Federal labor laws.

Openness and Transparency

Persuader Agreements: Employer and Labor Consultant Reporting under the

LMRDA

OLMS is proposing a regulatory initiative to provide workers with information critical to their effective participation in the workplace, both as union members and as employees. OLMS intends to propose regulations to better implement the public disclosure objectives of the

LMRDA in situations where an employer engages a consultant

Page 79592

in order to persuade employees concerning their rights to organize and bargain collectively. Under LMRDA section 203, an employer must report any agreement or arrangement with a consultant to persuade employees concerning their rights to organize and collectively bargain, or to obtain certain information concerning the activities of employees or a labor organization in connection with a labor dispute involving the employer. The consultant is also required to report such an agreement or arrangement with an employer. Statutory exceptions to these reporting requirements are set forth in LMRDA section 203(c), which provides, in part, that employers and consultants are not required to file a report by reason of the consultant's giving or agreeing to give

``advice'' to the employer. The Department is reconsidering the current policy concerning the scope of the ``advice exception.'' When workers have the necessary information about arrangements that have been made by their employer to persuade them whether or not to form, join or assist a union, they are better able to make a more informed choice about representation.

Employment and Training Administration (ETA)

The Employment and Training Administration (ETA) administers and oversees programs that prepare workers for good jobs at good wages by providing high quality job training, employment, labor market information, and income maintenance services through its national network of One-Stop centers. The programs within ETA promote pathways to economic independence for individuals and families. Through several laws, ETA is charged with administering numerous employment and training programs designed to assist the American worker in developing the knowledge, skills, and abilities that are sought after in the 21st century's economy.

Openness and Transparency

Temporary Non Agricultural Employment of H-2B Aliens in the United

States

As part of the Department's labor certification responsibilities, ETA certifies whether U.S. workers capable of performing the jobs for which employers are seeking foreign workers are available and whether the employment of foreign workers will adversely affect the wages and working conditions of U.S. workers similarly employed. Through the Wage and Hour Division (WHD), the Department enforces compliance with the conditions of an H-2B petition and Department of Labor-approved temporary labor certification.

The proposed rule seeks to ensure that only those employers who demonstrate a real temporary need for foreign workers will have access to the H-2B program. The proposed rule also will seek to provide U.S. workers with greater access to the jobs employers wish to fill with temporary H-2B workers through more robust recruitment by employers to demonstrate the unavailability of U.S. workers and through the creation of a national, electronic job registry. In addition, the Department is reviewing the current wage determination methodology to ensure that wages are not being adversely affected across industries and occupations. The proposed rule will explore strengthening existing worker protections, establishing new protections, and enhancing ETA program integrity measures and WHD enforcement to ensure adequate protections for both U.S. and H-2B workers. The proposal will include greater transparency and openness to provide U.S. workers with greater information and access to the job opportunities.

Addressing Targeted Concerns of Workers

Equal Employment Opportunity in Apprenticeship and Training, Amendment of Regulations

The revision of the National Apprenticeship Act Equal Opportunity in

Apprenticeship and Training (EEO) regulations is a critical element in the Department's vision to promote and expand registered apprenticeship opportunities in the 21st Century while safeguarding the welfare and safety of all apprentices. In October 2008, ETA issued a final rule updating 29 CFR part 29, the regulatory framework for registration of apprenticeship programs and apprentices, and administration of the

National Apprenticeship System. The companion EEO regulations, 29 CFR part 30, have not been amended since 1978. ETA proposes to update part 30 EEO in the Apprenticeship and Training regulations to ensure that they act in concert with the 2008 revised part 29 rule. The proposed

EEO regulations also will further Secretary Solis' vision of good jobs for everyone by ensuring that apprenticeship program sponsors develop and fully implement affirmative action efforts that provide equal opportunity for all applicants to apprenticeship and apprentices, regardless of race, gender, national origin, or disability. ETA is coordinating with OFCCP, which is developing a proposed regulation that would enhance the effectiveness of the affirmative action program requirements for Federal and federally assisted construction contractors and subcontractors.

PROPOSED RULE STAGE

December 20, 2010 (Volume 75, Number 243)

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DOCID:ua20de10_002-140

Page 79592-79593

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 94. CONSTRUCTION CONTRACTOR AFFIRMATIVE ACTION REQUIREMENTS

Priority:

Other Significant

Legal Authority: sec 201, 202, 205, 211, 301, 302, and 303 of EO 11246, as amended; 30

FR 12319; 32 FR 14303, as amended by EO 12086

CFR Citation: 41 CFR 60-1; 41 CFR 60-4

Legal Deadline:

None

Abstract:

This Notice of Proposed Rulemaking (NPRM) would revise the regulations in 41 CFR part 60-4 implementing the affirmative action requirements of

Executive Order 11246 that are applicable to Federal and federally assisted construction contractors. The NPRM will strengthen and enhance the effectiveness of the affirmative action program requirements for

Federal and federally-assisted construction contractors and subcontractors, particularly in the area of recruitment and job training.

Statement of Need:

The regulations implementing construction contractor affirmative action obligations under Executive Order 11246, as amended, were last revised in 1980. Recent data show that disparities in the representation of women and racial minorities continue to exist in on-site construction occupations in the construction industry. The NPRM would remove outdated regulatory provisions, propose a new method for establishing affirmative action goals, and propose

Page 79593

other revisions to the affirmative action requirements that reflect the realities of the labor market and employment practices in the construction industry today.

Summary of Legal Basis:

This action is not required by statute or court order. Legal Authority:

Sections 201, 202, 205, 211, 301, 302, and 303 of E.O. 11246, as amended, 30 FR 12319: 32 FR 14303, as amended by E.O. 12086.

Alternatives:

Regulatory alternatives will be addressed as the NPRM is developed

Anticipated Cost and Benefits:

There may be some additional costs to contractors as a result of the increased scope of required actions. The benefits would likely include increased diversity in construction workplaces and increased opportunities for women and minorities to get on-site construction jobs. More detailed cost and benefit analyses will be made as the NPRM is developed.

Risks:

Failure to provide updated regulations may impede the equal opportunity rights of some workers in protected classes.

Timetable:

Action

Date

FR Cite

NPRM

07/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

None

Federalism:

Undetermined

Agency Contact:

Sandra M. Dillon

Deputy Director, Division of Policy, Planning and Program Development

Department of Labor

Office of Federal Contract Compliance Programs 200 Constitution Avenue NW.

N3422

Washington, DC 20210

Phone: 202 693-0102

TDD Phone: 202 693-1337

Fax: 202 693-1304

Email: ofccp-public@dol.gov

Related RIN: Previously reported as 1215-AB81

RIN: 1250-AA01

December 20, 2010 (Volume 75, Number 243)

Unified Agenda

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:ua20de10_002-141

Page 79593

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Office of Labor-Management Standards (OLMS)

PROPOSED RULE STAGE

December 20, 2010 (Volume 75, Number 243)

Unified Agenda

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DOCID:ua20de10_002-142

Page 79593-79594

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 95. PERSUADER AGREEMENTS: EMPLOYER AND LABOR RELATIONS CONSULTANT

REPORTING UNDER THE LMRDA

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 29 USC 433; 29 USC 438

CFR Citation: 29 CFR 405; 29 CFR 406

Legal Deadline:

None

Abstract:

The Department intends to publish notice and comment rulemaking seeking consideration of a revised interpretation of section 203(c) of the

Labor-Management Reporting and Disclosure Act (LMRDA). That statutory provision creates an ``advice'' exemption from reporting requirements that apply to employers and other persons in connection with persuading employees about the right to organize and bargain collectively. A proposed revised interpretation would narrow the scope of the advice exemption.

Statement of Need:

The Department of Labor is proposing a regulatory initiative to better implement the public disclosure objectives of the Labor-Management

Reporting and Disclosure Act (LMRDA) regarding employer-consultant agreements to persuade employees concerning their rights to organize and bargain collectively. Under LMRDA section 203, an employer must report any agreement or arrangement with a third party consultant to persuade employees as to their collective bargaining rights or to obtain certain information concerning the activities of employees or a labor organization in connection with a labor dispute involving the employer. The consultant also is required to report concerning such an agreement or arrangement with an employer. Statutory exceptions to these reporting requirements are set forth in LMRDA section 203(c), which provides, in part, that employers and consultants are not required to file a report by reason of the consultant's giving or agreeing to give ``advice'' to the employer. The Department believes that its current policy concerning the scope of the ``advice exception'' is overbroad and that a narrower construction would better allow for the employer and consultant reporting intended by the LMRDA.

Regulatory action is needed to provide workers with information critical to their effective participation in the workplace.

Summary of Legal Basis:

This proposed rulemaking is authorized under U.S.C. sections 433 and 438 and applies to regulations at 29 CFR part 405 and 29 CFR part 406.

Alternatives:

Alternatives will be developed and considered in the course of notice and comment rulemaking.

Anticipated Cost and Benefits:

Anticipated costs and benefits of this proposed regulatory initiative have not been assessed and will be determined at a later date, as appropriate.

Risks:

This action does not affect public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

URL For More Information: www.olms.dol.gov

URL For Public Comments: www.regulations.gov

Page 79594

Agency Contact:

Andrew R. Davis

Chief, Division of Interpretations and Standards, Office of Labor-

Management Standards

Department of Labor

Office of Labor-Management Standards

Room N-5609, FP Building 200 Constitution Avenue NW.

Washington, DC 20210

Phone: 202 693-1254

Fax: 202 693-1340

Email: davis.andrew@dol.gov

Related RIN: Previously reported as 1215-AB79

RIN: 1245-AA03

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Wage and Hour Division (WHD)

PROPOSED RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 96. RIGHT TO KNOW UNDER THE FAIR LABOR STANDARDS ACT

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority: 29 USC 211(c)

CFR Citation: 29 CFR 516

Legal Deadline:

None

Abstract:

The Department of Labor proposes to update the recordkeeping regulations under the Fair Labor Standards Act in order to enhance the transparency and disclosure to workers of their status as the employer's employee or some other status, such as an independent contractor, and if an employee, how their pay is computed. The

Department also proposes to clarify that the mandatory manual preparation of ``homeworker'' handbooks applies only to employers of employees performing homework in the restricted industries. The title of this proposed rule has changed to better reflect the purpose of this action.

Statement of Need:

The recordkeeping regulation issued under the Fair Labor Standards Act

(FLSA), 29 CFR part 516, specifies the scope and manner of records covered employers must keep that demonstrate compliance with minimum wage, overtime, and child labor requirements under the FLSA, or the records to be kept that confirm particular exemptions from some of the

Act's requirements may apply. This proposal intends to update the recordkeeping requirements to foster more openness and transparency in demonstrating employers' compliance with applicable requirements to their workers, to better ensure compliance by regulated entities, and to assist in enforcement. In addition, the proposal intends to update the requirements for live-in domestic employees and, to clarify that the mandatory manual preparation of ``homeworker'' handbooks applies only to employers of employees performing homework in the restricted industries.

Summary of Legal Basis:

These regulations are authorized by section 11 of the Fair Labor

Standards Act, 29 U.S.C. 211.

Alternatives:

Alternatives will be developed in considering proposed revisions to the current recordkeeping requirements. The public will be invited to provide comments on the proposed revisions and possible alternatives.

Anticipated Cost and Benefits:

The Department will prepare estimates of the anticipated costs and benefits associated with the proposed rule.

Risks:

This action does not affect public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

04/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Local, State, Tribal

Federalism:

Undetermined

Agency Contact:

Montaniel Navarro

Fair Labor Standards Act Branch Chief, Division of Enforcement Policy

Department of Labor

Wage and Hour Division 200 Constitution Avenue NW.

Room S-3502

FP Building

Washington, DC 20210

Phone: 202 693-0067

Fax: 202 693-1387

Related RIN: Previously reported as 1215-AB78

RIN: 1235-AA04

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Employment and Training Administration (ETA)

PROPOSED RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 97. LABOR CERTIFICATION PROCESS AND ENFORCEMENT FOR TEMPORARY

EMPLOYMENT IN OCCUPATIONS OTHER THAN AGRICULTURE OR REGISTERED NURSING

IN THE UNITED STATES (H-2B WORKERS)

Priority:

Other Significant

Legal Authority: 8 USC 1101(a)(15)(H)(ii)(B)); 8 USC 1184(c)(1); 8 CFR 214.2(h)

CFR Citation: 20 CFR 655

Legal Deadline:

None

Abstract:

The Department of Homeland Security (DHS) regulations require employers to apply for a temporary labor certification from the Department of

Labor before H-2B visas may be approved. DOL certifies that there are not sufficient U.S. worker(s) who are capable of performing the temporary services or labor at the time of an application for a visa, and that the employment of the H-2B workers will not adversely affect the wages and working conditions of similarly employed U.S. workers.

This regulation proposes to re-engineer the H-2B program in order to enhance transparency and strengthen program integrity and protections of both U.S. workers and H-2B workers.

Statement of Need:

The Department has determined that a new rulemaking effort is necessary for

Page 79595

the H-2B program. The policy underpinnings of the current regulation, e.g., streamlining the H-2B process to defer many determinations of program compliance until after an application has been adjudicated, do not provide an adequate level of protection for either U.S. or foreign workers. The proposed rule seeks to enhance worker protections and increase the availability of job opportunities to qualified U.S. workers.

Summary of Legal Basis:

The Department of Labor's authority to revise these regulations derives from 8 U.S.C. 1101(a)(15)(H)(ii)(B) and 8 U.S.C. 1184(c)(1) and 8 CFR 214.2(h).

Alternatives:

The public will be afforded an opportunity to provide comments on the proposed regulatory changes when the Department publishes the NPRM in the Federal Register. A final rule will be issued after analysis of, and response to, public comments.

Anticipated Cost and Benefits:

Preliminary estimates of the anticipated costs of this regulatory action are under development. The Department of Labor is seeking information on potential additional or actual costs from employers and other interested parties through the NPRM in order to better assess the costs and benefits of the proposed provisions of the program. The proposed changes are thought to raise ``novel legal or policy issues'' but are not economically significant within the context of Executive

Order 12866 and are not a ``major rule'' under section 804 for the

Small Business Regulatory Enforcement Fairness Act.

Risks:

This action does not affect the public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

01/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

State

Agency Contact:

Dr. William L. Carlson

Administrator, Office of Foreign Labor Certification

Department of Labor

Employment and Training Administration

FP Building

Room C-4312 200 Constitution Avenue NW.

Washington, DC 20210

Phone: 202 693-3010

Email: carlson.william@dol.gov

RIN: 1205-AB58

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 98. EQUAL EMPLOYMENT OPPORTUNITY IN APPRENTICESHIP AND TRAINING,

AMENDMENT OF REGULATIONS

Priority:

Other Significant

Legal Authority: sec 1, 50 Stat 664, as amended (29 USC 50; 40 USC 276c; 5 USC 301);

Reorganization Plan No 14 of 1950, 64 Stat 1267 (5 USC app p 534)

CFR Citation: 29 CFR 30 (Revision)

Legal Deadline:

None

Abstract:

Revisions to the equal opportunity regulatory framework for the

National Apprenticeship Act are a critical element in the Department's vision to promote and expand Registered Apprenticeship opportunities in the 21st century while continuing to safeguard the welfare and safety of apprentices. In October 2008, the Agency issued a Final Rule updating regulations for Apprenticeship Programs and Labor Standards for Registration. These regulations, codified at title 29 Code of

Federal Regulations (CFR) part 29, had not been updated since 1977. The companion regulations, 29 CFR part 30, Equal Employment Opportunity

(EEO) in Apprenticeship and Training, have not been amended since 1978.

The Agency now proposes to update 29 CFR part 30 to ensure that the

National Registered Apprenticeship System is consistent and in alignment with EEO law, as it has developed since 1978, and recent revisions to title 29 CFR part 29. This second phase of regulatory updates will ensure that Registered Apprenticeship is positioned to continue to provide economic opportunity for millions of Americans while keeping pace with these new requirements.

Statement of Need:

Federal regulations for Equal Employment Opportunity (EEO) in

Apprenticeship and Training have not been updated since 1978. Updates to these regulations are necessary to ensure that DOL regulatory requirements governing the National Registered Apprenticeship System are consistent with the current state of EEO law, the ADA, and recent revisions to title 29 CFR part 29.

Summary of Legal Basis:

These regulations are authorized by the National Apprenticeship Act of 1937 (29 U.S.C. 50) and the Copeland Act (40 U.S.C. 276c). These regulations will set forth policies and procedures to promote equality of opportunity in apprenticeship programs registered with the U.S.

Department of Labor or in State Apprenticeship Agencies recognized by the U.S. Department of Labor.

Alternatives:

The public will be afforded an opportunity to provide comments on the proposed amendment to Apprenticeship EEO regulations when the

Department publishes a Notice of Proposed Rulemaking (NPRM) in the

Federal Register. A Final Rule will be issued after analysis and incorporation of public comments to the NRPM.

Anticipated Cost and Benefits:

The proposed changes are thought to raise ``novel legal or policy issue'' but are not economically significant within the context of

Executive Order 12866 and are not a ``major rule'' under Section 804 of the Small Business Regulatory Enforcement Fairness Act.

Risks:

This action does not affect the public health, safety, or the environment.

Timetable:

Action

Date

FR Cite

NPRM

07/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

Federal, State, Tribal

Page 79596

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

John V. Ladd

Office of Apprenticeship

Department of Labor

Employment and Training Administration 200 Constitution Avenue NW.

Room N5311

FP Building

Washington, DC 20210

Phone: 202 693-2796

Fax: 202 693-3799

Email: ladd.john@dol.gov

RIN: 1205-AB59

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Employee Benefits Security Administration (EBSA)

PRERULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 99. LIFETIME INCOME OPTIONS FOR PARTICIPANTS AND BENEFICIARIES IN

RETIREMENT PLANS

Priority:

Other Significant

Legal Authority: 29 USC 1135; ERISA sec 505

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Abstract:

This initiative will explore what steps, if any, that the Department could or should take, by regulation or otherwise, to enhance the retirement security of American workers by facilitating access to and use of lifetime income or income arrangements designed to provide a stream of income after retirement.

Statement of Need:

With a continuing trend away from defined benefit plans to defined contribution plans, employees are not only increasingly responsible for the adequacy of their retirement savings, but also for ensuring that their savings last throughout their retirement. Employees may benefit from access to and use of lifetime income or other arrangements that will reduce the risk of running out of funds during the retirement years. However, both access to and use of such arrangements in defined contribution plans is limited. The Department, taking into consideration recommendations of the ERISA Advisory Council and others, intends to explore what steps, if any, it could or should take, by regulation or otherwise, to enhance the retirement security of workers by increasing access to and use of such arrangements.

Summary of Legal Basis:

Section 505 of ERISA provides that the Secretary may prescribe such regulations as she finds necessary and appropriate to carry out the provisions of title I of the Act.

Alternatives:

Alternatives will be considered following a determination of the scope and nature of the regulatory guidance needed by the public.

Anticipated Cost and Benefits:

Preliminary estimates of the anticipated costs and benefits will be developed, as appropriate, following a determination regarding the alternatives to be considered.

Timetable:

Action

Date

FR Cite

RFI

02/02/10

75 FR 5253

RFI Comment Period End

05/03/10

Public Hearing Notice

08/10/10

75 FR 48367

Public Hearing

09/14/10

Review Public Record

04/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Agency Contact:

Jeffrey J. Turner

Chief, Division of Regulations, Office of Regulations and

Interpretations

Department of Labor

Employee Benefits Security Administration 200 Constitution Avenue NW.

FP Building

Room N-5655

Washington, DC 20210

Phone: 202 693-8500

RIN: 1210-AB33

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--EBSA

PROPOSED RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 100. DEFINITION OF ``FIDUCIARY''

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority: 29 USC 1002; ERISA sec 3(21); 29 USC 1135; ERISA sec 505

CFR Citation: 29 CFR 2510.3-21(c)

Legal Deadline:

None

Abstract:

This rulemaking would amend the regulatory definition of the term

``fiduciary'' set forth at 29 CFR 2510.3-21 (c) to more broadly define as employee benefit plan fiduciaries persons who render investment advice to plans for a fee within the meaning of section 3(21) of ERISA.

The amendment would take into account current practices of investment advisers and the expectations of plan officials and participants who receive investment advice.

Statement of Need:

This rulemaking is needed to bring the definition of ``fiduciary'' into line with investment advice practices and to recast the current regulation to better reflect relationships between investment advisers and their employee benefit plan clients. The current regulation may inappropriately limit the types of investment advice relationships that should give rise to fiduciary duties on the part of the investment adviser.

Summary of Legal Basis:

Section 505 of ERISA provides that the Secretary may prescribe such regulations as she finds necessary and appropriate to carry out the provisions of title I of the Act. Regulation 29 CFR 2510.3-21(c) defines the term fiduciary for certain purposes under section 3(21) of

ERISA.

Alternatives:

Alternatives will be considered following a determination of the scope and nature of the regulatory guidance needed by the public.

Page 79597

Anticipated Cost and Benefits:

Preliminary estimates of the anticipated costs and benefits will be developed, as appropriate, following a determination regarding the alternatives to be considered.

Timetable:

Action

Date

FR Cite

NPRM

10/22/10

75 FR 65263

NPRM Comment Period End

01/20/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Agency Contact:

Jeffrey J. Turner

Chief, Division of Regulations, Office of Regulations and

Interpretations

Department of Labor

Employee Benefits Security Administration 200 Constitution Avenue NW.

FP Building

Room N-5655

Washington, DC 20210

Phone: 202 693-8500

RIN: 1210-AB32

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Mine Safety and Health Administration (MSHA)

PROPOSED RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 101. RESPIRABLE CRYSTALLINE SILICA STANDARD

Priority:

Other Significant

Legal Authority: 30 USC 811; 30 USC 813

CFR Citation: 30 CFR 56 to 57; 30 CFR 70 to 72; 30 CFR 90

Legal Deadline:

None

Abstract:

Current standards limit exposures to quartz (crystalline silica) in respirable dust. The coal mining industry standard is based on the formula 10 mg/m3 divided by the percentage of quartz where the quartz percent is greater than 5 percent calculated as an MRE equivalent concentration. The metal and nonmetal mining industry standard is based on the 1973 American Conference of Governmental Industrial Hygienists

(ACGIH) Threshold Limit Values formula: 10 mg/m3 divided by the percentage of quartz plus 2. Overexposure to crystalline silica can result in some miners developing silicosis, an irreversible but preventable lung disease, which ultimately may be fatal. Both formulas are designed to limit exposures to 0.1 mg/m3 (100 ug) of silica. The

Secretary of Labor's Advisory Committee on the Elimination of

Pneumoconiosis Among Coal Mine Workers made several recommendations related to reducing exposure to silica. NIOSH recommends a 50 ug/m3 exposure limit for respirable crystalline silica. MSHA will publish a proposed rule to address miners' exposure to respirable crystalline silica.

Statement of Need:

MSHA standards are outdated; current regulations may not protect workers from developing silicosis. Evidence indicates that miners continue to develop silicosis. MSHA's proposed regulatory action exemplifies the agency's commitment to protecting the most vulnerable populations while assuring broad-based compliance. MSHA will regulate based on sound science to eliminate or reduce the hazards with the broadest and most serious consequences. MSHA intends to use OSHA's work on the health effects and risk assessment, adapting it as necessary for the mining industry.

Summary of Legal Basis:

Promulgation of this standard is authorized by sections 101 and 103 of the Federal Mine Safety and Health Act of 1977.

Alternatives:

This rulemaking would improve health protection from that afforded by the existing standards. MSHA will consider alternative methods of addressing miners' exposures based on the capabilities of the sampling and analytical methods.

Anticipated Cost and Benefits:

MSHA will prepare estimates of the anticipated costs and benefits associated with the proposed rule.

Risks:

For over 70 years, toxicology information and epidemiological studies have shown that exposure to respirable crystalline silica presents potential health risks to miners. These potential adverse health effects include simple silicosis and progressive massive fibrosis (lung scarring). Evidence indicates that exposure to silica may cause cancer.

MSHA believes that the health evidence forms a reasonable basis for reducing miners' exposure to respirable crystalline silica.

Timetable:

Action

Date

FR Cite

NPRM

07/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses, Governmental Jurisdictions

Government Levels Affected:

Local, State

URL For More Information: www.msha.gov/regsinfo.htm

URL For Public Comments: www.regulations.gov

Agency Contact:

Patricia W. Silvey

Director, Office of Standards, Regulations, and Variances

Department of Labor

Mine Safety and Health Administration 1100 Wilson Boulevard

Room 2350

Arlington, VA 22209-3939

Phone: 202 693-9440

Fax: 202 693-9441

Email: silvey.patricia@dol.gov

RIN: 1219-AB36

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 102. LOWERING MINERS' EXPOSURE TO COAL MINE DUST, INCLUDING CONTINUOUS

PERSONAL DUST MONITORS

Priority:

Other Significant

Legal Authority: 30 USC 811; 30 USC 813(h)

CFR Citation: 30 CFR 70; 30 CFR 71; 30 CFR 72; 30 CFR 75; 30 CFR 90

Legal Deadline:

None

Abstract:

The Federal Coal Mine Health and Safety Act of 1969 established the first comprehensive respirable dust

Page 79598

standards for coal mines. These standards were designed to reduce the incidence of coal workers' pneumoconiosis (CWP) or (black lung) and silicosis and eventually eliminate these diseases. While significant progress has been made toward improving the health conditions in our

Nation's coal mines, miners continue to be at risk of developing occupational lung disease, according to the National Institute for

Occupational Safety and Health (NIOSH). In September 1995, NIOSH issued a Criteria Document in which it recommended that the respirable coal mine dust permissible exposure limit (PEL) be cut in half. In February 1996, the Secretary of Labor convened a Federal Advisory Committee on the Elimination of Pneumoconiosis Among Coal Miners (Advisory

Committee) to assess the adequacy of MSHA's current program and standards to control respirable dust in underground and surface coal mines, as well as other ways to eliminate black lung and silicosis among coal miners. The Committee represented the labor, industry and academic communities. The Committee submitted its report to the

Secretary of Labor in November 1996, with the majority of the recommendations unanimously supported by the Committee members. The

Committee recommended a number of actions to reduce miners' exposure to respirable coal mine dust. This proposed rule is an important element in MSHA's Comprehensive Black Lung Reduction Strategy (Strategy) to

``End Black Lung Now'' and combines the following rulemaking actions:

(1) ``Occupational Exposure to Coal Mine Dust (Lowering Exposure),''

RIN 1219-AB64; (2) ``Verification of Underground Coal Mine Operators'

Dust Control Plans and Compliance Sampling for Respirable Dust,'' RIN 1219-AB14; (3) ``Determination of Concentration of Respirable Coal Mine

Dust,'' RIN 1219-AB18; and (4) ``Respirable Coal Mine Dust: Continuous

Personal Dust Monitor (CPDM),'' RIN 1219-AB48.

Statement of Need:

Comprehensive respirable dust standards for coal mines were designed to reduce the incidence, and eventually eliminate, CWP and silicosis.

While significant progress has been made toward improving the health conditions in our Nation's coal mines, miners remain at risk of developing occupational lung disease, according to NIOSH. Recent NIOSH data indicates increased prevalence of CWP ``clusters'' in several geographical areas, particularly in the Southern Appalachian Region.

Summary of Legal Basis:

Promulgation of this regulation is authorized by the Federal Mine

Safety and Health Act of 1977 as amended by the Mine Improvement and

New Emergency Response Act of 2006.

Alternatives:

MSHA is considering amendments, revisions, and additions to existing standards.

Anticipated Cost and Benefits:

MSHA developed a preliminary regulatory economic analysis to accompany the proposed rule.

Risks:

Respirable coal dust is one of the most serious occupational hazards in the mining industry. Occupational exposure to excessive levels of respirable coal mine dust can cause coal workers' pneumoconiosis and silicosis, which are potentially disabling and can cause death. MSHA is pursuing both regulatory and nonregulatory actions to eliminate these diseases through the control of coal mine respirable dust levels in mines and reduction of miners' exposure. MSHA developed a risk assessment to accompany the proposed rule.

Timetable:

Action

Date

FR Cite

NPRM

10/19/10

75 FR 64412

Hearings

11/15/10

75 FR 69617

NPRM Comment Period End

02/28/11

NPRM-Rescheduling of

Public Hearings;

Correction

11/30/10

75 FR 73995

Post Hearing Comment

Period End

02/28/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

URL For More Information: http://www.msha.gov/S&HINFO/BlackLung/homepage2009.asp

URL For Public Comments: http://www.regulations.gov

Agency Contact:

Patricia W. Silvey

Director, Office of Standards, Regulations, and Variances

Department of Labor

Mine Safety and Health Administration 1100 Wilson Boulevard

Room 2350

Arlington, VA 22209-3939

Phone: 202 693-9440

Fax: 202 693-9441

Email: silvey.patricia@dol.gov

RIN: 1219-AB64

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 103. SAFETY AND HEALTH MANAGEMENT PROGRAMS FOR MINES

Priority:

Other Significant

Unfunded Mandates:

Undetermined

Legal Authority: 30 USC 811 and 812

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Abstract:

MSHA held public meetings and gathered information and suggestions from the mining community on effective, comprehensive safety and health management programs, including programs used in the mining industry.

MSHA will use all information received to develop a proposed rule for safety and health management programs to eliminate hazards and prevent injuries and illnesses at mines.

Statement of Need:

Mining is one of the most hazardous industries in this country. Yet year after year, many mines experience low injury and illness rates and low violation rates. For these mine operators, preventing harm to their miners is more than compliance with safety and health requirements; it reflects an embodiment of a culture of safety--from CEO to the miner to the contractor. This culture of safety derives from a commitment to a systematic, effective, comprehensive management of safety and health at mines with full participation of all miners.

MSHA believes requiring effective safety and health management

Page 79599

programs in mining will create a sustained industry-wide effort to eliminate hazards and will result in the prevention of injuries and illnesses.

Summary of Legal Basis:

Promulgation of this standard is authorized by section 101 of the

Federal Mine Safety and Health Act of 1977 as amended by the Mine

Improvement and New Emergency Response Act of 2006.

Alternatives:

No reasonable alternatives to this regulation would be as comprehensive or as effective in eliminating hazards and preventing injuries and illnesses.

Anticipated Cost and Benefits:

MSHA will develop a preliminary regulatory economic analysis to accompany the proposed rule.

Risks:

The lack of a comprehensive safety and health management program contributes to a higher incidence of injury and illness rates and higher violation rates.

Timetable:

Action

Date

FR Cite

NPRM

06/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Patricia W. Silvey

Director, Office of Standards, Regulations, and Variances

Department of Labor

Mine Safety and Health Administration 1100 Wilson Boulevard

Room 2350

Arlington, VA 22209-3939

Phone: 202 693-9440

Fax: 202 693-9441

Email: silvey.patricia@dol.gov

RIN: 1219-AB71

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 104. PATTERN OF VIOLATIONS

Priority:

Other Significant

Unfunded Mandates:

Undetermined

Legal Authority: 30 USC 814(e); 30 USC 957

CFR Citation: 30 CFR 104

Legal Deadline:

None

Abstract:

MSHA is preparing a proposed rule to revise the Agency's existing regulation for pattern of violations contained in 30 CFR part 104. MSHA has determined that the existing pattern criteria and procedures do not reflect the statutory intent for section 104(e) of the Federal Mine

Safety and Health Act of 1977 (Mine Act) that operators manage health and safety conditions at mines so that the root causes of significant and substantial (S&S) violations are addressed before they become a hazard to the health and safety of miners. The legislative history of the Mine Act explains that Congress intended the pattern of violations tool be used for operators who have demonstrated a disregard for the health and safety of miners. The proposal would reflect statutory intent, simplify the pattern of violations criteria, and improve consistency in applying the patterns of violations criteria.

Statement of Need:

The pattern of violations provision was a new enforcement tool in the

Mine Act. The Mine Act places the ultimate responsibility for ensuring the safety and health of miners on mine operators. The goal of the pattern of violations proposed rule is to compel operators to manage health and safety conditions so that the root causes of S&S violations are found and fixed before they become a hazard to miners. MSHA's existing regulation is not consistent with the language, purpose, and legislative history of the Mine Act and hinders the Agency's use of pattern of violations to identify chronic violators who thumb their noses at the law by a continuing cycle of citation and abatement.

Summary of Legal Basis:

Promulgation of this standard is authorized by sections 104(e) and 957 of the Federal Mine Safety and Health Act of 1977.

Alternatives:

MSHA will consider alternative criteria for determining when a pattern of significant and substantial violations exists in order to improve health and safety conditions in mines and provide protection for miners. Congress provided the Secretary with broad discretion in determining criteria, recognizing that MSHA may need to modify the criteria as Agency experience dictates.

Anticipated Cost and Benefits:

MSHA will prepare estimates of the anticipated costs and benefits associated with the proposed rule.

Risks:

Mine operators with a chronic history of persistent serious violations needlessly expose miners to the same hazards again and again. These operators demonstrate a disregard for the safety and health of miners; this indicates a serious safety and health management problem at the mine. The existing regulation has not been effective in reducing repeated risks to miners at these mines.

Timetable:

Action

Date

FR Cite

NPRM

01/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses

Government Levels Affected:

None

URL For More Information: http://www.msha.gov/regsinfo.htm

URL For Public Comments: http://www.regulations.gov

Agency Contact:

Patricia W. Silvey

Director, Office of Standards, Regulations, and Variances

Department of Labor

Mine Safety and Health Administration 1100 Wilson Boulevard

Room 2350

Arlington, VA 22209-3939

Phone: 202 693-9440

Fax: 202 693-9441

Email: silvey.patricia@dol.gov

RIN: 1219-AB73

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 105. MAINTENANCE OF INCOMBUSTIBLE CONTENT OF ROCK DUST IN

UNDERGROUND COAL MINES

Priority:

Other Significant

Page 79600

Legal Authority: 30 USC 811, 864

CFR Citation: 30 CFR sec 75.403

Legal Deadline:

None

Abstract:

The Mine Safety and Health Administration (MSHA) issued an emergency temporary standard (ETS) under section 101(b) of the Federal Mine

Safety and Health Act of 1977 in response to the grave danger that miners in underground bituminous coal mines face when accumulations of coal dust are not made inert. MSHA concluded from investigations of mine explosions and other reports that immediate action was necessary to protect miners.

Accumulations of coal dust can ignite, resulting in an explosion, or after an explosion, it can propagate, increasing the severity of the explosion. The ETS requires mine operators to increase the incombustible content of combined coal dust, rock dust, and other dust to at least 80 percent in underground areas of bituminous mines. The

ETS further requires that the incombustible content of such combined dust be raised 0.4 percent for each 0.1 percent of methane present. The

ETS strengthens the protection for miners by reducing the potential for a coal mine explosion.

Statement of Need:

MSHA determined that a revised standard for ``Maintenance of

Incombustible Content of Rock Dust'' is necessary to immediately protect underground coal miners from hazards of coal dust explosions.

This determination is based on: (1) MSHA's accident investigation reports of mine explosions in intake air courses that involved coal dust (Dubaniewicz 2009); (2) the National Institute for Occupational

Safety and Health's Report of Investigations 9679 (Cashdollar et al. 2010), ``Recommendations for a New Rock Dusting Standard to Prevent

Coal Dust Explosions in Intake Airways``; and (3) MSHA's experience and data.

Summary of Legal Basis:

Promulgation of this standard is authorized by section 101(b) of the

Federal Mine Safety and Health Act of 1977.

Alternatives:

MSHA will consider revisions to the ETS, based on public comments received during the rulemaking process.

Anticipated Cost and Benefits:

MSHA estimates that the ETS would result in approximately $22.0 million in yearly costs for the underground bituminous coal mining industry.

The ETS provides additional safety protection for miners in underground bituminous coal mines from the explosion hazard of coal and other dusts. MSHA estimates that, on average, the ETS would prevent approximately 1.5 deaths every year and would prevent one additional injury about every 4 years.

Risks:

Based on NIOSH's data and recommendations, and MSHA's data and experience, the Secretary determined that miners are exposed to grave danger in areas of underground bituminous coal mines that are not properly and sufficiently rock dusted in accordance with the requirements in this ETS.

Timetable:

Action

Date

FR Cite

Emergency Temporary

Standard

09/23/10

75 FR 57849

Hearing

10/26/10

Hearing

10/28/10

Hearing

11/16/10

Hearing

11/18/10

Comment Period End

12/20/10

Final Action

06/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

URL For More Information: www.msha.gov/regsinfo.htm

URL For Public Comments: www.regulations.gov

Agency Contact:

Patricia W. Silvey

Director, Office of Standards, Regulations, and Variances

Department of Labor

Mine Safety and Health Administration 1100 Wilson Boulevard

Room 2350

Arlington, VA 22209-3939

Phone: 202 693-9440

Fax: 202 693-9441

Email: silvey.patricia@dol.gov

RIN: 1219-AB76

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Page 79600

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--MSHA

FINAL RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 106. PROXIMITY DETECTION SYSTEMS FOR UNDERGROUND MINES

Priority:

Other Significant

Legal Authority: 30 USC 811

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Abstract:

The Mine Safety and Health Administration (MSHA) will issue an emergency temporary standard (ETS) under section 101(b) of the Federal

Mine Safety and Health Act of 1977 in response to the grave danger that miners face when working near mobile equipment in underground mines.

MSHA has concluded, from investigations of accidents involving mobile equipment and other reports, that immediate action is necessary to protect miners. To date, in 2010, there have been five fatalities resulting from crushing and pinning accidents.

Mobile equipment can pin, crush, or strike a miner working near the equipment. Proximity detection technology can prevent these types of accidents. The ETS would strengthen the protection for underground miners by reducing the potential of pinning, crushing or striking hazards associated with working close to mobile equipment. As a part of the Secretary's strategy for securing safe and healthy workplaces, the

Mine Safety and Health Administration will undertake regulatory action related to reducing

Page 79601

injuries and fatalities to workers in close proximity to moving equipment and vehicles.

Statement of Need:

Mining is one of the most hazardous industries in this country. Miners continue to be injured or killed resulting from pinning, crushing, or striking accidents involving mobile equipment. Equipment is available to help prevent accidents that cause debilitating injuries and accidental death.

Summary of Legal Basis:

Promulgation of this standard is authorized by section 101(b) of the

Federal Mine Safety and Health Act of 1977 as amended by the Mine

Improvement and New Emergency Response Act of 2006.

Alternatives:

No reasonable alternatives to this regulation would be as comprehensive or as effective in eliminating hazards and preventing injuries.

Anticipated Cost and Benefits:

MSHA will develop a regulatory economic analysis to accompany the ETS.

Risks:

The lack of proximity detection systems on mobile equipment in underground mines contributes to a higher incidence of debilitating injuries and accidental deaths.

Timetable:

Action

Date

FR Cite

Request for Information

(RFI)

02/01/10

75 FR 5009

Comment Period Ended

04/02/10

Emergency Temporary

Standard

03/00/11

Final Action

12/00/11

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Patricia W. Silvey

Director, Office of Standards, Regulations, and Variances

Department of Labor

Mine Safety and Health Administration 1100 Wilson Boulevard

Room 2350

Arlington, VA 22209-3939

Phone: 202 693-9440

Fax: 202 693-9441

Email: silvey.patricia@dol.gov

RIN: 1219-AB65

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--Occupational Safety and Health Administration (OSHA)

PRERULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 107. INFECTIOUS DISEASES

Priority:

Economically Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 5 USC 533; 29 USC 657 and 658; 29 USC 660; 29 USC 666; 29 USC 669; 29

USC 673; . . .

CFR Citation: 29 CFR 1910

Legal Deadline:

None

Abstract:

Employees in health care and other high-risk environments face long- standing infectious diseases hazards such as tuberculosis (TB), varicella disease (chickenpox, shingles), and measles (rubeola), as well as new and emerging infectious disease threats, such as Severe

Acute Respiratory Syndrome (SARS) and pandemic influenza. Health care workers and workers in related occupations or who are exposed in other high-risk environments are at increased risk of contracting TB, SARS,

MRSA, and other infectious diseases that can be transmitted through a variety of exposure routes. OSHA is concerned about the ability of employees to continue to provide health care and other critical services without unreasonably jeopardizing their health.

OSHA is considering the need for a standard to ensure that employers establish a comprehensive infection control program and control measures to protect employees from infectious disease exposures to pathogens that can cause significant disease. Workplaces where such control measures might be necessary include: health care, emergency response, correctional facilities, homeless shelters, drug treatment programs, and other occupational settings where employees can be at increased risk of exposure to potentially infectious people. A standard could also apply to laboratories which handle materials that may be a source of pathogens, and to pathologists, coroners' offices, medical examiners, and mortuaries.

OSHA published an RFI on May 6, 2010, the comment period closed on

August 4, 2010. OSHA is currently analyzing the comments submitted by stakeholders.

Statement of Need:

In 2007, the healthcare and social assistance sector as a whole had 16.5 million employees. Healthcare workplaces can range from small private practices of physicians to hospitals that employ thousands of workers. In addition, healthcare is increasingly being provided in other settings such as nursing homes, free-standing surgical and outpatient centers, emergency care clinics, patients' homes, and prehospitalization emergency care settings. The Agency is particularly concerned by studies that indicate that transmission of infectious diseases to both patients and healthcare workers may be occurring as a result of incomplete adherence to recognized, but voluntary, infection control measures. Another concern is the movement of healthcare delivery from the traditional hospital setting, with its greater infrastructure and resources to effectively implement infection control measures, into more diverse and smaller workplace setting with less infrastructure and fewer resources, but with an expanding worker population.

Summary of Legal Basis:

The Occupational Safety and Health Act of 1970 authorizes the Secretary of Labor to set mandatory occupational safety and health standards to assure safe and healthful working conditions for working men and women

(29 U.S.C. 651).

Alternatives:

The alternative to the proposed rulemaking would be to take no regulatory action.

Page 79602

Anticipated Cost and Benefits:

The estimates of the costs and benefits are still under development.

Risks:

Analysis of risks is still under development.

Timetable:

Action

Date

FR Cite

Request for Information

(RFI)

05/06/10

75 FR 24835

RFI Comment Period End

08/04/10

Analyze Comments

12/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Dorothy Dougherty

Director, Directorate of Standards and Guidance

Department of Labor

Occupational Safety and Health Administration 200 Constitution Avenue NW.

FP Building

Room N-3718

Washington, DC 20210

Phone: 202 693-1950

Fax: 202 693-1678

Email: dougherty.dorothy@dol.gov

RIN: 1218-AC46

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Page 79602

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 108. INJURY AND ILLNESS PREVENTION PROGRAM

Priority:

Economically Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 29 USC 653; 29 USC 655(b); 29 USC 657

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Abstract:

OSHA is developing a rule requiring employers to implement an Injury and Illness Prevention Program. It involves planning, implementing, evaluating, and improving processes and activities that protect employee safety and health. OSHA has substantial data on reductions in injuries and illnesses from employers who have implemented similar effective processes. The Agency currently has voluntary Safety and

Health Program Management Guidelines (54 FR 3904-3916), published in 1989. An injury and illness prevention rule would build on these guidelines as well as lessons learned from successful approaches and best practices under OSHA's Voluntary Protection Program Safety and

Health Achievement Recognition Program and similar industry and international initiatives such as American National Standards

Institute/American Industrial Hygiene Association Z10 and Occupational

Health and Safety Assessment Series 18001. Twelve States have similar rules.

Statement of Need:

There are approximately 5,000 workplace fatalities and approximately 3.5 million serious workplace injuries every year. There are also many workplace illnesses caused by exposure to common chemical, physical, and biological agents. OSHA believes that an injury and illness prevention program is a universal intervention that can be used in a wide spectrum of workplaces to dramatically reduce the number and severity of workplace injuries. Such programs have been shown to be effective in many workplaces in the United States and internationally.

Summary of Legal Basis:

(29 U.S.C. 651).

Alternatives:

The alternatives to this rulemaking would be to issue guidance, recognition programs, or allow for the states to develop individual regulations. OSHA has used voluntary approaches to address the need, including publishing Safety and Health Program Management Guidelines in 1989. In addition, OSHA has two recognition programs, the Voluntary

Protection Program (known as VPP), and the Safety and Health

Achievement Recognition Program (known as SHARP). These programs recognize workplaces with effective safety and health programs. Several

States have issued regulations that require employers to establish effective safety and health programs.

Anticipated Cost and Benefits:

The scope of the proposed rulemaking and the costs and benefits are still under development for this regulatory action.

Risks:

A detailed risk analysis is underway.

Timetable:

Action

Date

FR Cite

Stakeholder Meetings

06/03/10

Initiate SBREFA

06/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Dorothy Dougherty

Director, Directorate of Standards and Guidance

Department of Labor

Occupational Safety and Health Administration 200 Constitution Avenue NW.

FP Building

Room N-3718

Washington, DC 20210

Phone: 202 693-1950

Fax: 202 693-1678

Email: dougherty.dorothy@dol.gov

RIN: 1218-AC48

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 109. BACKING OPERATIONS

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 29 USC 655(b)

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Page 79603

Abstract:

NIOSH reports that half of the fatalities involving construction equipment occur while the equipment is backing. Backing accidents cause 500 deaths and 15,000 injuries per year. Emerging technologies in the field of backing operations include after market devices, such as camera, radar, and sonar, to help monitor the presence of workers on foot in blind areas, and new monitoring technology, such as tag-based warning systems that use radio frequency (RFID) and magnetic field generators on equipment to detect electronic tags worn by workers.

Statement of Need:

A study by the Census of Fatal Occupational Injuries found that the most common primary sources of injury to be trucks (45%), road grading and surfacing machinery (15%), and cars (15%). That same study showed that of the 465 vehicle and equipment-related fatalities within work zones, 318 workers on foot were struck by a vehicle. Incidents involving backing vehicles were prominent among the worker-on-foot fatalities that occurred (51%). The primary injury sources of fatalities of workers on foot struck by a construction vehicle were trucks (61%) and construction machines (30%). OSHA believes that regulatory action is necessary to address risks associated with backup operations.

Summary of Legal Basis:

(29 U.S.C. 651).

Alternatives:

The alternative to the proposed rulemaking would be to take no regulatory action.

Anticipated Cost and Benefits:

The estimates of the costs and benefits are still under development.

Risks:

Analysis of risks is still under development.

Timetable:

Action

Date

FR Cite

RFI

05/00/11

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Ben Bare

Acting Director, Directorate of Construction

Department of Labor

Occupational Safety and Health Administration 200 Constitution Avenue NW.

FP Building

Room N-3468

Washington, DC 20210

Phone: 202 693-2020

Fax: 202 693-1689

RIN: 1218-AC52

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Page 79603

U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--OSHA

PROPOSED RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 110. OCCUPATIONAL EXPOSURE TO CRYSTALLINE SILICA

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect State, local or tribal governments.

Legal Authority: 29 USC 655(b); 29 USC 657

CFR Citation: 29 CFR 1910; 29 CFR 1915; 29 CFR 1917; 29 CFR 1918; 29 CFR 1926

Legal Deadline:

None

Abstract:

Crystalline silica is a significant component of the earth's crust, and many workers in a wide range of industries are exposed to it, usually in the form of respirable quartz or, less frequently, cristobalite.

Chronic silicosis is a uniquely occupational disease resulting from exposure of employees over long periods of time (10 years or more).

Exposure to high levels of respirable crystalline silica causes acute or accelerated forms of silicosis that are ultimately fatal. The current OSHA permissible exposure limit (PEL) for general industry is based on a formula proposed by the American Conference of Governmental

Industrial Hygienists (ACGIH) in 1968 (PEL=10mg/cubic meter/(% silica + 2), as respirable dust). The current PEL for construction and shipyards

(derived from ACGIH's 1970 Threshold Limit Value) is based on particle counting technology, which is considered obsolete. NIOSH and ACGIH recommend 50[micro]g/m3 and 25[micro]g/m3 exposure limits, respectively, for respirable crystalline silica.Both industry and worker groups have recognized that a comprehensive standard for crystalline silica is needed to provide for exposure monitoring, medical surveillance, and worker training. The American Society for

Testing and Materials has published recommended standards for addressing the hazards of crystalline silica. The Building Construction

Trades Department of the AFL-CIO has also developed a recommended comprehensive program standard. These standards include provisions for methods of compliance, exposure monitoring, training, and medical surveillance. OSHA is currently developing a NPRM.

Statement of Need:

Workers are exposed to crystalline silica dust in general industry, construction, and maritime industries. Industries that could be particularly affected by a standard for crystalline silica include:

Foundries, industries that have abrasive blasting operations, paint manufacture, glass and concrete product manufacture, brick making, china and pottery manufacture, manufacture of plumbing fixtures, and many construction activities including highway repair, masonry, concrete work, rock drilling, and tuckpointing. The seriousness of the health hazards associated with silica exposure is demonstrated by the fatalities and disabling illnesses that continue to occur. In 2005, the most recent year for which data is available, silicosis was identified on 161 death certificates as an underlying or contributing cause of death. It is likely that many more cases have occurred where silicosis went undetected. In addition, the International Agency for Research on

Cancer has designated crystalline silica as carcinogenic to humans, and the National Toxicology Program has concluded that respirable crystalline silica is a known human carcinogen. Exposure to crystalline silica has also been associated with an increased risk of developing tuberculosis and other nonmalignant respiratory diseases, as well as renal and autoimmune diseases. Exposure studies and OSHA enforcement data indicate that some

Page 79604

workers continue to be exposed to levels of crystalline silica far in excess of current exposure limits. Congress has included compensation of silicosis victims on Federal nuclear testing sites in the Energy

Employees' Occupational Illness Compensation Program Act of 2000. There is a particular need for the Agency to modernize its exposure limits for construction and shipyard workers, and to address some specific issues that will need to be resolved to propose a comprehensive standard.

Summary of Legal Basis:

The legal basis for the proposed rule is a preliminary determination that workers are exposed to a significant risk of silicosis and other serious disease and that rulemaking is needed to substantially reduce the risk. In addition, the proposed rule will recognize that the PELs for construction and maritime are outdated and need to be revised to reflect current sampling and analytical technologies.

Alternatives:

Over the past several years, the Agency has attempted to address this problem through a variety of non-regulatory approaches, including initiation of a Special Emphasis Program on silica in October 1997, sponsorship with NIOSH and MSHA of the National Conference to Eliminate

Silicosis, and dissemination of guidance information on its Web site.

Anticipated Cost and Benefits:

The scope of the proposed rulemaking and estimates of the costs and benefits are still under development.

Risks:

A detailed risk analysis is under way.

Timetable:

Action

Date

FR Cite

Completed SBREFA Report

12/19/03

Initiated Peer Review of

Health Effects and

Risk Assessment

05/22/09

Completed Peer Review

01/24/10

NPRM

04/00/11

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Dorothy Dougherty

Director, Directorate of Standards and Guidance

Department of Labor

Occupational Safety and Health Administration 200 Constitution Avenue NW.

FP Building

Room N-3718

Washington, DC 20210

Phone: 202 693-1950

Fax: 202 693-1678

Email: dougherty.dorothy@dol.gov

RIN: 1218-AB70

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 111. OCCUPATIONAL INJURY AND ILLNESS RECORDING AND REPORTING

REQUIREMENTS--MODERNIZING OSHA'S REPORTING SYSTEM

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority: 29 USC 657

CFR Citation: 29 CFR 1904

Legal Deadline:

None

Abstract:

OSHA is proposing changes to its reporting system for occupational injuries and illnesses. An updated and modernized reporting system would enable a more efficient and timely collection of data and would improve the accuracy and availability of the relevant records and statistics. This proposal involves modification to 29 CFR part 1904.41 to expand OSHA's legal authority to collect and make available injury and illness information required under part 1904.

Statement of Need:

The collection of establishment specific injury and illness data in electronic format on a timely basis is needed to help OSHA, employers, employees, researchers, and the public more effectively prevent workplace injuries and illnesses, as well as support President Obama's

Open Government Initiative to increase the ability of the public to easily find, download, and use the resulting dataset generated and held by the Federal Government.

Summary of Legal Basis:

The Occupational Safety and Health Act of 1970 authorizes the Secretary of Labor to develop and maintain an effective program of collection, compilation, and analysis of occupational safety and health statistics

(29 U.S.C. 673).

Alternatives:

The alternative to the proposed rulemaking would be to take no regulatory action.

Anticipated Cost and Benefits:

The estimates of the costs and benefits are still under development.

Risks:

Analysis of risks is still under development.

Timetable:

Action

Date

FR Cite

Stakeholder Meetings

05/25/10

75 FR 24505

Comment Period End

06/18/10

NPRM

09/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

None

Agency Contact:

Keith Goddard

Director, Directorate of Evaluation and Analysis

Department of Labor

Occupational Safety and Health Administration 200 Constitution Avenue NW.

FP Building

Room N-3718

Washington, DC 20210

Phone: 202 693-2400

Fax: 202 693-1641

Email: goddard.keith@dol.gov

RIN: 1218-AC49

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl

DOL--OSHA

FINAL RULE STAGE

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U.S. DEPARTMENT OF LABOR

Fall 2010 Statement of Regulatory Priorities

Secretary Solis has consistently stated that all of the work of the

Department of Labor is focused on achieving Good Jobs for Everyone. The

Labor Department's vision of a ``good job'' incl 112. HAZARD COMMUNICATION

Priority:

Economically Significant. Major under 5 USC 801.

Page 79605

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority: 29 USC 655(b); 29 USC 657

CFR Citation: 29 CFR 1910.1200; 29 CFR 1915.1200; 29 CFR 1917.28; 29 CFR 1918.90; 29

CFR 1926.59; 29 CFR 1928.21

Legal Deadline:

None

Abstract:

OSHA's Hazard Communication Standard (HCS) requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import, and prepare labels and material safety data sheets to convey the hazards and associated protective measures to users of the chemicals. All employers with hazardous chemicals in their workplaces are required to have a hazard communication program, including labels on containers, material safety data sheets (MSDS), and training for employees. Within the United States (U.S.), there are other Federal agencies that also have requirements for classification and labeling of chemicals at different stages of the life cycle.

Internationally, there are a number of countries that have developed similar laws that require information about chemicals to be prepared and transmitted to affected parties. These laws vary with regard to the scope of substances covered, definitions of hazards, the specificity of requirements (e.g., specification of a format for MSDSs), and the use of symbols and pictograms. The inconsistencies between the various laws are substantial enough that different labels and safety data sheets must often be used for the same product when it is marketed in different nations.

The diverse and sometimes conflicting national and international requirements can create confusion among those who seek to use hazard information. Labels and safety data sheets may include symbols and hazard statements that are unfamiliar to readers or not well understood. Containers may be labeled with such a large volume of information that important statements are not easily recognized.

Development of multiple sets of labels and safety data sheets is a major compliance burden for chemical manufacturers, distributors, and transporters involved in international trade. Small businesses may have particular difficulty in coping with the complexities and costs involved.

As a result of this situation, and in recognition of the extensive international trade in chemicals, there has been a long-standing effort to harmonize these requirements and develop a system that can be used around the world. In 2003, the United Nations adopted the Globally

Harmonized System of Classification and Labeling of Chemicals (GHS).

Countries are now adopting the GHS into their national regulatory systems.

Statement of Need:

Multiple sets of requirements for labels and safety data sheets present a compliance burden for U.S. manufacturers, distributors, and transports involved in international trade. The comprehensibility of hazard information and worker safety will be enhanced as the GHS will:

(1) Provide consistent information and definitions for hazardous chemicals; (2) address stakeholder concerns regarding the need for a standardized format for material safety data sheets; and (3) increase understanding by using standardized pictograms and harmonized hazard statements. The increase in comprehensibility and consistency will reduce confusion and thus improve worker safety and health. In addition, the adoption of the GHS would facilitate international trade in chemicals, reduce the burdens caused by having to comply with differing requirements for the same product, and allow companies that have not had the resources to deal with those burdens to be involved in international trade. This is particularly important for small producers who may be precluded currently from international trade because of the compliance resources required to address the extensive regulatory requirements for classification and labeling of chemicals. Thus every producer is likely to experience some benefits from domestic harmonization, in addition to the benefits that will accrue to producers involved in international trade. Several nations, including the European Union, have adopted the GHS with an implementation schedule through 2015. U.S. manufacturers, employers, and employees will be at a disadvantage in the event that our system of hazard communication is not in compliance with the GHS.

Summary of Legal Basis:

(29 U.S.C. 651).

Alternatives:

The alternative to the proposed rulemaking would be to take no regulatory action.

Anticipated Cost and Benefits:

The estimates of the costs and benefits are still under development.

Risks:

OSHA's risk analysis is under development.

Timetable:

Action

Date

FR Cite

ANPRM

09/12/06

71 FR 53617

ANPRM Comment Period End

11/13/06

Complete Peer Review of

Economic Analysis

11/19/07

NPRM

09/30/09

74 FR 50279

NPRM Comment Period End

12/29/09

Hearing

03/02/10

Hearing

03/31/10

Post Hearing Comment

Period End

06/01/10

Final Action

08/00/11

Regulatory Flexibility Analysis Required:

Government Levels Affected:

Local, State

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Dorothy Dougherty

Director, Directorate of Standards and Guidance

Department of Labor

Occupational Safety and Health Administration 200 Constitution Avenue NW.

FP Building

Room N-3718

Washington, DC 20210

Phone: 202 693-1950

Fax: 202 693-1678

Email: dougherty.dorothy@dol.gov

RIN: 1218-AC20

BILLING CODE 4510-23-S

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Introduction: Department Overview and Summary of Regulatory Priorities

The Department of Transportation (DOT) consists of 10 operating administrations and the Office of the Secretary, each of which has statutory responsibility for a wide range of regulations

DOT--Office of the Secretary (OST)

Page 79607

The Department stresses the importance of conducting high quality rulemakings in a timely manner and reducing the number of old rulemakings. To implement this, the Department has required the following actions: (1) Regular meetings of senior DOT officials to ensure effective policy leadership and timely decisions, (2) effective tracking and coordination of rulemakings, (3) regular reporting, (4) early briefings of interested officials, (5) regular training of staff, and (6) adequate allocations of resources. The Department has achieved significant success because of this effort. It allows the Department to use its resources more effectively and efficiently.

The Department's regulatory policies and procedures provide a comprehensive internal management and review process for new and existing regulations and ensure that the Secretary and other appropriate appointed officials review and concur in all significant

DOT rules. DOT continually seeks to improve its regulatory process. A few examples include: The Department's development of regulatory process and related training courses for its employees; its use of an electronic, Internet-accessible docket that can also be used to submit comments electronically; a ``list serve'' that allows the public to sign up for e-mail notification when the Department issues a rulemaking document; creation of an electronic rulemaking tracking and coordination system; the use of direct final rulemaking; the use of regulatory negotiation; an expanded Internet page that provides important regulatory information, including ``effects'' reports and status reports (http://regs.dot.gov/); and the use of Internet blogs and other Web 2.0 technology to increase and enhance public participation in its rulemaking process.

In addition, the Department continues to engage in a wide variety of activities to help cement the partnerships between its agencies and its customers that will produce good results for transportation programs and safety. The Department's agencies also have established a number of continuing partnership mechanisms in the form of rulemaking advisory committees.

The Department is also actively engaged in the review of existing rules to determine whether they need to be revised or revoked. These reviews are in accordance with section 610 of the Regulatory Flexibility Act,

Executive Order 12866, and the Department's Regulatory Policies and

Procedures. This includes determining whether the rules would be more understandable if they were written using a plain language approach.

Appendix D to our regulatory agenda highlights our efforts in this area.

The Department will also continue its efforts to use advances in technology to improve its rulemaking management process. For example, the Department created an effective tracking system for significant rulemakings to ensure that either rules are completed in a timely manner or delays are identified and fixed. Through this tracking system, a monthly status report is generated. To make its efforts more transparent, the Department has made this report Internet accessible.

By doing this, the Department is providing valuable information concerning our rulemaking activity and is providing information necessary for the public to evaluate the Department's progress in meeting its commitment to completing quality rulemakings in a timely manner.

The Department will continue to place great emphasis on the need to complete high quality rulemakings by involving senior departmental officials in regular meetings to resolve issues expeditiously.

Office of the Secretary of Transportation (OST)

The Office of the Secretary (OST) oversees the regulatory process for the Department. OST implements the Department's regulatory policies and procedures and is responsible for ensuring the involvement of top management in regulatory decisionmaking. Through the General Counsel's office, OST is also responsible for ensuring that the Department complies with the Administrative Procedure Act, Executive Order 12866

(Regulatory Planning and Review), DOT's Regulatory Policies and

Procedures, and other legal and policy requirements affecting rulemaking. Although OST's principal role concerns the review of the

Department's significant rulemakings, this office has the lead role in the substance of projects concerning aviation economic rules and other rules that affect multiple elements of the Department.

OST provides guidance and training regarding compliance with regulatory requirements and process for use by personnel throughout the

Department. OST also plays an instrumental role in the Department's efforts to improve our economic analyses; risk assessments; regulatory flexibility analyses; other related analyses; and data quality, including peer reviews.

OST also leads and coordinates the Department's response to the Office of Management and Budget's (OMB) intergovernmental review of other agencies' significant rulemaking documents and to Administration and congressional proposals that concern the regulatory process. The

General Counsel's Office works closely with representatives of other agencies, OMB, the White House, and congressional staff to provide information on how various proposals would affect the ability of the

Department to perform its safety, infrastructure, and other missions.

During fiscal year 2011, OST will continue to focus its efforts on enhancing airline passenger protections by requiring carriers to adopt various consumer service practices (2105-AD92).

OST will also continue its efforts to help coordinate the activities of several operating administrations that advance various departmental efforts that support the Administration's initiatives on promoting safety; stimulating the economy and creating jobs; sustaining and building America's transportation infrastructure; and improving livability for the people and communities who use transportation systems subject to the Department's policies.

Federal Aviation Administration (FAA)

The Federal Aviation Administration is charged with safely and efficiently operating and maintaining the most complex aviation system in the world. It is guided by its Flight Plan goals: Increased Safety,

Greater Capacity, International Leadership, and Organizational

Excellence. It issues regulations to provide a safe and efficient global aviation system for civil aircraft, while being sensitive to not imposing undue regulatory burdens and costs on small businesses.

FAA Activities that may lead to rulemaking in fiscal year 2011 include:

Promotion and expansion of safety information sharing efforts, such as FAA-industry partnerships and data-driven safety programs that prioritize and address risks before they lead to accidents. Specifically, FAA will continue implementing

Commercial Aviation Safety Team projects related to controlled flight into terrain, loss of control of an aircraft, uncontained engine failures, runway incursions, weather, pilot decisionmaking, and cabin safety. Some of these projects may result in rulemaking and guidance materials.

Page 79608

Continuing to work cooperatively to harmonize the U.S. aviation regulations with those of other countries, without compromising rigorous safety standards. The differences worldwide in certification standards, practice and procedures, and operating rules must be identified and minimized to reduce the regulatory burden on the international aviation system. The differences between the

FAA regulations and the requirements of other nations impose a heavy burden on U.S. aircraft manufacturers and operators, some of which are small businesses.

Standardization should help the U.S. aerospace industry remain internationally competitive. The FAA continues to publish regulations based on recommendations of Aviation

Rulemaking Committees that are the result of cooperative rulemaking between the U.S. and other countries.

In addition to the regulatory priorities specified below, additional priorities will come from the Airline Safety and

Federal Aviation Administration Extension Act of 2010, signed by the President on August 1, 2010.

FAA top regulatory priorities for 2010 to 2011 include:

Qualification, Service, and Use of Crewmembers and Aircraft

Dispatchers (2120-AJ00)

Helicopter Air Ambulance and Commercial Helicopter Safety

Initiatives and Miscellaneous Amendments (2120-AJ53)

Flight and Duty Time Limitations and Rest Requirements (2120-

AJ58)

The Crewmember and Aircraft Dispatcher Training rulemaking would include proposals to:

Reduce human error and improve performance among flight crewmembers, flight attendants, and aircraft dispatchers;

Enhance traditional training programs through the use of flight simulation training devices for flight crewmembers; and

Include additional training in areas critical to safety.

The Air Ambulance and Commercial Helicopter rulemaking would include proposals to:

Codify current agency guidance and address National

Transportation Safety Board recommendations;

Provide certificate holders and pilots with tools and procedures that will aid in reducing accidents;

Require additional equipment on board helicopters or air ambulances; and

Amend all part 135 commercial helicopter operations regulations to include equipment requirements, pilot training, and alternate airport weather minimums.

The Flight and Duty Time Limitations and Rest Requirements rulemaking would include proposals to:

Address fatigue mitigation and use existing fatigue science to establish minimum rest periods, flight time limitations, and duty period limits for flight crewmembers;

Incorporate the use of Fatigue Risk Management Systems as an option to provide operator flexibility for specific operations; and

Reduce human error attributed to fatigue among flight crewmembers.

Federal Highway Administration (FHWA)

The Federal Highway Administration (FHWA) carries out the Federal highway program in partnership with State and local agencies to meet the Nation's transportation needs. The FHWA's mission is to improve continually the quality and performance of our Nation's highway system and its intermodal connectors.

Consistent with this mission, the FHWA will continue:

With ongoing regulatory initiatives in support of its surface transportation programs;

To implement legislation in the least burdensome and restrictive way possible; and

To pursue regulatory reform in areas where project development can be streamlined or accelerated, duplicative requirements can be consolidated, recordkeeping requirements can be reduced or simplified, and the decisionmaking authority of our State and local partners can be increased.

FHWA's top regulatory priority for the fiscal year is to address the remaining congressionally directed rulemaking (Real-Time System

Management Information Program (2125-AF19)) resulting from the Safe,

Accountable, Flexible, and Efficient Transportation Equity Act: A

Legacy for Users (SAFETEA-LU). Additionally, the FHWA is in the process of reviewing all FHWA regulations to ensure that they are consistent with SAFETEA-LU and will update those regulations that are not consistent with this legislation.

Federal Motor Carrier Safety Administration (FMCSA)

The mission of the Federal Motor Carrier Safety Administration (FMCSA) is to reduce crashes, injuries, and fatalities involving commercial trucks and buses. A strong regulatory program is a cornerstone of

FMCSA's compliance and enforcement efforts to advance this safety mission. FMCSA develops new and more effective safety regulations based on three core priorities: Raising the bar for entry, maintaining high standards, and removing high-risk behavior. In addition to Agency- directed regulations, FMCSA develops regulations mandated by Congress, such as the Safe, Accountable, Flexible, and Efficient Transportation

Equity Act: A Legacy for Users (SAFETEA-LU). FMCSA regulations establish standards for motor carriers, drivers, vehicles, and State agencies receiving certain motor carrier safety grants and issuing commercial drivers' licenses.

FMCSA's regulatory plan for FY 2011 includes completion of a number of rulemakings that are high priorities for the Agency because they would have a positive impact on safety. Among the rulemakings included in the plan are: (1) Drivers Of Commercial Vehicles: Restricting The Use Of

Cellular Phones (RIN 2126-AB29), (2) Hours of Service (RIN 2126-AB26),

(3) Carrier Safety Fitness Determination (RIN 2126-AB11), (4)

Electronic On-Board Recorders (EOBRs) and Hours of Service Supporting

Documents (RIN 2126-AB20), and (5) National Registry of Certified

Medical Examiners (RIN 2126-AA97).

Together these priority rules could help to substantially improve commercial motor vehicle (CMV) safety on our Nation's highways by improving FMCSA's ability to provide safety oversight of motor carriers and drivers. For example, the Drivers of Commercial Vehicles:

Restricting the Use of Cellular Phones rulemaking (RIN 2126-AB29) would place restrictions on mobile phone usage while operating a CMV.

A major undertaking by FMCSA, which began in FY 2010, was to initiate a new rulemaking on Hours of Service (RIN 2126-AB26) as the result of a settlement agreement reached on October 26, 2009. Under terms of the settlement, FMCSA submitted a notice of proposed rulemaking to the

Office of Management and Budget within 9

Page 79609

months, and must issue a final rule within 21 months of the settlement.

In FY 2011, FMCSA will continue its work on the Comprehensive Safety

Analysis 2010 (CSA). The CSA initiative will improve the way FMCSA identifies and conducts carrier compliance and enforcement operations over the coming years. CSA's goal is to improve large truck and bus safety by assessing a wider range of safety performance data from a larger segment of the motor carrier industry through an array of progressive compliance interventions. FMCSA anticipates that the impacts of CSA and its associated rulemaking to put into place a new safety fitness standard will enable the Agency to prohibit ``unfit'' carriers from operating on the Nation's highways (the Carrier Safety

Fitness Determination(RIN 2126-AB11)) and will contribute further to the Agency's overall goal of decreasing CMV-related fatalities and injuries.

In FY 2011, FMCSA plans to issue a proposed rule on Electronic On-Board

Recorders and Hours of Service Supporting Documents (RIN 2126-AB20) to expand the number of carriers required to install and operate EOBRs and clarify the supporting document requirements beyond the population covered by the Agency's April 5, 2010, final rule.

Also in FY 2011, FMCSA plans to issue a final rule on the National

Registry of Certified Medical Examiners (RIN 2126-AA97) to establish training and testing requirements for healthcare professionals who issue medical certificates to CMV drivers.

In order to manage its rulemaking agenda, FMCSA continues to involve senior agency leaders at the earliest stages of its rulemakings, and continues to refine its regulatory development process. The Agency also holds senior executives accountable for meeting deadlines for completing rulemakings.

National Highway Traffic Safety Administration

The statutory responsibilities of the National Highway Traffic Safety

Administration (NHTSA) relating to motor vehicles include reducing the number of, and mitigating the effects of, motor vehicle crashes and related fatalities and injuries; providing safety performance information to aid prospective purchasers of vehicles, child restraints, and tires; and improving automotive fuel efficiency. NHTSA pursues policies that encourage the development of non-regulatory approaches when feasible in meeting its statutory mandates. It issues new standards and regulations or amendments to existing standards and regulations when appropriate. It ensures that regulatory alternatives reflect a careful assessment of the problem and a comprehensive analysis of the benefits, costs, and other impacts associated with the proposed regulatory action. Finally, it considers alternatives consistent with the Administration's regulatory principles.

NHTSA continues to pursue the high priority vehicle safety issue of occupant protection in rollover events and will issue a final rule establishing performance standards to reduce complete and partial ejections of vehicle occupants from outboard seating positions in fiscal year 2011. NHTSA will continue to work towards a final rule to require the installation of lap/shoulder belts in newly manufactured motorcoaches in accordance with NHTSA's 2007 Motorcoach Safety Plan and

DOT's 2009 Departmental Motorcoach Safety Action Plan. NHTSA also plans to publish a final rule on Rearview Visibility in 2011; this action will expand the required field of view to enable the driver of a motor vehicle to detect areas behind the motor vehicle to reduce death and injury resulting from backing incidents, particularly incidents involving small children and disabled persons.

NHTSA will continue its efforts to reduce domestic dependency on foreign oil in accordance with the Energy Independence and Security Act

(EISA) of 2007 by publishing in conjunction with EPA a joint notice of proposed rulemaking setting, for the first time, the corporate average fuel economy (CAFE) standards for both medium- and heavy-duty trucks.

NHTSA will also publish a notice of proposed rulemaking that would propose CAFE standards for light trucks and passenger cars for model years 2017 and beyond in fiscal year 2011.

In addition to numerous programs that focus on the safe performance of motor vehicles, the Agency is engaged in a variety of programs to improve driver and occupant behavior. These programs emphasize the human aspects of motor vehicle safety and recognize the important role of the States in this common pursuit. NHTSA has identified two high priority areas: Safety belt use and impaired driving. To address these issue areas, the Agency is focusing especially on three strategies-- conducting highly visible, well-publicized enforcement; supporting prosecutors who handle impaired driving cases and expanding the use of

DWI/Drug Courts, which hold offenders accountable for receiving and completing treatment for alcohol abuse and dependency; and adopting alcohol screening and brief intervention by medical and health care professionals. Other behavioral efforts encourage child safety-seat use; combat excessive speed and aggressive driving; improve motorcycle, bicycle, and pedestrian safety; and provide consumer information to the public.

Federal Railroad Administration (FRA)

FRA's current regulatory program contains numerous mandates resulting from the Rail Safety Improvement Act of 2008 (RSIA08), as well as actions supporting the Department's High-Speed Rail Strategic Plan.

RSIA08 alone has resulted in at least 18 rulemaking actions, which are competing for limited resources to meet statutory deadlines. FRA has prioritized these rulemakings according to the greatest effect on safety, as well as expressed congressional interest, and will work to complete as many rulemakings as possible prior to their statutory deadlines. Revised timelines for completion of unfinished regulations will be forwarded to Congress for consideration.

Through the Railroad Safety Advisory Committee (RSAC), FRA is working to complete RSIA08 actions that include developing requirements for train conductor certification, roadway worker protection, hours of service for employees of intercity and commuter passenger rail service, and training for railroad employees. Specifically, with regard to passenger hours of service, FRA is developing a notice of proposed rulemaking that would include proposals to establish hours of service limitations for train employees of commuter and intercity passenger railroads. The regulation will also address fatigue issues. RSAC- supported actions that advance high-speed passenger rail include proposed revisions to the Track Safety Standards dealing with vehicle- track interaction. FRA is also initiating a rulemaking related to the development of railroad risk reduction and system safety programs. This activity will be a multi-year effort due to the underlying statutory requirements that must be undertaken prior to the issuance of any final rule.

Federal Transit Administration (FTA)

FTA helps communities support public transportation by making grants of

Federal funding for transit vehicles, construction of transit facilities, and

Page 79610

planning and operation of transit and other transit-related purposes.

FTA regulatory activity focuses implementing the laws that apply to recipients' uses of federal funding and the terms and conditions of FTA grant awards. FTA policy regarding regulations is to:

Provide maximum benefit to the mobility of the nation's citizens and the connectivity of transportation infrastructure;

Provide maximum local discretion;

Ensure the most productive use of limited Federal resources;

Protect taxpayer investments in public transportation;

Incorporate principles of sound management into the grant management process.

As the needs for public transportation have changed over the years, the

Federal transit programs have grown in number and complexity. FTA's regulatory priorities for the coming year will reflect the mandates of the Agency's authorization statute, including, most notable, the Major

Capital Investments ``New Starts'' program and the State Safety

Oversight (SSO) program. The New Starts program is the main source of discretionary Federal funding for construction of rapid rail, light rail, commuter rail, and other forms of transit infrastructure. The SSO program addressed the safety of rapid rail systems and other forms of rail transit not otherwise regulated by the Federal Railroad

Administration. FTA also anticipates amending its regulations governing recipients' management of major capital projects and its Bus Testing rule.

Maritime Administration (MARAD)

The Maritime Administration (MARAD) administers Federal laws and programs to promote and strengthen the U.S. merchant marine to meet the economic and security needs of the Nation. To that end, MARAD's efforts are focused upon ensuring a strong American presence in the domestic and international trades and to expanding maritime opportunities for

American businesses and workers.

MARAD's regulatory objectives and priorities reflect the Agency's responsibility for ensuring the availability of a U.S. merchant marine that can provide water transportation services for American shippers and consumers and, in times of war or national emergency, for the U.S. armed forces. Major program areas include: The Maritime Security

Program; the Voluntary Intermodal Sealift Agreement program; the

National Defense Reserve Fleet and the Ready Reserve Force; the

Maritime Guaranteed Loan financing program; the United States Merchant

Marine Academy, and mariner education and training support programs; the Deepwater Port Licensing program; and monitoring and enforcement of

U.S. cargo preference laws. In April 2010, the Secretary announced

MARAD's newest program, the ``America's Marine Highway Program.''

MARAD's primary regulatory activities in fiscal year 2011 will be to assess existing cargo preference-related regulations, and to propose updates or new regulations where appropriate.

Pipeline and Hazardous Materials Safety Administration (PHMSA)

The Pipeline and Hazardous Materials Safety Administration (PHMSA) has responsibility for rulemaking under two programs. Through the Associate

Administrator for Hazardous Materials Safety, PHMSA administers regulatory programs under Federal hazardous materials transportation law and the Federal Water Pollution Control Act, as amended by the Oil

Pollution Act of 1990. Through the Associate Administrator for Pipeline

Safety, PHMSA administers regulatory programs under the Federal pipeline safety laws and the Federal Water Pollution Control Act, as amended by the Oil Pollution Act of 1990.

PHMSA will continue to work toward the elimination of deaths and injuries associated with the transportation of hazardous materials by all transportation modes, including pipeline. We will concentrate on the prevention of high-risk incidents identified through the evaluation of transportation incident data and findings of the National

Transportation Safety Board. PHMSA will use all available agency tools to assess data; evaluate alternative safety strategies, including regulatory strategies as necessary and appropriate; target enforcement efforts; and enhance outreach, public education, and training to promote safety outcomes.

PHMSA will continue to focus its safety efforts on the resolution of highest priority risks. PHMSA will consider regulatory changes to combat the dangers practice of distracted driving. In an effort to understand and mitigate crashes associated with driver distraction, the

DOT has been studying the distracted driving issue with respect to both behavioral and vehicle safety countermeasures. As part of the DOT's overall strategy to this problem, PHMSA plans to address the practice of text messaging (2137-AE63) and mobile phone (2137-AE65) use while driving. PHMSA's rules would apply to commercial motor vehicle drivers transporting a quantity of hazardous material requiring placarding under part 172 of the 49 CFR or any quantity of a material listed as a select agent or toxin in 42 CFR part 73.

PHMSA is also considering whether changes are needed to the regulations covering hazardous liquid onshore pipelines. In particular, PHMSA is considering whether it should extend regulation to certain pipelines currently exempt from regulation; whether other areas along a pipeline should either be identified for extra protection or be included as additional high consequence areas (HCAs) for Integrity Management (IM) protection; whether to establish and/or adopt standards and procedures for minimum lead detection requirements for all pipelines; whether to require the installation of emergency flow restricting devices (EFRDs) in certain areas; whether revised valve spacing requirements are needed on new construction or existing pipelines; whether repair timeframes should be specified for pipeline segments in areas outside the HCAs that are assessed a