Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2022
| Citation | 88 FR 10966 |
| Published date | 22 February 2023 |
| Record Number | 2023-02113 |
| Court | Regulatory Information Service Center |
| Section | Proposed rules |
Federal Register, Volume 88 Issue 35 (Wednesday, February 22, 2023)
[Federal Register Volume 88, Number 35 (Wednesday, February 22, 2023)]
[Proposed Rules]
[Pages 10966-11191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02113]
[[Page 10965]]
Vol. 88
Wednesday,
No. 35
February 22, 2023
Part IIRegulatory Information Service Center-----------------------------------------------------------------------Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions--Fall 2022
Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 /
UA: Reg Flex Agenda
[[Page 10966]]
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REGULATORY INFORMATION SERVICE CENTER
Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions--Fall 2022
AGENCY: Regulatory Information Service Center.
ACTION: Introduction to the Regulatory Plan and the Unified Agenda of
Federal Regulatory and Deregulatory Actions.
-----------------------------------------------------------------------
SUMMARY: Publication of the Fall 2022 Unified Agenda of Federal
Regulatory and Deregulatory Actions represents a key component of the
regulatory planning mechanism prescribed in Executive Order (``E.O.'')
12866, ``Regulatory Planning and Review,'' (58 FR 51735) and reaffirmed
in E.O. 13563, ``Improving Regulation and Regulatory Review,'' (76 FR
3821). 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).
The Unified Agenda of Regulatory and Deregulatory Actions (Unified
Agenda), published in the fall and spring, helps agencies fulfill all
of these requirements. All federal regulatory agencies have chosen to
publish their regulatory agendas as part of this publication. The
complete Unified Agenda and Regulatory Plan can be found online at
www.reginfo.gov and a reduced print version can be found in the Federal
Register. Information regarding obtaining printed copies can also be
found on the Reginfo.gov website (or below, VI. How Can Users Get
Copies of the Plan and the Agenda?).
The Fall 2022 Unified Agenda publication appearing in the Federal
Register includes 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.
The complete Fall 2022 Unified Agenda contains the Regulatory Plans
of 29 Federal agencies and 67 Federal agency regulatory agendas.
ADDRESSES: Regulatory Information Service Center (MV), General Services
Administration, 1800 F Street NW, 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: Boris Arratia, Director, Regulatory
Information Service Center (MV), General Services Administration, 1800
F Street NW, Washington, DC 20405, 703-795-0816. You may also send
comments to us by email at: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
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?
II. Why are the Regulatory Plan and the Unified Agenda published?
III. How are the Regulatory Plan and the Unified Agenda organized?
IV. What information appears for each entry?
V. Abbreviations
VI. How can users get copies of the Plan and the Agenda?
Introduction to the Fall 2022 Regulatory Plan
Agency Regulatory Plans
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of Housing and Urban Development
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Department of Veterans Affairs
Other Executive Agencies
Corporation for National and Community Service
Environmental Protection Agency
General Services Administration
National Aeronautics and Space Administration
National Archives and Records Administration
National Science Foundation
Office of Personnel Management
Pension Benefit Guaranty Corporation
Small Business Administration
Social Security Administration
Department of Defense/General Services Administration/National
Aeronautics and Space Administration (Federal Acquisition Regulation)
Independent Regulatory Agencies
Consumer Product Safety Commission
Federal Trade Commission
National Indian Gaming Commission
Nuclear Regulatory Commission
Regulatory Flexibility Agendas
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Other Executive Agencies
Environmental Protection Agency
General Services Administration
Office of Personnel Management
Small Business Administration
Joint Authority
Department of Defense/General Services Administration/National
Aeronautics and Space Administration (Federal Acquisition Regulation)
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Consumer Product Safety Commission
Federal Communications Commission
Federal Reserve System
National Labor Relations Board
Nuclear Regulatory Commission
Securities and Exchange Commission
Surface Transportation Board
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 and deregulatory priorities, and,
for the most part; and (2) a description of the most important
significant regulatory and deregulatory actions that the agency
reasonably
[[Page 10967]]
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. The complete Unified Agenda is available
to the public at www.reginfo.gov. The online Unified Agenda offers
flexible search tools and access to the historic Unified Agenda
database to1995. The complete online edition of the Unified Agenda
includes regulatory agendas from 65 Federal agencies. Agencies of the
United States Congress are not included.
The Fall 2022 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.
The regulatory agendas for agencies not publishing Regulatory
flexibility agendas are available to the public at http://reginfo.gov.
Cabinet Departments
Department of Housing and Urban Development*
Department of State
Department of Veterans Affairs*
Other Executive Agencies
Agency for International Development
Architectural and Transportation Barriers Compliance Board
Committee for Purchase From People Who Are Blind or Severely Disabled
Commission on Civil Rights
Corporation for National and Community Service*
Council on Environmental Quality
Court Services and Offender Supervision Agency for the District of
Columbia
Federal Mediation Conciliation Service
Institute of Museum and Library Services
Inter-American Foundation
National Aeronautics and Space Administration*
National Archives and Records Administration*
National Endowment for the Arts
National Endowment for the Humanities
National Mediation Board
National Science Foundation*
Office of Government Ethics
Office of the Intellectual Property Enforcement Coordinator
Office of Management and Budget
Office of National Drug Control Policy
Peace Corps
Pension Benefit Guaranty Corporation*
Railroad Retirement Board*
Social Security Administration*
U.S. Agency for Global Media
U.S. Commission on Civil Rights
Independent Agencies
Commodity Futures Trading Commission
Farm Credit Administration
Federal Deposit Insurance Corporation
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Maritime Commission
Federal Mine Safety and Health Review Commission
Federal Permitting Improvement Steering Council
Federal Trade Commission*
National Credit Union Administration
National Indian Gaming Commission*
National Transportation Safety Board
Postal Regulatory Commission
The Regulatory Information Service Center compiles 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 (incorporated in Executive Order 13563). The
Center also provides information about Federal regulatory activity to
the President and his Executive Office, the Congress, agency officials,
and the public.
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 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 helps 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,
``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, ``Regulatory Planning and Review,''
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 13563
Executive Order 13563, ``Improving Regulation and Regulatory
Review,'' January 18, 2011 (76 FR 3821) supplements and reaffirms the
principles, structures, and definitions
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governing contemporary regulatory review that were established in
Executive Order 12866, which includes the general principles of
regulation and public participation, and orders integration and
innovation in coordination across agencies; flexible approaches where
relevant, feasible, and consistent with regulatory approaches;
scientific integrity in any scientific or technological information and
processes used to support the agencies' regulatory actions; and
retrospective analysis of existing regulations.
Executive Order 13132
Executive Order 13132, ``Federalism,'' 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 a regulation with federalism implications, which either
preempt State law or impose non-statutory 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 a regulation, 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, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use,'' 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 in 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 which 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 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 part of the Agenda contains
a preamble providing information specific to that agency. 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' 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. 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
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agenda. This section also includes items the agency began and completed
between issues of the Agenda.
6. Long-Term Actions--are rulemakings reported during the
publication cycle that are outside of the required 12-month reporting
period for which the Agenda was intended. Completed Actions in the
publication cycle are rulemakings that are ending their lifecycle
either by Withdrawal or completion of the rulemaking process.
Therefore, the Long-Term and Completed RINs do not represent the
ongoing, forward-looking nature intended for reporting developing
rulemakings in the Agenda pursuant to Executive Order 12866, section
4(b) and 4(c). To further differentiate these two stages of rulemaking
in the Unified Agenda from active rulemakings, Long-Term and Completed
Actions are reported separately from active rulemakings, which can be
any of the first three stages of rulemaking listed above. A separate
search function is provided on www.reginfo.gov to search for Completed
and Long-Term Actions apart from each other and active RINs.
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 online 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 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 displayed in the form 12/00/19 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.
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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.
Included in the Regulatory Plan--whether the rulemaking was
included in the agency's current regulatory plan.
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, email 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, 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 RIN(s) associated with
activity related to this action, such as merged RINs, split RINs, new
activity for previously completed RINs, or duplicate RINs.
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.
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.
E.O.--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.
Legal Authority--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.
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, Public Law
112-4 is the fourth public law of the 112th 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
[[Page 10971]]
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 Regulatory Plan and 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 Unified
Agenda. Sequence numbers are not used in the online Unified Agenda.
U.S.C.--The United States Code is a consolidation and codification
of all general and permanent laws of the United States. The U.S.C. 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 Publishing 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 www.reginfo.gov, along with flexible
search tools.
The Government Publishing Office's GPO GovInfo website contains
copies of the Agendas and Regulatory Plans that have been printed in
the Federal Register. These documents are available at www.govinfo.gov.
Dated: December 20, 2022.
Boris Arratia,
Director.
Introduction to the Fall 2022 Regulatory Plan
Executive Order 12866, issued in 1993, requires the annual
production of a Unified Regulatory Agenda and Regulatory Plan. It does
so in order to promote transparency--or in the words of the Executive
Order itself, ``to have an effective regulatory program, to provide for
coordination of regulations, to maximize consultation and the
resolution of potential conflicts at an early stage, to involve the
public and its State, local, and tribal officials in regulatory
planning, and to ensure that new or revised regulations promote the
President's priorities and the principles set forth in this Executive
order.'' The requirements of Executive Order 12866 were reaffirmed in
Executive Order 13563, issued in 2011.
We are now providing the Fall 2022 Regulatory Plan. The regulatory
plans and agendas submitted by agencies and included here offer a
window into how the Administration plans to continue delivering on the
President's agenda to advance economic prosperity and equity, tackle
the climate crisis, advance public health, and much more to improve the
lives of the American people. Agencies will also be continuing their
work to implement landmark new legislation passed in 2022, including
the implementation of the PACT Act, (Pub. L. 117-168); the Inflation
Reduction Act, (Pub. L. 117-169); and the CHIPS and Science Act, (Pub.
L. 117-167); as well as ongoing efforts to implement the Infrastructure
Investment and Jobs Act (Bipartisan Infrastructure Law), Pub. L. 117-
58.
Department of Agriculture
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
1............................. Unfair Practices, Undue 0581-AE04 Proposed Rule.
Preferences, and Harm to
Competition Under the
Packers and Stockyards
Act (AMS-FTPP-21-0046).
2............................. Inclusive Competition and 0581-AE05 Proposed Rule.
Market Integrity Under
the Packers and
Stockyards Act (AMS-FTPP-
21-0045).
3............................. Poultry Growing 0581-AE18 Proposed Rule.
Tournament Systems:
Fairness and Related
Concerns--Harm to
Competition (AMS-FTPP-22-
0046).
4............................. Transparency in Poultry 0581-AE03 Final Rule.
Grower Contracting and
Tournaments (AMS-FTPP-21-
0044).
5............................. Organic Livestock and 0581-AE06 Final Rule.
Poultry Standards (AMS-
NOP-21-0073).
6............................. Special Supplemental 0584-AE82 Proposed Rule.
Nutrition Program for
Women, Infants and
Children (WIC):
Revisions in the WIC
Food Packages.
7............................. Child Nutrition Programs: 0584-AE88 Proposed Rule.
Revisions to Meal
Patterns Consistent With
the 2020 Dietary
Guidelines for Americans.
8............................. Community Eligibility 0584-AE93 Proposed Rule.
Provision: Increasing
Options for Schools.
9............................. Special Supplemental 0584-AE94 Final Rule.
Nutrition Program for
Women, Infants, and
Children (WIC):
Implementation of the
Access to Baby Formula
Act of 2022 and Related
Provisions.
10............................ Voluntary Labeling of 0583-AD87 Proposed Rule.
Products With ``Product
of USA'' and Similar
Statements.
11............................ Labeling of Meat and 0583-AD89 Proposed Rule.
Poultry Products Made
Using Animal Cell
Culture Technology.
12............................ Revision of the Nutrition 0583-AD56 Final Rule.
Facts Panels for Meat
and Poultry Products and
Updating Certain
Reference Amounts
Customarily Consumed.
13............................ Prior Label Approval 0583-AD78 Final Rule.
System: Expansion of
Generic Label Approval.
----------------------------------------------------------------------------------------------------------------
Department of Commerce
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
14............................ Section 1758 0694-AH80 Proposed Rule.
Technologies: Proposed
Controls; Request for
Comments.
[[Page 10972]]
15............................ The Imposition of 0694-AI84 Proposed Rule.
Emerging Technology
Export Controls on
Instruments for the
Automated Chemical
Synthesis of Peptides.
16............................ Updates to Bayh-Dole 0693-AB66 Final Rule.
Implementing Regulations.
17............................ Illegal, Unreported, and 0648-BG11 Final Rule.
Unregulated Fishing;
Fisheries Enforcement;
High Seas Driftnet
Fishing Moratorium
Protection Act (Reg Plan
Seq No. 17).
18............................ Amendments to the North 0648-BI88 Final Rule.
Atlantic Right Whale
Vessel Strike Reduction
Rule.
19............................ Setting and Adjusting 0651-AD65 Proposed Rule.
Trademark Fees.
----------------------------------------------------------------------------------------------------------------
Department of Defense
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
20............................ Department of Defense 0790-AK86 Proposed Rule.
(DoD)-Defense Industrial
Base (DIB) Cybersecurity
(CS) Activities.
21............................ Cybersecurity Maturity 0790-AL49 Proposed Rule.
Model Certification
(CMMC) Program.
22............................ Nondiscrimination on the 0790-AJ04 Final Rule.
Basis of Disability in
Programs or Activities
Assisted or Conducted by
the DoD and in Equal
Access to Information
and Communication
Technology Used by DoD.
23............................ Definitions of Gold Star 0790-AL56 Final Rule.
Family and Gold Star
Survivor.
24............................ Assessing Contractor 0750-AK81 Proposed Rule.
Implementation of
Cybersecurity
Requirements (DFARS Case
2019-D041).
25............................ Small Business Innovation 0750-AK84 Proposed Rule.
Research Program Data
Rights (DFARS Case 2019-
D043).
26............................ Defense Commercial 0750-AL57 Proposed Rule.
Solutions Opening (DFARS
Case 2022-D006).
27............................ Modification of Prize 0750-AL65 Proposed Rule.
Authority For Advanced
Technology Achievements
(DFARS Case 2022-D014).
28............................ DFARS Buy American Act 0750-AL74 Proposed Rule.
Requirements (DFARS Case
2022-D019).
29............................ Past Performance of 0750-AK16 Final Rule.
Subcontractors and Joint
Venture Partners (DFARS
Case 2018-D055).
30............................ Restriction on 0750-AL60 Final Rule.
Acquisition of Personal
Protective Equipment and
Certain Items From Non-
Allied Foreign Nations
(DFARS Case 2022-D009).
31............................ Natural Disaster 0710-AA78 Proposed Rule.
Procedures:
Preparedness, Response,
and Recovery Activities
of the Corps of
Engineers.
32............................ Policy and Procedures for 0710-AB22 Proposed Rule.
Processing Requests to
Alter U.S. Army Corps of
Engineers Civil Works
Projects Pursuant to 33
U.S.C. 408.
33............................ Flood Control Cost- 0710-AB34 Proposed Rule.
Sharing Requirements
Under the Ability to Pay
Provision.
34............................ USACE Implementing 0710-AB41 Proposed Rule.
Procedures for
Principles,
Requirements, and
Guidelines Applicable to
Actions Involving
Investment in Water
Resources.
35............................ Appendix C Procedures for 0710-AB46 Proposed Rule.
the Protection of
Historic Properties.
36............................ Revised Definition of 0710-AB47 Proposed Rule.
``Waters of the United
States''--Rule 2.
37............................ Credit Assistance for 0710-AB31 Final Rule.
Water Resources
Infrastructure Projects.
38............................ Revised Definition of 0710-AB40 Final Rule.
``Waters of the United
States''--Rule 1.
39............................ TRICARE Reimbursement of 0720-AB73 Final Rule.
Ambulatory Surgery
Centers and Outpatient
Services Provided in
Cancer and Children's
Hospitals.
40............................ TRICARE Coverage of 0720-AB83 Final Rule.
National Institute of
Allergy and Infectious
Disease Coronavirus
Disease 2019 Clinical
Trials.
41............................ Expanding TRICARE Access 0720-AB85 Final Rule.
to Care in Response to
the COVID-19 Pandemic.
42............................ Collection From Third 0720-AB87 Final Rule.
Party Payers of
Reasonable Charges for
Healthcare Services;
Amendment.
----------------------------------------------------------------------------------------------------------------
Department of Education
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
43............................ Nondiscrimination on the 1870-AA19 Proposed Rule.
Basis of Sex in
Athletics Education
Programs or Activities
Receiving Federal
Financial Assistance.
44............................ Nondiscrimination on the 1870-AA16 Final Rule.
Basis of Sex in
Education Programs or
Activities Receiving
Federal Financial
Assistance.
45............................ Gainful Employment....... 1840-AD57 Proposed Rule.
46............................ Improving Income Driven 1840-AD81 Proposed Rule.
Repayment.
----------------------------------------------------------------------------------------------------------------
Department of Energy
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
47............................ Clean Energy Rule for New 1904-AB96 Proposed Rule.
Federal Buildings and
Major Renovations.
[[Page 10973]]
48............................ Energy Conservation 1904-AD20 Final Rule.
Standards for
Residential Non-
Weatherized Gas Furnaces
and Mobile Home Gas
Furnaces.
49............................ Loan Guarantees for Clean 1901-AB59 Final Rule.
Energy Projects.
----------------------------------------------------------------------------------------------------------------
Department of Health and Human Services
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
50............................ Amendments to Civil 0936-AA09 Final Rule.
Monetary Penalty Law
Regarding Grants,
Contracts, and
Information Blocking.
51............................ Rulemaking on 0945-AA15 Proposed Rule.
Discrimination on the
Basis of Disability in
Health and Human
Services Programs or
Activities.
52............................ Nondiscrimination in 0945-AA17 Final Rule.
Health Programs and
Activities.
53............................ ONC Health IT 0955-AA03 Proposed Rule.
Certification Program
Updates, Health
Information Network
Attestation Process for
the Trusted Exchange
Framework and Common
Agreement, and
Enhancements to Support
Information Sharing.
54............................ Establishment of 0955-AA05 Proposed Rule.
Disincentives for Health
Care Providers who Have
Committed Information
Blocking.
55............................ Patient Engagement, 0955-AA06 Proposed Rule.
Information Sharing, and
Public Health
Interoperability.
56............................ Medications for the 0930-AA39 Proposed Rule.
Treatment of Opioid Use
Disorder.
57............................ Control of Communicable 0920-AA75 Final Rule.
Diseases; Foreign
Quarantine.
58............................ World Trade Center Health 0920-AA81 Final Rule.
Program; Addition of
Uterine Cancer to the
List of WTC-Related
Health Conditions.
59............................ Biologics Regulation 0910-AI14 Proposed Rule.
Modernization.
60............................ Certifications Concerning 0910-AI66 Proposed Rule.
Imported Foods.
61............................ Use of Salt Substitutes 0910-AI72 Proposed Rule.
to Reduce the Sodium
Content in Standardized
Foods.
62............................ Tobacco Product Standard 0910-AI76 Proposed Rule.
for Nicotine Level of
Certain Tobacco Products.
63............................ Mammography Quality 0910-AH04 Final Rule.
Standards Act.
64............................ Nonprescription Drug 0910-AH62 Final Rule.
Product With an
Additional Condition for
Nonprescription Use.
65............................ Tobacco Product Standard 0910-AI28 Final Rule.
for Characterizing
Flavors in Cigars.
66............................ Standards for the 0910-AI49 Final Rule.
Growing, Harvesting,
Packing, and Holding of
Produce for Human
Consumption Relating to
Agricultural Water.
67............................ Tobacco Product Standard 0910-AI60 Final Rule.
for Menthol in
Cigarettes.
68............................ Provider 0938-AU64 Proposed Rule.
Nondiscrimination
Requirements for Group
Health Plans and Health
Insurance Issuers in the
Group and Individual
Markets (CMS-9910).
69............................ Short-Term Limited 0938-AU67 Proposed Rule.
Duration Insurance;
Update (CMS-9904).
70............................ Assuring Access to 0938-AU68 Proposed Rule.
Medicaid Services (CMS-
2442).
71............................ Transitional Coverage for 0938-AU86 Proposed Rule.
Emerging Technologies
(CMS-3421).
72............................ Interoperability and 0938-AU87 Proposed Rule.
Prior Authorization for
MA Organizations,
Medicaid and CHIP
Managed Care and State
Agencies, FFE QHP
Issuers, MIPS Eligible
Clinicians, Eligible
Hospitals and CAHs (CMS-
0057).
73............................ Medicare and Medicaid 0938-AU90 Proposed Rule.
Program Integrity (CMS-
6084).
74............................ Culturally Competent and 0938-AU91 Proposed Rule.
Person-Centered
Requirements to Increase
Access to Care and
Improve Quality for All
(CMS-3418).
75............................ Mental Health Parity and 0938-AU93 Proposed Rule.
Addiction Equity Act and
the Consolidated
Appropriations Act, 2021
(CMS-9902).
76............................ Coverage of Certain 0938-AU94 Proposed Rule.
Preventive Services
Under the Affordable
Care Act (CMS-9903).
77............................ Contract Year 2024 0938-AU96 Proposed Rule.
Changes to the Medicare
Advantage, Medicare
Prescription Drug
Benefit, Medicare Cost
Plan Programs, Medicare
Overpayment Provisions
of the Affordable Care
Act, and PACE (CMS-4201).
78............................ FY 2024 Skilled Nursing 0938-AV02 Proposed Rule.
Facility (SNFs)
Prospective Payment
System and Consolidated
Billing and Updates to
the Value-Based
Purchasing and Quality
Reporting Programs (CMS-
1779).
79............................ Streamlining the Medicaid 0938-AU00 Final Rule.
and CHIP Application,
Eligibility
Determination,
Enrollment, and Renewal
Processes (CMS-2421).
80............................ Foster Care Legal 0970-AC89 Proposed Rule.
Representation.
81............................ Separate Licensing 0970-AC91 Proposed Rule.
Standards for Relative
or Kinship Foster Family
Homes.
82............................ Unaccompanied Children 0970-AC93 Proposed Rule.
Program Foundational
Rule.
83............................ Federal Licensing of 0970-AC94 Proposed Rule.
Office of Refugee
Resettlement Facilities.
84............................ Strengthening TANF as a 0970-AC97 Proposed Rule.
Safety Net and Work
Program.
85............................ Adoption and Foster Care 0970-AC98 Proposed Rule.
Analysis and Reporting
System (AFCARS).
86............................ Modification of the 0970-AC99 Proposed Rule.
Tribal Non-Federal Share
Requirement.
87............................ ANA Non-Federal Share 0970-AC88 Final Rule.
Emergency Waivers.
88............................ Older Americans Act, 0985-AA17 Proposed Rule.
Titles III, VI, and VII.
89............................ Adult Protective Services 0985-AA18 Proposed Rule.
Functions and Grant
Programs.
----------------------------------------------------------------------------------------------------------------
[[Page 10974]]
Department of Homeland Security
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
90............................ Victims of Qualifying 1615-AA67 Proposed Rule.
Criminal Activities;
Eligibility Requirements
for U Nonimmigrant
Status and Adjustment of
Status.
91............................ Improving the Regulations 1615-AC22 Proposed Rule.
Governing the Adjustment
of Status to Lawful
Permanent Residence and
Related Immigration
Benefits.
92............................ Particular Social Group 1615-AC65 Proposed Rule.
and Related Definitions
and Interpretations for
Asylum and Withholding
of Removal.
93............................ U.S. Citizenship and 1615-AC68 Proposed Rule.
Immigration Services Fee
Schedule and Changes to
Certain Other
Immigration Benefit
Request Requirements.
94............................ Bars to Asylum 1615-AC69 Proposed Rule.
Eligibility and Related
Procedures.
95............................ Modernization and Reform 1615-AC76 Proposed Rule.
of the H-2 Programs.
96............................ Citizenship and 1615-AC80 Proposed Rule.
Naturalization and Other
Related Flexibilities.
97............................ Relief Under the Violence 1615-AC81 Proposed Rule.
Against Women Act of
1994 and Subsequent
Legislation.
98............................ Security Bars and 1615-AC57 Final Rule.
Processing.
99............................ Cybersecurity in the 1625-AC77 Proposed Rule.
Marine Transportation
System.
100........................... MARPOL Annex VI; 1625-AC78 Proposed Rule.
Prevention of Air
Pollution From Ships.
101........................... Advance Passenger 1651-AB43 Proposed Rule.
Information System:
Electronic Validation of
Travel Documents.
102........................... Enhancing Surface Cyber 1652-AA74 Prerule.
Risk Management.
103........................... Vetting of Certain 1652-AA69 Proposed Rule.
Surface Transportation
Employees.
104........................... Amending Vetting 1652-AA70 Proposed Rule.
Requirements for
Employees With Access to
a Security
Identification Display
Area (SIDA).
105........................... Flight Training Security 1652-AA35 Final Rule.
Program.
106........................... Immigration Bond 1653-AA85 Final Rule.
Notifications and
Electronic Service.
107........................... Optional Alternative to 1653-AA86 Final Rule.
the Physical Examination
Associated With
Employment Eligibility
Verification (Form I-9).
108........................... National Flood Insurance 1660-AB06 Proposed Rule.
Program: Standard Flood
Insurance Policy,
Homeowner Flood Form.
109........................... Individual Assistance 1660-AB07 Proposed Rule.
Program Equity.
110........................... Update of FEMA's Public 1660-AB09 Proposed Rule.
Assistance Regulations.
111........................... Updates to Floodplain 1660-AB12 Proposed Rule.
Management and
Protection of Wetlands
Regulations.
112........................... National Flood Insurance 1660-AB11 Long-Term Action.
Program's Floodplain
Management Standards for
Land Management & Use, &
an Assessment of the
Program's Impact on
Threatened and
Endangered Species &
Their Habitats.
113........................... Ammonium Nitrate Security 1670-AA00 Proposed Rule.
Program.
114........................... Chemical Facility Anti- 1670-AA01 Proposed Rule.
Terrorism Standards
(CFATS).
----------------------------------------------------------------------------------------------------------------
Department of Housing and Urban Development
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
115........................... 24 CFR 5, 92, 93, 200, 2501-AE05 Proposed Rule.
247, 574, 576 578
Violence Against Women
Act Reauthorization Act
of 2022: Compliance in
HUD Housing Programs (FR-
6319).
116........................... 24 CFR 50 Floodplain 2506-AC54 Proposed Rule.
Management and
Protection of Wetlands
(FR-6272).
----------------------------------------------------------------------------------------------------------------
Department of Interior
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
117........................... Onshore Oil and Gas 1004-AE91 Final Rule.
Operations--Annual Civil
Penalties Inflation
Adjustments.
----------------------------------------------------------------------------------------------------------------
Department of Justice
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
118........................... Home Confinement Under 1120-AB79 Final Rule.
the Coronavirus Aid,
Relief, and Economic
Security (CARES) Act.
119........................... Implementation of the ADA 1190-AA73 Proposed Rule.
Amendments Act of 2008:
Federally Conducted
(Section 504 of the
Rehabilitation Act of
1973).
120........................... Nondiscrimination on the 1190-AA78 Proposed Rule.
Basis of Disability by
State and Local
Governments: Medical
Diagnostic Equipment.
121........................... Nondiscrimination on the 1190-AA79 Proposed Rule.
Basis of Disability:
Accessibility of Web
Information and Services
of State and Local
Governments.
122........................... Nondiscrimination on the 1190-AA77 Long-Term Action.
Basis of Disability by
State and Local
Governments; Public
Right-of-Way.
123........................... Medications to Prevent 1117-AB73 Proposed Rule.
Narcotic Opioid
Withdrawal Symptoms.
[[Page 10975]]
124........................... Expansion of Induction of 1117-AB78 Proposed Rule.
Buprenorphine via
Telemedicine Encounter.
125........................... Bars to Asylum 1125-AB12 Proposed Rule.
Eligibility and Related
Procedures.
126........................... Particular Social Group 1125-AB13 Proposed Rule.
and Related Definitions
and Interpretations for
Asylum and Withholding
of Removal.
127........................... Procedures for Asylum and 1125-AB15 Proposed Rule.
Withholding of Removal.
128........................... Appellate Procedures and 1125-AB18 Proposed Rule.
Decisional Finality in
Immigration Proceedings;
Administrative Closure.
129........................... Procedures for Credible 1125-AB20 Final Rule.
Fear Screening and
Consideration of Asylum,
Withholding of Removal
and CAT Protection
Claims by Asylum
Officers.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
130........................... Final Action on Proposal 1250-AA09 Final Rule.
to Rescind Implementing
Legal Requirements
Regarding the Equal
Opportunity Clause's
Religious Exemption.
131........................... Pre-enforcement Notice 1250-AA14 Final Rule.
and Conciliation
Procedures.
132........................... Form LM-10 Employer 1245-AA13 Final Rule.
Report.
133........................... Defining and Delimiting 1235-AA39 Proposed Rule.
the Exemptions for
Executive,
Administrative,
Professional, Outside
Sales and Computer
Employees.
134........................... Nondisplacement of 1235-AA42 Proposed Rule.
Qualified Workers Under
Service Contracts.
135........................... Updating the Davis-Bacon 1235-AA40 Final Rule.
and Related Acts
Regulations.
136........................... Wagner-Peyser Act 1205-AC02 Final Rule.
Staffing.
137........................... Definition of the Term 1210-AC02 Proposed Rule.
``Fiduciary''.
138........................... Mental Health Parity and 1210-AC11 Proposed Rule.
Addiction Equity Act and
the Consolidated
Appropriations Act, 2021.
139........................... Respirable Crystalline 1219-AB36 Proposed Rule.
Silica.
140........................... Safety Program for 1219-AB91 Final Rule.
Surface Mobile Equipment.
141........................... Prevention of Workplace 1218-AD08 Prerule.
Violence in Health Care
and Social Assistance.
142........................... Heat Illness Prevention 1218-AD39 Prerule.
in Outdoor and Indoor
Work Settings.
143........................... Infectious Diseases...... 1218-AC46 Proposed Rule.
144........................... Occupational Exposure to 1218-AD36 Final Rule.
COVID-19 in Healthcare
Settings.
----------------------------------------------------------------------------------------------------------------
Department of Transportation
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
145........................... +Enhancing Transparency 2105-AF10 Proposed Rule.
of Airline Ancillary
Service Fees.
146........................... +Accessible Lavatories on 2105-AE89 Final Rule.
Single-Aisle Aircraft:
Part II.
147........................... +Safety Management System 2120-AL60 Proposed Rule.
for Parts 21, 91, 135
and 145.
148........................... +National Electric 2125-AG10 Final Rule.
Vehicle Infrastructure
Formula Program.
149........................... +Heavy Vehicle Automatic 2127-AM36 Proposed Rule.
Emergency Braking.
150........................... +Light Vehicle Automatic 2127-AM37 Proposed Rule.
Emergency Braking (AEB)
with Pedestrian AEB.
151........................... +Fuel Efficiency and 2127-AM39 Proposed Rule.
Greenhouse Gas Standards
for Medium- and Heavy-
Duty Engines and
Vehicles.
152........................... +Light Vehicle CAFE 2127-AM55 Proposed Rule.
Standards Beyond MY 2026.
153........................... +Train Crew Staffing..... 2130-AC88 Proposed Rule.
154........................... +Pipeline Safety: Class 2137-AF29 Final Rule.
Location Requirements.
----------------------------------------------------------------------------------------------------------------
Department of Veterans Affairs
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
155........................... Updating VA Adjudication 2900-AR10 Proposed Rule.
Regulations for
Disability or Death
Benefit Claims Related
to Herbicide Exposure.
156........................... Pilot Veterans Services 2900-AR60 Proposed Rule.
Organization
Complementary and
Integrative Health Self-
Care Well-Being Center
Grant Program.
157........................... Expanded Burial Benefits. 2900-AR69 Proposed Rule.
158........................... Updating VA Adjudication 2900-AR75 Proposed Rule.
Regulations for
Disability or Death
Benefits Based on Toxic
Exposure.
159........................... Reevaluation of Claims 2900-AR76 Proposed Rule.
for Dependency and
Indemnity Compensation
Based on Public Law 117-
168.
160........................... Authorization of 2900-AR77 Proposed Rule.
Electronic Notice in
Claims Under Laws
Administered by the
Secretary of Veterans
Affairs.
161........................... Modifying Copayments for 2900-AQ30 Final Rule.
Veterans at High Risk
for Suicide.
162........................... Home Visits in Program of 2900-AQ96 Final Rule.
Comprehensive Assistance
for Family Caregivers
During COVID-19 National
Emergency.
163........................... Staff Sergeant Parker 2900-AR16 Final Rule.
Gordon Fox Suicide
Prevention Grant Program.
[[Page 10976]]
164........................... Copayment Exemption for 2900-AR48 Final Rule.
Indian Veterans.
165........................... Technical Revisions to 2900-AR73 Final Rule.
Expand Health Care for
Certain Toxic Exposure
and Overseas Contingency
Service.
166........................... Procedural Updates for 2900-AR74 Final Rule.
the PACT Act.
----------------------------------------------------------------------------------------------------------------
Environmental Protection Agency
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
167........................... Phasedown of 2060-AV84 Prerule.
Hydrofluorocarbons:
Management of Certain
Hydrofluorocarbons and
Substitutes Under
Subsection (h) of the
American Innovation and
Manufacturing Act of
2020.
168........................... PFAS-Related Designations 2050-AH25 Prerule.
as CERCLA Hazardous
Substances.
169........................... National Emission 2060-AU37 Proposed Rule.
Standards for Hazardous
Air Pollutants: Ethylene
Oxide Commercial
Sterilization and
Fumigation Operations.
170........................... Amendments to the NSPS 2060-AV09 Proposed Rule.
for GHG Emissions From
New, Modified, &
Reconstructed Stationary
Sources: EGUs.
171........................... Emission Guidelines for 2060-AV10 Proposed Rule.
Greenhouse Gas Emissions
From Fossil Fuel-Fired
Existing Electric
Generating Units.
172........................... Volume Requirements for 2060-AV14 Proposed Rule.
2023 and Beyond Under
the Renewable Fuel
Standard Program.
173........................... New Source Performance 2060-AV16 Proposed Rule.
Standards and Emission
Guidelines for Crude Oil
and Natural Gas
Facilities: Climate
Review.
174........................... Review of Final Rule 2060-AV20 Proposed Rule.
Reclassification of
Major Sources as Area
Sources Under Section
112 of the Clean Air Act.
175........................... Revisions to the Air 2060-AV41 Proposed Rule.
Emission Reporting
Requirements (AERR).
176........................... Phasedown of 2060-AV45 Proposed Rule.
Hydrofluorocarbons:
Allowance Allocation
Methodology for 2024 and
Later Years.
177........................... Restrictions on Certain 2060-AV46 Proposed Rule.
Uses of
Hydrofluorocarbons Under
Subsection (i) of the
American Innovation and
Manufacturing Act.
178........................... Implementing Regulations 2060-AV48 Proposed Rule.
Under 40 CFR Part 60
Subpart Ba Adoption and
Submittal of State Plans
for Designated
Facilities.
179........................... Multi-Pollutant Emissions 2060-AV49 Proposed Rule.
Standards for Model
Years 2027 and Later
Light-Duty and Medium-
Duty Vehicles.
180........................... Reconsideration of the 2060-AV52 Proposed Rule.
National Ambient Air
Quality Standards for
Particulate Matter.
181........................... NESHAP: Coal-and Oil- 2060-AV53 Proposed Rule.
Fired Electric Utility
Steam Generating Units-
Review of the Residual
Risk and Technology
Review.
182........................... Methane Emissions and 2060-AV83 Proposed Rule.
Waste Reduction
Incentive Program and
Revisions to the
Mandatory Greenhouse Gas
Reporting Rule for
Petroleum and Natural
Gas Systems.
183........................... Fees for the 2070-AK64 Proposed Rule.
Administration of the
Toxic Substances Control
Act (TSCA).
184........................... Methylene Chloride; 2070-AK70 Proposed Rule.
Rulemaking Under Section
6(a) of the Toxic
Substances Control Act
(TSCA).
185........................... 1-Bromopropane; 2070-AK73 Proposed Rule.
Rulemaking Under Section
6(a) of the Toxic
Substances Control Act
(TSCA).
186........................... Carbon Tetrachloride; 2070-AK82 Proposed Rule.
Rulemaking Under Section
6(a) of the Toxic
Substances Control Act
(TSCA).
187........................... Trichloroethylene; 2070-AK83 Proposed Rule.
Rulemaking Under Section
6(a) of the Toxic
Substances Control Act
(TSCA).
188........................... Perchloroethylene; 2070-AK84 Proposed Rule.
Rulemaking Under Section
6(a) of the Toxic
Substances Control Act
(TSCA).
189........................... N-Methylpyrrolidone; 2070-AK85 Proposed Rule.
Rulemaking Under Section
6(a) of the Toxic
Substances Control Act
(TSCA).
190........................... Procedures for Chemical 2070-AK90 Proposed Rule.
Risk Evaluation Under
the Toxic Substances
Control Act (TSCA).
191........................... Reconsideration of the 2070-AK91 Proposed Rule.
Dust-Lead Hazard
Standards and Dust-Lead
Post Abatement Clearance
Levels.
192........................... Hazardous and Solid Waste 2050-AH14 Proposed Rule.
Management System:
Disposal of Coal
Combustion Residuals
From Electric Utilities;
Legacy Surface
Impoundments.
193........................... Revisions to Standards 2050-AH24 Proposed Rule.
for the Open Burning/
Open Detonation of Waste
Explosives.
194........................... Listing of PFOA, PFOS, 2050-AH26 Proposed Rule.
PFBS, and GenX as
Resource Conservation
and Recovery Act (RCRA)
Hazardous Constituents.
195........................... Definition of Hazardous 2050-AH27 Proposed Rule.
Waste Applicable to
Corrective Action for
Solid Waste Management
Units.
196........................... Reporting Requirements 2050-AH28 Proposed Rule.
for Emissions From
Animal Waste Under the
Emergency Planning and
Community Right-to-Know
Act.
197........................... Federal Baseline Water 2040-AF62 Proposed Rule.
Quality Standards for
Indian Reservations.
[[Page 10977]]
198........................... Revised Definition of 2040-AG13 Proposed Rule.
``Waters of the United
States''.
199........................... National Primary Drinking 2040-AG16 Proposed Rule.
Water Regulations for
Lead and Copper:
Improvements (LCRI) (.
200........................... Water Quality Standards 2040-AG17 Proposed Rule.
Regulatory Revisions to
Protect Tribal Reserved
Rights.
201........................... Per- and Polyfluoroalkyl 2040-AG18 Proposed Rule.
Substances (PFAS)
National Primary
Drinking Water
Regulation Rulemaking.
202........................... Effluent Limitations 2040-AG23 Proposed Rule.
Guidelines and Standards
for the Steam Electric
Power Generating Point
Source Category.
203........................... Control of Air Pollution 2060-AU41 Final Rule.
From New Motor Vehicles:
Heavy-Duty Engine and
Vehicle Standards.
204........................... NESHAP: Coal- and Oil- 2060-AV12 Final Rule.
Fired Electric Utility
Steam Generating Units-
Revocation of the 2020
Reconsideration, and
Affirmation of the
Appropriate and
Necessary Supplemental
Finding.
205........................... Pesticides; Exemptions of 2070-AK54 Final Rule.
Certain Plant-
Incorporated Protectants
(PIPs) Derived From
Newer Technologies.
206........................... Asbestos Part 1: 2070-AK86 Final Rule.
Chrysotile Asbestos;
Regulation of Certain
Conditions of Use Under
Section 6(a) of the
Toxic Substances Control
Act (TSCA).
207........................... Hazardous and Solid Waste 2050-AH07 Final Rule.
Management System:
Disposal of Coal
Combustion Residuals
From Electric Utilities;
Federal CCR Permit
Program.
208........................... Hazardous and Solid Waste 2050-AH18 Final Rule.
Management System:
Disposal of CCR; A
Holistic Approach to
Closure Part B:
Implementation of
Closure.
209........................... Accidental Release 2050-AH22 Final Rule.
Prevention Requirements:
Risk Management Program
Under the Clean Air Act;
Safer Communities by
Chemical Accident
Prevention.
210........................... Clean Water Act Section 2040-AG12 Final Rule.
401: Water Quality
Certification.
211........................... Revised Definition of 2040-AG19 Final Rule.
``Waters of the United
States''.
----------------------------------------------------------------------------------------------------------------
Office of Personnel Management
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
212........................... Postal Service Health 3206-AO43 Final Rule.
Benefits Program.
----------------------------------------------------------------------------------------------------------------
Pension Benefit Guaranty Corporation
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
213........................... Actuarial Assumptions for 1212-AB54 Proposed Rule.
Determining an
Employer's Withdrawal
Liability.
214........................... Special Financial 1212-AB53 Final Rule.
Assistance by PBGC.
----------------------------------------------------------------------------------------------------------------
Social Security Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
215........................... Use of Electronic Payroll 0960-AH88 Proposed Rule.
Data To Improve Program
Administration.
216........................... Omitting Food From In- 0960-AI60 Proposed Rule.
Kind Support and
Maintenance Calculations.
217........................... Social Security Number 0960-AI80 Proposed Rule.
Use in Government
Records.
218........................... Revised Medical Criteria 0960-AG65 Proposed Rule.
for Evaluating Digestive
Disorders and Skin
Disorders.
----------------------------------------------------------------------------------------------------------------
Consumer Product Safety Commission
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
219........................... Regulatory Options for 3041-AC31 Final Rule.
Table Saws.
220........................... Petition for Rulemaking 3041-AD31 Final Rule.
to Eliminate Accessible
Cords on Window Covering
Products.
221........................... Furniture Tip Overs: 3041-AD65 Final Rule.
Clothing Storage Units.
----------------------------------------------------------------------------------------------------------------
[[Page 10978]]
Nuclear Regulatory Commission
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking stage
----------------------------------------------------------------------------------------------------------------
222........................... Enhanced Weapons for 3150-AJ55 Prerule.
Spent Fuel Storage
Installations and
Transportation--Section
161A Authority [NRC-2015-
0018].
223........................... American Society of 3150-AK23 Proposed Rule.
Mechanical Engineers
Code Cases and Update
Frequency [NRC-2018-
0291].
224........................... Risk-Informed, Technology 3150-AK31 Proposed Rule.
Inclusive Regulatory
Framework [NRC-2019-
0062].
225........................... Renewing Nuclear Power 3150-AK32 Proposed Rule.
Plant Operating
Licenses--Environmental
Review [NRC-2018-0296].
226........................... Revision of Fee 3150-AK58 Proposed Rule.
Schedules: Fee Recovery
for FY 2023 [NRC-2021-
0024].
----------------------------------------------------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Statement of Regulatory Priorities
The U.S. Department of Agriculture's (USDA) fall 2022 Regulatory
Agenda and Plan prioritizes initiatives fostering 21st century
innovation like delivering broadband to farmers, ranchers, small
businesses, and rural communities, addressing the effects of climate
change such as drought and wildfire risks via climate-smart
agriculture, expanding economic and market opportunity at home and
abroad, job creation, improving access and delivery of our programs,
particularly among historically underserved people and communities, and
tackling food and nutrition insecurity while maintaining a safe food
supply. Meanwhile, as we've responded to immediate needs during the
past two years, USDA will continue to leverage our existing programs in
response to those unforeseen domestic and international events and
national emergencies that impact the American farm economy, schools,
individual households, and our National Forests. Finally, we note that
all USDA programs, including the priorities contained in this
Regulatory Plan, will be structured to advance the cause of equity by
removing barriers and opening new opportunities.
In 2022, the USDA:
Risk Management Agency implemented the Pandemic Cover Crop Program
that reduced crop insurance premiums for agricultural producers to help
them maintain cover crop systems, an important conservation practice,
while keeping producers eligible for a premium benefit under the
program.
Food and Nutrition Service (FNS) implemented a final rule that
establishes Standards for Milk, Whole Grains, and Sodium in its Child
Nutrition Programs for school years 2022-2023 and 2023-2024 to give
schools time to transition in the short term as FNS works to develop
long-term nutrition standards--based on the newest Dietary Guidelines
for America and extensive input from a wide range of partners--that
will work for schools, families, and industry alike. In 2022, FNS also
implemented streamlining requirements in its Child Nutrition Programs
to simplify the application process, enhance monitoring requirements,
offer more clarity on existing requirements, and provide more
discretion at the State agency level to manage program operations.
In late 2022, USDA plans to announce Phase 2 of the Emergency
Relief Program that provides assistance to producers who suffered crop
losses due to qualifying disaster events, and the Pandemic Assistance
Revenue Program, a new program that provides support for agricultural
producers impacted by the COVID-19 pandemic. In addition, this action
makes changes to the Coronavirus Food Assistance Program; the Emergency
Conservation Program; the Emergency Assistance for Livestock,
Honeybees, and Farm-Raised Fish Program; the Livestock Forage Disaster
Program; the Livestock Indemnity Program; the Noninsured Crop Disaster
Assistance Program; and general payment eligibility provisions. For
more information about this rule, see RIN 0503-AA75.
Outlined below are some of USDA's most important upcoming
regulatory actions for 2023. These include efforts to restore and
expand economic opportunity; address the climate crisis; and support
agricultural markets that are free, open and promote competition. This
Regulatory Plan also reflects USDA's continued commitments to ensuring
a safe and nutritious food supply and animal welfare protections. As
always, our Semiannual Regulatory Agenda contains information on a
broad-spectrum of USDA's initiatives and upcoming regulatory actions.
Combat Climate Change To Support America's Working Lands, Natural
Resources and Communities
Special Areas; Roadless Area Conservation; National Forest System
Lands in Alaska: In November 2021, USDA proposed to repeal a final rule
promulgated in 2020 that exempted the Tongass National Forest from the
2001 Roadless Area Conservation Rule (2001 Roadless Rule). The 2001
Roadless Rule prohibited timber harvest and road construction or
reconstruction within designated Inventoried Roadless Areas, with
limited exceptions. USDA is planning to finalize this proposed rule in
a manner consistent with President Biden's Executive Order 13990,
Protecting Public Health and the Environment and Restoring Science to
Tackle the Climate Crisis, directing review of Federal regulations
issued during the previous four years that may conflict with protecting
the environment, and in support of efforts to confront the climate
crisis. For more information about this rule, see RIN 0596-AD51.
Foster an Equitable and Competitive Marketplace for All Agricultural
Producers
Inclusive Competition and Market Integrity Rules Under the Packers
and Stockyards Act: In October 2022, USDA proposed to revise
regulations under the Packers and Stockyards (P&S) Act, prohibiting
certain prejudices and disadvantages and unjustly discriminatory
conduct against covered producers in the livestock, meat, and poultry
markets. The proposal identified retaliatory practices that interfere
with lawful communications, assertion of rights, and participation in
associations, among other protected activities. The proposal also
identified unlawfully deceptive practices that violate the P&S Act with
respect to contract formation, contract performance, contract
termination and contract refusal. The purpose of the final rule is to
promote inclusive competition and market integrity in the livestock,
meats, and poultry markets. For more information about this rule, see
RIN 0581-AE05.
Transparency in Poultry Grower Contracting and Tournaments Systems:
The final rule would address the use of poultry grower ranking systems
as a method of payment and settlement grouping for poultry growers
under
[[Page 10979]]
contract in poultry growing arrangements with live poultry dealers. The
final rule would establish certain requirements with which a live
poultry dealer must comply if a poultry grower ranking system is
utilized to determine grower payment. A live poultry dealer's failure
to comply would be deemed an unfair, unjustly discriminatory, and
deceptive practice according to factors outlined in the final rule. A
proposed rule was published in the Federal Register on June 8, 2022, 87
FR 48091. For more information about this rule, see RIN 0581-AE03.
Unfair Practices, Undue Preferences, and Harm to Competition under
the Packers and Stockyards Act: The proposal would revise regulations
under the Packers and Stockyards Act (Act), providing clarity regarding
conduct that may violate the Act, including addressing harm to
competition. For more information about this rule, see RIN 0581-AE04.
Poultry Growing Tournament Systems: Fairness and Related Concerns--
Harm to Competition: The proposal seeks to address the use of poultry
grower ranking systems, commonly known as ``tournaments'' in contract
poultry production. Based on inputs from poultry growers, the proposal
will seek to improve the market for poultry grower services. An advance
notice of proposed rulemaking was published in the Federal Register on
June 8, 2022, 87 FR 34814. For more information about this rule, see
RIN 0581-AE18.
Provide All Americans Safe, Nutritious Food
USDA's Food Safety and Inspection Service (FSIS) continues to
ensure that meat, poultry, and egg products are safe, wholesome, and
properly marked, labeled, and packaged, and prohibits the distribution
in-commerce of meat, poultry, and egg products that are adulterated or
misbranded. One of FSIS' top priorities is to develop a more
comprehensive and effective strategy to reduce Salmonella illnesses
associated with poultry products. The agency is gathering the data and
information necessary to support future action and move closer to the
national target of a 25 percent reduction in Salmonella illnesses.
In addition, to enhance the safety of raw beef products, FSIS is
strengthening its sampling and testing programs for shiga-toxin
producing Escherichia coli in these products.
Moreover, consistent with the President's priorities of advancing
the country's economic recovery and promoting economic resilience, FSIS
is proposing several rules to improve regulatory certainty, which
assure consumers that meat, poultry, and egg products are safe and
truthfully labeled and fosters fair competition among the regulated
industry. In a similar vein, AMS has prepared proposed standards for
organic livestock and poultry production.
Voluntary Labeling of Meat Products With ``Product of USA'' and
Similar Statements: In accordance with Executive Order 14036, Promoting
Competition in the American Economy, FSIS will propose to address
concerns that the voluntary ``Product of USA'' label claim may confuse
consumers about the origin of FSIS regulated products and undermine
fair competition. FSIS intends to define the voluntary claim so that it
is more meaningful to consumers and ensures a fair and competitive
marketplace for American farmers and ranchers. For more information
about this rule, see RIN 0583-AD87.
Labeling of Meat or Poultry Products Comprised of or Containing
Cultured Animal Cells; Revision of the Nutrition Facts Panels for Meat
and Poultry Products and Updating Certain Reference Amounts Customarily
Consumed; and Prior Label Approval System: Expansion of Generic Label
Approval: FSIS will propose to establish new requirements for the
labeling of meat or poultry products made using animal cell culture
technology. FSIS also plans to finalize two other labeling rules, one
to update nutrition labeling for meat and poultry products and another
to expand the categories of meat and poultry product labels deemed
generically approved that may be used in commerce without prior FSIS
review and approval. The rule expanding the categories of generically
approved labels will reduce labeling costs for meat and poultry
establishments, including small and very small establishments. The
three rules will provide additional certainty about what is required
for meat and poultry labeling while ensuring that consumers have
accurate information about the food they buy. For more information
about these rules, see RINs 0583-AD56, 0583-AD78, and 0583-AD89.
National Organic Program; Organic Livestock and Poultry Standards:
The final rule would establish standards that support additional
practice standards for organic livestock and poultry production. This
final action would add provisions to the USDA organic regulations to
address and clarify livestock and poultry living conditions (for
example, outdoor access, housing environment and stocking densities),
health care practices (for example physical alterations, administering
medical treatment, euthanasia), and animal handling and transport to
and during slaughter. For more information about this rule, see RIN
0581-AE06.
FNS' Child Nutrition Programs: Revisions to Meal Patterns
Consistent with the 2020 Guidelines forAmericans: The proposed
revisions would revise meal patterns in the National School Lunch
Program and School Breakfast Program to make school meals healthier and
more consistent with the most recent Dietary Guidelines for Americans
while reflecting the nutrient needs of children at risk for food
insecurity. For more information about this rule, see RIN 0584-AE88.
FNS' Special Supplemental Nutrition Program for Women, Infants and
Children (WIC): Revisions in the WIC Food Packages: Consistent with
recommendations from the National Academies of Sciences, Engineering,
and Medicine and the latest Dietary Guidelines for Americans, the
proposal seeks to provide participants with greater choices in variety
and food package sizes. For more information about this rule, see RIN
0584-AE82.
FNS' Community Eligibility Provision: Increasing Options for
Schools: The Community Eligibility Provision (CEP) is an option for
schools to offer no-cost meals to all students without the burden of
collecting household applications. This provision saves local
educational agencies time and money by streamlining paperwork and
administrative requirements and facilitates low-income children's
access to nutritious school meals. This rule would lower the minimum
participation threshold, which would expand access to CEP and provide
greater flexibility to States and schools that want to use additional
State and local funds to provide no-cost meals to students. For more
information about this rule, see RIN 0584-AE93.
USDA--AGRICULTURAL MARKETING SERVICE (AMS)
Proposed Rule Stage
1. Unfair Practices, Undue Preferences, and Harm to Competition Under
the Packers and Stockyards Act (AMS-FTPP-21-0046) [0581-AE04]
Priority: Other Significant.
Legal Authority: 7 U.S.C. 181 to 229c
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: This action proposes to revise regulations issued under
the Packers and Stockyards Act (Act) (7
[[Page 10980]]
U.S.C.181 229c), providing clarity regarding conduct that may violate
the Act. Revisions are intended to support market growth, assure fair
trade practices and competition, and protect livestock and poultry
growers and producers. The action addresses long-standing issues
related to competitiveness and showings of harm or likely harm to
competition.
Statement of Need: Revisions to regulations pertaining to the
Packers and Stockyards Act (Act) clarify the types of conduct by
packers, swine contractors, or live poultry dealers that the
Agricultural Marketing Service (AMS) considers unfair practices or
undue preferences and a violation of sections 202(a) or 202(b) of the
Act.
Sections 202(a) and 202(b) of the P&S Act are broadly written to
prohibit unjustly practices and undue preferences. Industry members
have complained that the regulations effectuating the Act are too vague
and do not provide adequate clarity about the types of conduct or
action that are likely to violate the Act. This rule is needed to
provide essential clarity about what would be considered violations of
the Act.
Revisions to regulations pertaining to the Packers and Stockyards
Act (Act) that would also clarify the scope of the Act are needed to
establish what conduct or action, depending on their nature and the
circumstances, violate the Act without a finding of harm or likely harm
to competition or as they may relate to harm or likely harm to
competition as such terms were contemplated under the Act. Such
revisions reflect the Department of Agriculture's (USDA) longstanding
position in this regard.
Summary of Legal Basis: The Packers and Stockyards Act (Act)
authorizes AMS to determine if conduct within the poultry and livestock
industries are unfair practices or undue preferences and, therefore a
violation of the Act.
The Act provides USDA with the authority to assure fair competition
and trade practices and to safeguard farmers against receiving less
than the true market value of their livestock. Sections 202(c), (d),
and (e) of the Act limit the application of those sections to acts or
practices that have an adverse effect on competition, such as acts
restraining commerce, creating a monopoly, or producing another type of
antitrust injury. However, provisions in sections 202(a) and (b)
restrict practices that are deceptive, unfair, unjust, undue, and
unreasonable; terms that are understood to encompass more than
anticompetitive conduct. USDA's position is that Congress did not
intend application of sections 202(a) and (b) to be limited to
instances in which there is harm to competition.
Alternatives: USDA considered doing nothing. However, courts are
not unanimous in their findings. Further, several courts disagree with
USDA's position. Lack of clarity hinders the agency's ability to
consistently administer and enforce the Act.
Anticipated Cost and Benefits: USDA estimate annual costs related
to this rule of $9 million for the first five years, decreasing in
subsequent years, for total ten-year costs of $66 million. We believe
the primary benefit of the proposed regulation is the increased ability
to protect producers and growers through enforcement of the Act for
violations of section 202(a) and/or (b) that do not result in harm, or
a likelihood of harm, to competition.
Risks: Courts have recognized that the proper analysis of alleged
violations of these two sections depends on the facts of each case.
However, four courts of appeals have disagreed with USDA's
interpretation of the Act and have concluded that plaintiffs could not
prove their claims under those sections without proving harm to
competition or likely harm to competition. There is a risk if future
legal challenge of USDA interpretation of sections 202(c), (d), and (e)
of the Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Michael V. Durando, Deputy Administrator, Fair
Trade Practices Program, Department of Agriculture, Agricultural
Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-
0237, Phone: 202 720-219.
RIN: 0581-AE04
USDA--AMS
2. Inclusive Competition and Market Integrity Under the Packers and
Stockyards Act (AMS-FTPP-21-0045) [0581-AE05]
Priority: Other Significant.
Legal Authority: 7 U.S.C. 181 to 229c
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: This final rule would supplement a recent revision to
regulations issued under the Packers and Stockyards Act (Act) (7
U.S.C.181 229c) that provided criteria for the Secretary to consider
when determining whether certain conduct or action by packers, swine
contractors, or live poultry dealers is unduly or unreasonably or
advantageous. Supplemental amendments clarify the conduct the
Department considers unfair, preferential unjustly discriminatory, or
deceptive and a violation of sections 202(a) and (b) of the Act. The
rule also clarifies the criteria and types of conduct that would be
considered unduly or unreasonably preferential, advantageous,
prejudicial, or disadvantageous and violations of the Act.
Statement of Need: Revisions to regulations pertaining to the
Packers and Stockyards Act (Act) clarify the types of conduct by
packers, swine contractors, or live poultry dealers that the
Agricultural Marketing Service (AMS) considers unfair, unjustly
discriminatory, or deceptive and a violation of section 202(a) of the
Act, regardless of whether such action harms or is likely to harm
competition. The rule also clarifies the criteria and/or types of
conduct that would be considered unduly or unreasonably preferential,
advantageous, prejudicial, or disadvantageous and a violation of
section 202(b) of the Act.
Sections 202(a) and 202(b) of the P&S Act are broadly written to
prohibit unjustly practices and undue preferences and prejudices.
Industry members have complained that the regulations effectuating the
Act are too vague and do not provide adequate clarity about the types
of conduct or action that are likely to violate the Act. This rule is
needed to provide essential clarity about what would be considered
violations of the Act, regardless of whether such violations harm or
are likely to harm competition.
Summary of Legal Basis: The Packers and Stockyards Act (Act)
authorizes AMS to determine if conduct within the poultry and livestock
industries are unfair, unjustly discriminatory, or deceptive and,
therefore a violation of the Act.
Alternatives: AMS considered taking no further action, allowing 100
years of case law to determine precedent in making determinations about
whether certain behaviors violate the Act. AMS also considered
revisiting the withdrawn 2016 rulemaking approach that would have
identified criteria with which to determine whether certain behaviors
violate the Act.
Anticipated Cost and Benefits: USDA estimates first-year costs
associated with this rule to be $517 thousand, with decreased costs
each year thereafter, resulting in a ten-year total cost of $2.88
[[Page 10981]]
million. AMS expects this rule to benefit all segments of the industry,
providing greater clarity about what would be considered violations of
the Act. AMS expects this rule, coupled with a concurrent rule on the
scope of the Act, to strengthen enforcement of the Act, resulting in
fairer and more competitive markets for producers and poultry growers.
Risks: Industry is divided about adding lists or examples of
specific prohibited conduct to the regulations. Some argue such lists
would inhibit freedom to forge contracts that fit individual
situations, while others contend greater specificity is required so
that affected parties can more readily identify violative behavior.
Industry is also split on the question of whether identified prohibited
behaviors must be found to harm or likely harm competition to be
considered violations of the Act. AMS expects to resolve some of the
controversy by being proactive and transparent with the industry to
allow for critical discussions and decisions on the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/03/22 87 FR 60010
NPRM Comment Period Extended........ 11/30/22 87 FR 73507
NPRM Comment Period End............. 12/02/22
NPRM Comment Period Extended End.... 01/17/23
Final Rule.......................... 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael V. Durando, Deputy Administrator, Fair
Trade Practices Program, Department of Agriculture, Agricultural
Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-
0237, Phone: 202 720-0219.
RIN: 0581-AE05
USDA--AMS
3. Poultry Growing Tournament Systems: Fairness and Related Concerns--
Harm to Competition (AMS-FTPP-22-0046) [0581-AE18]
Priority: Other Significant.
Legal Authority: 7 U.S.C. 181 et seq., 192
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: This action seeks comments on proposed amendments to
regulations that promote transparency in the poultry grower ranking
systems, more commonly known as tournaments, in contract poultry
production. Proposed amendments serve to remove obstacles to fair
contracting.
Statement of Need: Executive Order 14036 Promoting Competition in
the American Economy, directs the Secretary of Agriculture to address
unfair treatment of farmers and improve conditions of competition in
their markets by considering rulemaking to address, among other things,
certain practices related to poultry grower ranking systems. AMS is
responding to numerous complaints from poultry growers about the use of
tournament systems and recognizes that measures beyond disclosure and
transparency may be necessary to address those practices, given the
economic power imbalances and competition concerns that exist in
today's markets. Responses to requests for comment have helped AMS
tailor further policy development and rulemaking under the Packers and
Stockyards Act, as amended, to address, through specific prohibitions,
limits, and/or conventionalities, potential unfairness that may arise
from the use of the tournament contracts in the poultry sector.
Summary of Legal Basis: Sections 202(a) and 202(b) of the Packers
and Stockyards Act prohibits unfair practices and undue preferences.
Alternatives: The alternative considered is to continue with other
efforts already underway to enhance fair and competitive markets in
poultry. These include: (1) a separate rulemaking, under RIN 0581-AE03,
in which USDA proposed a series of new transparency measures designed
to address many grower concerns relating to deception and lack of
access to critical information in connection with poultry contracting
and tournament systems; (2) under the American Rescue Plan Act's
provision to enhance supply chain resiliency, investing directly into
the creation of new, and expansion of existing, local and regional meat
and poultry processing enterprises; and (3) in partnership with DOJ,
through such means as a newly established joint complaints and tips
portal, www.farmerfairness.gov, enhancing enforcement activities
including responding in a more coordinated manner to a range of
competition and fair markets concerns.
Anticipated Cost and Benefits: AMS is at an early stage of
evaluating the costs and benefits of the contemplated regulatory
interventions. However, expected benefits include greater certainty,
investment, and supply of poultry products, greater returns to poultry
growers and enhanced rural economic welfare, and expanded competitive
choices in the poultry sector. Expected costs may include compliance
costs, such as certain contract change costs.
Risks: Agricultural production is an inherently risky endeavor, and
returns have some level of risk no matter the marketing channel or
structural arrangement. Tournament systems do not insulate growers from
the financial risk, liquidity risk, the risk from incomplete contracts,
and the lack of control over inputs and production variables.
Tournaments also introduce new categories of risks to growers: Group
composition risk and added risks of settlement-related deception or
fraud. The risks of deception or fraud as discussed above include the
inability of growers to verify the accuracy of payments, and to detect
discrimination or retaliation.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM: Request for Comments......... 06/08/22 87 FR 34814
ANPRM Comment Period End............ 09/06/22
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Stephen Slinsky, Department of Agriculture,
Agricultural Marketing Service, 1400 Independence Avenue SW,
Washington, DC 20250, Phone: 901 287-9719, Email:
[email protected].
RIN: 0581-AE18
USDA--AMS
Final Rule Stage
4. Transparency in Poultry Grower Contracting and Tournaments (AMS-
FTPP-21-0044) [0581-AE03]
Priority: Other Significant.
Legal Authority: 7 U.S.C. 181 to 229c
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: This action amends regulations issued under the Packers
and Stockyards Act (P&S Act), revising the list of disclosures and
information live poultry dealers must furnish to poultry growers and
sellers with whom dealers make poultry growing arrangements. The rule
establishes parameters for the use of poultry grower ranking systems by
dealers to determine settlement payments for poultry growers.
Amendments are intended to
[[Page 10982]]
promote transparency in poultry production contracting and to give
poultry growers relevant information with which to make business
decisions.
Statement of Need: Differences in size and imbalances of power
between parties in contractual poultry growing arrangements can have
detrimental effects on one of the contracting parties and may result in
marketplace inefficiencies. An often-cited concern is the live poultry
dealer's full control over inputs, e.g., chick, feed, medication, etc.,
to the poultry growing process. Industry members have asked the
Agricultural Marketing Service (AMS) to address such imbalances by
specifying the conduct that would be considered violative of the
Packers and Stockyards Act (Act).
Summary of Legal Basis: The Agricultural Marketing Service (AMS) is
delegated authority by the Secretary of Agriculture to enforce the P&S
Act. AMS has received numerous complaints regarding the imbalance of
power in poultry growing agreements, wherein one side controls all of
the inputs, then arbitrarily ranks grower performance against other
growers to determine pay.
Alternatives: AMS considered finalizing a 2016 proposed rule that
would have identified criteria for determining whether a live poultry
dealer's use of a grower ranking system for payment purposes might be
unlawful under the Packers and Stockyards Act.
Anticipated Cost and Benefits: USDA estimates the first-year costs
associated with this proposed rule to be $17.37 million. Subsequent
year costs are expected to be significantly less than first-year costs,
resulting in a ten-year total cost of $34.64 million. USDA expects the
primary benefit of the regulation will be the increased ability to
protect poultry growers from unfair practices associated with the use
of poultry grower ranking systems. At the same time, the rule is
expected to improve efficiencies through the use of new technologies
and to reduce market failures among poultry growers.
Risks: Extended litigation over legal challenges from the industry
could result in the rule being struck down by the courts, hindering the
agency's ability to enforce the Act for years.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/08/22 87 FR 34980
NPRM Comment Period End............. 08/08/22 .......................
Notice of Reopening of Comment 08/08/22 87 FR 48091
Period.
NPRM Comment Period End............. 08/23/22
Final Rule.......................... 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael V. Durando, Deputy Administrator, Fair
Trade Practices Program, Department of Agriculture, Agricultural
Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-
0237, Phone: 202 720-0219.
RIN: 0581-AE03
USDA--AMS
5. Organic Livestock and Poultry Standards (AMS-NOP-21-0073) [0581-
AE06]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 7 U.S.C. 6501 to 7 U.S.C. 6524
CFR Citation: 7 CFR 205.
Legal Deadline: None.
Abstract: This action establishes additional practice standards for
organic livestock and poultry production. The rule amends the USDA
organic regulations related to: livestock and poultry living conditions
(for example, outdoor access, housing environment, and stocking
densities); animal health care (for example, physical alterations,
administering medical treatment, and euthanasia); animal transport; and
slaughter.
Statement of Need: The Organic Livestock and Poultry Standards
(OLPS) rule is needed to clarify the USDA organic standards for
livestock and poultry living conditions and health practices. The
current regulations for livestock production provide general
requirements but some of these provisions are ambiguous and have led to
inconsistent divergent practices, particularly in the organic poultry
sector. This rule responds to nine recommendations from the National
Organic Standards Board and findings from a USDA Office of Inspector
General (OIG) report. (See USDA, Office of the Inspector General. March
2010. Audit Report 01601-03-Hy, Oversight of the National Organic
Program. Available at: http://www.usda.gov/oig/rptsauditsams.htm.) This
rule includes provisions to support the expression of natural behaviors
and the welfare of organic livestock and poultry.
Summary of Legal Basis: OLPS is authorized by the Organic Foods
Production Act of 1990 (OFPA), 7 U.S.C. 65016524. OFPA authorizes the
USDA to establish national standards governing the marketing of certain
agricultural products as organically produced products to assure
consumers that organically produced products meet a consistent standard
and to facilitate interstate commerce in fresh and processed food that
is organically produced.
Alternatives: AMS considered several alternatives and presents
these in the rule. AMS presents two compliance date alternatives in the
rule that would affect the costs and benefits of the rule.
Additionally, AMS discusses alternatives to specific policies included
in the rule, including alternative indoor and outdoor space
requirements, and non-regulatory alternatives, including consumer
education or no rule.
Anticipated Cost and Benefits: AMS assumes no costs or benefits are
accumulated for clarifying and codifying existing practices. However,
AMS does expect costs and benefits to occur for organic broiler
production through increased indoor space and for organic broilers and
in egg production through increased outdoor access for layers.
AMS estimates that the discounted costs for layer operations would
range between $3.6 million and $8.4 million annually. To monetize the
benefits of this rule, AMS used research that measured consumers'
willingness-to-pay for outdoor access at a premium of between $0.16 and
$0.25 per dozen eggs, controlling for other factors, including the
organic label. Based on this, AMS estimates the annually discounted
benefits falling between $11.6 million to $27.1 million.
AMS estimates that the total annual discounted costs for broiler
compliance would be between $5.7 million and $6.3 million. The benefits
for broilers are calculated using a willingness-to-pay at a premium of
$0.34/lb. With this willingness-to-pay, the annual discounted benefits
range between $97 million and $107 million.
Qualitatively, AMS also anticipates the rule will establish a clear
standard protecting the value of the USDA organic seal to consumers,
provide a consistent, level playing field for organic livestock
producers, and facilitate enforcement of organic livestock and poultry
standards.
Risks: This rule is similar to the rule published on January 19,
2017 (82 FR 7042). That rule was subsequently withdrawn and never
became effective. The USDA continues to face two legal challenges
related to the withdrawal of that rule. USDA argued in its
[[Page 10983]]
withdrawal of the rule that USDA had no authority under the Organic
Foods Production Act to promulgate the rule, so there is legal risk in
reversing direction and publishing a similar rule.
Publishing a new proposed rule indicated that the USDA is taking
new steps to advance the regulations. This has been viewed favorably by
some, although others would prefer reinstating the January 2017 rule
without the associated steps required to finalize a new rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/09/22 87 FR 48562
NPRM Comment Period End............. 10/11/22
Comment Period Extended............. 10/11/22 87 FR 61268
Comment Period Extended End......... 11/10/22
Final Rule.......................... 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Erin Healy, Director, Standards Division, National
Organic Program, Department of Agriculture, Agricultural Marketing
Service, Washington, DC 20024, Phone: 202 617-4942, Email:
[email protected].
Related RIN: Related to 0581-AD44, Related to 0581-AD74, Related to
0581-AD75
RIN: 0581-AE06
USDA--FOOD AND NUTRITION SERVICE (FNS)
Proposed Rule Stage
6. Special Supplemental Nutrition Program for Women, Infants and
Children (WIC): Revisions in the WIC Food Packages [0584-AE82]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1786, sec. 17(f)(11)(C)
CFR Citation: 7 CFR 246.10.
Legal Deadline: None.
Abstract: This proposed rulemaking would amend regulations
governing the WIC food packages to: (1) incorporate recommendations of
the National Academies of Science, Engineering, and Medicine 2017
scientific report, Review of WIC Food Packages: Improving Balance and
Choice; (2) align with 2020 Dietary Guidelines for Americans; and (3)
make other administrative revisions or clarifications to food package
requirements.
Statement of Need: The National Academies of Sciences, Engineering,
and Medicine (NASEM) issued a 2017 report with recommendations to align
the WIC food packages with the available nutrition science and to
reflect the supplemental nature of the Program. In December 2020, the
USDA and the Department of Health and Human Services released the 2020-
2025 Dietary Guidelines for Americans (DGAs). USDA FNS will propose
rulemaking to incorporate NASEM recommendations and align the food
package with the latest DGAs.
Summary of Legal Basis: 42 U.S.C. 1786, sec. 17(f)(11)(C).
Alternatives: N/A.
Anticipated Cost and Benefits: This is discussed in the Regulatory
Impact Analysis which was published on November 21, 2022 as an appendix
to the rule, available at 87 FR 71090.
Risks: N/A.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/21/22 87 FR 71090
NPRM Comment Period End............. 02/21/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal, Local, State.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
Agency Contact: Michael DePiro, Department of Agriculture, Food and
Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone:
703 305-2876, Email: [email protected].
Maureen Lydon, Department of Agriculture, Food and Nutrition
Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-
7713, Email: [email protected].
RIN: 0584-AE82
USDA--FNS
7. Child Nutrition Programs: Revisions to Meal Patterns Consistent With
the 2020 Dietary Guidelines for Americans [0584-AE88]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1758, sec. 9(f)(1)
CFR Citation: 7 CFR 210.10; 7 CFR 210.11; 7 CFR 215.7a; 7 CFR
220.8; 7 CFR 226.20; . . .
Legal Deadline: None.
Abstract: This rule will propose long-term school nutrition
standards based on the Dietary Guidelines for Americans, 2020-2025, and
feedback from child nutrition program stakeholders. The proposed
revisions are expected to make school meals more nutritious and more
consistent with the goals of the most recent Dietary Guidelines, as
required by statute. In addition, FNS is merging ``Buy American
Provision in the National School Lunch and School Breakfast Programs''
(0584-AE91),which was listed as a long-term rule on the Fall 2021
Regulatory Agenda, with this rule (0584-AE88). When developing this
proposed rule, FNS will consider comments submitted in response to the
February 2022 final rule, ``Child Nutrition Programs: Transitional
Standards for Milk, Whole Grains, and Sodium'' (0584-AE81). FNS will
also consider comments submitted in response to the August 2021
``Request for Information: Buy American in the National School Lunch
Program and School Breakfast Program,'' including feedback on how FNS
can better support local schools as they strive to purchase domestic
foods and food products.
Statement of Need: The proposed revisions are needed to make school
meals more nutritious and more consistent with the goals of the most
recent Dietary Guidelines, as required by statute.
Summary of Legal Basis: 42 U.S.C. 1758, sec. 9(f)(1).
Alternatives: Alternatives not identified to date.
Anticipated Cost and Benefits: These would be addressed in the
Regulatory Impact Analysis for the rule.
Risks: None known at this time.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/23
------------------------------------------------------------------------
[[Page 10984]]
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Federalism: Undetermined.
Agency Contact: Michael DePiro, Department of Agriculture, Food and
Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone:
703 305-2876, Email: [email protected].
Maureen Lydon, Department of Agriculture, Food and Nutrition
Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-
7713, Email: [email protected].
Related RIN: Merged with 0584-AE913
RIN: 0584-AE88
USDA--FNS
8. Community Eligibility Provision: Increasing Options for
Schools [0584-AE93]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 1759a(a)(1)(F)
CFR Citation: 7 CFR 245.9.
Legal Deadline: None.
Abstract: This proposed rule would lower the minimum participation
threshold for Community Eligibility Provision (CEP) elections.
Currently, to elect CEP, a local educational agency (LEA), group of
schools, or individual school must meet a minimum identified student
percentage threshold of 40 percent. This rule would lower the minimum
participation threshold, which would provide an additional option for
LEAs and schools to receive special assistance payments as Federal
reimbursement for meals served to students, in lieu of taking
applications.
Statement of Need: The Community Eligibility Provision (CEP) is an
option for schools to offer no-cost meals to all students without the
burden of collecting household applications. This provision saves local
educational agencies time and money by streamlining paperwork and
administrative requirements and facilitates low-income children's
access to nutritious school meals. Lowering the participation threshold
expands access to CEP and provides greater flexibility to States and
schools that want to use additional State and local funds to provide
no-cost meals to students.
Summary of Legal Basis: Per the Richard B. Russell National School
Lunch Act (42 U.S.C. 1759a(a)(1)(F)(viii)(II)): ``For each school year
beginning on or after July 1, 2014, the Secretary may use a threshold
that is less than 40 percent.''
Alternatives: None.
Anticipated Cost and Benefits: Expanding access to CEP to
additional schools is not expected to measurably increase costs to the
Federal government due to the cost sharing aspect. FNS anticipates that
this provision could impact State and/or local costs. FNS expects that
local educational agencies that choose to elect CEP at lower
eligibility levels will have increased State and/or local obligations.
A cost/benefit analysis will be addressed in the economic analysis
section to be included within the rule.
Risks: No risks have been identified at this time.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State, Tribal.
Agency Contact: Michael DePiro, Department of Agriculture, Food and
Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone:
703 305-2876, Email: [email protected].
Maureen Lydon, Department of Agriculture, Food and Nutrition
Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-
7713, Email: [email protected].
RIN: 0584-AE93
USDA--FNS
Final Rule Stage
9. Special Supplemental Nutrition Program for Women, Infants,
and Children (WIC): Implementation of the Access to Baby Formula Act of
2022 and Related Provisions [0584-AE94]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 117-129
CFR Citation: 7 CFR 246.
Legal Deadline: None.
Abstract: This rule would amend 7 CFR 246 to codify the provisions
of the Access to Baby Formula Act of 2022 (ABFA). ABFA amends Section
17 of the Child Nutrition Act of 1966 to (1) add requirements to State
agency infant formula cost containment contracts; and (2) establish
waiver authority to the Secretary of Agriculture to address certain
emergencies, disasters, and supply chain disruptions impacting WIC. FNS
would make other related technical corrections and updates as necessary
to modernize applicable WIC Program regulations.
Statement of Need: This rule would codify requirements for State
agencies to include language in their WIC infant formula rebate
contracts that describes remedies in the event of an infant formula
recall, including how an infant formula manufacturer would protect
against disruption to program participants in the State (i.e., ensure
that WIC participants can purchase formula using WIC benefits). The
rule would also codify permanent expanded waiver authority to aid
participants in obtaining and redeeming WIC benefits during certain
emergencies, disasters, and supply chain disruptions impacting WIC.
Finally, the rule would make other miscellaneous technical corrections
and updates as necessary to update WIC regulations.
Summary of Legal Basis: The Access to Baby Formula Act of 2022
(ABFA, Pub. L. 117-129) amends section 17 of the Child Nutrition Act of
1966 (Pub. L. 89-642).
Alternatives: No alternatives have been identified at this time.
Anticipated Cost and Benefits: The costs associated with
implementing the rule's regulatory requirements are not expected to
significantly add to current program costs at the State and local
levels.
Risks: No risks have been identified at this time.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Final Rule With Comment............. 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Agency Contact: Michael DePiro, Department of Agriculture, Food and
Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone:
703 305-2876, Email: [email protected].
Maureen Lydon, Department of Agriculture, Food and Nutrition
Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-
7713, Email: [email protected].
RIN: 0584-AE94
[[Page 10985]]
USDA--FOOD SAFETY AND INSPECTION SERVICE (FSIS)
Proposed Rule Stage
10. Voluntary Labeling of Products With ``Product of USA'' and Similar
Statements [0583-AD87]
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.; 21
U.S.C. 1031 et seq.
CFR Citation: 9 CFR 317.8.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) is
proposing to amend its regulations to define the conditions under which
the labeling of products can bear voluntary statements indicating that
the product is of United States (U.S.) origin, such as Product of USA
or Made in the USA.
Statement of Need: In 2018 and 2019, FSIS received two petitions
requesting that it change its policy regarding the labeling of meat
products to indicate U.S. origin. After considering the petitions and
the public comments submitted in response to them, FSIS concluded that
adherence to the current labeling policy guidance may be causing
confusion in the marketplace with respect to certain imported products
and that the current labeling policy may no longer meet consumer
expectations of what the Product of USA claim signifies. In 2021, FSIS
received another petition related to its Product of USA policy. The
Agency wants to ensure that any changes to its current policy are
accomplished by an open and transparent process. Therefore, FSIS
commissioned a consumer survey and decided that, instead of changing
the Policy Book entry, it would initiate rulemaking to define the
conditions under which the labeling of FSIS-regulated products would be
permitted to bear voluntary statements indicating that the product is
of U.S. origin.
Summary of Legal Basis: Under the Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act
(PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act
(21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry,
and egg products must be approved by the Secretary of Agriculture, who
has delegated this authority to FSIS, before these products can enter
commerce. The Acts prohibit the sale or offer for sale by any person,
firm, or corporation of any article in commerce under any name or other
marking or labeling that is false or misleading or in any container of
a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The
Acts also prohibit the distribution in commerce of meat or poultry
products that are adulterated or misbranded. The FMIA and PPIA give
FSIS broad authority to promulgate such rules and regulations as are
necessary to carry out the provisions of the Acts (21 U.S.C. 621 and
463(b)).
Alternatives: FSIS has considered the current labeling guidance and
the alternatives proposed in the two petitions: (1) to amend the FSIS
Policy Book to state that FSIS-regulated products may be labeled as
Product of USA only if significant ingredients are of domestic origin
and; (2) to amend the FSIS Policy Book to provide that any FSIS
regulated product labeled as Made in the USA, Product of the USA, USA
Beef or in any other manner that suggests that the origin is the United
States, be derived from animals that have been born, raised, and
slaughtered in the United States. FSIS is conducting a comprehensive
review of origin labeling claims and conducting a consumer perception
survey pursuant to developing the proposed regulations.
Anticipated Cost and Benefits: Establishments may incur costs
associated with voluntarily changing their labels as a result of any
revised Product of USA labeling claim definition. This proposed rule is
expected to benefit consumers as well as producers by providing them
more specific information on what Product of USA means for FSIS-
regulated products.
Risks: N/A.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Melissa Hammar, Acting Director, Regulations
Development Staff, Department of Agriculture, Food Safety and
Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-
3700, Phone: 202 720-2096, Email: [email protected].
RIN: 0583-AD87
USDA--FSIS
11. Labeling of Meat and Poultry Products Made Using Animal Cell
Culture Technology [0583-AD89]
Priority: Other Significant.
Legal Authority: 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR ch. III.
Legal Deadline: None.
Abstract: This notice of proposed rulemaking seeks public comments
to inform future Food Safety and Inspection Service (FSIS) regulations
for the labeling of meat and poultry products made using animal cell
culture technology.
Statement of Need: Many companies, both domestic and foreign, are
currently developing cultured products derived from the cells of food
animals amenable to the Federal Meat Inspection Act (FMIA; 21 U.S.C.
601 et seq.) (cattle, sheep, swine, goats, and fish of the order
Siluriformes, e.g., catfish) or the Poultry Products Inspection Act
(PPIA; 21 U.S.C. 451 et seq.) (chickens, turkeys, ducks, geese,
guineas, ratites, and squabs). Human food products derived from these
species fall under FSIS jurisdiction.
Summary of Legal Basis: 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.) require that meat and poultry products be
truthfully and accurately labeled and that their labels be pre-approved
by FSIS (21 U.S.C. 607(d) and 457(c), respectively), prior to movement
in commerce. FSIS issues labeling regulations and reviews and approves
meat and poultry product labels pursuant to these statutory labeling
requirements. Food products made using animal cell culture technology
and derived from the cells of livestock subject to the FMIA or the PPIA
are subject to the labeling (and other applicable) requirements of
these Acts and the regulations issued thereunder.
Alternatives: FSIS will consider at least three alternatives for
the rule: (1) Adopting a naming convention that is preferred by
cellular agriculture industry; (2) Adopting a naming convention that is
preferred by traditional agriculture industry; (3) Adopting a naming
convention that is preferred by consumers groups.
Anticipated Cost and Benefits: This proposed rule would benefit the
public by providing truthful and accurate labeling of meat and poultry
products produced using animal cell culture technology.
FSIS expects its costs to be minimal and that current FSIS staffing
would meet sketch approval needs.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 09/03/21 86 FR 49491
ANPRM Comment Period End............ 12/02/21
NPRM................................ 08/00/23
------------------------------------------------------------------------
[[Page 10986]]
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Melissa Hammar, Acting Director, Regulations
Development Staff, Department of Agriculture, Food Safety and
Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-
3700, Phone: 202 720-2096, Email: [email protected].
RIN: 0583-AD89
USDA--FSIS
Final Rule Stage
12. Revision of the Nutrition Facts Panels for Meat and Poultry
Products and Updating Certain Reference Amounts Customarily Consumed
[0583-AD56]
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 317; 9 CFR 381; 9 CFR 413.
Legal Deadline: None.
Abstract: Consistent with the changes that the Food and Drug
Administration (FDA) finalized, the Food Safety and Inspection Service
(FSIS) is amending the Federal meat and poultry products inspection
regulations to update and revise the nutrition labeling requirements
for meat and poultry products to reflect recent scientific research and
dietary recommendations and to improve the presentation of nutrition
information to assist consumers in maintaining healthy dietary
practices.
Statement of Need: On May 27, 2016, the Food and Drug
Administration (FDA) published two final rules: (1) ``Food Labeling:
Revision of the Nutrition and Supplement Facts Labels'' (81 FR 33742);
and (2) ``Food Labeling: Serving Sizes of Foods that Can Reasonably be
Consumed at One Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments'' (81
FR 34000). FDA finalized these rules to update the Nutrition Facts
label to reflect new nutrition and public health research, to reflect
recent dietary recommendations from expert groups, and to improve the
presentation of nutrition information to help consumers make more
informed choices and maintain healthy dietary practices. FSIS has
reviewed FDA's analysis and, to ensure that nutrition information is
presented consistently across the food supply, FSIS is amending the
nutrition labeling regulations for meat and poultry products to
parallel, to the extent possible, FDA's regulations. This approach will
help increase clarity of information for consumers and will improve
efficiency in the marketplace.
Summary of Legal Basis: Under the Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act
(PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act
(21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry,
and egg products must be approved by the Secretary of Agriculture, who
has delegated this authority to FSIS, before these products can enter
commerce. The Acts prohibit the sale or offer for sale by any person,
firm, or corporation of any article in commerce under any name or other
marking or labeling that is false or misleading or in any container of
a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The
Acts also prohibit the distribution in commerce of meat or poultry
products that are adulterated or misbranded. The FMIA and PPIA give
FSIS broad authority to promulgate such rules and regulations as are
necessary to carry out the provisions of the Acts (21 U.S.C. 621 and
463(b)).
To prevent meat and poultry products from being misbranded, the
meat and poultry product inspection regulations require that the labels
of meat and poultry products include specific information, such as
nutrition labels, and that such information be displayed as prescribed
in the regulations (9 CFR part 317 and part 381). The nutrition
labeling requirements for meat and meat food products are in 9 CFR
317.300-317.400, and the nutrition labeling requirements for poultry
products are in 9 CFR 381.400-381.500.
Alternatives: FSIS considered three alternatives for the final
rule: (1.) No action; (2.) A 24-month compliance period for large
businesses and a 36-month compliance period for small businesses (as
proposed); or (3.) A 12-month compliance period for large businesses
and a 24-month compliance period for small businesses for faster label
harmonization.
Anticipated Cost and Benefits: These regulations are expected to
benefit consumers by increasing and improving dietary information
available in the market. Firms will incur a one-time cost for
relabeling, recordkeeping costs, and costs associated with voluntary
reformulation. Many firms have voluntarily begun using the FDA format,
which will reduce costs.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/19/17 82 FR 6732
NPRM Comment Period End............. 04/19/17
Final Action........................ 06/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Melissa Hammar, Acting Director, Regulations
Development Staff, Department of Agriculture, Food Safety and
Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-
3700, Phone: 202 720-2096, Email: [email protected].
RIN: 0583-AD56
USDA--FSIS
13. Prior Label Approval System: Expansion of Generic Label Approval
[0583-AD78]
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.; 21
U.S.C. 1031 et seq.
CFR Citation: 9 CFR 412.2(a)(1); 9 CFR 317.7; 9 CFR 381.128; 9 CFR
412.2(b).
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) is amending
its labeling regulations to expand the categories of meat, poultry, and
egg product labels that it will deem generically approved and thus not
required to be submitted to FSIS. These reforms will reduce the
regulatory burden on producers seeking to bring products to market, as
well as the Agency costs expended to evaluate the labels.
Statement of Need: This action is needed to reduce the regulatory
burden on producers seeking to bring products to market, as well as the
Agency costs expended to evaluate the labels. Based on FSIS experience
evaluating the labels in question and the ability of inspection
personnel to verify labeling in the field, FSIS anticipates this action
will have no impact on food safety or the accuracy of meat, poultry,
and egg product labeling.
Summary of Legal Basis: The Acts direct the Secretary of
Agriculture to maintain meat, poultry, and egg inspection programs
designed to assure consumers that these products are safe, wholesome,
not adulterated, and properly marked, labeled, and packaged. Section
7(d) of the Federal Meat Inspection Act (21 U.S.C. 607(d)) states:
[[Page 10987]]
No article subject to this title shall be sold or offered for sale by
any person, firm, or corporation, in commerce, under any name or other
marking or labeling which is false or misleading, or in any container
of a misleading form or size, but established trade names and other
marking and labeling and containers which are not false or misleading
and which are approved by the Secretary are permitted. The Poultry
Products Inspection Act and the Egg Products Inspection Act contain
similar language in section 21 U.S.C. 457(c) and 1036(b), respectively.
Alternatives: FSIS considered three alternatives for the rule:
taking no action, adopting the current proposal except with continued
evaluation of labels that would otherwise be generically approved, and
allowing all labels to be generically approved.
Anticipated Cost and Benefits: There are no additional costs to
industry, or the Agency associated with this rule. FSIS will continue
to verify that product labels, including those that are generically
approved, are truthful and not misleading and otherwise comply with
FSIS' requirements.
This rule is expected to reduce the number of labels industry is
required to submit to FSIS for evaluation by approximately 35 percent.
Establishments will realize a cost savings because they will no longer
need to incur costs for submitting certain types of labels to FSIS for
evaluation (e.g., preparing a printer's proof). In addition,
streamlining the evaluation process for specific types of labels will
allow a faster introduction of products into the marketplace by
reducing wait times for label approvals.
FSIS will also benefit from a reduction in the number of labels
submitted to it for review. FSIS will be able to reallocate staff hours
from evaluating labels towards the development of labeling policy.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/14/20 85 FR 56538
NPRM Comment Period End............. 11/13/20
Final Rule.......................... 01/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Melissa Hammar, Acting Director, Regulations
Development Staff, Department of Agriculture, Food Safety and
Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-
3700, Phone: 202 720-2096, Email: [email protected].
RIN: 0583-AD78
BILLING CODE 3410-90-P
DEPARTMENT OF COMMERCE
Statement of Regulatory and Deregulatory Priorities
Established in 1903, the Department of Commerce (Commerce or
Department) is one of the oldest Cabinet-level agencies in the Federal
Government. Commerce's mission is to create the conditions for economic
growth and opportunity across all American communities by promoting
innovation, entrepreneurship, competitiveness, and environmental
stewardship. Commerce has 12 operating units, which manage a diverse
portfolio of programs and services ranging from trade promotion and
economic development assistance to improved broadband access and the
National Weather Service, and from standards development and
statistical data production, including the decennial census, to patents
and fisheries management. Across these varied activities, the
Department seeks to provide a foundation for a more equitable,
resilient, and globally competitive economy.
To fulfill its mission, Commerce works in partnership with
businesses, educational institutions, community organizations,
government agencies, and individuals to:
Innovate by creating new ideas through cutting-edge
science and technology, from advances in nanotechnology to ocean
exploration to broadband deployment, and by protecting American
innovations through the patent and trademark system;
Support entrepreneurship and commercialization by enabling
community development and strengthening minority businesses and small
manufacturers;
Maintain U.S. economic competitiveness in the global
marketplace by promoting exports and foreign direct investment,
ensuring a level playing field for U.S. businesses, and ensuring that
technology transfer is consistent with our nation's economic and
security interests;
Provide effective management and stewardship of our
nation's resources and assets to ensure sustainable economic
opportunities; and
Make informed policy decisions and enable better
understanding of the economy and our communities by providing timely,
accessible, and accurate economic and demographic data.
Responding to the Administration's Regulatory Philosophy and Principles
Commerce's Regulatory Plan tracks the most important regulations
that the Department anticipates issuing to implement these policy and
program priorities and foster sustainable and equitable growth. Of
Commerce's 12 primary operating units, three bureaus--the National
Oceanic and Atmospheric Administration (NOAA), the United States Patent
and Trademark Office (USPTO), and the Bureau of Industry and Security
(BIS)--issue the vast majority of the Department's regulations, and
these three bureaus account for all the planned actions that are
considered the Department's most important significant pre-regulatory
or regulatory actions for FY 2022.
National Oceanic and Atmospheric Administration
NOAA's mission is built on three pillars: science, service, and
stewardship--to understand and predict changes in climate, weather,
oceans, and coasts; to share that knowledge and information with
others; and to conserve and manage coastal and marine ecosystems and
resources.
At its core, NOAA is a scientific agency. It observes, measures,
monitors, and collects data from the depths of the ocean to the surface
of the sun, and it does so following principles of scientific
integrity. These data are turned into weather and climate models and
forecasts that are then used for everything from local weather
forecasts to predicting the movement of wildfire smoke to identifying
the impacts of climate change on fisheries and living marine resources.
With respect to service, NOAA not only collects data but is
mandated to make it operational, and NOAA seeks to be the authoritative
provider of climate products and services. By providing Federal, State,
and local government partners, the private sector, and the public with
actionable environmental information, NOAA can facilitate decisions in
the face of climate change. Such decisions can range from businesses
planning the location of offices; insurance companies trying to
incorporate climate risk into their insurance policies; and
municipalities looking to ensure that plans for construction of new
housing developments will be resilient to increasing sea level risk,
flooding, and heavy precipitation.
[[Page 10988]]
The final pillar of NOAA's mission is stewardship. NOAA seeks to
conserve our lands, waters, and natural resources, protecting people
and the environment now and for future generations. As part of
Commerce, moreover, NOAA recognizes that economic growth must go hand-
in-hand with environmental stewardship. For example, with respect to
the nation's fisheries, NOAA looks simultaneously to optimize
productivity and ensure sustainability in order to boost long-term
economic growth and competitiveness in this vital sector of the U.S.
economy. Similarly, national marine sanctuaries both protect important
natural resources and also are significant drivers of eco-tourism and
local recreation.
Within NOAA, the National Marine Fisheries Services (NMFS) and the
National Ocean Service (NOS) are the components that most often
exercise regulatory authority to implement NOAA's mission. NMFS
oversees the management and conservation of the nation's marine
fisheries; protects marine mammals and Endangered Species Act (ESA)-
listed marine and anadromous species; and promotes economic development
of the U.S. fishing industry. NOS assists the coastal states in their
management of land and ocean resources in their coastal zones,
including estuarine research reserves; manages national marine
sanctuaries; monitors marine pollution; and directs the national
program for deep-seabed minerals and ocean thermal energy.
Much of NOAA's rulemaking is conducted pursuant to the following
key statutes:
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 from shore). As itemized in the Unified Agenda, NOAA
plans to take several hundred actions in FY 2022 under Magnuson-Stevens
Act authority, of which roughly 20 are expected to be significant
rulemakings, as defined in Executive Order 12866. With certain
exceptions, rulemakings under Magnuson-Stevens are usually initiated by
the actions of eight regional Fishery Management Councils (FMCs or
Councils). These Councils are comprised of representatives from the
commercial and recreational fishing sectors, environmental groups,
academia, and Federal and State government, and they are responsible
for preparing fishery management plans (FMPs) and FMP amendments, and
for recommending implementing regulations for each managed fishery.
FMPs address a variety of issues, including maximizing fishing
opportunities on healthy stocks, rebuilding overfished stocks, and
addressing gear conflicts. After considering the FMCs' recommendations
in light of the standards and requirements set forth in the Magnuson-
Stevens Act and in other applicable laws, NOAAmay issue regulations to
implement the proposed FMPs and FMP amendments.
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
intentional take of marine mammals. The MMPA allows, upon request and
subsequent authorization, the incidental take of marine mammals by U.S.
citizens who engage in a specified activity (e.g., oil and gas
development, pile driving) within a specified geographic region. NMFS
authorizes incidental take under the MMPA if it finds that the taking
would be of small numbers, have no more than a ``negligible impact'' on
those marine mammal species or stock, and would not have an
``unmitigable adverse impact'' on the availability of the species or
stock for ``subsistence'' uses. NMFS also initiates rulemakings under
the MMPA to establish a management regime to reduce marine mammal
mortalities and injuries as a result of interactions with fisheries. In
addition, the MMPA allows NMFS to permit the take or import of wild
animals for scientific research or public display or to enhance the
survival of a species or stock.
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. NMFS and the Department of Interior's Fish and Wildlife
Service (FWS) jointly administer the provisions of the ESA: NMFS
manages marine and several anadromous species, and FWS manages land and
freshwater species. Together, NMFS and FWS work to protect critically
imperiled species from extinction. NMFS rulemaking actions under the
ESA 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, as indicated in the list of
highlighted actions below, NMFS and FWS may also issue rules clarifying
how particular provisions of the ESA will be implemented.
The National Marine Sanctuaries Act
The National Marine Sanctuaries Act (NMSA) authorizes the Secretary
of Commerce to designate and protect as national marine sanctuaries
areas of the marine environment with special national significance due
to their conservation, recreational, ecological, historical,
scientific, cultural, archeological, educational, or aesthetic
qualities. The primary objective of the NMSA is to protect marine
resources, such as coral reefs, sunken historical vessels, or unique
habitats.
NOAA's Office of National Marine Sanctuaries (ONMS), within NOS,
has the responsibility for management of national marine sanctuaries.
ONMS regulations, issued pursuant to NMSA, prohibit specific kinds of
activities, describe and define the boundaries of the designated
national marine sanctuaries, and set up a system of permits to allow
the conduct of certain types of activities that would otherwise not be
allowed.
These regulations can, among other things, regulate and restrict
activities that may injure natural resources, including all extractive
and destructive activities, consistent with community-specific needs
and NMSA's purpose to ``facilitate to the extent compatible with the
primary objective of resource protection, all public and private uses
of the resources of these marine areas.'' In FY 2022, NOAA is expected
to have at least three regulatory actions under NMSA.
Coastal Zone Management Act
The Coastal Zone Management Act (CZMA) was passed in 1972 to
preserve, protect, and develop and, where possible, to restore and
enhance the resources of the nation's coastal zone. The CZMA creates a
voluntary state-federal partnership, where coastal states (States in,
or bordering on, the Atlantic, Pacific or Arctic Ocean, the Gulf of
Mexico, Long Island Sound, or one or more of the Great Lakes), may
elect to develop comprehensive programs that meet federal approval
standards. Currently, 34 of the 35 eligible entities are implementing a
federally approved coastal management plan approved by the Secretary of
Commerce.
[[Page 10989]]
NOAA's Regulatory Plan Actions
Of the numerous regulatory actions that NOAA is planning for this
year and that are included in the Unified Agenda, there are five,
described below, that the Department considers to be of particular
importance.
1. Illegal, Unreported, and Unregulated Fishing; Fisheries
Enforcement; High Seas Driftnet Fishing Moratorium Protection Act
(0648-BG11): The United States is a signatory to the Port State
Measures Agreement (PSMA). The agreement is aimed at combating illegal,
unreported, and unregulated (IUU) fishing activities through increased
port inspection of foreign fishing vessels and by preventing the
products of illegal fishing from landing and entering into commerce.
The High Seas Driftnet Fishing Moratorium Act (Fishing Moratorium Act)
implemented provisions of the PSMA, and NOAA issued regulations under
the Fishing Moratorium Act in 2011 and 2013. Since then, the provisions
of the Fishing Moratorium Act have been amended by the Illegal,
Unreported and Unregulated Fishing Enforcement Act of 2015 (Pub. L.
114-81) and the Ensuring Access to Pacific Fisheries Act (Pub. L. 114-
327). This proposed rule would implement amendments made by these later
two laws. NMFS will also propose changes to the definition of IUU
fishing for the purposes of identifying and certifying nations.
2. Amendments to the North Atlantic Right Whale Vessel Strike
Reduction Rule (0648-BI88): Regulatory modifications are needed to
further reduce the likelihood of mortalities and serious injuries to
endangered North Atlantic right whales from vessel collisions, which
are a primary cause of the species' decline and greatly contributing to
the ongoing Unusual Mortality Event (2017-present). Following two
decades of growth, the species has been in decline over the past decade
with a population estimate of only 368 individuals as of 2019. Vessel
strikes are one of the two primary causes of North Atlantic right whale
mortality and serious injury across their range, and human-caused
mortality to adult females in particular is limiting recovery of the
species. Entanglement in fishing gear is the other primary cause of
mortality and serious injury, which is being addressed by separate
regulatory actions.
3. Endangered and Threatened Wildlife and Plants; Revision of the
Regulations for Listing Endangered and Threatened Species and
Designation of Critical Habitat (0648-BJ44): This action responds to
section 2 of the Executive Order on Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis (E.O.
13990) and the associated Fact Sheet (List of Agency Actions for
Review). This is a joint rulemaking by NMFS and the FWS (the Services)
to rescind the regulatory definition of the term ``habitat.'' This
previously undefined term was defined by regulation for the first time
in 2020 for the purpose of designating critical habitat under the ESA.
Pursuant to Executive Order 13990, the Services also considered the
alternatives of retaining the existing habitat definition or revising
the habitat definition and will be considering any alternatives
provided during the public comment period on the proposed rule.
4. Endangered and Threatened Wildlife and Plants; Regulations for
Listing Species and Designating Critical Habitat (0648-BK47): This
action responds to section 2 of the Executive Order on Protecting
Public Health and the Environment and Restoring Science to Tackle the
Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of
Agency Actions for Review). This is a joint rulemaking by the Services
to revise joint regulations issued in 2019 implementing section 4 of
the ESA. Specifically addressed in this action are joint regulations
that address the classification of species as threatened or endangered
and the criteria and process for designating critical habitat for
listed species. Pursuant to Executive Order 13990, the Services
reviewed the specific regulatory provisions that had been revised in
the 2019 final rule. Following a review of the 2019 rule, the Services
are proposing to revise a portion of these regulations but are also
soliciting public comments on all aspects of the 2019 rule before
issuing a final rule.
5. Endangered and Threatened Wildlife and Plants; Revision of
Regulations for Interagency Cooperation (0648-BK48): This action
responds to section 2 of the Executive Order on Protecting Public
Health and the Environment and Restoring Science to Tackle the Climate
Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency
Actions for Review). This is a joint rulemaking by the Services to
revise joint regulations implementing section 7 of the ESA, which
requires Federal agencies to consult with the Services whenever any
action the agency undertakes, funds, or authorizes may affect
endangered or threatened species or their critical habitat, to ensure
that the action does not jeopardize listed species or adversely modify
critical habitat. In 2019, the Services revised various aspects of the
regulations governing the consultation process under ESA Section 7
including, significantly, how the Services define the ``effects of the
action,'' which has importance for determining the scope of
consultation. Pursuant to Executive Order 13990, the Services reviewed
the specific regulatory provisions that had been revised in the 2019
final rule. Following this review of the 2019 rule, the Services are
proposing to revise a portion of these regulations, including ``effects
of the action,'' but are also soliciting public comments on all aspects
of the 2019 rule before issuing a final rule. In addition to revising
provisions from the 2019 rule, the Services are proposing to clarify
the responsibilities of a Federal agency and the Services regarding the
requirement to reinitiate consultation.
The United States Patent and Trademark Office
The USPTO's mission is to foster innovation, competitiveness, and
economic growth, domestically and abroad, by delivering high quality
and timely examination of patent and trademark applications, guiding
domestic and international intellectual property policy, and delivering
intellectual property information and education worldwide.
Major Programs and Activities
The USPTO is responsible for granting U.S. patents and registering
trademarks. This system of secured property rights, which has its
foundation in Article I, Section 8, Clause 8, of the Constitution
(providing that Congress shall have the power to ``promote the Progress
of Science and useful Arts, by securing for limited Times to Authors
and Inventors the exclusive Right to their respective Writings and
Discoveries'') has enabled American industry to flourish. New products
have been invented, new uses for old ones discovered, and employment
opportunities created for millions of Americans. The continued demand
for patents and trademarks underscores the importance to the U.S.
economy of effective mechanisms to protect new ideas and investments in
innovation, as well as the ingenuity of American inventors and
entrepreneurs.
In addition to granting patents and trademarks, the USPTO advises
the President of the United States, the Secretary of Commerce, and U.S.
government agencies on intellectual property (IP) policy, protection,
and enforcement; and promotes strong and effective IP protection around
the world. The USPTO furthers effective IP
[[Page 10990]]
protection for U.S. innovators and entrepreneurs worldwide by working
with ther agencies to secure strong IP provisions in free trade and
other international agreements. It also provides training, education,
and capacity building programs designed to foster respect for IP and
encourage the development of strong IP enforcement regimes by U.S.
trading partners. As part of its work, the USPTO administers
regulations located at title 37 of the Code of Federal Regulations
concerning its patent and trademark services and the other functions it
performs.
The USPTO's Regulatory Plan Actions
1. Final Rule: Changes to Implement Provisions of the Trademark
Modernization Act of 2020 (0651-AD55): The USPTO amends the rules of
practice in trademark cases to implement provisions of the Trademark
Modernization Act of 2020. This rule establishes ex parte expungement
and reexamination proceedings for cancellation of a registration when
the required use in commerce of the registered mark has not been made;
provides for a new nonuse ground for cancellation before the Trademark
Trial and Appeal Board; establishes flexible USPTO action response
periods; and amends the existing letter-of-protest rule to indicate
that letter-of-protest determinations are final and non-reviewable. The
rule also sets fees for petitions requesting institution of ex parte
expungement and reexamination proceedings, and for requests to extend
USPTO action response deadlines.
The two new ex parte proceedings created by this rulemaking--one
for expungement and one for reexamination--are intended to help ensure
the accuracy of the trademark register by providing a new mechanism for
removing a registered mark from the trademark register or cancelling
the registration as to certain goods and/or services, when the
registrant has not used the mark in commerce. The proposed changes will
give U.S. businesses new tools to clear away unused registered
trademarks from the federal trademark register and will give the USPTO
the ability to move applications through the system more efficiently.
Bureau of Industry and Security
BIS advances U.S. national security, foreign policy, and economic
objectives by maintaining and strengthening adaptable, efficient, and
effective export control and treaty compliance systems as well as by
administering programs to prioritize certain contracts to promote the
national defense and to protect and enhance the defense industrial
base.
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 includes
the Commerce Control List (CCL), which describes commodities, software,
and technology that are subject to licensing requirements for specific
reasons for control. The EAR also regulates U.S. persons' participation
in certain boycotts administered by foreign governments. The National
Security 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, provide for surveys to assess the capabilities of the
industrial base to support the national defense, 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 the Chemical Weapons Convention treaty.
The Additional Protocol Regulations implement similar requirements for
certain civil nuclear and nuclear-related items with respect to an
agreement between the United States and the International Atomic Energy
Agency.
BIS also has an enforcement component with nine offices covering
the United States, as well as BIS export control officers 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 promote
effective export controls through cooperation with other governments.
In FY 2022, BIS plans to publish a number of proposed and final
rules amending the EAR. These rules will cover a range of issues,
including emerging and foundational technology, country specific
policies, CCL revisions based on decisions by the four multilateral
export control regimes (Australia Group, Missile Technology Control
Regime, Nuclear Suppliers Group, and Wassenaar Arrangement), and
implementation of any interagency agreed transfers from the United
States Munitions List to the CCL.
BIS's Regulatory Plan Actions
1. Authorization of Certain ``Items'' to Entities on the Entity
List in the Context of Specific Standards Activities (0694-AI06): BIS
is amending the EAR to clarify its applicability to releases of
technology for standards setting or development to support U.S.
participation in standards efforts.
2. Commerce Control List: Implementation of Controls on
``Software'' Designed for Certain Automated Nucleic Acid Assemblers and
Synthesizers (0694-AI08): BIS is publishing this final rule to amend
the CCL by adding a new Export Control Classification Number (ECCN)
2D352 to control software that is designed for automated nucleic acid
assemblers and synthesizers controlled under ECCN 2B352.j and capable
of designing and building functional genetic elements from digital
sequence data. These amendments to the CCL are based upon a finding,
consistent with the emerging and foundational technologies interagency
process set forth in section 1758 of the Export Control Reform Act of
2018 (ECRA) (50 U.S.C. 4817), that such software is capable of being
utilized in the production of pathogens and toxins and, consequently,
the absence of export controls on such software could be exploited for
biological weapons purposes.
3. Information Security Controls: Cybersecurity Items (0694-AH56):
In 2013, the Wassenaar Arrangement (WA), a multilateral export control
regime in which the United States participates, added cybersecurity
items to the WA List, including a definition for ``intrusion
software.'' In 2015, public comments on a BIS proposed implementation
rule revealed serious issues concerning scope and implementation
regarding these controls. Based on these comments, as well as
substantial commentary from Congress, the private sector, academia,
civil society, and others on the potential unintended consequences of
the 2013 controls, the U.S. government returned to the WA to
renegotiate the controls. This interim final rule outlines the progress
the United States has made in this area, revises implementation, and
requests from the public information about the impact of these revised
controls on U.S. industry and the cybersecurity community. These items
warrant controls because these tools could be used for surveillance,
espionage, or other actions that disrupt, deny or degrade the network
or devices on it.
4. Imposition of Export Controls on Certain Brain-Computer
Interface (BCI)
[[Page 10991]]
Emerging Technology (0694-AI41): Section 1758 of ECRA, as codified
under 50 U.S.C. 4817, authorizes BIS to establish appropriate controls
on the export, reexport or transfer (in-country) of emerging and
foundational technologies. Pursuant to ECRA, BIS has identified Brain
Computer Interface technology as part of a representative list of
technology categories for which BIS will seek public comment to
determine whether this is an emerging technology that is important to
U.S. national security and for which effective controls can be
implemented. In this Advance Notice of Proposed Rulemaking, BIS is
seeking comments specifically concerning whether this technology could
provide the United States, or any of its adversaries, with a
qualitative military or intelligence advantage. In addition, BIS is
seeking public comments on how to ensure that the scope of any controls
that may be imposed on this technology in the future would be effective
and appropriate with respect to their potential impact on legitimate
commercial or scientific applications.
5. Foundational Technologies: Proposed Controls (0694-AH80): BIS is
considering expanding controls on certain foundational technologies.
Foundational technologies may be items that are currently subject to
control for military end use or military end user reasons.
Additionally, foundational technologies may be additional items, for
which an export license is generally not required (except for certain
countries), that also warrant review to determine if they are
foundational technologies essential to the national security. For
example, such controls may be reviewed if the items are being utilized
or are required for innovation in developing conventional weapons or
enabling foreign intelligence collection activities or weapons of mass
destruction applications. In an effort to address this concern, this
proposed rule would amend the CCL by adding controls on certain
aircraft reciprocating or rotary engines and powdered metals and
alloys. This rule requests public comments to ensure that the scope of
these proposed controls will be effective and appropriate, including
with respect to their potential impact on legitimate commercial or
scientific applications.
6. Removal of Certain General Approved Exclusions (GAEs) Under the
Section 232 Steel and Aluminum Tariff Exclusions Process (0694-AH55):
On December 14, 2020, BIS published an interim final rule (the December
14 rule) that revised aspects of the process for requesting exclusions
from the duties and quantitative limitations on imports of aluminum and
steel discussed in three previous Commerce interim final rules
implementing the exclusion process authorized by the President under
section 232 of the Trade Expansion Act of 1962, as amended (232), as
well as a May 26, 2020, notice of inquiry. The December 14 rule added
123 General Approved Exclusions (GAEs) to the regulations. The addition
of GAEs was an important step in improving the efficiency and
effectiveness of the 232 exclusions process for certain Harmonized
Tariff Schedule of the United States (HTSUS) codes for steel and
aluminum that had not received objections. Commerce determined it could
authorize imports under GAEs for these specified HTSUS codes for all
importers instead of requiring each importer to submit an exclusion
request. Subsequently, based on Commerce's review of the public
comments received in response to the December 14 rule and additional
analysis conducted by Commerce of 232 exclusion request submissions,
Commerce determined that a subset of the GAEs added in the December 14
rule did not meet the criteria for inclusion as a GAE and should
therefore be removed. Commerce is removing these GAEs in this interim
final rule to ensure that only those GAEs that meet the stated criteria
from the December 14 rule will continue to be included as eligible
GAEs. Lastly, this interim final rule makes two conforming changes to
the GAE list for a recent change to one HTSUS classification and adds a
footnote to both GAE supplements to address future changes to the
HTSUS.
DOC--BUREAU OF INDUSTRY AND SECURITY (BIS)
Proposed Rule Stage
14. Section 1758 Technologies: Proposed Controls; Request for Comments
[0694-AH80]
Priority: Other Significant.
Legal Authority: 50 U.S.C. 4801 to 4852
CFR Citation: 15 CFR 742; 15 CFR 774.
Legal Deadline: None.
Abstract: The Bureau of Industry and Security (BIS), Department of
Commerce, which maintains controls on the export, reexport, and
transfer (in-country) of dual-use and less sensitive military items
through the Export Administration Regulations (EAR), including the
Commerce Control List (CCL), is considering imposing controls pursuant
to Section 1758. This rule requests public comments to ensure that the
scope of these proposed controls will be effective and appropriate,
including with respect to their potential impact on legitimate
commercial or scientific applications.
Statement of Need: As part of the National Defense Authorization
Act (NDAA) for Fiscal Year 2019 (Public Law 115-232), Congress enacted
the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4817). Section
1758 of ECRA authorizes the Bureau of Industry and Security (BIS) to
establish appropriate controls on the export, reexport, or transfer
(in-country) of emerging and foundational technologies. With this
proposed rule, BIS continues to identify technologies that may warrant
more restrictive controls than they have at present and establishes a
control framework applicable to certain unilaterally-controlled
emerging and foundational technologies.
Summary of Legal Basis: There are a variety of legal authorities
under which BIS operates. However, ECRA (50 U.S.C. 4817) provides the
most substantive legal basis for BIS's actions under this proposed
rule.
Alternatives: There are not alternatives to this rule. This rule
serves as the first tranche of controls specifically outlining
foundational technologies.
Anticipated Cost and Benefits: The anticipated costs and benefits
of this proposed rule are not applicable.
Risks: There are no applicable risks to this proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 08/27/20 85 FR 52934
ANPRM Correction and Comment 10/09/20 85 FR 64078
Extension.
ANPRM Comment Period End............ 10/26/20
ANPRM Correction and Comment 11/09/20
Extension Period End.
NPRM................................ 02/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
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: Logan D. Norton, Department of Commerce, Bureau of
Industry and Security, 1401 Constitution Avenue, Washington, DC 20230,
Phone: 202 812-1762, Email: [email protected].
[[Page 10992]]
RIN: 0694-AH80
DOC--BIS
15. The Imposition of Emerging Technology Export Controls on
Instruments for the Automated Chemical Synthesis of Peptides [0694-
AI84]
Priority: Other Significant.
Legal Authority: 50 U.S.C. 4817(a)(2)(C)
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Bureau of Industry and Security (BIS) has identified
instruments for the automated synthesis of peptides (automated peptide
synthesizers) for evaluation according to the criteria in section 1758
of the Export Control Reform Act of 2018 (ECRA) pertaining to emerging
and foundational technologies. On September 13, 2022, BIS published an
advance notice of proposed rulemaking (87 FR 55930) that requested
public comments on the potential uses of this technology, particularly
with respect to its impact on U.S. national security (e.g., whether
such technology could provide the United States, or any of its
adversaries, with a qualitative military or intelligence advantage).
Taking into consideration the public comments on BIS's September 2022
ANPRM, this rule proposes to implement export controls on certain
automated peptide synthesizers, consistent with the criteria in section
1758 of ECRA.
Statement of Need: Recent advances in peptide synthesis technology
and instrumentation have increased both the speed of peptide synthesis
and the length of peptide products, including peptides and proteins
greater than 100 amino acids in length. Most protein toxins that are
controlled under Export Control Classification Number (ECCN) 1C351 on
the Commerce Control List (CCL) (see Supplement No. 1 to part 774 of
the EAR) are over 100 amino acids in length and have an average length
of 300 amino acids (with the notable exception of conotoxins, which
range between 10-100 amino acids in length). Consequently, absent the
imposition of additional controls on the export, reexport or transfer
(in-country) of certain peptide synthesis technology and
instrumentation (e.g., automated peptide synthesizers), there would be
an increased risk that such technology and instrumentation could be
used to produce controlled toxins for biological weapons purposes.
Summary of Legal Basis: Certain instruments for the automated
synthesis of peptides (automated peptide synthesizers) have been
identified by BIS for evaluation according to the criteria in Section
1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-
4852) pertaining to emerging and foundational technologies.
Alternatives: Consistent with 5 U.S.C. 603(c), BIS is considering
significant alternatives to the imposition of controls on automated
peptide synthesizers and will assess whether the alternatives would:
(1) accomplish the stated objectives of this rule (consistent with the
Section 1758 requirements in ECRA); and (2) minimize any significant
economic impact of this rule on U.S. industry and academia. BIS could
impose broad controls on automated peptide synthesizers that would
capture most of these instruments. However, that option would have a
greater impact not only on small businesses, but also on research and
development laboratories (both academic and corporate), which are
involved in advancing biological technology. BIS is considering focused
controls on automated peptide synthesizers that are determined to be
capable of posing a greater risk of diversion to biological weapons
activities. BIS considers that this approach would be the least
disruptive alternative for implementing export controls in a manner
consistent with controlling technology that has been determined,
through the Section 1758 technology interagency process authorized
under ECRA, to be essential to U.S. national security.
Anticipated Cost and Benefits: BIS estimates that it will receive
roughly 15 license applications per year if Section 1758 export
controls are imposed on automated peptide synthesizers. To the extent
that compliance with these controls would impose a burden on U.S.
industry and academia, BIS believes the burden would be minimal. In
addition, the reclassification process would need to be done only once
per license applicant for exports, reexports or transfers (in-country)
of these items and, consequently, would constitute a one-time burden
for each applicant. Similarly, assessing the availability of license
exceptions and/or applying for and using BIS licenses would impose some
minimal burden on affected persons. The benefit, from a national
security perspective, would be the imposition of export controls on
those automated peptide synthesizers that are determined to be capable
of posing a greater risk of diversion to biological weapons activities.
Risks: The imposition of overly broad (or otherwise improperly
targeted) Section 1758 export controls on peptides or peptide
synthesizers could impair the ability of companies in the United States
to compete effectively with potential competitors in other countries,
which could adversely affect the leadership of U.S. companies in the
field of peptide manufacturing. On the other hand, failure to impose
controls that effectively target those automated peptide synthesizers
that could be of concern for biological weapons purposes, could
increase the potential threat of terrorist attacks involving toxins
produced by such synthesizers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 09/13/22 87 FR 5593
ANPRM Comment Period End............ 10/28/22
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Willard Fisher, Export Administration Specialist,
Department of Commerce, Bureau of Industry and Security, 14th Street
and Pennsylvania Avenue NW, Washington, DC 20230, Phone: 202 482-2440,
Fax: 202 482-3355, Email: [email protected].
RIN: 0694-AI84
DOC--NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST)
Final Rule Stage
16. Updates to Bayh-Dole Implementing Regulations [0693-AB66]
Priority: Other Significant.
Legal Authority: 37 U.S.C. 206 et seq.
CFR Citation: 37 CFR 401; 37 CFR 404; 37 CFR 501.
Legal Deadline: None.
Abstract: The revisions will add language to provide additional
clarity in subject invention and utilization reporting requirements,
U.S. industry preference, and other regulations that impact the
transfer of technology from federally funded research and development.
The final rule aims to improve the transition of federally funded
innovations from the laboratory to the marketplace by reducing the
regulatory burdens for technology transfer.
Statement of Need: This rule would revise the Bayh Dole Act
implementing regulations in order to make technical corrections;
reorganize certain
[[Page 10993]]
subsections; remove outdated and/or unnecessary sections; improve
reporting by federal agencies; and provide clarifications.
Summary of Legal Basis: The rule revisions would be promulgated
under the University and Small Business Patent Procedures Act of 1980,
Public Law 96-517 (as amended), codified at 35 U.S.C. 200 et seq.,
commonly known as the Bayh-Dole Act or Bayh-Dole.
Alternatives: There are not alternatives to this rule.
Anticipated Cost and Benefits: The action would remove duplicative
text, streamline the implementing regulations, and reduce regulatory
burdens, all at no additional cost.
Risks: There are no applicable risks to this rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/04/21 86 FR 35
NPRM Comment Period End............. 04/05/21
Final Action........................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Henry N. Wixon, Chief Counsel for NIST, Department
of Commerce, National Institute of Standards and Technology, 100 Bureau
Drive, Stop 1052, Gaithersburg, MD 20899-1052, Phone: 301 975-2803,
Fax: 301 926-6241, Email: [email protected].
RIN: 0693-AB66
DOC--NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA)
Final Rule Stage
17. Illegal, Unreported, and Unregulated Fishing; Fisheries
Enforcement; High Seas Driftnet Fishing Moratorium Protection Act
[0648-BG11]
Priority: Other Significant.
Legal Authority: Pub. L. 114-81
CFR Citation: 50 CFR 300.
Legal Deadline: None.
Abstract: This proposed rule would make conforming amendments to
regulations implementing the various statutes amended by the Illegal,
Unreported and Unregulated Fishing Enforcement Act of 2015 (Pub. L.
114-81). The Act amends several regional fishery management
organization implementing statutes as well as the High Seas Driftnet
Fishing Moratorium Protection Act. It also provides authority to
implement two new international agreements under the Antigua
Convention, which amends the Convention for the establishment of an
Inter-American Tropical Tuna Commission, and the United Nations Food
and Agriculture Organization Agreement on Port State Measures to
Prevent, Deter, and Eliminate Illegal, Unreported and Unregulated
Fishing (Port State Measures Agreement), which restricts the entry into
U.S. ports by foreign fishing vessels that are known to be or are
suspected of engaging in illegal, unreported, and unregulated fishing.
This proposed rule would also implement the Port State Measures
Agreement. To that end, this proposed rule would require the collection
of certain information from foreign fishing vessels requesting
permission to use U.S. ports. It also includes procedures to designate
and publicize the ports to which foreign fishing vessels may seek entry
and procedures for conducting inspections of these foreign vessels
accessing U.S. ports. Further, the rule would establish procedures for
notification of: the denial of port entry or port services for a
foreign vessel, the withdrawal of the denial of port services if
applicable, the taking of enforcement action with respect to a foreign
vessel, or the results of any inspection of a foreign vessel to the
flag nation of the vessel and other competent authorities as
appropriate.
Statement of Need: The United States is a signatory to the Port
State Measures Agreement (PSMA). The agreement is aimed at combating
illegal, unreported and unregulated (IUU) fishing activities through
increased port inspection of foreign fishing vessels and thereby
closing seafood markets to the products of illegal fishing. In
addition, regulations to identify and certify nations for IUU fishing
and other adverse fishing activities under the authority of the High
Seas Driftnet Fishing Moratorium Protection Act must be updated to
conform to statutory changes. NMFS will also propose changes to the
definition of IUU fishing for the purposes of identifying and
certifying nations under that Act.
Summary of Legal Basis: This action is required under several
statutes: Magnuson-Stevens Fishery Conservation and Management Act
(P.L. 94-265 as amended by P.L. 109-479); Illegal, Unreported, and
Unregulated Fishing Enforcement Act of 2015 (P.L. 114-81); Ensuring
Access to Pacific Fisheries Act (P.L. 114-327); High Seas Driftnet
Fishing Moratorium Protection Act (P.L. 104-43). The Secretary of
Commerce is authorized to issue regulations to implement the statutory
obligations to counter IUU fishing by foreign fishing vessels and to
prevent the importation of illegally harvested seafood.
Alternatives: Alternatives to taking action at the port would
include taking action at sea against IUU fishing vessels and in the
supply chain against detected IUU fishing products. At-sea monitoring
and inspection is part of an overall strategy to combat IUU fishing,
but it is extremely expensive, resources are limited, and the U.S. has
limited jurisdiction to board foreign-flag vessels at sea. Likewise,
tracing and removing illegal products already released into the U.S.
seafood market would be difficult and resource intensive.
Preventing entry of IUU fishing vessels into ports or investigating
fishing vessels at the port is an efficient and effective approach to
combat illegal activity and to prevent illegal products from entering
the supply chain. There are no alternatives to the conforming
amendments to the High Seas Driftnet Fishing Moratorium Protection Act.
Without these changes, the implementing regulations would not be
consistent with the revised statute. However, the statute authorizes
the Secretary of Commerce to amend the regulatory definition of IUU
fishing for the purposes of identifying and certifying nations. NMFS
has considered several activities that constitute illegal fishing and
proposes amendments to the definition to counter these forms of IUU
fishing. Alternatives to amending the IUU fishing definition would
include the adoption of binding measures at regional fishery
organizations to counter the activities of concern. While NMFS is
pursuing this approach, amending the definition provides a more direct
means of addressing the problem through the identification of nations
and potential trade restrictions.
Anticipated Cost and Benefits: The anticipated costs will be
minimal in that foreign vessels requesting permission to visit U.S.
ports are already required to report. Under this rule, fishing vessel
masters will have to include more information about the vessel and its
cargo when they submit an electronic notice of arrival to the U.S.
Coast Guard. Based on the information submitted, NMFS may deny port
privileges for vessels known to have engaged in illegal fishing or may
meet the vessel in port to conduct an inspection. The minimal
additional data elements required of foreign fishing vessels will be
submitted through the existing U.S. Coast Guard system for electronic
Notices of Arrival and Departure, thus reporting costs are
[[Page 10994]]
not anticipated to affect shipping patterns, port usage, or
international commerce. In addition, vessel inspections will be
coordinated and planned based on the notice of arrival submitted prior
to entry into port, thus delays for inspection will be minimal and not
result in significant costs to legitimate vessels. Benefits of the rule
will accrue when IUU vessels are denied entry, and illegal seafood
products are precluded from the U.S. supply chain, thereby maintaining
higher prices and market share for legitimate producers of fishery
products. In addition, benefits will accrue from reduced costs of
inspection and monitoring at ports of entry due to the advance notice
provided and the ability of NMFS and Coast Guard to take a risk
management approach to vessel inspection. Should the United States
impose trade restrictions on foreign nations due to the expanded
definition of IUU fishing, some costs would be borne by U.S. importers
who would have to adjust their supply chains. However, many U.S.
importers and seafood dealers are already adjusting supply chains to
respond to consumer demand for lawfully-acquired, sustainable and
environmentally responsible seafood. The benefits of additional steps
to counter IUU fishing will accrue to law-abiding harvesters,
processors and traders as fish stocks are recovered and they no longer
must compete with illegitimate products in the supply chain.
Risks: If the port entry reporting and inspection provisions of
this rule were not implemented, there is an increased risk of IUU
fishing vessels entering U.S. ports and/or the products of IUU fishing
infiltrating the U.S. supply chain. In addition, the U.S. would be out
of compliance with its international obligations under the PSMA. If the
revisions to the High Seas Driftnet Fishing Moratorium Protection Act
are not implemented through conforming amendments to the regulations
and through additions to the definition of IUU fishing, nations might
not be identified under the statute, therefore diminishing the
likelihood of corrective actions to counter IUU fishing.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/08/22 87 FR 40763
NPRM Comment Period End............. 09/06/22
Final Action........................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Alexa Cole, Director, Office of International
Affairs and Seafood Inspection, Department of Commerce, National
Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver
Spring, MD 20910, Phone: 301 427-8286, Email: [email protected].
RIN: 0648-BG11
DOC--NOAA
18. Amendments to the North Atlantic Right Whale Vessel Strike
Reduction Rule [0648-BI88]
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et seq.; 16 U.S.C. 1531 et seq.
CFR Citation: 50 CFR 224.
Legal Deadline: None.
Abstract: NMFS has completed a review of the North Atlantic right
whale vessel speed rule (per 50 CFR 224.105; 78 FR 73726, December 9,
2013). Through this action, NMFS invites comment on the report as well
as information that may inform potential revisions to existing
management strategies and regulations to further reduce the risk of
vessel strikes of North Atlantic right whales.
Statement of Need: This action is needed to further reduce the
likelihood of mortalities and serious injuries to endangered North
Atlantic right whales from vessel collisions, which are a leading cause
of the species' decline and contributing to the ongoing Unusual
Mortality Event (2017-present). Following two decades of growth, the
species has been in decline over the past decade with a best population
estimate of fewer than 350 individuals. Entanglement in fishing gear
and vessel strikes are the two primary causes of North Atlantic right
whale mortality and serious injury across their range, and human-caused
mortality to adult females, in particular, is limiting recovery of the
species.
Summary of Legal Basis: NMFS is implementing this rule pursuant to
its rulemaking authority under MMPA section 112(a) (16 U.S.C. 1382(a)),
and ESA section 11(f) (16 U.S.C. 1540(f)).
Alternatives: In January 2021, NMFS released, and solicited public
comment on, an assessment of the current right whale vessel speed rule
(50 CFR 224.105). The assessment highlighted the need to address
collision risk from vessels less than 65 ft in length and modify the
boundaries and timing of Seasonal Management Areas (SMAs) to better
reflect current whale and vessel traffic distribution, along with other
recommendations to improve vessel strike mitigation efforts. In 2022,
NMFS completed a coastwide right whale vessel strike risk model
(Garrison et al. 2022), which informed development of the proposed
modifications to the existing speed rule. At the proposed rule stage,
there are a number of alternatives considered in the draft Regulatory
Impact Review and draft Environmental Assessment. The Preferred
Alternative would modify the spatial and temporal boundaries of the
existing SMAs to create newly proposed Seasonal Speed Zones (SSZs), add
smaller vessels down to 35 ft in length, and establish a mandatory
Dynamic Speed Zone program.
Anticipated Cost and Benefits: Under the Preferred Alternative,
NMFS estimated modifications to the speed rule would cost just over $46
million per year. Estimated costs would be borne primarily by the
owners and operators of vessels currently transiting within newly
expanded portions of SSZs along the U.S. East Coast. Owners and
operators of vessels of applicable size classes that regularly transit
within active SSZs at speeds in excess of 10 knots would be most
affected. Vessels operating in the Northeast and Mid-Atlantic regions
are expected to bear the majority of costs (89%). Potential benefits
stemming from this action include a reduction in North Atlantic right
whale mortalities and serious injuries resulting from collisions with
vessels, with potential reduction in vessel strike risk for other large
whale species.
Risks: This will be a high-profile action and is essential to
ensure long-term recovery of North Atlantic right whales. Given the
endangered status of the North Atlantic right whale, the large
geographic area, and number of stakeholders subject to the updated
regulations, modification to the current speed rule will be both
controversial and of high interest. Changes to the current speed rule
are necessary to: (1) address a misalignment between existing Seasonal
Management Areas and places/times with elevated strike risk, and (2)
mitigate currently unregulated lethal strike risk from vessels 35-65 ft
in length.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/01/22 87 FR 46921
[[Page 10995]]
NPRM Comment Period End............. 09/30/22
NPRM Comment Period Extension....... 09/16/22 87 FR 56925
NPRM Comment Period Extension End... 10/31/22
Final Action........................ 06/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Kim Damon-Randall, Director, Office of Protected
Resources, Department of Commerce, National Oceanic and Atmospheric
Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone:
301 427-8400, Email: [email protected].
Related RIN: Related to 0648-AS36
RIN: 0648-BI88
DOC--PATENT AND TRADEMARK OFFICE (PTO)
Proposed Rule Stage
19. Setting and Adjusting Trademark Fees [0651-AD65]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 112-29
CFR Citation: 37 CFR 2.
Legal Deadline: None.
Abstract: The United States Patent and Trademark Office (USPTO or
Office) takes this action to set and adjust Trademark fee amounts to
provide the Office with a sufficient amount of aggregate revenue to
recover its aggregate cost of operations while helping the Office
maintain a sustainable funding model, ensure the integrity of the
Trademark register, and promote efficiency of processes.
Statement of Need: The purpose of this rule is to set and adjust
trademark fee amounts to provide sufficient aggregate revenue to cover
the agency's aggregate cost of operations. To this end, this rule
creates new or changes existing fees for trademark services.
Summary of Legal Basis: The Leahy-Smith America Invents Act (AIA),
enacted in 2011, provided USPTO with the authority to set and adjust
its fees for patent and trademark services. This authority was extended
by the Study of Underrepresented Classes Chasing Engineering and
Science Success (SUCCESS) Act of 2018. Since then, USPTO has conducted
an internal biennial fee review, in which it undertook internal
consideration of the current fee structure, and considered ways that
the structure might be improved, including rulemaking pursuant to the
USPTO's fee-setting authority. This fee review process involves public
outreach, including, as required by the Act, a public hearing held by
the USPTO's Trademark Public Advisory Committee, as well as public
comment and other outreach to the user community and public in general.
Alternatives: This rulemaking action is currently in development
and alternatives have not yet been determined.
Anticipated Cost and Benefits: This rulemaking action is currently
in development and aggregate annual economic impacts have not yet been
determined. The user fees charged by the USPTO for its services are
considered transfer payments that do not affect the total resources
available to society, and therefore the changes to trademark fees
proposed by this rulemaking are transfers, and are not costs of this
rulemaking.
Risks: The USPTO will set and adjust trademark fee amounts to
provide the Office with a sufficient amount of aggregate revenue to
recover its aggregate cost of operations while helping the Office
maintain a sustainable funding model, ensure the integrity of the
Trademark register, and promote efficiency of processes. Therefore, one
risk of taking no action could be that USPTO might not be able to
recover its aggregate costs of operations in the long run.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/23
NPRM Comment Period End............. 01/00/24
Final Action........................ 07/00/24
Final Action Effective.............. 09/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Organizations.
Government Levels Affected: None.
Agency Contact: Brendan Hourigan, Director, Office of Planning and
Budget, Department of Commerce, Patent and Trademark Office, P.O. Box
1450, Alexandria, VA 22313-1450, Phone: 571 272-8966, Fax: 571 273-
8966, Email: [email protected].
RIN: 0651-AD65
BILLING CODE 3410-12-P
DEPARTMENT OF DEFENSE
Statement Of Regulatory Priorities
Background
The Department of Defense (DoD) is the largest Federal department,
employing over 1.6 million military personnel and 750,000 civilians
with operations all over the world. DoD's enduring mission is to
provide combat-credible military forces needed to deter war and protect
the security of our nation. To guide this mission, the Secretary of
Defense has outlined three top priorities, which are to defend the
nation, take care of our people, and succeed through teamwork. In
addition, the National Defense Strategy sets out how DoD will
contribute to advancing and safeguarding vital U.S. national
interests--protecting the American people, expanding America's
prosperity, promoting global security, seizing new strategic
opportunities, and realizing and defending our democratic values.
Because of this expansive and diversified mission and reach, DoD
regulations can address a broad range of matters and have an impact on
varied members of the public, as well as other federal agencies.
Pursuant to Executive Order 12866, ``Regulatory Planning and
Review'' (September 30, 1993) and Executive Order 13563, ``Improving
Regulation and Regulatory Review'' (January 18, 2011), the DoD issues
this Regulatory Plan and Agenda to provide notice about the DoD's
regulatory and deregulatory actions.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (January 18, 2011), the Department
continues to review existing regulations with a goal to eliminate
outdated, unnecessary, or ineffective regulations; account for the
currency and legitimacy of each of the Department's regulations; and
ultimately reduce regulatory burden and costs.
DOD Priority Regulatory Actions
The regulatory and deregulatory actions identified in this
Regulatory Plan embody the core of DoD's regulatory priorities for
Fiscal Year (FY) 2023 and help support President Biden's regulatory
priorities, the Secretary of Defense's top priorities, and those
priorities set out in the National Defense Strategy. The DoD regulatory
prioritization is focused on initiatives that:
[[Page 10996]]
Promote the country's economic resilience, including
addressing COVID-related and other healthcare issues.
Support underserved communities and improve small business
opportunities.
Promote competition in the American economy.
Promote diversity, equity, inclusion, and accessibility in
the Federal workforce.
Support national security efforts, especially safeguarding
Federal Government information and information technology systems.
Tackle the climate crisis and protect the environment; and
Address military family matters.
Rules That Promote the Country's Economic Resilience
Pandemic COVID-19 Rules
Pursuant to Executive Order 13987, ``Organizing and Mobilizing the
United States Government to Provide a Unified and Effective Response to
Combat COVID-19 and to Provide United States Leadership on Global
Health and Security,'' January 20, 2021; Executive Order 13995,
``Ensuring an Equitable Pandemic Response and Recovery,'' January 21,
2021; Executive Order 13997, ``Improving and Expanding Access to Care
and Treatments for COVID-19,'' January 21, 2021; and Executive Order
13999, ``Protecting Worker Health and Safety,'' January 21, 2021, the
Department temporarily modified its TRICARE regulation so TRICARE
beneficiaries have access to the most up-to-date care required for the
diagnosis and treatment of COVID-19. TRICARE continues to reimburse
like Medicare, to the extent practicable, as required by statute. The
Department is researching the impacts of making some of those
modifications permanent and may pursue such future action.
These modifications include:
TRICARE Coverage of National Institute of Allergy and Infectious
Disease--Coronavirus Disease 2019 Clinical Trials. RIN 0720-AB83
This final rule is required to finalize certain temporary
flexibilities enacted in interim final rules published in 2020 in
response to the COVID-19 pandemic. This rule finalizes provisions
published in two interim final rules (IFRs) with request for comment,
which temporarily added coverage for the treatment use of investigation
drugs under U.S. Food and Drug Administration (FDA) approved expanded
access programs when for the treatment of coronavirus disease 2019
(COVID-19) and permitted coverage of National Institute of Allergy and
Infectious Disease (NIAID)-sponsored clinical trials for the treatment
or prevention of COVID-19.
Expanding TRICARE Access to Care in Response to the COVID-19 Pandemic.
RIN 0720-AB85
This interim final rule with comment will temporarily amend the
TRICARE regulation at 32 CFR part 199 by: (1) adding freestanding End
Stage Renal Disease facilities as a category of TRICARE-authorized
institutional provider and modifying the reimbursement for such
facilities; and (2) adopting Medicare New COVID-19 Treatments Add-on
Payments (NTCAPs). The TRICARE regulation is temporarily being modified
(except for the modifications to paragraphs 199.6(b)(4)(xxi) and
199.14(a)(1)(iii)(E)(7), which will not expire), but, in each case,
only to the extent necessary to ensure that TRICARE beneficiaries have
access to the most up-to-date care required for the prevention,
diagnosis, and treatment of COVID-19, and that TRICARE continues to
reimburse like Medicare, to the extent practicable, as required by
statute. The modifications to paragraphs 199.6(b)(4)(xxi) and
199.14(a)(1)(iii)(E)(7) establish freestanding End Stage Renal Disease
(ESRD) facilities as a category of TRICARE-authorized institutional
provider and modify TRICARE reimbursement of freestanding ESRD
facilities. These provisions will improve TRICARE beneficiary access to
medically necessary dialysis and other ESRD services and supplies.
These provisions also support the requirement that TRICARE reimburse
like Medicare, and will help to alleviate regional health care
shortages due to the COVID-19 pandemic by ensuring access to dialysis
care in freestanding ESRD facilities rather than hospital outpatient
departments. The modification to paragraph 199.14(a)(iii)(E) adopts
Medicare's New COVID-19 Treatments Add-on Payment (NCTAP) for COVID-19
cases that meet Medicare's criteria. This provision increases access to
emerging COVID-19 treatments and supports the requirement that TRICARE
reimburse like Medicare.
Restriction on Acquisition of Personal Protective Equipment and Certain
Items From Non-Allied Foreign Nations (DFARS Case 2022-D009). RIN 0750-
AL60
This rule implements section 802 of the National Defense
Authorization Act for Fiscal Year 2022, which prohibits acquisition of
personal protective equipment related to healthcare and certain other
healthcare-related items from non-allied foreign nations. Decreasing
dependence on personal protective equipment and certain other items
originating in non-allied foreign nations is a matter of public health
and national security, especially during a declared public health
emergency. The domestic supply chain for personal protective equipment
and certain other items is critical. An adequate continued supply is
vital to ensure domestic control with minimal disruption in production
and to reduce U.S. dependence on non-allied foreign nations. Potential
benefits of this rule will be the elimination of counterfeit covered
items within the domestic supply chain and reduced dependence on
foreign sources that are not allies of the United States. In addition,
this restriction will further promote growth in domestic capabilities
and may provide additional opportunities to domestic small businesses
for future procurement and manufacturing efforts, increasing domestic
sourcing of personal protective equipment and other covered items.
Medical Debt Relief
Collection From Third Party Payers of Reasonable Charges for Healthcare
Services. RIN 0720-AB87
This rule discusses new debt waiver process for medical debt owed
for services rendered at Military Treatment Facilities to civilians who
are not covered beneficiaries and implements section 702 of the FY 2021
NDAA. Under section 702, the Secretary of Defense may waive a fee
charged to a civilian who is not a covered beneficiary if after any
insurance payments the civilian is not able to pay for the trauma or
other medical care provided to the civilian; and the provision of such
care enhanced the medical readiness of the health care provider or
health care providers furnishing such care.
Executive Order 13985, ``Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government'' January 20,
2021
Rules That Promote Diversity, Equity, Inclusion, and Accessibility in
the Federal Workforce
Nondiscrimination on the Basis of Disability in Program or Activities
Assisted or Conducted by the DoD and in Equal Access to Information and
Communication Technology Used by DoD, and Procedures for Resolving
Complaints. RIN: 0790-AJ04
Revisions to this regulation: (1) update and clarify the
obligations that
[[Page 10997]]
Section 504 of the Rehabilitation Act of 1973 (section 504) imposes on
recipients of Federal financial assistance and the Military Departments
and Components (DoD Components); (2) reflect the most current Federal
statutes and regulations, as well as developments in Supreme Court
jurisprudence, regarding unlawful discrimination on the basis of
disability and promotes consistency with comparable provisions
implementing title II of the Americans with Disabilities Act (ADA); (3)
implement section 508 of the Rehabilitation Act of 1973 (section 508),
requiring DoD make its electronic and information technology accessible
to individuals with disabilities; (4) establish and clarify obligations
under the Architectural Barriers Act of 1968 (ABA), which requires that
DoD make facilities accessible to individuals with disabilities; and
(5) Provide complaint resolution and enforcement procedures pursuant to
section 504 and the complaint resolution and enforcement procedures
pursuant to section 508. These revisions incorporate the directive of
Executive Order 14035, ``Diversity, Equity, Inclusion, and
Accessibility in the Federal Workforce'' by defining, clarifying,
advancing accessibility throughout DoD programs and activities.
USACE Implementing Procedures for Principles, Requirements, and
Guidelines Applicable to Actions Involving Investment in Water
Resources. RIN 0710-AB41
Section 2031 of the Water Resources Development Act of 2007 (Pub.
L. 110-114) called for revisions to the 1983 Principles and Guidelines
for Water and Land Related Resources Implementation Studies, resulting
in the issuance of the Principles and Requirements (P&R) guidance
document in March 2013 and the Interagency Guidelines in December 2014,
which together comprise the Principles, Requirements, and Guidelines
(PR&G). The PR&G are intended to provide a common framework and
comprehensive policy and guidance for analyzing a diverse range of
water resources projects, programs, activities, and related actions
involving Federal investment in water resources. The U.S. Army Corps of
Engineers (Corps) proposes a regulation to show how it would apply the
PR&G to the Corps' mission and authorities. In this proposed
regulation, the Corps intends to increase consistency and compatibility
in Federal water resources investment decision making to include
considerations such as analyzing a broader range of long-term costs and
benefits, enhancing collaboration, including a more thorough and
transparent risk and uncertainty analyses, and improving resilience for
dealing with emerging challenges, including climate change.
Flood Control Cost-Sharing Requirements Under the Ability To Pay
Provision. RIN: 0710-AB34
Section 103(m) of the Water Resources Development Act (WRDA) of
1986, as amended (33 U.S.C. 2213(m)), authorizes the USACE to reduce
the non-Federal share of the cost of a study or project for certain
communities that are not able financially to afford the standard cost-
share. Part 241 of title 33 in the Code of Federal Regulations provides
the criteria that the USACE uses in making these determinations where
the primary purpose of the study or project is flood damage reduction.
The proposed rule would update this regulation, by broadening its
applicability to include projects with other purposes (instead of just
flood damage reduction) and the feasibility study of a project (instead
of just design and construction). The WRDA 2000 modified section 103(m)
to also include the following mission areas: environmental protection
and restoration, flood control, navigation, storm damage protection,
shoreline erosion, hurricane protection, and recreation or an
agricultural water supply project which have not yet been added to the
regulation. It also included the opportunity to cost share all phases
of a USACE project to also include feasibility in addition to the
already covered design and construction. This rule would provide a
framework for deciding which projects are eligible for consideration
for a reduction in the non-Federal cost share based on ability to pay.
Rules That Support Underserved Communities and Improve Small Business
Opportunities
Rules of Particular Interest to Small Business
Small Business Innovation Research Program Data Rights (DFARS Case
2019-D043). RIN 0750-AK84
This rule implements changes made by the Small Business
Administration (SBA) related to data rights in the Small Business
Innovation Research (SBIR) Program and Small Business Technology
Transfer (STTR) Program Policy Directive, published in the Federal
Register on April 2, 2019 (84 FR 12794). The SBIR and STTR programs
fund a diverse portfolio of startups and small businesses across
technology areas and markets to stimulate technological innovation,
meet Federal research and development (R&D) needs, and increase
commercialization to transition R&D into impact. The final SBA Policy
Directive includes several revisions to clarify data rights, which
require corresponding revisions to the Defense Federal Acquisition
Regulation Supplement (DFARS). These changes include harmonizing
definitions, lengthening the SBIR/STTR protection period from 5 years
to 20 years, and providing for the granting of Government-purpose
rights license in place of an unlimited rights license upon expiration
of the SBIR/STTR protection period.
Executive Order 14036, ``Promoting Competition in the American
Economy'' July 9, 2021
Rule That Promotes Competition in the American Economy
Past Performance of Subcontractors and Joint Venture Partners (DFARS
Case 2018-D055). RIN 0750-AK16
This rule implements section 823 of the National Defense
Authorization Act for Fiscal Year 2019, which establishes a requirement
for use of the best available information regarding past performance of
subcontractors and joint venture partners when awarding DoD
construction and architect-engineer contracts. Section 823 requires
annual performance evaluations for first-tier subcontractors and
individual parties to joint ventures performing construction and
architect-engineer contracts valued at either $750,000 or more, or 20
percent of the value of the prime contract (whichever is higher), in
accordance with specified conditions. In addition, processes for
exceptions from the annual evaluation requirement will be established
for construction and architect-engineer contracts where submission of
annual evaluations would not provide the best representation of the
performance of a contractor, including subcontractors and joint venture
partners under specified conditions. This rule will make it easier for
subcontractors and individual parties to joint ventures to establish a
record of their past performance. These entities will be able to take
credit for the work they performed on contracts and subcontracts, which
will help them be more competitive when bidding on future DoD
contracts. This will help increase competition for DoD contracts.
[[Page 10998]]
Defense Commercial Solutions Opening (DFARS Case 2022-D006). RIN 0750-
AL57
This rule implements section 803 of the National Defense
Authorization Act for Fiscal Year 2022 (Pub. L. 117-81), which
establishes a permanent authority for the Secretary of Defense and
those of the military departments to acquire innovative commercial
products and commercial services through a competitive selection of
proposals resulting from a general solicitation and the peer review of
such proposals. Products and services purchased under this authority
are treated as commercial. This rule will enable DoD to access
innovative products and services of entities that may not have done
business with DoD in the past. Such entities may compete for additional
DoD contracts, thereby increasing competition for DoD contracts.
Modification of Prize Authority for Advanced Technology Achievements
(DFARS Case 2022-D014). RIN 0750-AL65
This rule implements section 822 of the National Defense
Authorization Act for Fiscal Year 2022 (Pub. L. 117-81). Section 822
revises 10 U.S.C. 2374a regarding the award of prizes for advanced
technology achievement to: (1) authorize the award of procurement
contracts and other agreements ``as another type of prize'' (as in
other than cash prizes); (2) permit the award of prizes, including
procurement contracts and other agreements, in excess of $10,000,000
with the approval of the Under Secretary of Defense for Research and
Engineering; and (3) require DoD provide Congress with notice of an
award of a procurement contract or other agreement under this program
that exceeds $10 million. This rule will help to expand the Defense
Industrial Base, thereby increasing competition for future DoD
contracts.
DFARS Buy American Act Requirements (DFARS Case 2022-D019). RIN 0750-
AL74
This rule implements the requirements of Executive Order 14005,
Ensuring the Future Is Made in All of America by All of America's
Workers. Changes to the Federal Acquisition Regulation (FAR) are being
made via RIN 9000-AO22 (FAR Case 2021-008, Amendments to the FAR Buy
American Act Requirements). This rule proposes conforming changes to
the DFARS.
Rules That Support National Security Efforts
Assessing Contractor Implementation of Cybersecurity Requirements
(DFARS Case 2019-D041). RIN 0750-AK81
The purpose of this rule is to ensure that Defense Industrial Base
(DIB) contractors will adequately protect sensitive unclassified
information at a level commensurate with the risk, accounting for
information flow down to its subcontractors in a multi-tier supply
chain.
Cybersecurity Maturity Model Certification (CMMC) Program. RIN 0790-
AL49
This rule establishes a requirement for Defense Industrial Base
(DIB) contractors to be assessed against the Cybersecurity Maturity
Model Certification (CMMC) 2.0 in order to qualify for award of
designated future DoD contracts. This model is designed to provide
increased assurance to the Department that contractors are compliant
with existing information security standards for Federal Contract
Information (FCI) and Controlled Unclassified Information (CUI) and are
fully capable of protecting such information at a level commensurate
with risk from cybersecurity threats.
Department of Defense (DoD)-Defense Industrial Base (DIB) Cybersecurity
(CS) Activities. RIN: 0790-AK86
This rule will allow a broader community of defense contractors to
access to relevant cyber threat information the Department believes is
critical in defending unclassified networks and information systems and
protecting DoD warfighting capabilities. These revisions seek to
address the increasing cyber threat targeting all defense contractors
by expanding eligibility to defense contractors that process, store,
develop, or transmit DoD Controlled Unclassified Information (CUI).
This rule is part of DoD's approach to collaborate with industry to
counter cyber threats through information sharing.
Rules That Tackle the Climate Crisis and Protect the Environment
Policy and Procedures for Processing Requests To Alter U.S. Army Corps
of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408. RIN: 0710-
AB22
Where a party other than the USACE seeks to use or alter a Civil
Works project that USACE constructed, the proposed use or alteration is
subject to the prior approval of the USACE. Some examples of such
alterations include an improvement to the project; relocation of part
of the project; or installing utilities or other non-project features.
These alterations may be proposed by local or state governments, other
federal agencies, private corporations, or private citizens, for
example. This requirement was established in section 14 of the Rivers
and Harbors Act of 1899 and is codified at 33 U.S.C. 408 (section 408).
Section 408 provides that the USACE may grant permission for another
party to alter a Civil Works project, upon a determination that the
alteration proposed will not be injurious to the public interest and
will not impair the usefulness of the Civil Works project. The USACE is
proposing to convert its policy that governs the section 408 program to
a binding regulation. This policy, Engineer Circular 1165-2-220,
Policy, and Procedural Guidance for Processing Requests to Alter U.S.
Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408,
was issued in September 2018.
Natural Disaster Procedures: Preparedness, Response, and Recovery
Activities of the Corps of Engineers. RIN 0710-AA78
The U.S. Army Corps of Engineers (Corps) is proposing to update the
Federal regulation that covers the procedures that the Corps uses under
section 5 of the Flood Control Act of 1941, as amended (33 U.S.C.
701n), commonly referred to as Public Law 84-99. The Corps relies on
this program to prepare for, respond to, and help communities recover
from a flood, hurricane, or other natural disaster, including the
repair of damage to eligible flood risk reduction infrastructure. The
Corps initiated this rulemaking process through an advanced notice of
proposed rulemaking (ANPRM) on February 13, 2015. As a next step, the
Corps is planning to propose revisions to the program to address
statutory changes under various Water Resources Development Act
provisions and to formalize certain agency guidance relating to natural
disaster procedures. Hurricane Katrina (2005), Hurricane Sandy (2012),
flooding on the Mississippi and Missouri Rivers (2008, 2011, and 2013),
and Hurricanes Harvey, Irma, and Maria (2017) have provided a more
detailed understanding of the nature and severity of risk associated
with flood control projects. In addition, the maturation of risk-
informed decision-making approaches and technological advancements
influenced the outlook on the implementation of Public Law 84-99
activities, with a shift toward better
[[Page 10999]]
alignment with Corps Levee Safety and National Flood Risk Management
Programs, as well as the National Preparedness and Response Frameworks.
Through these programs, the Corps works with non-Federal sponsors and
stakeholders to assess, communicate, and manage the risks to people,
property, and the environment associated with levee systems and flood
risks.
Credit Assistance for Water Resources Infrastructure Projects. RIN:
0710-AB31
The USACE proposes to implement a new credit program for dam safety
work at non-Federal dams. The program is authorized under the Water
Infrastructure Finance and Innovation Act of 2014 (WIFIA) and Division
D, Title 1 of the Consolidated Appropriations Act of 2021. WIFIA
authorizes the USACE to provide secured (direct) loans and loan
guarantees (Federal Credit instruments) to eligible water resources
infrastructure projects and to charge fees to recover all or a portion
of the USACE' cost of providing credit assistance and the costs of
conducting engineering reviews and retaining expert firms, including
financial and legal services, to assist in the underwriting and
servicing of Federal credit instruments. Projects would be evaluated
and selected by the Secretary of the Army (the Secretary), based on the
requirements and the criteria described in this rule.
Appendix C Procedures for the Protection of Historic Properties. RIN
0710-AB46
The U.S. Army Corps of Engineers (Corps) considers the effects of
its actions on historic properties pursuant to section 106 of the
National Historic Preservation Act (NHPA). The Corps' Regulatory
Program's regulations for complying with the NHPA are outlined at 33
CFR 325 Appendix C. Since these regulations were promulgated in 1990,
there have been amendments to the NHPA and revisions to the Advisory
Council on Historic Preservation's (ACHP) regulations at 36 CFR part
800. In response, the Corps issued interim guidance until rulemaking
could be completed in order to ensure full compliance with the NHPA and
ACHP's regulations. Appendix C is intended to provide the implementing
procedures for the Regulatory Program's compliance with Section 106 of
the National Historic Preservation Act.
Rulemaking is required to ensure the Regulatory Program is
compliant with the NHPA and ACHP's implementing regulations at 36 CFR
800 for federal agency compliance with Section 106.
Revised Definition of ``Waters of the United States''--Rule 1 RIN:
0710--AB40. Related RIN: 2040-AG19
In April 2020, the EPA, and the Department of the Army (``the
agencies'') published the Navigable Waters Protection Rule (NWPR) that
revised the previously codified definition of ``waters of the United
States'' (85 FR 22250, April 21, 2020). The agencies are now initiating
this new rulemaking process that restores the regulations (51 FR 41206)
in place prior to the 2015 ``Clean Water Rule: Definition of `Waters of
the United States'' (80 FR 37054, June 29, 2015), updated to be
consistent with relevant Supreme Court decisions. The agencies
conducted a substantive re-evaluation of the definition of ``waters of
the United States'' in accordance with the Executive Order 13990 and
determined that they need to revise the definition to ensure the
definition is consistent with the best available science, protects the
environment, ensures access to clean water, considers how climate
change resiliency may be affected by the definition of waters of the
United States, and ensures environmental justice is prioritized in the
rulemaking process. The agencies intend to consider further revisions
in a second rule in light of additional stakeholder engagement and
implementation considerations, scientific developments, and
environmental justice values. This effort will also be informed by the
experience of implementing the pre-2015 rule, the 2015 Clean Water
Rule, and the 2020 Navigable Waters Protection Rule.
Revised Definition of ``Waters of the United States''--Rule 2 RIN:
0710-AB47
The Department of the Army and the Environmental Protection Agency
intend to pursue a second rule defining ``Waters of the United States''
to consider further revisions to the agencies' first rule (RIN 0710-
AB40) which proposes to restore the regulations in place prior to the
2015 ``Clean Water Rule: Definition of 'Waters of the United States''
(80 FR 37054, June 29, 2015), updated to be consistent with relevant
Supreme Court Decisions, and reflect a reasonable interpretation based
on the record before the agencies, including the best available
science. This second rule proposes to include revisions reflecting on
additional stakeholder engagement and implementation considerations,
scientific developments, and environmental justice values. This effort
will also be informed by the experience of implementing the pre-2015
rule, the 2015 Clean Water Rule, and the 2020 Navigable Waters
Protection Rule.
Rules That Address Military Family Matters
Definitions of Gold Star Family and Gold Star Survivor. RIN 0790-AL56
This rule implements section 626 of the FY 2022 NDAA to define the
terms ``gold star family'' and ``gold star survivor'' for consistent
use across all military departments. The Defense Department treats all
surviving family members equally and survivor benefits are the same
across the board unless their Service member is killed or dies from
causes under dishonorable conditions.
TRICARE; Reimbursement of Ambulatory Surgery Centers and Outpatient
Services Provided in Cancer and Children's Hospitals. RIN 0720-AB73
This final rule will revise: (1) 32 CFR 199.2 by adding, in
alphabetical order, the definitions of ``Ambulatory Surgery Center'',
``Cancer hospital'', and ``Children's hospital''; (2) 32 CFR 199.6 to
include news requirements that Ambulatory Surgery Centers (ASC)
participating in Medicare must meet all program requirements; and (3)
32 CFR 199.14 to implement Medicare's payment methodologies for
reimbursing ambulatory surgery centers and Cancer and Children's
Hospitals. The combined impact of is rule is a cost-saving of
approximately $45 million, which would be offset by $1.5 million in
administrative costs to implement the changes. This estimated reduction
in costs of $45 million is a transfer from providers to DoD.
DOD--OFFICE OF THE SECRETARY (OS)
Proposed Rule Stage
20. Department of Defense (DOD)-Defense Industrial Base (DIB)
Cybersecurity (CS) Activities [0790-AK86]
Priority: Other Significant.
Legal Authority: 10 U.S.C. 391; 10 U.S.C. 2224; 44 U.S.C. 3541; 10
U.S.C. 393
CFR Citation: 32 CFR 236.
Legal Deadline: None.
Abstract: The DIB CS Program currently provides cyber threat
information to cleared defense contractors. Proposed revisions would
allow all defense contractors who process, store, develop, or transit
DoD controlled unclassified information to
[[Page 11000]]
be eligible for the program and to receive cyber threat information.
Expanding participation will allow a broader community of defense
contractors to participate in the DIB CS Program and is in alignment
with the National Defense Strategy.
Statement of Need: The unauthorized access and compromise of DoD
unclassified information and operations poses an imminent threat to
U.S. national security and economic security interests and contractors
are being targeted on a daily basis. Many of these contractors are
small and medium size contractors that can benefit from partnering with
DoD to enhance and supplement their cybersecurity capabilities.
Summary of Legal Basis: This revised regulation supports the
Administration's effort to promote public-private cyber collaboration
by expanding eligibility for the DIB CS voluntary cyber threat
information sharing program to all defense contractors. This regulation
aligns with DoD's statutory responsibilities for cybersecurity
engagement with those contractors supporting the Department.
Alternatives: (1) No action alternative: Maintain status quo with
the ongoing voluntary cybersecurity program for cleared contractors.
(2) Next best alternative: DoD posts generic cyber threat information
and cybersecurity best practices on a public accessible website without
directly engaging participating companies.
Anticipated Cost and Benefits: Participation in the voluntary DIB
CS Program enables DoD contractors to access Government Furnished
Information and collaborate with the DoD Cyber Crime Center (DC3) to
better respond to and mitigate cyber threats. In order to join the DIB
CS Program, there is an initial labor burden to apply to the program
and provide point of contact information which is estimated to take 20
minutes per company. In addition, there is a cost for defense
contractors to voluntarily share cyber indicator information. DoD
estimates that each response will take a respondent two hours to
complete. The costs are under review as part of 0704-0489 and 0704-
0490. For DIB participants, this program provides cyber threat
information and technical assistance through analyst-to-analyst
exchanges, mitigation and remediation strategies, and cybersecurity
best practices in a collaborative environment for participating
companies.
Risks: Threats to unclassified information systems represent a risk
of compromise of DoD information and mission. This threat is
particularly acute for small and medium size companies with less mature
cybersecurity capabilities. Through collaboration with DoD and the
sharing with other contractors in the DIB CS Program, defense
contractors will be better prepared to mitigate the cyber risk they
face today and in the future.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Agency Contact: McKay Tolboe, Director, Cybersecurity Policy and
Partnerships CIO, Department of Defense, Office of the Secretary, 4800
Mark Center, Alexandria, VA 22311, Phone: 571 372-4640, Email:
[email protected].
RIN: 0790-AK86
DOD--OS
21. Cybersecurity Maturity Model Certification (CMMC) Program [0790-
AL49]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
PL 104-4.
Legal Authority: 5 U.S.C. 301; Pub. L. 116-92, sec. 1648
CFR Citation: 32 CFR 170.
Legal Deadline: None.
Abstract: DOD is proposing to implement the Cybersecurity Maturity
Model Certification (CMMC) Framework, to help assess a Defense
Industrial Base (DIB) contractor's compliance with and implementation
of cybersecurity requirements to safeguard Federal Contract Information
(FCI) and Controlled Unclassified Information (CUI) transiting non-
federal systems and mitigate the threats posed by Advanced Persistent
Threats--adversaries with sophisticated levels of expertise and
significant resources.
Statement of Need: CMMC is designed to provide increased assurance
to the DoD that a DIB contractor can adequately protect sensitive
unclassified information (i.e., FCI and CUI) at a level commensurate
with the risk, and accounting for information flow down to its
subcontractors in a multi-tier supply chain.
Summary of Legal Basis: 5 U.S.C. 301 authorizes the head of an
Executive department or military department to prescribe regulations
for the government of his or her department, the conduct of its
employees, the distribution and performance of its business, and the
custody, use, and preservation of its records, papers, and property.
41 U.S.C 1303; Pub. L. 116-92, sec. 1648 directs the Secretary of
Defense to develop a consistent, comprehensive framework to enhance
cybersecurity for the U.S. defense industrial base. Developing the CMMC
Program was as an important first step toward meeting these
requirements.*
Alternatives: DoD considered and adopted several alternatives
during the development of this rule that reduce the burden on the DIB
community and still meet the objectives of the rule. These alternatives
include: (1) maintaining status quo, leveraging only the current
requirements implemented in DFARS provision 252.204-7019 and DFARS
clause 252.204-7020 requiring DIB contractors and offerors to self-
assess utilizing the DoD Assessment Methodology and entering a Basic
Summary Score; (2) revising CMMC 1.0 to CMMC 2.0 in response to public
comments, to reduce the burden for small businesses and contractors who
do not process, store or transmit critical CUI by eliminating the
requirement to hire a C3PAO and instead allow self-assessment with
annual affirmations to maintain compliance at CMMC Level 1, and llowing
triennial self-certification with an annual affirmation to maintain
compliance for some CMMC Level 2 programs; (3) exempting contracts and
orders exclusively for the acquisition of commercially available off-
the-shelf items; and (4) implementing a phased implementation for CMMC.
In addition, the Department took into consideration the timing of
the requirement to achieve a specified CMMC level: (1) at time of
proposal or offer submission, (2) post contract award, or (3) at the
time of contract award.
Anticipated Cost and Benefits: The theft of intellectual property
and sensitive information, including FCI and CUI, from all U.S.
industrial sectors due to malicious cyber activity threatens U.S.
economic and national security. The Council of Economic Advisors
estimates that malicious cyber activity cost the U.S. economy between
$57 billion and $109 billion in 2016. Over a ten-year period, that
burden would equate to an estimated $570 billion to $1.09 trillion
dollars in costs.
Risks: The aggregate loss of intellectual property and certain
unclassified information from the DoD supply chain can undercut U.S.
technical advantages and innovation, as
[[Page 11001]]
well as significantly increase risk to national security.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Diane L. Knight, Senior Management and Program
Analyst, Department of Defense, Office of the Secretary, 4800 Mark
Center Drive, Suite 12E08, Alexandria, VA 22350, Phone: 202 770-9100,
Email: [email protected].
RIN: 0790-AL49
DOD--OS
Final Rule Stage
22. Nondiscrimination on the Basis of Disability in Programs or
Activities Assisted or Conducted by the DOD and in Equal Access to
Information and Communication Technology Used by DOD [0790-AJ04]
Priority: Other Significant.
Legal Authority: Pub. L. 100-259; Pub. L. 102-569; 29 U.S.C. 791 to
794d; 42 U.S.C. ch. 51 and 126; E.O. 12250
CFR Citation: 32 CFR 56.
Legal Deadline: None.
Abstract: The Department is finalizing revisions to implement
Section 504 of the Rehabilitation Act of 1973, which prohibits
discrimination on the basis of disability in programs or activities
receiving Federal financial assistance from DoD and those programs or
activities conducted by DoD. The regulation also implements section 508
of the Rehabilitation Act, which requires DoD make its electronic and
information technology accessible to individuals with disabilities.
Additionally, the regulation implements the Architectural Barriers Act
of 1968, which requires that DoD make facilities accessible to
individuals with disabilities. Finally, the regulation updates the
complaint resolution and enforcement procedures pursuant to section 504
and the complaint resolution and enforcement procedures pursuant to
section 508.
Statement of Need: Finalization of this Department-wide rule will
clarify the longstanding policy of the Department. It will modernize
the Department's practices in addressing issues of discrimination. This
rule amends the Department's prior regulation to include updated
accessibility standards for recipients of Federal financial assistance
to be more user-friendly and to support individuals with disabilities.
This update incorporates the directive of Executive Order 14035,
Diversity, Equity, Inclusion, and Accessibility in the Federal
Workforce by defining, clarifying, advancing accessibility throughout
DoD programs and activities.
Summary of Legal Basis: Title 28, Code of Federal Regulations, part
41, implementing Executive Order 12250, assigns the DOJ responsibility
to coordinate implementation of section 504 of the Rehabilitation Act.
This rule is being finalized under the authorities of title 29,
U.S.C., chapter 16, subchapter V, sections 794 through 794d, codifying
legislation prohibiting discrimination on the basis of disability under
any program or activity receiving Federal financial assistance or under
any program or activity conducted by any Federal agency, including
provisions establishing the United States Access Board and requiring
Federal agencies to ensure that information and communication
technology is accessible to and usable by individuals with disabilities
Alternatives: The Department considered taking no new action and
continuing to rely on the existing regulation. The Department
considered issuing sub-regulatory guidance to clarify existing
regulation. Both options were rejected because of the need to update
and clarify the Department's obligations pursuant to section 504 and
section 508 of the Rehabilitation Act of 1973, as amended.
Anticipated Cost and Benefits: TBD.
Risks: Without this final rule, the Department's current regulation
is inconsistent with current Federal statutes and regulations, as well
as developments in Supreme Court jurisprudence, regarding unlawful
discrimination on the basis of disability. Consistent with
congressional intent, the provisions in the final rule are consistent
with the nondiscrimination provisions in DOJ regulations implementing
title II of the ADA Amendments Act (applicable to state and local
government entities).
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/16/20 85 FR 43168
NPRM Comment Period End............. 09/14/20
Final Action........................ 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: DoD internal guidance will be located in
DoD Instruction 1020.dd (``Unlawful Discrimination on the Basis of
Disability in Programs or Activities Receiving Federal Financial
Assistance from, or Conducted by, the DoD''). This Instruction will
publish after the finalization of this rule.
Agency Contact: Randy Cooper, Director, Department of Defense
Disability EEO Policy and Compliance Department of Defense, Office of
the Secretary 4000 Defense Pentagon Room 5D64, Washington, DC 20301-
4000, Phone: 703 571-9327, Email: [email protected].
RIN: 0790-AJ04
DOD--OS
23. Definitions of Gold Star Family and Gold Star Survivor [0790-AL56]
Priority: Other Significant.
Legal Authority: Pub. L. 117-81
CFR Citation: 32 CFR 46.
Legal Deadline: Final, Statutory, December 27, 2022, Sec 626 of the
NDAA 2022 (Pub. L. 117-81).
Section 626 of the NDAA 2022 (Pub. L. 117-81) requires publication
of an interim final rule no later than one year after the date of the
enactment of this Act.
Abstract: This rule implements section 626 of the National Defense
Authorization Act for Fiscal Year 2022 (Pub. L. 117-81) to establish
standard definitions, for use across the military departments, of the
terms ``gold star family'' and ``gold star survivor.''
Statement of Need: The objective of the rule is to establish
standard definitions, for use across the military departments, of the
terms gold star family and gold star survivor.
Summary of Legal Basis: This rule is proposed under the authorities
of section 626(c) of Public Law 117-81, FY 2022 NDAA.
Alternatives: The alternative is to take no action.
Anticipated Cost and Benefits: The cost to publish this new rule
and update the Defense Department's policies is estimated at $900,000.
This includes the public's time to review the proposed rule and
resources needed to respond to any public comments, publish the
[[Page 11002]]
interim rule, revise policies, and possibly revamp the Navy and Coast
Guard's long-term case management programs.
Risks: This action does not reduce risks to public health, safety,
or the environment, or effect other risks within the jurisdiction of
the Defense Department.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 06/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Deborah S. Skillman, Director, Department of
Defense, Office of the Secretary, 1500 Defense Pentagon, Washington, DC
20301-1500, Phone: 571 372-5333, Email:
[email protected].
RIN: 0790-AL56
DOD--DEFENSE ACQUISITION REGULATIONS COUNCIL (DARC)
Proposed Rule Stage
24. Assessing Contractor Implementation of Cybersecurity Requirements
(DFARS Case 2019-D041) [0750-AK81]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 41 U.S.C. 1303; Pub. L. 116-92, sec. 1648
CFR Citation: 48 CFR 204; 48 CFR 212; 48 CFR 217; 48 CFR 252.
Legal Deadline: None.
Abstract: DoD is amending an interim rule to implement the CMMC
framework 2.0 in order to protect against the theft of intellectual
property and sensitive information from the Defense Industrial Base
(DIB) sector. The CMMC framework is a DoD certification process that
measures a company's institutionalization of processes and
implementation of cybersecurity practices. This rule provides the
Department with assurances that a DIB contractor can adequately protect
sensitive unclassified information at a level commensurate with the
risk, accounting for information flow down to its subcontractors in a
multi-tier supply chain.
Statement of Need: The purpose of this DFARS rule is to ensure that
Defense Industrial Base (DIB) contractors will adequately protect
sensitive unclassified information at a level commensurate with the
risk, accounting for information flow down to its subcontractors in a
multi-tier supply chain.
Summary of Legal Basis: This rule is being implemented under the
authority of 41 U.S.C. 1303 and section 1648 of the National Defense
Authorization Act for Fiscal Year (FY) 2020 (Pub. L. 116-92). The USD
(A&S) has the authority and responsibility for promulgating DoD
procurement rules under the OFPP statute, codified at title 41 of the
U.S. Code. Section 1648 of the National Defense Authorization Act for
Fiscal Year 2020 (Pub. L. 116-92) directs the Secretary of Defense to
develop a risk-based cybersecurity framework for the DIB sector, such
as CMMC, as the basis for a mandatory DoD standard.
Alternatives:DoD considered and adopted several alternatives during
the development of the interim rule that reduced the burden on small
entities and still meet the objectives of the rule. DoD will consider
similar alternatives for the amendment rule. These alternatives
include: (1) exempting contracts and orders exclusively for the
acquisition of commercially available off-the-shelf items; and (2)
implementing a phased rollout and stipulating that the inclusion a CMMC
requirement in new contracts until that time be approved by the Office
of the Under Secretary of Defense for Acquisition and Sustainment.
Anticipated Cost and Benefits: The annualized value of costs
beginning in fiscal year 2021 (calculated in perpetuity in 2016 dollars
at a 7 percent discount rate) associated with implementing the CMMC
Framework in the interim is $4 billion. The primary benefit of this
rule is improving the protection of the Department's sensitive
information and reducing the threat to DIB sector intellectual property
by:
Enabling assessments at the entity-level of contractor
implementation of cyber security processes and practices that should
already be in place;
Requiring comprehensive implementation of cybersecurity
requirements rather than plans of action to accomplish implementation;
Verifying DIB sector contractor and subcontractor
cybersecurity postures; and
Reducing duplicative or repetitive assessments of our
industry partners through standardization.
Risks: The theft of intellectual property and sensitive information
from all U.S. industrial sectors due to malicious cyber activity
threatens economic security and national security. Malicious cyber
actors have and continue to target the DIB sector and the supply chain
of the Department of Defense. These attacks not only focus on the large
prime contractors, but also target subcontractors that make up the
lower tiers of the DoD supply chain. Many of these subcontractors are
small entities that provide critical support and innovation. The
aggregate loss of intellectual property and certain unclassified
information from the DoD supply chain can undercut U.S. technical
advantages and innovation, as well as significantly increase risk to
national security.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 09/29/20 85 FR 48513
Interim Final Rule Effective........ 11/30/20
NPRM................................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Public Compliance Cost: Base Year for Dollar Estimates: 2021.
Agency Contact: Jennifer D. Johnson, Office of the Under Secretary
of Defense for Acquisition and Sustainment, Department of Defense,
Defense Acquisition Regulations Council, Defense Pricing and
Contracting, Defense Acquisition Regulations System, Room 3B938, 3060
Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email:
[email protected].
Related RIN: Split from 0750-AL68, Related to 0790-AL49
RIN: 0750-AK81
DOD--DARC
25. Small Business Innovation Research Program Data Rights (DFARS Case
2019-D043) [0750-AK84]
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303
CFR Citation: 48 CFR 227; 48 CFR 252.
Legal Deadline: None.
Abstract: DoD is proposing to amend the Defense Federal Acquisition
Regulation Supplement (DFARS) to implement changes related to data
rights in the Small Business Administration's Policy Directive for the
Small Business Innovation Research (SBIR) Program, published in the
Federal Register on April 2, 2019 (84 FR 12794). The final SBA Policy
Directive includes several revisions to clarify data rights, which
require corresponding revisions to the DFARS.
Statement of Need: This rule is necessary to implement the Small
[[Page 11003]]
Business Administration (SBA) policies related to data rights in the
Small Business Innovation Research (SBIR) Program and Small Business
Technology Transfer (STTR) Program Policy Directive, published in the
Federal Register on April 2, 2019 (84 FR 12794). The final SBA Policy
Directive includes several revisions to clarify data rights, which
require corresponding revisions to the DFARS.
Summary of Legal Basis: The legal basis for this rule is 15 U.S.C.
638, which provides the authorization, policy, and framework for SBIR/
STTR programs.
Alternatives: There are no alternatives that would meet the stated
objective of this rule.
Anticipated Cost and Benefits: While specific costs and savings
have not been quantified, this rule is expected to have significant
benefit for small businesses participating in the DoD SBIR and STTR
programs. SBIR and STTR enable small businesses to explore their
technological potential and provide the incentive to profit from its
commercialization. By including qualified small businesses in the
nation's research and development arena, high-tech innovation is
stimulated, and the United States gains entrepreneurial spirit as it
meets its specific research and development needs.
Risks: The continuous protection of a contractor's SBIR/STTR data
while actively pursuing or commercializing its technology with the
Federal Government, provides a significant incentive for innovative
small businesses to participate in these programs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 08/31/20 85 FR 53758
Correction.......................... 09/21/20 85 FR 59258
ANPRM Comment Period End............ 10/30/20
Comment Period Extended............. 12/04/20 85 FR 78300
ANPRM Comment Period End............ 01/31/21
NPRM................................ 12/19/22 87 FR 77680
NPRM Comment Period End............. 02/17/23
Final Action........................ 11/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Jennifer D. Johnson, Office of the Under Secretary
of Defense for Acquisition and Sustainment, Department of Defense,
Defense Acquisition Regulations Council, Defense Pricing and
Contracting, Defense Acquisition Regulations System, Room 3B938, 3060
Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email:
[email protected].
RIN: 0750-AK84
DOD--DARC
26. Defense Commercial Solutions Opening (DFARS Case 2022-D006) [0750-
AL57]
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303; Pub. L. 117-81, sec. 803; 10
U.S.C. 2380(c)
CFR Citation: 48 CFR 212.
Legal Deadline: None.
Abstract: DoD is proposing to amend the Defense Federal Acquisition
Regulation Supplement to implement section 803 of the National Defense
Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81)
that amends 10. U.S.C. 2380 to establish a permanent authority for the
Secretary of Defense and those of the military departments to acquire
innovative commercial products and commercial services through a
competitive selection of proposals resulting from a general
solicitation and the peer review of such proposals. Products and
services purchased under this authority are treated as commercial.
Statement of Need: This rule is necessary to implement section 803
of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L.
117-81), which establishes a permanent authority for the Secretary of
Defense and those of the military departments to acquire innovative
commercial products and commercial services through a competitive
selection of proposals resulting from a general solicitation and the
peer review of such proposals. Products and services purchased under
this authority are treated as commercial.
Summary of Legal Basis: The legal basis for this rule is 41 U.S.C.
1303 and section 803 of Public Law 117-81.
Alternatives: There are no alternatives that would meet the
requirements of section 803 of Public Law 117-81.
Anticipated Cost and Benefits: This rule will enable DoD to access
innovative products and services of entities that may not have not done
business with DoD in the past. Such entities may compete for additional
DoD contracts, thereby increasing competition for DoD contracts.
Risks: The difficulty of accessing innovative products and services
of these entities creates a risk for DoD with regard to finding
solutions and obtaining products and services that meet the
Department's needs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Jennifer D. Johnson, Office of the Under Secretary
of Defense for Acquisition and Sustainment, Department of Defense,
Defense Acquisition Regulations Council, Defense Pricing and
Contracting, Defense Acquisition Regulations System, Room 3B938, 3060
Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email:
[email protected].
RIN: 0750-AL57
DOD--DARC
27. Modification of Prize Authority for Advanced Technology
Achievements (DFARS Case 2022-D014) [0750-AL65]
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303; 10 U.S.C. 2374a; Pub. L. 117-81,
sec. 822
CFR Citation: 48 CFR 235.
Legal Deadline: None.
Abstract: DoD is proposing to amend the Defense Federal Acquisition
Regulation Supplement to implement section 822 of the National Defense
Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81),
which revises 10 U.S.C. 2374a regarding the award of prizes for
advanced technology achievement to: (1) authorize the award of
procurement contracts and other agreements ``as an other type of
prize'' (as in other than cash prizes); (2) permit the award of prizes,
including procurement contracts and other agreements, in excess of
$10,000,000 with the approval of the Under Secretary of Defense for
Research and Engineering; and (3) require DoD provide Congress with
notice of an award of a procurement contract or other agreement under
this program that exceeds $10 million.
Statement of Need: This rule is necessary to implement section 822
of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L.
117-81). Section 822 revises 10 U.S.C. 2374a regarding the award of
prizes for advanced technology achievement to: (1) authorize the award
of procurement contracts and other agreements as an other type of prize
(as in other than cash prizes); (2) permit the award of prizes,
including procurement contracts and other agreements, in excess of
$10,000,000 with the approval of the
[[Page 11004]]
Under Secretary of Defense for Research and Engineering; and (3)
require DoD provide Congress with notice of an award of a procurement
contract or other agreement under this program that exceeds $10
million.
Summary of Legal Basis: The legal basis for this rule is 41 U.S.C.
1303 and section 822 of Public Law 117-81.
Alternatives: There are no alternatives that would meet the
requirements of section 822 of Public Law 117-81.
Anticipated Cost and Benefits: This rule will help to expand the
Defense Industrial Base, thereby increasing competition for future DoD
contracts.
Risks: The difficulty of accessing advanced technologies creates a
risk for DoD with regard to finding solutions and obtaining products
and services that meet the Department's needs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Jennifer Johnson, Defense Acquisition Regulations
System, Department of Defense, Defense Acquisition Regulations Council,
3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060, Phone:
571 372-6100, Email: [email protected].
RIN: 0750-AL65
DOD--DARC
28. DFARS Buy American Act Requirements (DFARS Case 2022-D019)
[0750-AL74]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 41 U.S.C. 1303
CFR Citation: 48 CFR 225; 48 CFR 252.
Legal Deadline: None.
Abstract: DoD is proposing to amend the Defense Federal Acquisition
Regulation Supplement (DFARS) to implement the requirements of
Executive Order 14005, Ensuring the Future Is Made in All of America by
All of America's Workers. Changes to the Federal Acquisition Regulation
(FAR) are being made via RIN 9000-AO22 (FAR Case 2021-008, Amendments
to the FAR Buy American Act Requirements). This rule proposes
conforming changes to the DFARS.
Statement of Need: This rule is necessary to implement Executive
Order 14005, Ensuring the Future Is Made in All of America by All of
America's Workers, which increases the required percentage of domestic
content for end products and construction material. Changes to the
Federal Acquisition Regulation (FAR) are being made via RIN 9000-AO22
(FAR Case 2021-008, Amendments to the FAR Buy American Act
Requirements). This rule proposes conforming changes to the DFARS.
Summary of Legal Basis: The legal basis for this rule is 41 U.S.C.
1303 and Executive Order 14005, Ensuring the Future Is Made in All of
America by All of America's Workers.
Alternatives: There are no alternatives that would meet the
requirements of Executive Order 14005.
Anticipated Cost and Benefits: This rule increases the percentage
for use in the domestic content text applied to offers of end products
and construction materials to determine domestic or foreign origin. The
rule will strengthen domestic preferences under the Buy American
statute. It is expected that this rule will benefit large and small
U.S. manufacturers supplying domestic end products and materials.
Risks: There is a risk that U.S. manufacturers would experience a
competitive disadvantage without the increase in the required domestic
content.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Jennifer D. Johnson, Office of the Under Secretary
of Defense for Acquisition and Sustainment, Department of Defense,
Defense Acquisition Regulations Council, Defense Pricing and
Contracting, Defense Acquisition Regulations System, Room 3B938, 3060
Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email:
[email protected].
RIN: 0750-AL74
DOD--DARC
Final Rule Stage
29. Past Performance of Subcontractors and Joint Venture Partners
(DFARS Case 2018-D055) [0750-AK16]
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303; Pub. L. 115-232, sec. 823
CFR Citation: 48 CFR 215; 48 CFR 236; 48 CFR 242; 48 CFR 252.
Legal Deadline: Final, Statutory, February 9, 2019, 180 days after
enactment.
Abstract: DoD is issuing a final rule to amend the Defense Federal
Acquisition Regulation Supplement (DFARS) to implement section 823 of
the National Defense Authorization Act for Fiscal Year 2019, which
establishes a requirement for use of the best available information
regarding past performance of subcontractors and joint venture partners
when awarding DoD construction and architect-engineer (A&E) contracts.
Section 823 requires annual performance evaluations for first-tier
subcontractors and individual partners of joint venture construction
and A&E contracts valued at either $750,000 or more, or 20 percent of
the value of the prime contract (whichever is higher), in accordance
with specified conditions. In addition, processes for exceptions from
the annual evaluation requirement will be established for construction
and A&E contracts where submission of annual evaluations would not
provide the best representation of the performance of a contractor,
including subcontractors and joint venture partners under specified
conditions. This rule will amend DFARS part 242 to incorporate these
new requirements and processes.
Statement of Need: This rule is necessary to implement section 823
of the National Defense Authorization Act for Fiscal Year 2019 (Pub. L.
115-232), which establishes a requirement for use of the best available
information regarding past performance of subcontractors and joint
venture partners when awarding DoD construction and architect-engineer
contracts. Section 823 requires annual performance evaluations for
first-tier subcontractors and individual parties to joint ventures
performing construction and architect-engineer contracts valued at
either $750,000 or more, or 20 percent of the value of the prime
contract (whichever is higher), in accordance with specified
conditions. In addition, processes for exceptions from the annual
evaluation requirement will be established for construction and
architect-engineer contracts where submission of annual evaluations
would not provide the best representation of the performance of a
contractor, including subcontractors and joint venture partners under
specified conditions.
Summary of Legal Basis: The legal basis for this rule is 41 U.S.C.
1303 and section 823 of Public Law 115-232.
Alternatives: There are no alternatives that would meet the
requirements of section 823 of Public Law 115-232.
[[Page 11005]]
Anticipated Cost and Benefits: This rule will make it easier for
subcontractors and individual parties to joint ventures to establish a
record of their past performance. These entities will be able to take
credit for the work they performed on contracts and subcontracts, which
will help them be more competitive when bidding on future DoD
contracts. This will help increase competition for DoD contracts.
Risks: Due to the difficulty of establishing a record of past
performance on DoD contracts, there is a risk of reduced
competitiveness for subcontractors and individual parties to joint
ventures.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/20/21 86 FR 27358
NPRM Comment Period End............. 07/19/21
Final Action........................ 02/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Jennifer D. Johnson, Office of the Under Secretary
of Defense for Acquisition and Sustainment, Department of Defense,
Defense Acquisition Regulations Council, Defense Pricing and
Contracting, Defense Acquisition Regulations System, Room 3B938, 3060
Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email:
[email protected].
RIN: 0750-AK16
DOD--DARC
30. Restriction on Acquisition of Personal Protective Equipment and
Certain Items From Non-Allied Foreign Nations (DFARS Case 2022-D009)
[0750-AL60]
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303; Pub. L. 117-81 sec. 802; 10 U.S.C.
2533e
CFR Citation: 48 CFR 225; 48 CFR 252.
Legal Deadline: None.
Abstract: DoD is issuing an interim rule to amend the Defense
Federal Acquisition Regulation Supplement to implement section 802 of
the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022
NDAA (Pub. L. 117-81). Section 802 adds 10 U.S.C. 2533e which prohibits
the acquisition of personal protective equipment and certain other
items from non-allied foreign nations. An exception applies if: (1) the
Secretary of Defense determines that a covered item of satisfactory
quality and quantity, in the required form, cannot be procured as and
when needed from nations other than a covered country to meet
requirements at a reasonable price; (2) a covered item is for use
outside of the United States; or (3) if the procurement for a covered
material is at or below $150,000. A limitation provides that a proposed
procurement in an amount greater than $150,000 may not be divided into
several purchases or contracts for lesser amounts in order to qualify
for an exception.
Statement of Need: This rule is needed to implement section 802 of
the National Defense Authorization Act for Fiscal Year 2022 (Pub. L.
117-81), which prohibits the acquisition of personal protective
equipment related to healthcare and certain other healthcare-related
items from non-allied foreign nations. The prohibition does not apply
to items for use outside of the United States or if the procurement is
valued at or below $150,000. In addition, the prohibition does not
apply if the Secretary of Defense determines that a covered item of
satisfactory quality and quantity, in the required form, cannot be
procured as and when needed from nations other than non-allied nations
to meet requirements at a reasonable price.
Summary of Legal Basis: The legal basis for this rule is 41 U.S.C.
1303 and section 802 of Public Law 117-81.
Alternatives: There are no alternatives that would meet the
requirements of section 802 of Public Law 117-81.
Anticipated Cost and Benefits: Decreasing dependence on personal
protective equipment and certain other items, as identified in section
802, originating in non-allied foreign countries is a matter of public
health and national security especially during a declared public health
emergency. The domestic supply chain for personal protective equipment
and certain other items is critical. An adequate continued supply is
vital to ensure domestic control with minimal disruption in production
and to reduce U.S. dependence on non-allied foreign countries. This
restriction is similar to other domestic sourcing restrictions required
by 10 U.S.C. 2533 in effect to reduce dependence on non-allied foreign
sources and to continue to promote growth in domestic capability.
This rule restricts the acquisition of covered items (personal
protective equipment for use in preventing the spread of disease and
certain other items) from non-allied foreign nations. The restriction
will not apply--
To acquisitions of the covered items for use outside of
the United States;
For acquisitions at or below $150,000; or
If it is determined that covered items of satisfactory
quality and quantity, in the required form, cannot be procured as and
when needed from nations other than the covered countries to meet the
requirements at a reasonable price.
Estimated impacts to industry may include minor compliance costs to
validate with suppliers the origin of covered items to comply with the
prohibition. Based on data from the Federal Procurement Data System for
fiscal years 2019, 2020, and 2021 for contracts awarded in Product
Service Code 65 (Medical, Dental, and Veterinary Equipment and
Supplies) in the United States valued at or above $150,000, DoD awarded
an average of 1,677 such contracts to 192 unique entities, of which 105
were small businesses. It is not known what percentage of these awards
might involve personal protective equipment and other covered items
from the covered countries.
Potential benefits of this rule will be the elimination of
counterfeit covered items within the domestic supply chain and reduced
dependence on foreign sources that are not allies of the United States.
In addition, this restriction will further promote growth in domestic
capabilities and may provide additional opportunities to domestic small
businesses for future procurement and manufacturing efforts, increasing
domestic sourcing of personal protective equipment and other covered
items.
Risks: A shortage of supply of personal protective equipment and
certain other items would put at risk public health and the safety and
well-being of the general public. A shortage of these items also would
hinder DoD's mission readiness.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 02/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Jennifer Johnson, Defense Acquisition Regulations
System, Department of Defense, Defense Acquisition Regulations Council,
3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060, Phone:
[[Page 11006]]
571 372-6100, Email: [email protected].
RIN: 0750-AL60
DOD--U.S. ARMY CORPS OF ENGINEERS (COE)
Proposed Rule Stage
31. Natural Disaster Procedures: Preparedness, Response, and Recovery
Activities of the Corps of Engineers [0710-AA78]
Priority: Other Significant.
Legal Authority: 33 U.S.C. 701n
CFR Citation: 33 CFR 203.
Legal Deadline: None.
Abstract: The U.S. Army Corps of Engineers (Corps) is proposing to
update the Federal regulation that covers the procedures that the Corps
uses under section 5 of the Flood Control Act of 1941, as amended (33
U.S.C. 701n), commonly referred to as Public Law 84-99. The Corps
relies on this program to prepare for, respond to, and help communities
recover from a flood, hurricane, or other natural disaster, including
the repair of damage to eligible flood risk reduction infrastructure.
The Corps initiated this rulemaking process through an advanced notice
of proposed rulemaking (ANPRM) on February 13, 2015. As a next step,
the Corps is planning to propose revisions to the program to address
statutory changes under various Water Resources Development Act
provisions and to formalize certain agency guidance relating to natural
disaster procedures. The notice of proposed rulemaking (NPRM) would
also include a summary of the comments to the ANPRM.
Statement of Need: Since the last revision in 2003, significant
disasters, including Hurricane Katrina (2005), Hurricane Sandy (2012),
flooding on the Mississippi and Missouri Rivers (2008, 2011, and 2013),
and Hurricanes Harvey, Irma, and Maria (2017) have provided a more
detailed understanding of the nature and severity of risk associated
with flood control projects. In addition, the maturation of risk-
informed decision making approaches and technological advancements
influenced the outlook on the implementation of Public Law 84-99
activities, with a shift toward better alignment with Corps Levee
Safety and National Flood Risk Management Programs, as well as the
National Preparedness and Response Frameworks. Through these programs,
the Corps works with non-Federal sponsors and stakeholders to assess,
communicate, and manage the risks to people, property, and the
environment associated with levee systems and flood risks. Revisions to
part 203 are necessary to implement statutes that amended or otherwise
affected Public Law 84-99, as explained in the next section.
Summary of Legal Basis: Public Law 84-99 authorizes an emergency
fund to be expended at the discretion of the Chief of Engineers for
preparation for natural disasters, flood fighting, rescue operations,
repairing or restoring flood control works, emergency protection of
federally authorized hurricane or shore protection projects, and the
repair and restoration of federally authorized hurricane and shore
protection projects damaged or destroyed by wind, wave, or water of
other than ordinary nature.
1. Subsection 3029(a) of the Water Resources Reform and Development
Act of 2014 (WRRDA 2014) (Pub. L. 113-121) authorized the Chief of
Engineers, under certain circumstances, to make modifications to flood
control and hurricane or shore protections works damaged during flood
or coastal storms events, as well as the authority to implement
nonstructural alternatives in the repair and restoration of hurricane
or shore protection works.
2. Subsection 3029(b) of WRRDA 2014 authorized the Secretary of the
Army to undertake a review of implementation of Public Law 84-99 to
ensure the safety of affected communities to future flooding and storm
events; the resiliency of water resources development projects to
future flooding and storm events; the long-term cost-effectiveness of
water resources development projects that provide flood control and
hurricane and storm damage reduction benefits; and the policy goals and
objectives that were the President outlined as a response to recent
extreme weather events at that time are met.
3. Section 3011 of WRRDA 2014 states that a levee system shall
remain eligible for rehabilitation assistance under Public Law 84-99,
as long as the system sponsor continues to make satisfactory progress,
as determined by the Secretary of the Army, on an approved system wide
improvement framework or letter of intent.
4. Section 1176 of the Water Resources Development Act of 2016
(WRDA 2016) (Pub. L. 114-322, title I) provided an express definition
of nonstructural alternatives, as that term is used in Public Law 84-
99, and authorized the Chief of Engineers, under certain circumstances,
to increase the level of protection of flood control or hurricane or
shore protection works or increase the capacity of a pumping station
when conducting repair or restoration activities to such works under
Public Law 84-99.
Alternatives:
1. No rule update: Implement all changes through agency discretion.
Alternative not selected because the Public Law 84-99 amendments are
very prescriptive, and it is inappropriate for those conflicts to
exist.
2. Modify: Evaluate required changes and determine which require
implementation via agency discretion and those requiring an update to
the rule. Alternative not selected because of inconsistent
implementation that would result and the repeal and replace alternative
is the most straightforward, given the number of update changes
throughout this CFR section.
3. Repeal and replace (Selected Alternative): Incorporate and
integrate the current state of practice for flood risk management
principles and concepts through the provision of agency policy codified
in a federal rule. The intended benefit is to encourage broader
community flood risk management activities, as undertaken by non-
Federal project sponsors. The rule alternative also consolidates recent
Public Law 84-99 amendments into one comprehensive rule, ensuring the
public understands how the Corps would implement them.
Anticipated Cost and Benefits: Overall, the purpose of the proposed
changes to this regulation are expected to improve the effectiveness of
federal and local investments to reduce flood risks in both riverine
and coastal settings. These proposed changes take advantage of our
increased understanding of project risks, moving from an assessment of
how the project is expected to perform to a focus on a broader set of
actions to reduce risk to life, including operations, maintenance,
planning, and execution actions to improve emergency warning and
evacuation and other activities to improve the ability of communities
and individuals to understand and manage project-related risks.
Informed by more detailed understanding of risk for levee systems, the
Federal Government and non-Federal sponsors should be able to apply the
available resources to the risk management activities that most
effectively reduce riverine flood risk and avoid expenditures that have
little risk reduction benefit.
Risks: The rule is not expected to have a significant effect on
risks to public health and safety. It would revise and update 33 CFR
203 and reflect the current state of practice for flood risk management
principles and concepts. It would also amend and clarify the current
role of the Corps in preparing
[[Page 11007]]
for, and responding a natural disaster, and in helping in the recovery
effort. The rule may also encourage broader community flood risk
management activities, as undertaken by non-Federal project sponsors.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 02/13/15 80 FR 8014
ANPRM Comment Period End............ 04/14/15
NPRM................................ 11/15/22 87 FR 68386
NPRM Comment Period End............. 01/17/23
Final Action........................ 11/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Willem Helms, Department of Defense, U.S. Army
Corps of Engineers, CECW-HS, 441 G Street NW, Washington, DC 20314,
Phone: 202 761-5909, Email: [email protected].
RIN: 0710-AA78
DOD--COE
32. Policy and Procedures for Processing Requests To Alter U.S. Army
Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408
[0710-AB22]
Priority: Other Significant.
Legal Authority: 33 U.S.C. 408
CFR Citation: 33 CFR 350.
Legal Deadline: None.
Abstract: Where a party other than the U.S. Army Corps of Engineers
(Corps) seeks to use or alter a Civil Works project that the Corps
constructed, the proposed use or alteration is subject to the prior
approval of the Corps. Some examples of such alterations include an
improvement to the project; relocation of part of the project; or
installing utilities or other non-project features. This requirement
was established in section 14 of the Rivers and Harbors Act of 1899 and
is codified at 33 U.S.C. 408 (section 408). Section 408 provides that
the Corps may grant permission for another party to alter a Civil Works
project upon a determination that the alteration proposed will not be
injurious to the public interest and will not impair the usefulness of
the Civil Works project. The Corps is proposing to convert its policy
that governs the section 408 program to a binding regulation. This
policy, Engineer Circular 1165-2-220, Policy and Procedural Guidance
for Processing Requests to Alter U.S. Army Corps of Engineers Civil
Works Projects Pursuant to 33 U.S.C. 408, was issued in September 2018.
Statement of Need: Through the Civil Works program, the U.S. Army
Corps of Engineers (Corps), in partnership with stakeholders, has
constructed many Civil Works projects across the Nation's landscape.
Given the widespread locations of these projects, there may be a need
for others outside of the Corps to alter or occupy these projects and
their associated lands. Reasons for alterations could include
activities such as improvements to the project; relocation of part of
the project; or installing utilities or other non-project features. In
order to ensure that these projects continue to provide their intended
benefits to the public, Congress provided that any use or alteration of
a Civil Works project by another party is subject to the prior approval
of the Corps. This requirement was established in section 14 of the
Rivers and Harbors Act of 1899 and is codified at 33 U.S.C. 408
(section 408). Specifically, section 408 provides that the Corps may
grant permission for another party to alter a Civil Works project upon
a determination that the alteration proposed will not be injurious to
the public interest and will not impair the usefulness of the Civil
Works project. The Corps is proposing to convert its policy that
governs the section 408 program to a binding regulation. Engineer
Circular 1165-2-220, Policy and Procedural Guidance for Processing
Requests to Alter U.S. Army Corps of Engineers Civil Works Projects
Pursuant to 33 U.S.C. 408 was issued in September 2018.
Summary of Legal Basis: The Corps has legal authority over the
section 408 program under 33 U.S.C. 408.
Alternatives: The preferred alternative would be to conduct
rulemaking to issue the requirements governing the section 408 review
process in the form of a binding regulation. The current Corps policy
appears in an Engineer Circular that has expired. The next best
alternative would involve issuing these requirements in the form of an
Engineer Regulation. That alternative would not fulfill the intent of
the law because it would not be binding on the regulated public.
Anticipated Cost and Benefits: The proposed rule would reduce costs
to the regulated public by clarifying the applicable requirements and
providing consistent implementation of these requirements across the
Corps program. It is anticipated that a form would be developed for
submission of requests which would trigger the Paperwork Reduction Act
compliance process and any associated costs will be evaluated at that
time.
Risks: The proposed action is not anticipated to increase risk to
public health, safety, or the environment because it outlines the
procedures the Corps will follow when evaluating requests for section
408 permissions. The Corps will comply with all statutory requirements
when reviewing requests.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Virginia Rynk, Department of Defense, U.S. Army
Corps of Engineers, Attn: CECW-EC, 441 G Street NW, Washington, DC
20314, Phone: 202 761-4741.
RIN: 0710-AB22
DOD--COE
33. Flood Control Cost-Sharing Requirements Under the Ability To Pay
Provision [0710-AB34]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 2213(m)
CFR Citation: 33 CFR 241.
Legal Deadline: None.
Abstract: Section 103(m) of the Water Resources Development Act
(WRDA) of 1986, as amended (33 U.S.C. 2213(m)), authorizes the U.S.
Army Corps of Engineers (Corps) to reduce the non-Federal share of the
cost of a study or project for certain communities that are not able
financially to afford the standard non-Federal cost-share. Part 241 of
Title 33 in the Code of Federal Regulations provides the criteria that
the Corps uses in making these determinations where the primary purpose
of the study or project is flood damage reduction. The proposed rule
would update this regulation, by broadening its applicability to
include projects with other purposes (instead of just flood damage
reduction) and the feasibility study of a project (instead of just
design and construction).
Statement of Need: The Corps may conduct a rulemaking to propose
amendments to the Corps' regulations at 33 CFR part 241 for Corps
projects. The WRDA 2000 modified section 103(m) to also include the
following mission areas: environmental protection and
[[Page 11008]]
restoration, flood control, navigation, storm damage protection,
shoreline erosion, hurricane protection, and recreation or an
agricultural water supply project which have not yet been added to the
regulation. It also included the opportunity to cost share all phases
of a USACE project to also include feasibility in addition to the
already covered design and construction. This rule would provide a
framework for deciding which projects are eligible for consideration
for a reduction in the non-Federal cost share based on ability to pay.
Summary of Legal Basis: 33 U.S.C. 2213(m).
Alternatives: The preferred alternative is to conduct rulemaking to
amend 33 CFR 241 by broadening the project purposes for which the Corps
could reduce the non-Federal cost-share based on ability to pay and by
allowing such a reduction for feasibility studies. The next best
alternative would be to provide additional guidance instead of amending
the existing regulation. This alternative could lead to confusion for
the regulated public.
Anticipated Cost and Benefits: The proposed rule would add Corps
procedures on the ability to pay provision allowing for consistent
implementation across the Corps and clear understanding of the program
and its requirements by the regulated public.
Risks: The proposed action is not anticipated to increase risk to
public health, safety, or the environment because it outlines the
procedures the Corps will follow when evaluating the ability to pay
provision for cost-sharing with the non-Federal sponsor.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Agency Contact: Amy Frantz, Program Manager, Department of Defense,
U.S. Army Corps of Engineers, CECW-P, 441 G Street NW, Washington, DC
20314, Phone: 202 761-0106, Email: [email protected].
Related RIN: Previously reported as 0710-AA91
RIN: 0710-AB34
DOD--COE
34. USACE Implementing Procedures for Principles, Requirements, and
Guidelines Applicable to Actions Involving Investment in Water
Resources [0710-AB41]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Sec. 2031 of Pub. L. 110-114
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: Section 2031 of the Water Resources Development Act of
2007 (Pub. L. 110-114) called for revisions to the 1983 Principles and
Guidelines for Water and Land Related Resources Implementation Studies,
resulting in the issuance of the Principles and Requirements (P&R)
guidance document in March 2013 and the Interagency Guidelines in
December 2014, which together comprise the Principles, Requirements,
and Guidelines (PR&G). The PR&G are intended to provide a common
framework and comprehensive policy and guidance for analyzing a diverse
range of water resources projects, programs, activities, and related
actions involving Federal investment in water resources. The U.S. Army
Corps of Engineers (Corps) proposes a regulation to show how it would
apply the PR&G to the Corps' mission and authorities. In this proposed
regulation, the Corps intends to increase consistency and compatibility
in Federal water resources investment decision making to include
considerations such as analyzing a broader range of long-term costs and
benefits, enhancing collaboration, including a more thorough and
transparent risk and uncertainty analyses, and improving resilience for
dealing with emerging challenges, including climate change.
Statement of Need: The Corps needs to develop implementing
procedures for the Principles, Requirements, and Guidelines (PR&G) per
a requirement under section 110 of the Water Resources Development Act
of 2020.
Summary of Legal Basis: Section 110 of the Water Resources
Development Act of 2020 directed the Corps to implement the PR&G. Also
see section 2031 of Public Law 110-114.
Alternatives: The Corps could implement PR&G with guidance rather
than through rulemaking; however, such procedures would not be binding
on the Corps or the public as any procedures would not have undergone
APA rulemaking. The Corps would not develop procedures to implement
PR&G and instead rely solely on the PR&G documents to implement. This
could result in confusion and a lack of consistency for the Corps and
the public as to how and when to apply PR&G to Civil Works authorities.
The Corps proposes to conduct rulemaking to ensure the PR&G
implementing procedures are clear for the Corps and the public as well
as binding.
Anticipated Cost and Benefits: As this rulemaking action is
implementing procedures for the Corps to ensure compliance with the
PR&G, there may be some administrative costs incurred to the Corps for
implementation and training. There would be benefits accrued to the
public in the form of reduced confusion and assurance of consideration
of comprehensive benefits for water resource development projects. The
rulemaking action would also result in more net beneficial project
outcomes from improved decision making.
Risks: The proposed action is not anticipated to increase risk to
public health, safety, or the environment because it outlines the
procedures the Corps will follow for implementing a federal statutory
requirement in WRDA as well as Administration policy. The Corps will
comply with all statutory requirements when implementing PR&G.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Stacey M. Jensen, Office of the Assistant Secretary
of the Army, Department of Defense, U.S. Army Corps of Engineers, 108
Army Pentagon, Washington, DC 22202, Phone: 703 695-6791, Email:
[email protected].
RIN: 0710-AB41
DOD--COE
35. Appendix C Procedures for the Protection of Historic Properties
[0710-AB46]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 401; 33 U.S.C. 1344; 33 U.S.C. 1413
CFR Citation: 33 CFR 325.
Legal Deadline: None.
Abstract: The U.S. Army Corps of Engineers (Corps) considers the
effects
[[Page 11009]]
of its actions on historic properties pursuant to section 106 of the
National Historic Preservation Act (NHPA). The Corps' Regulatory
Program's regulations for complying with the NHPA are outlined at 33
CFR 325 appendix C. Since these regulations were promulgated in 1990,
there have been amendments to the NHPA and revisions to the Advisory
Council on Historic Preservation's (ACHP) regulations at 36 CFR part
800. In response, the Corps issued interim guidance until rulemaking
could be completed in order to ensure full compliance with the NHPA and
ACHP's regulations. The Corps proposes to revise its regulations to
conform to the ACHP regulations.
Statement of Need: Appendix C intends to provide the implementing
procedures for the Regulatory Program's compliance with section 106 of
the National Historic Preservation Act. Rulemaking is required to
ensure the Regulatory Program is compliant with the NHPA and ACHP's
implementing regulations at 36 CFR 800 for federal agency compliance
with Section 106. The NHPA and the ACHP regulations have been updated
since Appendix C was promulgated.
Summary of Legal Basis: Appendix C was promulgated through an APA
rulemaking process intended to provide compliance with section 106 of
the NHPA specific to the Regulatory Program.
Alternatives: Alternatives considered include retaining appendix C,
which in its current state is not compliant with the updates to NHPA or
the ACHP implementing regulations for federal agencies. The current
appendix C is also not compliant with the NHPA and Administration
policies regarding Tribal Nations. Another alternative is to rescind
Appendix C and have the Regulatory Program rely on the ACHP
implementing regulations. This would ensure consistency with the Civil
Works program of the Corps and ensure compliance with the statutory and
regulation language. Another alternative is to modify appendix C to
update the regulation incorporating changes made since promulgation to
the NHPA and ACHP implementing regulations. The goal would be to ensure
compliance with NHPA and the ACHP implementing regulations but the end
result would be comparable to the rescission alternative with more
resource and workload effort. It would also result in continued
confusion for the public with the differing name from ACHP's
regulations and Civil Works implementation.
Anticipated Cost and Benefits: As this rulemaking action is
implementing procedures for the Corps to ensure compliance with the
NHPA, there may be some administrative costs incurred to the Corps for
training. There would be benefits accrued to the public in the form of
reduced confusion and assurance of consideration of potential adverse
effects to historic properties and items and areas of cultural/
religious significance.
Risks: The proposed action is not anticipated to increase risk to
public health, safety, or the environment because it outlines the
procedures the Corps will follow for implementing a federal statutory
requirement. The Corps will comply with all statutory requirements when
reviewing permit applications.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Margaret Gaffney-Smith, Regulatory Program Manager,
Department of Defense, U.S. Army Corps of Engineers, Attn: CECW-CO, 441
G Street NW, Washington, DC 20314, Phone: 202 761-4229.
RIN: 0710-AB46
DOD--COE
36. Revised Definition of ``Waters of the United States''--Rule 2
[0710-AB47]
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 1344
CFR Citation: 33 CFR 328.
Legal Deadline: None.
Abstract: The EPA and the Department of the Army (the agencies'')
intend to pursue a second rule defining ''Waters of the United States''
to consider further revisions to the agencies' first rule (RIN 2040-
AG13), which proposes to develop regulations that are founded on the
familiar framework of the pre-2015 regulations, are consistent with the
statute and informed by relevant Supreme Court decisions, and that
reflect a reasonable interpretation based on the record before the
agencies, including the best available science. This second rule
proposes to include revisions reflecting on additional stakeholder
engagement and implementation considerations, scientific developments,
and environmental justice values. This effort would also be informed by
the experience of implementing the pre-2015 rule, the 2015 Clean Water
Rule, and the 2020 Navigable Waters Protection Rule.
Statement of Need: In 2015, the Environmental Protection Agency and
the Department of the Army (``the agencies'') published the ``Clean
Water Rule: Definition of `Waters of the United States' (80 FR 37054,
June 29, 2015).'' In April 2020, the agencies published the Navigable
Waters Protection Rule (85 FR 22250, April 21, 2020). The agencies
conducted a substantive re-evaluation of the definition of ``waters of
the United States'' in accordance with the Executive Order 13990 and
determined that they need to revise the definition to ensure the
agencies listen to the science, protect the environment, ensure access
to clean water, consider how climate change resiliency may be affected
by the definition of waters of the United States, and to ensure
environmental justice is prioritized in the rulemaking process.
Summary of Legal Basis: The Clean Water Act (33 U.S.C. 1251 et
seq.).
Alternatives: Please see EPA's alternatives. EPA is the lead for
this rulemaking action.
Anticipated Cost and Benefits: Please see EPA's statement of
anticipated costs and benefits. EPA is the lead for this rulemaking
action.
Risks: Please see EPA's risks. EPA is the lead for this rulemaking
action.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Stacey M. Jensen, Office of the Assistant Secretary
of the Army, Department of Defense, U.S. Army Corps of Engineers, 108
Army Pentagon, Washington, DC 22202, Phone: 703 695-6791, Email:
[email protected].
RIN: 0710-AB47
DOD--COE
Final Rule Stage
37. Credit Assistance for Water Resources Infrastructure Projects
[0710-AB31]
Priority: Other Significant.
Legal Authority: Pub. L. 114-94; Pub. L. 114-322; Pub. L. 115-270;
33 U.S.C. 3901
[[Page 11010]]
CFR Citation: 33 CFR 386.
Legal Deadline: None.
Abstract: The U.S. Army Corps of Engineers (Corps) is implementing
a new credit program for dam safety work at non-Federal dams. The
program is authorized under the Water Infrastructure Finance and
Innovation Act of 2014 (WIFIA) and Division D, title 1 of the
Consolidated Appropriations Act of 2020. WIFIA authorizes the Corps to
provide secured (direct) loans and loan guarantees (Federal Credit
instruments) to eligible water resources infrastructure projects and to
charge fees to recover all or a portion of the Corps' cost of providing
credit assistance and the costs of conducting engineering reviews and
retaining expert firms, including financial and legal services, to
assist in the underwriting and servicing of Federal credit instruments.
Projects will be evaluated and selected by the Secretary of the Army
(the Secretary) based on the requirements and the criteria described in
this rule.
Statement of Need: The USACE WIFIA program is focused on providing
Federal loans, and potentially to also include loan guarantees, to
projects for maintaining, upgrading, and repairing dams identified in
the National Inventory of Dams owned by non-federal entities. These
loans will be repaid with non-Federal funding.
Summary of Legal Basis: The USACE WIFIA program was authorized
under subtitle C of title V of the Water Resources Reform and
Development Act of 2014 (WRRDA 2014), which authorizes USACE to provide
secured (direct) loans, and potentially to also include loan
guarantees, to eligible water resources infrastructure projects (needed
further authorization was provided by Division D, title 1 of the
Consolidated Appropriations Act of 2020). The statute also authorizes
USACE to charge fees to recover all or a portion of USACE's cost of
providing credit assistance and the costs of conducting engineering
reviews and retaining expert firms, including financial and legal
services, to assist in the underwriting and servicing of Federal credit
instruments.
The Fiscal 2021 Consolidated Appropriations Act, provided USACE
WIFIA appropriations of $2.2M admin, and $12M credit subsidy and a loan
volume limit of $950M. These appropriated funds are limited to fund
projects focused on maintaining, upgrading, and repairing dams
identified in the National Inventory of Dams owned by non-federal
entities, essentially dams where the primary owner is a state, local
government, public utility, or private owner.
Alternatives: The preferred alternative would be to conduct
proposed rulemaking to implement a new credit program for dam safety
work at non-Federal dams in the form of a binding regulation in
compliance with the Water Infrastructure Finance and Innovation Act of
2014 (WIFIA) and Division D, title 1 of the Consolidated Appropriations
Act of 2020. The next best alternative would involve issuing these
implementing procedures in the form of an Engineer Regulation. That
alternative would not fulfill the intent of the law because it would
not be binding on the regulated public. The no action alternative would
be to not conduct rulemaking which would not fulfill the authorization
provided by Congress.
Anticipated Cost and Benefits: The proposed rule would add Corps
procedures to the CFR on the implementation of a new credit program for
dam safety work at non-Federal dams to allow for consistent
implementation across the Corps and clear understanding of the program
and its requirements by the regulated public. The USACE would incur
costs to administer the loan program while benefits are expected for
the public in the form of benefits from projects enabled by WIFIA
loans. WIFIA compliance costs likely include costs associated with
application and transaction processing fees, which are waived or
reduced for small and disadvantaged communities, obtaining a credit
rating letter, any consultant fees (not required), completing
applications, reporting requirements, and record keeping. These costs
are not anticipated to represent a significant economic impact,
especially given that participation in the program is voluntary.
Risks: The proposed action is not anticipated to increase risk to
public health, safety, or the environment because it outlines the
procedures the Corps will follow for implementing a federal loan
program. The Corps will comply with all statutory requirements when
reviewing requests.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/10/22 87 FR 35473
NPRM Comment Period End............. 08/09/22
Final Action........................ 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Aaron Snyder, Department of Defense, U.S. Army
Corps of Engineers, 441 G Street NW, Washington, DC 20314, Phone: 651
290-5489, Email: [email protected].
Related RIN: Merged with 0710-AB32
RIN: 0710-AB31
DOD--COE
38. Revised Definition of ``Waters of the United States''--Rule 1
[0710-AB40]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 1344
CFR Citation: 33 CFR 328.
Legal Deadline: None.
Abstract: In April 2020, the EPA, and the Department of the Army
(the ``agencies'') published the Navigable Waters Protection Rule
(NWPR) that revised the previously-codified definition of ``waters of
the United States'' (85 FR 22250, April 21, 2020). The agencies
initiated the development of regulations that are founded on the
familiar framework of the pre-2015 regulations, are consistent with the
statute and informed by relevant Supreme Court decisions, and that
reflect a reasonable interpretation based on the record before the
agencies, including the best available science. The proposal was open
for public comment between Dec 2021 and Feb 2022. It is planned that
this rule will be finalized by the end of the calendar year (2022).
Statement of Need: In 2015, the Environmental Protection Agency and
the Department of the Army (``the agencies'') published the ``Clean
Water Rule: Definition of `Waters of the United States (80 FR 37054,
June 29, 2015).'' In April 2020, the agencies published the Navigable
Waters Protection Rule (85 FR 22250, April 21, 2020). The agencies
conducted a substantive re-evaluation of the definition of ``waters of
the United States'' in accordance with the Executive Order 13990 and
determined that they need to revise the definition to ensure the
agencies listen to the science, protect the environment, ensure access
to clean water, consider how climate change resiliency may be affected
by the definition of waters of the United States, and to ensure
environmental justice is prioritized in the rulemaking process.
Summary of Legal Basis: The Clean Water Act (33 U.S.C. 1251 et
seq.).
Alternatives: Please see EPA's alternatives. EPA is the lead for
this rulemaking action.
Anticipated Cost and Benefits: Please see EPA's statement of
anticipated costs
[[Page 11011]]
and benefits. EPA is the lead for this rulemaking action.
Risks: Please see EPA's risks. EPA is the lead for this rulemaking
action.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/07/21 86 FR 69372
NPRM Comment Period End............. 02/07/22
Final Action........................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Stacey M. Jensen, Office of the Assistant Secretary
of the Army, Department of Defense, U.S. Army Corps of Engineers, 108
Army Pentagon, Washington, DC 22202, Phone: 703 695-6791 Email:
[email protected].
RIN: 0710-AB40
DOD--OFFICE OF ASSISTANT SECRETARY FOR HEALTH AFFAIRS (DODOASHA)
Final Rule Stage
39. TRICARE Reimbursement of Ambulatory Surgery Centers and Outpatient
Services Provided in Cancer and Children's Hospitals [0720-AB73]
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch. 55
CFR Citation: 32 CFR 199.
Legal Deadline: None.
Abstract: The Department of Defense, Defense Health Agency, is
revising its regulation on the reimbursement of ambulatory surgery
centers (ASC) and outpatient services provided in Cancer and Children's
Hospitals (CCHs). Revisions are in accordance with the statutory
provision at title 10 of the U.S.C., section 1079(i)(2) that requires
TRICARE's 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. In accordance with this requirement, TRICARE will: (1) adopt
Medicare's payment methodology for Ambulatory Surgery Centers (ASC) and
(2) adopt Medicare's payment methodology for outpatient services
provided in Cancer and Children's Hospitals (CCHs). Although Medicare's
reimbursement methods for ASC and CCHs are different, it is prudent to
adopt both the Medicare ASC system and to adopt the Outpatient
Prospective Payment System (OPPS) with hold-harmless adjustments
(meaning the provider is not reimbursed less than their costs) for CCHs
simultaneously to align with our statutory requirement to reimburse
like Medicare at the same time. This rule makes the modifications
necessary to implement TRICARE reimbursement methodologies similar to
those applicable to Medicare beneficiaries for outpatient services
rendered in ASCs and CCHs.
Statement of Need: The rule finalizes modifications to TRICARE
regulation necessary to implement Medicare-similar reimbursement
methods for Ambulatory Surgery Centers (ASCs) and Cancer and Children's
Hospitals (CCHs). This is outlined in 10 U.S.C. 1079(i)(2) which
requires TRICARE's 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.
Summary of Legal Basis: This rule is issued under 10 U.S.C. 1073
(a)(2) giving authority and responsibility to the Secretary of Defense
to administer the TRICARE program.
Alternatives:
(1) No action.
(2) Permitting a transition period for Ambulatory Surgery Centers
(ASCs). DHA explored the use of a transition period that blended the
current reimbursement method with the proposed method. This would
slowly shift the rates to be fully aligned with Medicare at the end of
the transition and would protect providers from lower payments. After
comparing the differences in rates, DHA found that many providers are
likely to see an increase in reimbursement, which would not be
effective until the end of the transition period. Some providers may
see a decrease in payments, but on the whole, Medicare's payments have
been found to be adequate based upon a Medicare Payment Advisory
Committee (MedPAC) review. As a result, DHA will not adopt a transition
period.
(3) Permitting a transition period for Cancer and Children's
Hospitals (CCHs). DHA explored the use of a transition period that
blended the current reimbursement method with the proposed, and slowly
shifted the rates to be fully aligned with Medicare at the end of the
transition. This would be done to protect providers from payments below
their cost, in the event that the rates are significantly affected. To
protect CCHs, DHA will ensure that CCHs are reimbursed the greater of
100% of their costs or the OPPS payment. Because many CCH providers
will receive payment increases, a transition period would not be
beneficial for them. Historically, transitions are done to protect
providers from payments below their costs. However, in this case,
providers will be held-harmless, so no transition is necessary.
Anticipated Cost and Benefits: Economic impact of this rule is
based on analysis of expected outcomes had the rule been implemented in
2021. The overall impact to the DoD, for ASC reimbursement, would be
$10 million in reduced payments for ASCs. The overall impact to the
DoD, for adopting OPPS for CCHs, would be $35 million in reduced
payments to these providers. The combined impact is a cost-saving of
approximately $45 million, which would be offset by $1.5 million in
administrative costs to implement the changes. This estimated reduction
in costs of $45 million is a transfer from providers to DoD.
Risks: None. DHA is adopting the new Ambulatory Surgery Center
(ASC) and Cancer and Children's Hospital (CCH) reimbursement systems to
be consistent with Medicare's, as required by statute. Although DHA
expects a decrease in total TRICARE payments for ASCs; however, rates
for almost half the high-volume ASC surgeries will increase under the
new ASC payment system. DHA also notes that even if some ASCs deny
access to some surgeries, TRICARE beneficiaries would be largely
protected from access problems as these patients could have their
surgeries performed in hospital outpatient departments (HOPDs).
Additionally, CCHs will be held harmless, as they will receive, at a
minimum, one-hundred percent of its costs, or the higher payment under
Outpatient Prospective Payment System (OPPS). Under the new method,
CCHs may be eligible for the General Temporary Military Contingency
Payment Adjustments (GTMCPA) that will ensure network adequacy during
military contingency operations. These GTMCPAs will be issued in the
same manner as those made currently under TRICARE's OPPS.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/29/19 84 FR 65718
NPRM Comment Period End............. 01/28/20
Final Action........................ 02/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
[[Page 11012]]
Agency Contact: Jahanbakhsh Badshan, Department of Defense, Office
of Assistant Secretary for Health Affairs, 16401 East Centretech
Parkway, Aurora, CO 80011, Phone: 303 676-3881, Email:
[email protected].
RIN: 0720-AB73
DOD--DODOASHA
40. TRICARE Coverage of National Institute of Allergy and Infectious
Disease Coronavirus Disease 2019 Clinical Trials [0720-AB83]
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch. 55
CFR Citation: 32 CFR 199.
Legal Deadline: None.
Abstract: This rule finalizes provisions published in two interim
final rules with request for comment, which temporarily added coverage
for the treatment use of investigation drugs under U.S. Food and Drug
Administration (FDA) approved expanded access programs when for the
treatment of coronavirus disease 2019 (COVID-19) and permitted coverage
of National Institute of Allergy and Infectious Disease (NIAID)-
sponsored clinical trials for the treatment or prevention of COVID-19.
Statement of Need: This final rule is required to finalize certain
temporary flexibilities enacted in interim final rules published in
2020 in response to the COVID-19 pandemic.
Pursuant to the President's national emergency declaration and as a
result of the worldwide COVID-19 pandemic, the Assistant Secretary of
Defense for Health Affairs hereby temporarily modified the regulation
at 32 CFR 199.4(e)(26) to permit TRICARE coverage for National
Institute of Allergy and Infectious Disease (NIAID)-sponsored COVID-19
phase I, II, III, and IV clinical trials for the treatment or
prevention of coronavirus disease 2019 (COVID-19). This provision
supports increased access to emerging therapies for TRICARE
beneficiaries.
Summary of Legal Basis: This rule is issued under 10 U.S.C.
1073(a)(2) giving authority and responsibility to the Secretary of
Defense to administer the TRICARE program.
Alternatives:
(1) No action.
(2) The second alternative the DoD considered was implementing a
more limited benefit change for COVID-19 patients by not covering phase
I clinical trials. Although this would have the benefit of reimbursing
only care that has more established evidence in its favor, this
alternative is not preferred because early access to treatments is
critical for TRICARE beneficiaries given the rapid progression of the
disease and the lack of available approved treatments.
Anticipated Cost and Benefits: Any cost to beneficiaries would be
consistent with existing costs under the TRICARE Program (such as cost-
shares and copayments). Finalizing TRICARE coverage of clinical trials
will benefit TRICARE beneficiaries by ensuring they continue to have
access to emerging therapies in the safest setting possible.
In the interim final rule, DoD estimated the total cost for TRICARE
participation in NIAID-sponsored COVID-19 clinical trials would be
$3.2M for the duration of the national emergency, with an additional
$4.0M for continued care for beneficiaries enrolled in clinical trials
prior to termination of the national emergency. There were several
assumptions we made in developing this estimate. The duration of the
COVID-19 national emergency is uncertain; however, for the purposes of
this estimate, we assumed the national emergency would expire on
September 30, 2021. As of the drafting of the IFR, there were 27 NIAID-
sponsored COVID-19 clinical trials begun since the start of the
national emergency. We assumed 6.2 new trials every 30 days, for a
total of 126 trials by September 2021. We assumed, based on average
trial enrollment and that TRICARE beneficiaries would participate in
trials at the same rate as the general population, that 4,549 TRICARE
beneficiaries would participate through September 2021. Each of the
assumptions in this estimate is highly uncertain, and our estimate
could be higher or lower depending on real world events (more or fewer
trials, a longer or shorter national emergency, and/or higher or lower
participation in clinical trials by TRICARE beneficiaries).
Benefits: These changes expand the therapies available to TRICARE
beneficiaries in settings that ensure informed consent of the
beneficiary, and where the benefits of treatment outweigh the potential
risks. Participation in clinical trials may provide beneficiaries with
benefits such as reduced hospitalizations and/or use of a mechanical
ventilator. Although we cannot estimate the value of avoiding these
outcomes quantitatively, the potential long-term consequences of
serious COVID-19 illness, including permanent cardiac or lung damage,
are not insignificant. Beneficiary access to emerging therapies that
reduce these long-term consequences or even death can be considered to
be high-value for those able to participate.
TRICARE providers will be positively affected by being able to
provide their patients with a broader range of treatment options. The
general public will benefit from an increased pool of available
participants for the development of treatments and vaccines for COVID-
19, as well as the evidence (favorable or otherwise) that results from
this participation.
Risks: None. This rule will not directly affect the efficient
functioning of the economy or private markets. However, increasing the
pool of available participants for clinical trials may help speed the
development of treatments or vaccines for COVID-19. Once effective
treatments or vaccines for COVID-19 exist, individuals are likely to be
more confident interacting in the public sphere, resulting in a
positive impact on the economy and private markets.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 10/30/20 85 FR 68753
Interim Final Rule Effective........ 10/30/20
Interim Final Rule Comment Period 11/30/20
End.
Final Action........................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Jennifer Stankovic, Department of Defense, Office
of Assistant Secretary for Health Affairs, 16401 E Centretech Parkway,
Aurora, CO 80011-9066, Phone: 303 676-3742, Email:
[email protected].
Related RIN: Related to 0720-AB81, Related to 0720-AB82
RIN: 0720-AB83
DOD--DODOASHA
41. Expanding TRICARE Access to Care in Response to the COVID-19
Pandemic [0720-AB85]
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch. 55
CFR Citation: 32 CFR 199.
Legal Deadline: None.
Abstract: This interim final rule with comment will temporarily
amend the TRICARE regulation at 32 CFR part 199 by: (1) adding
freestanding End Stage Renal Disease facilities as a category of
TRICARE-authorized institutional
[[Page 11013]]
provider and modifying the reimbursement for such facilities; and (2)
adopting Medicare New COVID-19 Treatments Add-on Payments (NTCAPs).
Statement of Need: Pursuant to the President's emergency
declaration and as a result of the COVID-19 pandemic, the Assistant
Secretary of Defense for Health Affairs is temporarily modifying the
following regulations (except for the modifications to paragraphs
199.6(b)(4)(xxi) and 199.14(a)(1)(iii)(E)(7), which will not expire),
but, in each case, only to the extent necessary to ensure that TRICARE
beneficiaries have access to the most up-to-date care required for the
prevention, diagnosis, and treatment of COVID-19, and that TRICARE
continues to reimburse like Medicare, to the extent practicable, as
required by statute.
The modifications to paragraphs 199.6(b)(4)(xxi) and
199.14(a)(1)(iii)(E)(7) establish freestanding End Stage Renal Disease
(ESRD) facilities as a category of TRICARE-authorized institutional
provider and modify TRICARE reimbursement of freestanding ESRD
facilities. These provisions will improve TRICARE beneficiary access to
medically necessary dialysis and other ESRD services and supplies.
These provisions also support the requirement that TRICARE reimburse
like Medicare, and will help to alleviate regional health care
shortages due to the COVID-19 pandemic by ensuring access to dialysis
care in freestanding ESRD facilities rather than hospital outpatient
departments.
The modification to paragraph 199.14(a)(iii)(E) adopts Medicare's
New COVID-19 Treatments Add-on Payment (NCTAP) for COVID-19 cases that
meet Medicare's criteria. This provision increases access to emerging
COVID-19 treatments and supports the requirement that TRICARE reimburse
like Medicare.
Summary of Legal Basis: This rule is issued under 10 U.S.C. 1073
(a)(2) giving authority and responsibility to the Secretary of Defense
to administer the TRICARE program.
Alternatives:
(1) No action.
(2) The second alternative the Department of Defense considered was
to adopt Medicare's ESRD reimbursement methodology, the ESRD
Prospective Payment System (PPS), in total. While this would have been
completely consistent with the statutory provision to pay institutional
providers using the same reimbursement methodology as Medicare, this
alternative is not preferred because there is still a relatively low
volume of TRICARE beneficiaries who receive dialysis services from
freestanding ESRDs and who are not enrolled to Medicare. The cost of
implementing the full ESRD PPS system is estimated to be at least
$600,000.00 in start-up costs, plus ongoing administrative costs, to
ensure all adjustments were made for each claim, plus additional
special pricing software or algorithms. In contrast, we estimate that
the option provided in this IFR can be implemented relatively quickly
(within six months of publication), and for approximately $300,000.00
in start-up costs with lower ongoing administrative costs. Further, the
flat rate will provide the ESRD facilities with predictability with
regard to TRICARE payments and will reduce uncertainty and specialized
coding or case-mix documentation requirements that may be required by
the ESRD PPS, reducing the administrative burden on the provider.
To summarize, adopting the ESRD PPS was considered, but was deemed
impracticable and overly burdensome to both the Government and
providers due to the relative low volume of claims that will be priced
and paid by TRICARE as primary under this system.
Anticipated Cost and Benefits: $8.08 million. Only the ESRD
provisions are expected to result in recurring incremental health care
costs; the remaining two provisions are expected to result in one-time
cost increases.
This estimate includes approximately $0.9M in administrative costs
and $5.9M in direct health care costs.
$1.8M of the total cost impact is expected to be a one-time start-
up cost for both the temporary and permanent provisions, while the
permanent ESRD provisions are expected to result in $5M in incremental
annual costs.
Risks: None. This rule will promote the efficient functioning of
the economy and markets by modifying the regulations to better
reimburse health care providers for care provided during the COVID-19
pandemic, particularly as strain on the health care economy is being
felt due to reductions in higher cost elective procedures.
Additionally, this rule will increase the access of TRICARE
beneficiaries to more providers administering COVID-19 vaccinations,
which promotes the efficient functioning of the U.S. economy by
quickening the pace at which the public receives COVID-19 vaccinations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 03/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Jahanbakhsh Badshah, Healthcare Program
Specialist--Reimbursement, Department of Defense, Office of Assistant
Secretary for Health Affairs, 16401 E Centretech Parkway, Aurora, CO
80011, Phone: 303 676-3881, Email: [email protected].
RIN: 0720-AB85
DOD--DODOASHA
42. Collection From Third Party Payers of Reasonable Charges for
Healthcare Services; Amendment [0720-AB87]
Priority: Other Significant.
Legal Authority: NDAA 2021, sec. 702
CFR Citation: 32 CFR 220.
Legal Deadline: None.
Abstract: The National Defense Authorization Act (NDAA) section 702
for Fiscal Year (FY) 2021 provides authority to waive fees charged for
certain civilian non-beneficiary patients: (1) after the patient's
insurance pays, if any, the civilian is not able to pay for the trauma
or other medical care provided to the civilian; and (2) the provision
of such care enhances the knowledge, skills, and abilities of health
care providers, as determined by the Secretary. The amendment of 32 CFR
220.7 would delegate authority to the Secretary of Defense or a
Secretary of Defense established representative to waive medical debt
owed for services rendered at Military Treatment Facilities (MTF) if
the patient requests a medical debt waiver and meets the two specified
criteria.
This amendment should be made as current legislation and policies
can lead to an undue financial burden on non-beneficiary patients who
have incurred medical debt from treatment at MTFs. The Debt Collection
Improvement Act of 1996 and the Digital Accountability and Transparency
act of 2014 drive federal collection activities and can place
individuals indebted to the government at risk of financial hardship.
By making these changes, the Secretary of Defense would have the
ability to waive non-beneficiary civilian debt in cases where the
patient is unable to pay as determined using U.S. Treasury guidelines
and when the care provided enhances the knowledge, skills, and
abilities of health care providers.
Statement of Need: Section 702 of the FY 2021 NDAA amends 10 U.S.C.
1079b by inserting a new subsection regarding the waiver of fees. Under
section 702,
[[Page 11014]]
the Secretary of Defense may waive a fee charged to a civilian who is
not a covered beneficiary if after insurance payments, if any, the
civilian is not able to pay for the trauma or other medical care
provided to the civilian; and the provision of such care enhanced the
medical readiness of the health care provider or health care providers
furnishing such care. This rule prescribes a new debt waiver process
for medical debt owned for services rendered at Military Treatment
Facilities to civilians who are not covered beneficiaries.
Summary of Legal Basis: Section 702 of the FY 2021 NDAA amends 10
U.S.C. 1079b by inserting a new subsection regarding the waiver of
fees. Under section 702, the Secretary of Defense may waive a fee
charged to a civilian who is not a covered beneficiary if after
insurance payments, if any, the civilian is not able to pay for the
trauma or other medical care provided to the civilian; and the
provision of such care enhanced the medical readiness of the health
care provider or health care providers furnishing such care.
Alternatives:
Alternative #1: The first alternative will use an outside agency,
the Centralized Receivable Service (CRS) to complete the patient
ability-to-pay assessment and make a recommendation to the DHA Cost
Accounting Division (CAD) Financial Operations (FO). CAD FO will then
make the final determination based on that recommendation. This
alternative will utilize DHA's existing relationship with CRS, a
program under the U.S. Department of Treasury focused on managing pre-
delinquent debt and debt in the early stages of delinquency before it
is referred to the U.S. Treasury.
Alternative #2: The DoD considered a second alternative in which
the DHA UBO will stand up a cell to complete the ability-to-pay
assessments and make a recommendation. The recommendations will be
directed to either the DHA CAD FO for accounts under $100,000 or to the
Deputy Assistant Director (DAD) FO for accounts over $100,000.
Alternative #3: Option 3, which is DoD's preferred approach due to
operational efficiency gains, would leverage existing partnerships with
CRS and U.S. Treasury. For active or non-delinquent debt, the MTF UBO
will direct all uninsured non-beneficiary accounts to CRS for billing.
The patient can request a waiver by contacting CRS as directed on their
invoice, the MTF will direct the account information to CRS to complete
the financial analysis. If a patient is deemed financially culpable,
collections will be pursued by CRS. If not, CRS will calculate an
amount the debtor can pay within 3-5 years and waive the remaining
debt. CRS would report decisions to DHA following established business
rules and guidelines including monthly accounting of all waiver and
compromise agreements to DHA, and immediately report waived amounts
over $100,000. Any additional business rules will be decided by DHA FO
and DHA General Counsel.
Anticipated Cost and Benefits: This cost will be the fee paid to
CRS for their services, totaling an estimated $145, 711. Time required
for this alternative is an estimated 17 days based on CRS reported
process completion estimates from the DAMP program. This would include
time for the civilian to compile required documents, for CRS to draft
the package and assess ability to pay, as well as CRS response time for
a decision and any other follow-up activities for each request for
waiver.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 08/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: DeLisa Prater, DHA Uniform Business Office Program
Manager, Department of Defense, Office of Assistant Secretary for
Health Affairs, 8111 Gatehouse Road, Suite #221, Falls Church, VA
22042-5101, Phone: 703 275-6380, Email: [email protected].
RIN: 0720-AB87
BILLING CODE 5001-06-P
DEPARTMENT OF EDUCATION
Statement of Regulatory Priorities
I. Introduction
The U.S. Department of Education (Department) supports States,
local communities, institutions of higher education, and families in
improving education and other services nationwide to ensure that all
Americans, including those with disabilities and who have been
underserved, receive a high-quality and safe education and are prepared
for employment that provides a livable wage. We provide leadership and
financial assistance pertaining to education and related services at
all levels to a wide range of stakeholders and individuals, including
State educational and other agencies, local school districts, providers
of early learning programs, elementary and secondary schools,
institutions of higher education, career and technical schools,
nonprofit organizations, students, members of the public, families, and
many others. These efforts are helping to advance equity, recover from
the COVID-19 pandemic, and ensure that all children and students from
pre-kindergarten through grade 12 will be ready for, and succeed in,
postsecondary education and employment, and that students attending
postsecondary institutions, or participating in other postsecondary
education options, are prepared for a profession or career.
We also vigorously monitor and enforce the implementation of
Federal civil rights laws in educational programs and activities that
receive Federal financial assistance from the Department, and support
innovative and promising programs, research and evaluation activities,
technical assistance, and the dissemination of data, research, and
evaluation findings to improve the quality of education.
Overall, the laws, regulations, and programs that the Department
administers will affect nearly every American during his or her life.
Indeed, in the 2021-22 school year, about 56 million students attended
an estimated 129,000 elementary and secondary schools in approximately
13,600 districts, and about 20 million students enrolled in
postsecondary institutions of higher education. Many of these students
benefit from some degree of financial assistance or support from the
Department.
In developing and implementing regulations, guidance, technical
assistance, evaluations, data gathering and reporting, and monitoring
related to our programs, we are committed to working closely with
affected persons and groups. Our core mission includes serving the most
vulnerable, and facilitating equal access for all, to ensure all
students receive a high-quality and safe education and complete it with
a well-considered and attainable path to a sustainable career. Toward
these ends, we work with a broad range of interested parties and the
general public, including families, students, and educators; State,
local, and Tribal governments; other Federal agencies; and neighborhood
groups, community-based early learning programs, elementary and
secondary schools, postsecondary institutions, rehabilitation service
providers, adult education providers, professional associations, civil
rights organizations,
[[Page 11015]]
nonprofits, advocacy organizations, businesses, and labor
organizations.
If we determine that it is necessary to develop regulations, we
seek public participation at the key stages in the rulemaking process.
We invite the public to submit comments on all proposed regulations
through the internet or by regular mail. We also continue to seek
greater public participation in our rulemaking activities through the
use of transparent and interactive rulemaking procedures and new
technologies.
To facilitate the public's involvement, we participate in the
Federal Docket Management System (FDMS), an electronic single
Government-wide access point (www.regulations.gov) that enables the
public to submit comments on different types of Federal regulatory
documents and read and respond to comments submitted by other members
of the public during the public comment period. This system provides
the public with the opportunity to submit comments electronically on
any notice of proposed rulemaking or interim final regulations open for
comment as well as read and print any supporting regulatory documents.
II. Regulatory Priorities
The following are the key rulemaking actions the Department is
planning for the coming year. These rulemaking actions advance the
Department's mission of ``promot[ing] student achievement and
preparation for global competitiveness by fostering educational
excellence and ensuring equal access.'' These rulemaking actions also
advance the President's priorities of ensuring that every American has
access to a high-quality education, regardless of background, and that
government should affirmatively work to expand educational
opportunities for underserved communities. During his time in office,
the President has repeatedly made clear the importance of advancing
equity and opportunity for those who have historically been
underserved, both as a general matter and with regard to the education
system in particular.
See Executive Order 13985 (On Advancing Racial Equity and Support
for Underserved Communities Through the Federal Government); Executive
Order 14021 (Guaranteeing an Educational Environment Free From
Discrimination on the Basis of Sex, Including Sexual Orientation or
Gender Identity); Executive Order 14041 (White House Initiative on
Advancing Educational Equity, Excellence, and Economic Opportunity
Through Historically Black Colleges and Universities); Executive Order
14045 (White House Initiative on Advancing Educational Equity,
Excellence, and Economic Opportunity for Hispanics); Executive Order
14049 (White House Initiative on Advancing Educational Equity,
Excellence, and Economic Opportunity for Native Americans and
Strengthening Tribal Colleges and Universities); and Executive Order
14050 (White House Initiative on Advancing Educational Equity,
Excellence, and Economic Opportunity for Black Americans). The
rulemaking actions on the Department's agenda seek to advance the
President's priorities, as set out in these executive orders and more
broadly. Our regulatory agenda covers a wide range of topics, and a
wide range of educational institutions-- from those serving our
youngest children to colleges, universities, and adult education
programs. In each of these contexts, promoting equity and opportunity
for students who have been historically underserved is central to the
Department's regulatory plan.
Postsecondary Education/Federal Student Aid
The Department's upcoming higher education regulatory efforts
include the following areas:
Improving Income Driven Repayment
Gainful Employment
These rulemakings are focused on improving the rules governing
student loan repayment and protecting students and taxpayers from
career-training programs that fail to provide sufficient value, among
other topics. These rulemakings reflect the Department's commitment to
helping borrowers successfully manage their student loans and
protecting students from harmful programs and practices that may derail
their postsecondary and career goals. Through these regulatory efforts,
the Department plans to address gaps in postsecondary outcomes,
particularly those related to student loan repayment delinquency, and
default, as well as the returns students receive for their investments.
For its higher education rulemakings, generally the Department uses a
negotiated rulemaking process. We selected participants for the
negotiated rulemaking committees from nominees of the organizations and
groups that represent the interests significantly affected by the
proposed regulations. To the extent possible, we selected nominees who
reflect the diversity among program participants.
The Department used this negotiated rulemaking process for its
rulemakings on Improving Income Driven Repayment and Gainful
Employment. On Improving Income Driven Repayment, the Department plans
to create or adjust an income driven repayment plan that would allow
borrowers to more easily afford their student loan payments. For
Gainful Employment, the Department plans to propose regulations on
program eligibility under the HEA, including regulations that determine
whether postsecondary educational programs prepare students for gainful
employment in recognized occupations, and the conditions under which
programs remain eligible for student financial assistance programs
under Title IV of the HEA.
Civil Rights/Title IX
The Secretary proposed to amend its regulations implementing Title
IX of the Education Amendments of 1972, as amended, consistent with the
priorities of the Biden-Harris Administration. These priorities include
those set forth in Executive Order 13988 on Preventing and Combating
Discrimination on the Basis of Gender Identity or Sexual Orientation
and Executive Order 14021 on Guaranteeing an Educational Environment
Free from Discrimination on the Basis of Sex, Including Sexual
Orientation and Gender Identity.
Student Privacy
The Department is considering policy options to amend the Family
Educational Rights and Privacy Act (FERPA) regulations, to update,
clarify, and improve the current regulations. The proposed regulations
are also needed to implement statutory amendments to FERPA contained in
the Uninterrupted Scholars Act of 2013 and the Healthy, Hunger-Free
Kids Act of 2010, to reflect a change in the name of the office
designated to administer FERPA, and to make changes related to the
enforcement responsibilities of the office concerning FERPA.
Recently Completed Rulemakings
Additionally, the Department has recently concluded a number of
critical rulemakings, including Public Service Loan Forgiveness;
Borrower Defense to Repayment; Improving Discharges for Total and
Permanent Disabilities, Closed Schools, and False Certification;
Determining the Amount of Federal Education Assistance Funds Received
by Institutions of Higher Education (90/10); and Pell Grants for Prison
Education Programs. For Public Service Loan Forgiveness, the Department
streamlined the process for receiving loan forgiveness after 10 years
of qualifying payments on qualifying loans while engaging in public
service. For
[[Page 11016]]
Borrower Defense, the Secretary amended the regulations that specify
the acts or omissions of an institution of higher education that a
borrower may assert as a defense to repayment of a loan made under the
Federal Direct Loan Program. In Improving Discharges for Total and
Permanent Disabilities, Closed Schools, and False Certification, the
Department improved areas where Congress has provided borrowers with
relief or benefits related to Federal student loans. This includes
authorities granted under the Higher Education Act (HEA) that allow the
Department to cancel loans for borrowers who meet certain criteria,
such as having a total and permanent disability, attending a school
that closed, or having been falsely certified for a student loan. For
these borrowers, the Secretary amended the regulations relating to
borrower eligibility and streamlined application requirements and the
application and certification processes. On the 90/10 rule, in response
to changes to the HEA made by the American Rescue Plan Act of 2021, the
Department amended provisions governing whether proprietary
institutions meet requirements that institutions receive at least 10
percent of their revenue from sources other than Federal education
assistance funds. To increase access to educational opportunities, the
Department also issued regulations that would guide correctional
facilities and eligible institutions of higher education that seek to
establish eligibility for the Pell Grant program for individuals who
are incarcerated.
III. Principles for Regulating
Over the next year, we may need to issue other regulations because
of new legislation or programmatic changes. In doing so, we will follow
the Principles for Regulating, which determine when and how we will
regulate. Through consistent application of those 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
similar enough that a uniform approach through regulation would be
meaningful and do more good than harm.
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 regulating.
To the extent possible, establish performance objectives
rather than specify the behavior or manner of compliance a regulated
entity must adopt.
Encourage flexibility, to the extent possible and as
needed to enable institutional forces to achieve desired results.
ED--OFFICE FOR CIVIL RIGHTS (OCR)
Proposed Rule Stage
43. Nondiscrimination on the Basis of Sex in Athletics
Education Programs or Activities Receiving Federal Financial Assistance
[1870-AA19]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1681 et seq.
CFR Citation: 34 CFR 106.
Legal Deadline: None.
Abstract: The Department plans to issue a final rule amending its
regulations implementing Title IX of the Education Amendments of 1972,
20 U.S.C. 1681 et seq., consistent with the priorities of the Biden-
Harris Administration. These priorities include those set forth in
Executive Order 13988 on Preventing and Combating Discrimination on the
Basis of Gender Identity or Sexual Orientation and Executive Order
14021 on Guaranteeing an Educational Environment Free from
Discrimination on the Basis of Sex, Including Sexual Orientation and
Gender Identity.
Statement of Need: This rulemaking is necessary to align the Title
IX regulations to fully implement the statute.
Summary of Legal Basis: We are conducting this rulemaking under 20
U.S.C. 1681 et seq.
Alternatives: We have limited information about the alternatives at
this time.
Anticipated Cost and Benefits: We have limited information about
the costs and benefits at this time.
Risks: We have limited information about the risks at this time.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Alejandro Reyes, Department of Education, Office
for Civil Rights, 400 Maryland Avenue SW, Room PCP-6125, Washington, DC
20202, Phone: 202 245-7272, Email: [email protected].
RIN: 1870-AA19
ED--OCR
Final Rule Stage
44. Nondiscrimination on the Basis of Sex in Education Programs or
Activities Receiving Federal Financial Assistance [1870-AA16]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1681 et seq.
CFR Citation: 34 CFR 106.
Legal Deadline: None.
Abstract: The Department plans to issue a final rule amending its
regulations implementing Title IX of the Education Amendments of 1972,
20 U.S.C. 1681 et seq., consistent with the priorities of the Biden-
Harris Administration. These priorities include those set forth in
Executive Order 13988 on Preventing and Combating Discrimination on the
Basis of Gender Identity or Sexual Orientation and Executive Order
14021 on Guaranteeing an Educational Environment Free from
Discrimination on the Basis of Sex, Including Sexual Orientation and
Gender Identity. The proposed amendments include, among others,
revisions to 34 CFR 106.2 (Definitions), 106.6 (Effect of other
requirements and preservation of rights), 106.8 (Designation of
coordinator, dissemination of policy, and adoption of grievance
procedures), 106.10 (Scope), 106.11 (Application), 106.30
(Definitions), 106.31 (Education programs or activities), 106.40
(Parental,
[[Page 11017]]
family, or marital status; pregnancy or related conditions), 106.44
(Action by a recipient to operate its education program or activity
free from sex discrimination), 106.45 (Grievance procedures for the
prompt and equitable resolution of complaints of sex discrimination),
106.46 (Grievance procedures for the prompt and equitable resolution of
complaints of sex-based harassment involving student complainants or
student respondents at postsecondary institutions); 106.51
(Employment), 106.57 (Parental, family, or marital status; pregnancy or
related conditions), 106.60 (Pre-employment inquiries), and 106.71
(Retaliation).
Statement of Need: This rulemaking is necessary to align the Title
IX regulations with the priorities of the Biden-Harris Administration,
including those set forth in the Executive Order on Preventing and
Combating Discrimination on the Basis of Gender Identity or Sexual
Orientation (E.O. 13988) and the Executive Order on Guaranteeing an
Educational Environment Free from Discrimination on the Basis of Sex,
Including Sexual Orientation and Gender Identity (E.O. 14021).
Summary of Legal Basis: We are conducting this rulemaking under 20
U.S.C. 1681 et seq.
Alternatives: This was discussed in the notice of proposed
rulemaking (NPRM) and will be discussed in the final regulations.
Anticipated Cost and Benefits: This was discussed in the notice of
proposed rulemaking (NPRM) and will be discussed in the final
regulations.
Risks: This was discussed in the notice of proposed rulemaking
(NPRM) and will be discussed in the final regulations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/12/22 87 FR 41390
Final Action........................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: State.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
Agency Contact: Alejandro Reyes, Department of Education, Office
for Civil Rights, 400 Maryland Avenue SW, PCP-6125, Washington, DC
20202, Phone: 202 245-7705, Email: [email protected].
RIN: 1870-AA16
ED--OFFICE OF POSTSECONDARY EDUCATION (OPE)
Proposed Rule Stage
45. Gainful Employment [1840-AD57]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1001; 20 U.S.C. 1002; 20 U.S.C. 1003; 20
U.S.C. 1088; 20 U.S.C. 1091; 20 U.S.C. 1094; 20 U.S.C. 1099(b); 20
U.S.C. 1099(c); 20 U.S.C. 1082; . . .
CFR Citation: 34 CFR 668; 34 CFR 600.
Legal Deadline: None.
Abstract: The Secretary plans to propose to amend 34 CFR parts 668
and 600 on institution and program eligibility under the HEA, including
regulations that determine whether postsecondary educational programs
prepare students for gainful employment in recognized occupations, and
the conditions under which institutions and programs remain eligible
for student financial assistance programs under Title IV of the HEA.
Statement of Need: This rulemaking is necessary to determine
whether postsecondary educational programs prepare students for gainful
employment and the conditions under which institutions and programs
remain eligible for student financial assistance programs under Title
IV of the HEA.
Summary of Legal Basis: We are conducting this rulemaking under the
following authorities: 20 U.S.C. 1001; 20 U.S.C. 1002; 20 U.S.C. 1003;
20 U.S.C. 1088; 20 U.S.C. 1091; 20 U.S.C. 1094; 20 U.S.C. 1099(b); 20
U.S.C. 1099(c); and 20 U.S.C. 1082.
Alternatives: We have limited information about the alternatives at
this time.
Anticipated Cost and Benefits: We have limited information about
the anticipated costs and benefits at this time.
Risks: We have limited information about the risks at this time.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Intent to Commence 05/26/21 86 FR 28299
Negotiated Rulemaking.
NPRM................................ 04/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Gregory Martin, Department of Education, Office of
Postsecondary Education, 400 Maryland Avenue SW, Room 2C136,
Washington, DC 20202, Phone: 202 453-7535, Email:
[email protected].
RIN: 1840-AD57
ED--OPE
46. Improving Income Driven Repayment [1840-AD81]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 20 U.S.C. 1070g; 20 U.S.C. 1087a, et seq.
CFR Citation: 34 CFR 685.
Legal Deadline: None.
Abstract: The Secretary plans to propose amendments to the
regulations governing income-contingent repayment plans by amending the
Revised Pay as You Earn (REPAYE) repayment plan, and to restructure and
rename the repayment plan regulations under the William D. Ford Federal
Direct Loan (Direct Loan) Program, including combining the Income
Contingent Repayment (ICR) and the Income-Based Repayment (IBR) plans
under the umbrella term of Income-Driven Repayment (IDR) plans.
Statement of Need: This rulemaking is necessary to make
improvements to the income-driven repayment plans created under the ICR
authority in Higher Education Act of 1965 that allows the Secretary to
cap payments at a set share of a borrower's income.
Summary of Legal Basis: 20 U.S.C. 1070g, 1087a, et seq., unless
otherwise noted.
Alternatives: We have limited information about the alternatives at
this time.
Anticipated Cost and Benefits: We have limited information about
the anticipated costs and benefits at this time.
Risks: We have limited information about the risks at this time.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Intent to Commence 05/26/21 86 FR 28299
Negotiated Rulemaking.
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Tamy Abernathy, Department of Education, Office of
Postsecondary Education, 400 Maryland Avenue SW, 2C-232, Washington, DC
20202, Phone: 202 453-5970, Email: [email protected].
[[Page 11018]]
RIN: 1840-AD81
BILLING CODE 4000-01-P
DEPARTMENT OF ENERGY
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 remediation, and energy research. The Department's
mission is to:
Promote dependable, affordable and environmentally sound
production and distribution of energy;
Advance energy efficiency and conservation;
Provide responsible stewardship of the Nation's nuclear
weapons;
Provide a responsible resolution to the environmental
legacy of nuclear weapons production; and
Strengthen U.S. scientific discovery, economic
competitiveness, and improve quality of life through innovations in
science and technology.
The Department's regulatory activities are essential to achieving
its critical mission and to implementing the President's clean energy
and climate initiatives. Among other things, the Regulatory Plan and
the Unified Agenda contain the rulemakings the Department will be
engaged in during the coming year to fulfill the Department's
commitment to meeting deadlines for issuance of energy conservation
standards and related test procedures. The Regulatory Plan and Unified
Agenda also reflect the Department's continuing commitment to cut
costs, reduce regulatory burden, and increase responsiveness to the
public.
Energy Efficiency Program for Consumer Products and Commercial
Equipment
The Energy Policy and Conservation Act (EPCA) requires DOE to set
appliance efficiency standards at levels that achieve the maximum
improvement in energy efficiency that is technologically feasible and
economically justified. The Department continues to follow its schedule
for setting new appliance efficiency standards by both tackling its
backlog of rulemakings with missed statutory deadlines and advancing
rulemakings with upcoming statutory deadlines. In 2022, DOE has
published 55 actions relating to energy conservation standards,
including nine final actions; 45 actions relating to test procedures,
including 18 final rules; and four actions related to coverage
determinations, including three final rules. DOE tentatively plans to
publish three additional actions relating to energy conservation
standards and seven actions relating to test procedures by the end of
the year. These rulemakings are expected to save American consumers
billions of dollars in energy costs over a 30-year timeframe.
The Department is highlighting one important energy conservation
standard rule entitled ``Energy Conservation Standards for Residential
Non-Weatherized Gas Furnaces and Mobile Home Gas Furnaces.'' For non-
weatherized gas furnaces and mobile home gas furnaces, DOE estimates
that energy savings for active mode operation (in terms of annual fuel
utilization efficiency (AFUE)) will be 5.48 quads over 30 years and
that the net benefit to the Nation will be between $6.2 billion and
$21.6 billion. DOE estimates that energy savings for standby mode and
off mode operation will be 0.28 quads over 30 years and that the net
benefit to the Nation will be between $1.1 billion and $3.4 billion.
Federal Agency Leadership in Climate Change
Beyond the appliance program, DOE is supporting Federal agency
leadership in climate change in various ways, including in its ``Clean
Energy Rule for New Federal Buildings and Major Renovations'' (Clean
Energy Rule), which implements a provision of the Energy Independence
and Security Act of 2007 (EISA) that requires the Department to
establish revised-performance standards for the construction of all new
Federal buildings, including commercial buildings, multi-family high-
rise residential buildings, and low-rise residential buildings.
Consistent with the requirements in EISA, this rule presents revised
Federal building energy performance standards that would require
reductions in Federal agencies' on-site use of fossil fuels (which
include coal, petroleum, natural gas, oil shales, bitumens, tar sands,
and heavy oils) consistent with the targets of EPCA and EISA, and
provides processes by which agencies can petition DOE for the downward
adjustment of these targets for buildings. For covered buildings for
which design for construction or whole building renovation begins in
fiscal year 2030 or beyond, the fossil fuel-generated energy
consumption of the building must be zero for all building types and
climate zones, based on the calculation established in the regulations.
Investing in Clean Energy Projects
The ``Loan Guarantees for Clean Energy Projects'' interim final
rule would amend DOE's regulations implementing the Title XVII loan
guarantee program to incorporate new categories of eligible projects
and other provisions of the Energy Act of 2020, the Infrastructure
Investment Act of 2021, and the Inflation Reduction Act of 2022. The
rule would also include other changes to the existing regulations based
on experiences gained implementing the Title XVII program and on
comments recently received from stakeholders in response to DOE's
Request for Information. The rule would enable DOE's use of nearly $300
billion of additional loan authority for a broad range of energy
projects.
DOE--ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)
Proposed Rule Stage
47. Clean Energy Rule for New Federal Buildings and Major Renovations
[1904-AB96]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 6834(a)(3)(D)
CFR Citation: 10 CFR 433; 10 CFR 435.
Legal Deadline: Other, Statutory, Subject to the requirements in 42
U.S.C. 6834(a)(3)(D).
Abstract: This rulemaking implements provisions of the Energy
Independence and Security Act of 2007 that require the U.S. Department
of Energy (DOE) to establish revised-performance standards for the
construction of all new Federal buildings, including commercial, multi-
family high-rise residential and low-rise residential buildings. This
rulemaking will specifically address the reduction of fossil fuel-
generated energy consumption in new buildings and buildings undergoing
major renovations, as well as how agencies may petition DOE for a
downward adjustment of the requirements if they believe meeting
required energy reduction levels would be technically impracticable.
This effort was previously reported as the Fossil Fuel-Generated Energy
Consumption Reduction for New Federal Buildings and Major Renovations
of Federal Buildings rulemaking.
Statement of Need: The Energy Independence and Security Act of 2007
(EISA 2007) requires certain new
[[Page 11019]]
Federal buildings and Federal buildings undergoing major renovations to
meet fossil fuel-generated consumption reduction targets based on
fiscal year.
Summary of Legal Basis: Section 433(a) of EISA 2007 2007 (Pub. L.
110-140) amended section 305 of the Energy Conservation and Production
Act (ECPA) and directed the DOE to establish regulations that require
fossil fuel-generated energy consumption reductions for certain new
Federal buildings and Federal buildings undergoing major renovations.
(42 U.S.C. 6834(a)(3)(D)(i)) For these buildings, section 305 of ECPA,
as amended by EISA 2007, mandates that the buildings be designed so
that a building's fossil fuel-generated energy consumption is reduced
as compared with such energy consumption by a similar building in
fiscal year (FY) 2003 (as measured by Commercial Buildings Energy
Consumption Survey (CBECS) or Residential Energy Consumption Survey
(RECS) data from the DOE's Energy Information Administration (EIA)) by
55 percent beginning in FY2010, 65 percent beginning in FY2015, 80
percent beginning in FY2020, 90 percent beginning in FY2025, and 100
percent beginning in FY2030. (42 U.S.C. 6834(a)(3)(D)(i)(I)).
Alternatives: The statute requires DOE to establish regulations
implementing the specific fossil fuel-generated energy consumption
targets for certain new Federal buildings and Federal buildings
undergoing major renovations. The targets may be adjusted with respect
to a specific building upon petition from an agency, with agreement
from the DOE Secretary. In implementing these regulations, DOE
considers the technologies available to achieve the statutory targets
and those relevant for petitions submitted by agencies.
Anticipated Cost and Benefits: The cumulative net present value
(NPV) of the proposed Clean Energy Rule compliant buildings ranges from
-$16.0 Million (at a 7-percent discount rate) to -$85.3 Million (at a
3-percent discount rate).DOE also analyzed an additional case where the
future grid emission factors were assumed to follow a 95% reduction by
2035 (95 by 2035) profile as defined in the National Renewable Energy
Laboratory's (NREL) 2021 Standard Scenarios Report: A U.S. Electricity
Sector Outlook. This case represents a change in national electricity
generation which assumes national power sector CO\2\ emissions reach
95% below 2005 levels by 2035 and are eliminated on a net basis by
2050. The cumulative NPV of the proposed Clean Energy Rule compliant
buildings in the 95 by 2035 case ranges from $104.6 Million (at a 7-
percent discount rate) to $83.4 Million (at a 3-percent discount rate).
Risks: Optional field--no response.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/15/10 75 FR 63404
NPRM Comment Period End............. 12/14/10
Supplemental NPRM................... 10/14/14 79 FR 61693
Supplemental NPRM Comment Period End 12/15/14
Supplemental Notice of Proposed 12/00/22
Rulemaking (NPRM).
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal.
URL For More Information: www.energy.gov/eere/femp/notices-and-rules.
URL For Public Comments: www.regulations.gov.
Agency Contact: Ashley Armstrong, Director Regulatory Buildings,
EE-5B, Department of Energy, Energy Efficiency and Renewable Energy,
Building Technologies Office, 1000 Independence Avenue SW, Washington,
DC 20585, Phone: 202 586-6590, Email: [email protected].
RIN: 1904-AB96
DOE--EE
Final Rule Stage
48. Energy Conservation Standards for Residential Non-Weatherized Gas
Furnaces and Mobile Home Gas Furnaces [1904-AD20]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 6295(f)(4)(C); 42 U.S.C. 6295(m)(1); 42
U.S.C. 6295(gg)(3)
CFR Citation: 10 CFR 429; 10 CFR 430.
Legal Deadline: NPRM, Judicial, April 24, 2015, Final Rule,
Judicial, the later date of April 24, 2016, or one year after the
issuance of the proposed rule.
Abstract: The Energy Policy and Conservation Act, as amended,
(EPCA) prescribes energy conservation standards for various consumer
products and certain commercial and industrial equipment, including
residential furnaces. EPCA also requires the U.S. Department of Energy
(DOE) to determine whether more-stringent amended standards would be
technologically feasible and economically justified and would save a
significant amount of energy. DOE proposes amended and new energy
conservation standards for non-weatherized gas furnaces and mobile home
gas furnaces pursuant to a court-ordered remand of DOE's 2011
rulemaking for these products and other statutory requirements.
Statement of Need: EPCA requires minimum energy efficiency
standards for certain appliances and commercial equipment, including
residential furnaces.
Summary of Legal Basis: Title III of the Energy Policy and
Conservation Act of 1975 (EPCA), Public Law 94-163 (42 U.S.C. 6291-
6309, as codified), established the Energy Conservation Program for
Consumer Products Other Than Automobiles. Pursuant to EPCA, any new or
amended energy conservation standard that the U.S. Department of Energy
(DOE) prescribes for certain products, such as residential furnaces,
shall be designed to achieve the maximum improvement in energy
efficiency that is technologically feasible and economically justified
(42 U.S.C. 6295(o)(2)(A)) and result in a significant conservation of
energy (42 U.S.C. 6295(o)(3)(B)).
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 in the statute.
Anticipated Cost and Benefits: DOE finds that the benefits to the
Nation of the proposed energy standards for Residential Non-Weatherized
Gas Furnaces and Mobile Home Gas Furnaces (such as energy savings,
consumer average lifecycle cost savings, an increase in national net
present value, and emission reductions) outweigh the burdens (such as
loss of industry net present value). For non-weatherized gas furnaces
and mobile home gas furnaces, DOE estimates that energy savings for
active mode operation (in terms of annual fuel utilization efficiency
(AFUE)) will be 5.48 quads over 30 years and that the net benefit to
the Nation will be between $6.2 billion and $21.6 billion. DOE
estimates that energy savings for standby mode and off mode operation
will be 0.28 quads over 30 years and that the net benefit to the Nation
will be between $1.1 billion and $3.4 billion.
[[Page 11020]]
Risks: Optional field--no response.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Public Meeting............ 10/30/14 79 FR 64517
NPRM and Notice of Public Meeting... 03/12/15 80 FR 13120
NPRM Comment Period Extended........ 05/20/15 80 FR 28851
NPRM Comment Period Extended End.... 07/10/15
Notice of Data Availability (NODA).. 09/14/15 80 FR 55038
NODA Comment Period End............. 10/14/15
NODA Comment Period Reopened........ 10/23/15 80 FR 64370
NODA Comment Period Reopened End.... 11/06/15
Supplemental NPRM and Notice of 09/23/16 81 FR 65720
Public Meeting.
Supplemental NPRM Comment Period End 11/22/16
SNPRM Comment Period Reopened....... 12/05/16 81 FR 87493
SNPRM Comment Period End............ 01/06/17
Notice of NPRM Withdrawal........... 01/15/21 86 FR 3873
NPRM................................ 07/07/22 87 FR 40590
Notification of data availability 08/30/22 87 FR 52861
(NODA), public meeting, and
extension of the comment period.
NPRM Comment Period End............. 10/06/22
Final Action........................ 09/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL For More Information: www1.eere.energy.gov/buildings/appliance_standards/product.aspx/productid/72.
URL For Public Comments: www.regulations.gov/#!docketDetail;D=EERE-
2014-BT-STD-0031.
Agency Contact: Julia Hegarty, Department of Energy, 1000
Independence Avenue SW, Washington, DC 20585, Phone: 240 597-6737,
Email: [email protected].
RIN: 1904-AD20
DOE--DEPARTMENTAL AND OTHERS (ENDEP)
Final Rule Stage
49. Loan Guarantees for Clean Energy Projects [1901-AB59]
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 16511 et seq.
CFR Citation: 10 CFR 609.
Legal Deadline: None.
Abstract: The Inflation Reduction Act (IRA) has added new
categories of eligible projects to the U.S. Department of Energy (DOE)
Loan Programs Office's program authorized by Title XVII of the Energy
Policy Act of 2005, as amended (42 U.S.C. 16511 et seq.). This requires
immediate and material changes to DOE's existing regulations (10 CFR
part 609) implementing the Title XVII program for DOE to be able to
accept applications and issue loan guarantees for those categories of
projects. The loan authority and appropriations authorized under the
IRA are available through September 30, 2026, making the implementation
of the authority time-sensitive. The rule would also include changes to
the existing regulations based on experience gained implementing the
Title XVII loan guarantee program and to reflect amendments to Title
XVII enacted by the Energy Policy Act of 2020 and the Infrastructure
Investment and Jobs Act of 2021.
Statement of Need: The existing regulations governing Title XVII do
not contemplate certain categories of projects and terms applicable to
Title XVII, as amended by recent legislation. As such, DOE must revise
its regulations in order to effectuate the new categories of eligible
projects and terms.
Summary of Legal Basis: Title XVII of the Energy Policy Act of
2005, Public Law 109-58 (42 U.S.C. 16511 et seq.) established a program
for the Department of Energy to guarantee loans for innovative projects
that avoid, reduce, or sequester air pollutants or anthropogenic
emissions of greenhouse gases. Title XVII has since been amended,
including most recently under the Consolidated Appropriations Act of
2021 (Energy Act of 2020), Public Law 116-260, the Infrastructure
Investment and Jobs Act of 2021, Public Law 117-158 (IIJA), and the
Inflation Reduction Act of 2022, Public Law 117-169 (IRA).
Alternatives: This rulemaking seeks to codify recent legislative
changes to the Title XVII program and make changes to DOE's regulations
to improve implementation of the program. DOE recently solicited input
from stakeholders to understand how it could improve the Title XVII
program.
Anticipated Cost and Benefits: The Title XVII rule sets forth the
policies and procedures DOE uses for the application process, which
includes receiving, evaluating, and approving loan guarantees to
support eligible projects under Title XVII. While the rule itself will
not have a direct economic impact, it will enable DOE's use of nearly
$300 billion of additional loan authority provided under the IIJA and
IRA.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 02/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Rebecca Limmer, Chief Counsel, Department of
Energy, 1000 Independence Avenue SW, Washington, DC 20585, Phone: 202
586-1174, Email: [email protected].
RIN: 1901-AB59
BILLING CODE 6450-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Statement of Regulatory Priorities for Fiscal Year 2023
As the federal agency with principal responsibility for protecting
the health of all Americans and for providing essential human services,
the Department of Health and Human Services (HHS or the Department)
implements programs that strengthen the health care system; advance
scientific knowledge and innovation; and improve the health, safety,
and wellbeing of the American people.
The Department's Regulatory Plan for fiscal year (FY) 2023 is
focused on expanding access to health care, tackling disparities and
advancing equity, increasing the nation's public health preparedness,
and supporting the wellbeing of families and communities. To highlight
a few of these regulatory priorities:
This Plan expands access to health care and strengthens
behavioral health, with rules that expand evidence-based behavioral
health treatment via telehealth and streamline enrollment and improve
access to care for children and families through the Medicaid
[[Page 11021]]
program and the Children's Health Insurance Program (CHIP), among
others.
The Department is also taking action to advance equity in
health and social outcomes, including through rules designed to prevent
discrimination and protect every person's ability to equitably obtain
health care and human services, regardless of where they live, who they
are, or their background.
Forthcoming rules would also increase the nation's public
health preparedness, such as measures aimed at ensuring Americans are
able to access safe produce and imported foods, and rules that would
bolster the Department's ability to respond to the spread of COVID-19
and prevent future public health threats.
This Plan supports the wellbeing of families and
communities by including rules that would strengthen services for older
Americans to allow them to live in their communities, as well as ensure
that children and youth receive the care and support they need to
thrive.
In short, the Department's Regulatory Plan reflects the Biden-
Harris Administration's commitment to continue building a better,
healthier America, through rules designed to help protect the public
health and to improve the health and wellbeing of every person touched
by HHS programs.
I. Building and Expanding Access to Affordable Health Care
The Biden-Harris Administration is committed to ensuring that high-
quality health care is accessible and affordable for every American.
The Inflation Reduction Act of 2022 (IRA), signed by President Biden in
August, lowers costs for American families by continuing increased
premium tax credits for plans under the Affordable Care Act (ACA),
allowing the federal government to negotiate prices for certain drugs
under Medicare, and more. The Bipartisan Safer Communities Act of 2022,
signed by President Biden in June, expands capacity and advances access
to behavioral health treatment, particularly for children and youth.
Additionally, President Biden's Executive Order on Continuing to
Strengthen Americans' Access to Affordable, Quality Health Coverage
(E.O. 14070) calls on federal agencies--including the Department--to
continue to expand the availability of health care coverage, improve
its quality, strengthen benefits, and help more Americans enroll.
Charged with overseeing federal health programs such as Medicare,
Medicaid, CHIP, and the ACA Marketplace, the Department plays a central
role in the Administration's agenda to protect and strengthen access to
health care. From day one of this Administration, the Department has
worked closely with states to expand Medicaid to hundreds of thousands
of newly eligible people and to allow Medicaid enrollees who are
pregnant to keep their coverage for up to one year after pregnancy. The
Department has also maximized opportunities to enroll a record number
of people in ACA coverage and strengthened policies related to coverage
and benefits in the ACA Marketplace. These actions, alongside others,
have contributed to an all-time low uninsured rate among Americans.
Over the next year, the Department will build upon its previous
efforts by pursuing rules aimed at enhancing coverage and access to
benefits in the ACA Marketplaces and the Medicaid, CHIP, and Medicare
programs; expanding the accessibility and affordability of drugs and
medical products; addressing behavioral health needs; and streamlining
the secure exchange of health information.
a. Enhancing Coverage and Access in the ACA Marketplaces, Medicaid,
CHIP, and Medicare
The Department will take several regulatory actions in the next
year to improve access to care for Americans in the ACA Marketplace,
Medicaid, CHIP, and Medicare. For example, the Department expects to
finalize a rule on eligibility and enrollment processes in Medicaid and
CHIP that will streamline the application, eligibility determination,
enrollment, and renewal processes for these programs and create new
pathways to maximize enrollment and retention of eligible individuals.
Additional rules would promote access to care in Medicaid and CHIP
and raise standards for hospitals, providers, and other entities
participating in Medicare and Medicaid. For example, the Department
plans to issue a proposed rule that would establish cultural competency
and person-centered care requirements for all provider and supplier
types that participate in the Medicare and Medicaid programs.
The HHS Regulatory Plan also includes regulations aimed at
improving access to care for consumers in the ACA Marketplaces. For
instance, the Department plans to propose a rule on provider
nondiscrimination requirements for certain health plans and issuers.
This rule would protect patients' access to care and promote
competition by ensuring that plans do not engage in unlawful
discrimination against health care providers. The Department will also
work to ensure access to benefits and services afforded under the law.
A critical part of this work will include amending regulations on
contraceptive coverage which guarantee cost-free coverage to the
consumer under the ACA. Finally, the Department will propose to amend
regulations on short-term limited duration plans to better ensure
access to comprehensive coverage for Americans, especially those with
pre-existing conditions.
In addition to the above, the Centers for Medicare & Medicaid
Services (CMS) will issue several annual payment rules and notices over
the next year that affect federal health programs, including Medicare
and the ACA Marketplace. These rules, though they are not included in
the HHS Regulatory Plan, will include policies that further the
Secretary's priority of expanding access to affordable, high-quality
health care.
b. Expanding the Accessibility and Affordability of Drugs and Medical
Products
Over the next year, the Department will continue expanding the
accessibility and affordability of drugs and other medical products for
Americans. For example, the Department expects to issue a final rule to
set requirements for nonprescription drug products with an additional
condition to ensure appropriate self-selection or appropriate actual
use (or both) for consumers. This rule is expected to increase consumer
access to nonprescription drugs, which could mean a reduction in under-
treatment of certain diseases and conditions. The Department also plans
to propose updates to the Food and Drug Administration (FDA) biologics
regulations to support competition and enhance consumer choice through
changes that would prevent efforts to delay or block competition from
biosimilars and interchangeable products.
The Department is also working to implement the IRA through
policies aimed at reducing the high cost of prescription drugs for
people with Medicare. Furthermore, the Department is committed to
making sure Medicare beneficiaries are able to access emerging
technologies and will initiate notice and comment rulemaking in the
coming months to explore policy options that would create an
accelerated approval pathway. This pathway would build on prior
initiatives, including coverage with evidence development.
In addition, in November 2022, the Department issued a proposed
rule on the Administrative Dispute Resolution
[[Page 11022]]
(ADR) process used to settle certain disputes among covered entities
and manufacturers arising under the 340B Drug Pricing Program. This
rule would establish new requirements and procedures for the Program's
ADR process, making the process more equitable and accessible for
participation by program participants, and supporting the Program's
mission to expand access to health care for underserved communities.
c. Addressing Behavioral Health Needs
The Secretary remains committed to expanding access to integrated
and equitable behavioral health services, including by addressing the
impacts of the COVID-19 pandemic on mental health and substance use,
which have disproportionately affected young people and underserved
communities. This commitment will guide the Department's planned
regulatory activity for FY 2023, which includes several rules aimed at
tackling mental health challenges and substance use disorders.
For example, the HHS Regulatory Plan includes a proposed rule that
is intended to make permanent certain telehealth flexibilities for
substance use disorder treatments that were granted during the COVID-19
public health emergency. This rule would allow certain providers to
provide buprenorphine via telehealth, as well as provide extended take-
home doses of methadone to patients, when it is safe and appropriate to
do so. Both changes are intended to increase access to comprehensive
opioid use disorder treatment and may address barriers to treatment
such as transportation, geographic proximity, employment, or other
required activities of daily living.
Working closely with the Departments of Labor and the Treasury, the
Department will also issue a proposed rule to implement portions of the
Mental Health Parity and Addiction Equity Act (MHPAEA) and the
Consolidated Appropriations Act, 2021. The MHPAEA is a federal law that
prevents group health plans and health insurance issuers that provide
mental health or substance use disorder benefits from imposing less
favorable benefit limitations on those benefits than on medical and
surgical benefits. This rule would clarify group health plans and
health insurance issuers' obligations under the MHPAEA and promote
compliance with MHPAEA, among other improvements.
In November 2022, the Department also announced a proposed rule on
the confidentiality of substance use disorder patient records.
Consistent with the CARES Act, this rule would align HHS regulations
governing the disclosure and use of substance use disorder patient
records (42 CFR part 2) with aspects of the HIPAA Privacy, Breach
Notification, and Enforcement Rules; strengthen protections against
uses and disclosures of patients' substance use disorder records for
civil, criminal, administrative, and legislative proceedings; and
require that a HIPAA Notice of Privacy Practices address privacy
practices with respect to Part 2 records.
d. Streamlining the Secure Exchange of Health Information
The secure exchange of health information and interoperability
among health care providers and other entities improves patient care,
promotes competition, reduces costs, and provides more accurate public
health data.
To help ensure greater interoperability and transparency, the HHS
Regulatory Plan includes rules focused on addressing and preventing
information blocking, consistent with the 21st Century Cures Act (Cures
Act). For instance, the Department plans to finalize a rule that would,
among other things, empower the HHS Office of the Inspector General
(OIG) to investigate claims of information blocking and impose civil
monetary penalties on health IT developers and health information
networks where appropriate. Another complementary proposed rule would
implement the Secretary's authority under the Cures Act to establish
appropriate disincentives for health care providers found to have
committed information blocking. The Department is also proposing a rule
on the Electronic Health Record (EHR) Reporting Program condition and
maintenance of certification requirements under the Office of the
National Coordinator for Health Information Technology (ONC) Health IT
Certification Program, which would include enhancements to support
information sharing under the information blocking regulations.
The Department is also advancing interoperability policies in the
context of the federal health programs it administers and oversees. For
example, the Department will propose rules to improve the electronic
exchange of health care data and streamline processes related to prior
authorization for Medicare Advantage (MA) organizations, Medicaid
managed care plans, CHIP managed care entities, state Medicaid and CHIP
fee-for-service (FFS) programs, and Qualified Health Plan (QHP) issuers
on the Federally Facilitated Exchange (FFE). Similarly, the
Department's upcoming proposed rule on strengthening and improving the
Medicare Advantage and prescription drug programs will include
provisions proposing to enhance interoperability within Medicare.
II. Tackling Disparities and Advancing Equity
Equity is the focus of over a dozen Executive Orders issued by
President Biden, and it remains a cornerstone of the Biden-Harris
Administration's agenda. The Department recognizes that people of
color, people with disabilities, lesbian, gay, bisexual, transgender,
queer, and intersex (LGBTQI+) people, and other underserved groups in
the U.S. have been systematically denied a full and fair opportunity to
participate in economic, social, and civic life. Among its other
manifestations, this history of inequality shows up as persistent
disparities in health and social outcomes and in access to care.
As the federal agency responsible for ensuring the health and
wellbeing of Americans, the Department, under Secretary Becerra's
leadership, is committed to tackling these entrenched inequities and
their root causes throughout its programs and policies. The
Department's regulatory priority of tackling disparities and advancing
equity includes rules aimed at preventing and remedying discrimination;
strengthening health and safety standards for consumer products that
impact underserved communities; and promoting equity in federally
supported health care services.
In addition to the specific rulemakings identified in this section,
HHS is committed to advancing equity in all aspects of the Department's
work. Consistent with President Biden's Executive Order on Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government (E.O. 13985), the Department's efforts in this area
include an ongoing assessment of whether underserved communities face
barriers in accessing benefits and opportunities in HHS programs and
whether policy changes are necessary to advance equity. This process
continues to inform the Department's broader regulatory agenda.
a. Preventing and Remedying Discrimination
The HHS Regulatory Plan includes actions to eliminate
discrimination as a barrier for historically marginalized communities
seeking access to HHS programs and activities. For instance, the
Department plans to finalize its rule
[[Page 11023]]
on nondiscrimination in health programs and activities, which would
amend the existing regulations implementing section 1557 of the ACA,
ensuring that the regulations reflect the proper scope of the statute's
protections. Because discrimination in the U.S. health care system is a
driver of health disparities, the Section 1557 regulations present a
key opportunity for the Department to promote equity and ensure
protection of health care as a right.
Additionally, the Department will issue a proposed rule addressing
discrimination on the basis of disability in health and human services
programs or activities. This rule would revise regulations under
section 504 of the Rehabilitation Act of 1973 to address unlawful
discrimination on the basis of disability in HHS-funded health and
human services programs. Topics that HHS may cover include
nondiscrimination in medical treatment, child welfare programs and
services, value assessment methodologies, accessible medical equipment,
information and communication technology, and other relevant health and
human services activities.
b. Strengthening Health and Safety Standards for Consumer Products That
Impact Underserved Communities
To protect the public health and advance equity, the Department
continues to pursue regulatory action with respect to consumer products
that harm the health of underserved groups.
Over the next year, the Department plans to finalize two rules that
prohibit menthol as a characterizing flavor in cigarettes and prohibit
all characterizing flavors (other than tobacco) in cigars. These and
other potential future regulatory actions have the potential to
significantly reduce disease and death from combusted tobacco product
use, the leading cause of preventable death in the United States.
The regulations are also expected to promote better health outcomes
across population groups. Evidence shows that tobacco is
disproportionately marketed to underserved communities and vulnerable
populations--such as disproportionate storefront and outdoor marketing,
as well as point-of-sale marketing, in Black, Hispanic, and low-income
communities. The disparities in tobacco marketing and use shape
disparities in tobacco-related disease and death. These planned
regulatory actions by the Department on tobacco are expected not only
to benefit the population as a whole, but, in doing so, also
substantially decrease tobacco-related health disparities.
c. Promoting Equity in Federally Supported Health Care Services
The Department continues to seek out opportunities to embed equity
throughout HHS programs and policies, including in federally supported
health care services. The World Trade Center (WTC) Health Program is a
limited federal health program that provides no-cost medical monitoring
and treatment for certified WTC-related health conditions to those
directly affected by the 9/11 attacks. The Department plans to issue a
proposed rule to add uterine cancer to the List of WTC-Related Health
Conditions.Permitting the Program to pay for medically necessary
treatment, this rule would advance health equity for those WTC Health
Program members who are found to have WTC-related uterine cancer.
III. Increasing Public Health Preparedness
Protecting the nation's public health is a primary responsibility
of the Department. This responsibility includes ensuring that the right
protections and infrastructure are in place to help the nation to
respond to public health threats and outbreaks quickly and effectively,
including COVID-19. It also includes ensuring healthy and safe food for
every American through protections against foodborne illness in the
food supply chain.
In service of this regulatory priority, over the next year, the
Department is pursuing rules that would bolster the nation's resilience
to handle COVID-19 and future public health threats and improve
Americans' access to safe and nutritious food.
a. Bolstering the Nation's Resilience To Handle COVID-19 and Future
Public Health Threats
The Department continues to play a central role in the Biden-Harris
Administration's whole-of-government response to the COVID-19 pandemic.
From ensuring access to COVID-19 testing, treatment, and vaccines, to
bolstering the capacity of the health care system in a public health
emergency, Secretary Becerra has leveraged the Department's full
resources to pursue a comprehensive strategy to combat COVID-19.
In the context of COVID-19 and other disease outbreaks, it is
crucial for public health authorities to be able to identify and
evaluate persons who may have been exposed to a communicable disease.
Currently, on an interim basis, the Centers for Disease Control and
Prevention (CDC) is authorized to require airlines to collect certain
data regarding passengers and crew arriving from foreign countries for
the purposes of health education, treatment, prophylaxis, or other
appropriate public health interventions, including contact tracing and
travel restrictions. The Department intends to finalize this regulation
in FY 2023. This would allow the Department to continue to receive data
in a timely manner and more effectively provide critical public health
services in response to COVID-19 and other communicable diseases that
may put Americans' health at risk.
In addition to strengthening the public health system, the
Department is continuing to address the need for flexibility in HHS
programs to minimize disruptions and alleviate burdens that may be
caused by COVID-19 or future emergencies. To that end, the Department
also plans to finalize its rule allowing current grantees under the
Administration for Native Americans (ANA) to request an emergency
waiver for the non-federal share match. This update to ANA's regulation
would provide a new provision for recipients to request an emergency
waiver in the event of a natural or man-made emergency such as a public
health pandemic.
b. Improving Access to Safe and Nutritious Food
To help ensure healthy and safe food for every American, the HHS
Regulatory Plan includes rules that improve the Department's ability to
identify foodborne illnesses, prevent them from reoccurring, and remove
unsafe products from the market. It also supports the goals of the
White House Conference on Hunger, Nutrition, and Health, by advancing
work to improve consumers' ability to access nutritious food to prevent
disease and protect public health.
For example, the Department will finalize a rule intended to
improve the safety of produce by requiring farms to conduct
comprehensive assessments of pre-harvest agricultural water that would
help farms identify and mitigate hazards in water used to grow produce.
Moreover, the Department is proposing a rule that would require
importers of certain foods to certify, or otherwise provide appropriate
assurances, that these imported foods comply with U.S. safety
requirements. This rule would help prevent potentially harmful imported
foods from reaching consumers and thereby improve the safety of the
U.S. food supply. In November 2022, the Department finalized its rule
establishing additional recordkeeping requirements for persons
[[Page 11024]]
who manufacture, process, pack, or hold foods identified on the Food
Traceability List (FTL). This rule is intended to make it easier to
rapidly and effectively track the movement of a food to prevent or
mitigate a foodborne illness outbreak.
In addition, the Department seeks to improve dietary patterns in
the United States to help reduce the burden of diet-related chronic
diseases. One way HHS is working towards creating a healthier food
supply is by proposing a rule that would permit use of salt
substitutes, rather than salt, to help reduce the amount of sodium in
standardized foods.
IV. Supporting the Wellbeing of Families and Communities
The Department strives to support the wellbeing of Americans by
funding and providing access to a range of critical social services.
Millions of people benefit from HHS programs that help older adults and
people with disabilities participate fully in their communities,
promote opportunity and economic security for families, help refugees
and other eligible newcomers integrate and thrive, and provide care for
unaccompanied children. The Secretary recognizes that these programs
and forms of assistance are more important than ever due to the COVID-
19 pandemic and its economic consequences, which have had an outsized
impact on people of color and other underserved communities.
To sustain and strengthen these essential benefits and services,
the Department is prioritizing regulations that would improve their
quality and accessibility while reducing burdens and increasing the
efficiency of service delivery. The Secretary's regulatory priority in
this area includes rules aimed at strengthening high-quality services
for older adults, expanding opportunities for children and youth to
thrive, and providing pathways to economic success.
a. Strengthening High-Quality Services for Older Adults
The HHS Regulatory Plan includes rules aimed at enhancing the
ability of Administration for Community Living (ACL) programs to
protect the rights and wellbeing of older adults. For instance, the
Department plans to propose regulations for Adult Protective Services
(APS) programs that will strengthen services for older adults and
adults with disabilities that experience adult maltreatment.
Additionally, the Department will propose changes to its Older
Americans Act (OAA) regulations to support long-term care services,
nutrition, caregiver supports, and more, for older adults. In both
rulemakings, the Department plans to incorporate applicable elements
E.O. 13985 and ensure access to services for individuals with the
greatest social and economic need.
Furthermore, consistent with the Biden-Harris Administration's
Nursing Home Reform Action Plan, the Department's Regulatory Plan
includes efforts to improve the safety and quality of care in the
nation's nursing homes. For example, in the next year, the Department
plans to issue proposed rules that are intended to institute minimum
staffing standards in nursing homes, protect residents, and prevent
fraud, waste, and abuse.
b. Expanding Opportunities for Children and Youth To Thrive
The Department's mission to provide effective human services
includes a focus on protecting the wellbeing of children and youth.
This focus has special significance given the COVID-19 pandemic and its
economic consequences, which have deeply affected the lives of children
and youth--particularly Black, Latino, Indigenous, Native American, and
other underserved youth with disproportionate involvement in the child
welfare system. Several rules planned for FY 2023 are aimed at
enhancing programs and protections for youth and families experiencing
foster care, unaccompanied children in the Department's care, and
individuals entitled to child support.
As part of its focus on the foster care and the child welfare
system, the Department will propose changes to the Adoption and Foster
Care Analysis and Reporting System (AFCARS) regulations that would help
the Department to administer foster care and adoption assistance
programs more effectively and better serve children and families. This
rule would require title IV-E agencies to collect and report for AFCARS
additional information related to the Indian Child Welfare Act of 1978
and the sexual orientation of youth in the reporting population and
their foster parents, adoptive parents, and legal guardians. The
Department will also propose a rule allowing licensing standards for
relative or kinship foster family homes that are different from non-
relative or non-kinship homes. The proposed change would address
barriers to licensing relatives and kin who can provide continuity and
a safe and loving home for children when they cannot be with their
parents. Additionally, the Department will issue a proposed rule to
facilitate the provision of independent legal representation to a child
who is a candidate for foster care, or in foster care, and to a parent
preparing for participation in foster care legal proceedings. Improving
access to independent legal representation may help prevent the removal
of a child from the home or, for a child in foster care, achieve
permanence faster.
Moreover, the Department's commitment to children and youth
includes rules intended to ensure the highest level of services and
care for unaccompanied children in the Department's custody. For
instance, the Department will propose a new rule to strengthen and
codify protections and service provisions for children cared for by the
Office of Refugee Resettlement's (ORR's) Unaccompanied Children
Program. Furthermore, the Department will issue a proposed rule that
would provide new regulations governing the federal licensing of ORR
facilities, which may be used in certain situations when state
governments do not provide state licensing for such facilities.
Finally, the Department is taking action to protect the
sustainability of tribal child support programs. The Department's
forthcoming proposed rule on tribal child support programs would modify
the non-federal share of the program expenditures requirement,
including 90/10 and 80/20 cost sharing rates.
c. Providing Pathways to Economic Success
In administering the Temporary Assistance for Needy Families (TANF)
program, the Department works with states, territories, and tribes to
help children and families achieve economic success. The COVID-19
pandemic highlighted the importance of using federal investments and
existing program flexibilities strategically to reduce family poverty
and alleviate economic crises, especially for families of color and
underserved communities. In the next year, the Department plans to
issue a proposed rule to reform the TANF program to strengthen the
safety net and work preparation program for families and individuals
with the lowest income, change allowable uses of TANF funds to refocus
on the intended purposes of TANF, improve work program effectiveness,
and reduce administration burden. These changes are intended to improve
the overall wellbeing of families while addressing inequities in
program services and policies.
[[Page 11025]]
HHS--OFFICE OF THE INSPECTOR GENERAL (OIG)
Final Rule Stage
50. Amendments to Civil Monetary Penalty Law Regarding Grants,
Contracts, and Information Blocking [0936-AA09]
Priority: Other Significant.
Legal Authority: 21st Century Cures Act; Pub. L. 114-255; secs.
4004 and 5003; Bipartisan Budget Act of 2018 (BBA 2018), Pub. L. 115-
123. sec. 50412
CFR Citation: 42 CFR 1003; 42 CFR 1005.
Legal Deadline: None.
Abstract: The final regulation modifies 42 CFR 1003 and 1005 by
addressing three issues. First, the 21st Century Cures Act (Cures Act)
provision that authorizes the Department of Health and Human Services
(HHS) to impose civil monetary penalties, assessments, and exclusions
upon individuals and entities that engage in fraud and other misconduct
related to HHS grants, contracts, and other agreements. Second, the
Cures Act information blocking provisions that authorize the Office of
Inspector General to investigate claims of information blocking and
provide HHS the authority to impose CMPs for information blocking.
Third, the Bipartisan Budget Act of 2018 increases in penalty amounts
in the Civil Monetary Penalties Law.
Statement of Need: The 21st Century Cures Act (Cures Act) set forth
new authorities which need to be added to HHS's existing civil monetary
penalty authorities. This final rule seeks to add the new authorities
to the existing civil monetary penalty regulations and to set forth the
procedural and appeal rights for individuals and entities. The
Bipartisan Budget Act of 2018 (BBA) amended the Civil Monetary
Penalties Law (CMPL) to increase the amounts of certain civil monetary
penalties which requires amending the existing regulations for
conformity. The final rule seeks to ensure alignment between the
increased civil monetary penalties in the statute and the civil
monetary penalties set forth in the OIG's rules.
Summary of Legal Basis:
The legal authority for this regulatory action is found in: (1)
section 1128A(a)-(b) of the Social Security Act, the Civil Monetary
Penalties Law (42 U.S.C. 1320a-7a), which provides for civil monetary
penalty amounts; (2) section 1128A(o)-(s) of the Social Security Act,
which provides for civil monetary penalties for fraud and other
misconduct related to grants, contracts, and other agreements; and (3)
section 3022(b) of the Public Health Service Act (42 U.S.C. 300jj-52),
which provides for investigation and enforcement of information
blocking.
Alternatives: The regulations incorporate the statutory changes to
HHS's authority found in the Cures Act and the BBA. The alternative
would be to rely solely on the statutory authority and not align the
regulations accordingly. However, we concluded that the public benefit
of providing clarity by placing the new civil monetary penalties and
updated civil monetary penalty amounts within the existing regulatory
framework outweighed any burdens of additional regulations promulgated.
Anticipated Cost and Benefits: We believe that there are no
significant costs associated with these proposed revisions that would
impose any mandates on State, local, or Tribal governments or the
private sector. The regulation will provide a disincentive for
bottlenecks to the flow of health data that exist, in part, because
parties are reticent to share data across the healthcare system or
prefer not to do so. The final rule will help foster interoperability,
thus improving care coordination, access to quality healthcare, and
patients' access to their healthcare data.
Risks: To be determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/24/20 85 FR 22979
NPRM Comment Period End............. 06/23/20
Final Action........................ 03/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Chris Hinkle, Senior Advisor, Department of Health
and Human Services, Office of the Inspector General, 330 Independence
Avenue SW, Washington, DC 20201, Phone: 202 891-6062, Email:
[email protected].
RIN: 0936-AA09
HHS--OFFICE FOR CIVIL RIGHTS (OCR)
Proposed Rule Stage
51. Rulemaking on Discrimination on the Basis of Disability in Health
and Human Services Programs or Activities [0945-AA15]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: sec. 504 of the Rehabilitation Act of 1973; 29
U.S.C. 794
CFR Citation: 45 CFR 84.
Legal Deadline: None.
Abstract: This proposed rule would revise regulations under section
504 of the Rehabilitation Act of 1973 to address unlawful
discrimination on the basis of disability in vital HHS-funded health
and human services programs. Covered topics may include
nondiscrimination in medical treatment, child welfare programs and
activities, value assessment methods, accessible medical equipment,
information and communication technology, and other relevant health and
human services activities.
Statement of Need: To robustly enforce the prohibition of
discrimination on the basis of disability, OCR will update the section
504 of the Rehabilitation Act regulations to clarify obligations and
address issues that have emerged in our enforcement experience
(including complaints OCR has received), case law, and statutory
changes under the Americans with Disabilities Act and other relevant
laws, in the forty-plus years since the regulation was promulgated. OCR
has heard from complainants and many other stakeholders, as well as
Federal partners, including the National Council on Disability, on the
need for updated regulations in a number of important areas.
Summary of Legal Basis: The current regulations have not been
updated to be consistent with the Americans with Disabilities Act, the
Americans with Disabilities Amendments Act, or the 1992 Amendments to
the Rehabilitation Act, all of which made changes that should be
reflected in the HHS section 504 regulations. Under Executive Order
12250, the Department of Justice has provided a template for HHS to
update this regulation.
Alternatives: OCR considered issuing guidance, and/or investigating
individual complaints and compliance reviews. However, we concluded
that not taking regulatory action could result in continued
discrimination, inequitable treatment and even untimely deaths of
people with disabilities. OCR continues to receive complaints alleging
serious acts of disability discrimination each year. While we continue
to engage in enforcement, we believe that our enforcement and
recipients' overall compliance with the law will be better supported by
the presence of a clearly articulated regulatory framework than
continuing the status quo. Continuing to conduct case-by-case
investigations without a broader framework risks lack
[[Page 11026]]
of clarity on the part of providers and violations of section 504 that
could have been avoided and may go unaddressed. By issuing a proposed
rule, we are undertaking the most efficient and effective means of
promoting compliance with section 504.
Anticipated Cost and Benefits: The Department anticipates that this
rulemaking will result in significant benefits, namely by providing
clear guidance to the covered entity community regarding requirements
to administer their health programs and activities in a non-
discriminatory manner. In turn, the Department anticipates cost savings
as individuals with disabilities can access a range of health care
services. The Department expects that the rule, when finalized, will
generate some changes in action and behavior that may generate some
costs. The rule will address a wide range of issues, with varying
impacts and a comprehensive analysis is underway.
Risks: To be determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Molly Burgdorf, Section Chief, Civil Rights
Division, Department of Health and Human Services, Office for Civil
Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800
368-1019, TDD Phone: 800 537-7697, Email: [email protected].
RIN: 0945-AA15
HHS--OCR
Final Rule Stage
52. Nondiscrimination in Health Programs And Activities [0945-AA17]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: sec. 1557 of the Patient Protection and Affordable
Care Act (42 U.S.C. 18116); 42 U.S.C. 1302; 42 U.S.C. 1395; 42 U.S.C.
1395eee(f); 42 U.S.C. 1396u-4(f); 42 U.S.C. 2000d-1; 20 U.S.C. 1405; 29
U.S.C. 794; 42 U.S.C. 290dd-2; 21 U.S.C. 1174; 42 U.S.C. 300gg to
300gg-63; 42 U.S.C. 300gg-91; 42 U.S.C. 300gg-92; 42 U.S.C. 300gg-111
to 300gg-139 as amended, sec. 3203; Pub. L. 116-136, 134 Stat. 281; 42
U.S.C. 18021 to 18024; 42 U.S.C. 18031 to 18033; 42 U.S.C. 18041 to
18042; 42 U.S.C. 18044; 42 U.S.C. 18051; 42 U.S.C. 18054; 42 U.S.C.
18061; 42 U.S.C. 18063; 42 U.S.C. 18071; 42 U.S.C. 18081 to 18083; 26
U.S.C. 36B
CFR Citation: 42 CFR 438; 42 CFR 440; 42 CFR 457; 42 CFR 460; 45
CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 91; 45 CFR 92; 45 CFR 147; 45 CFR
155; 45 CFR 156; . . .
Legal Deadline: None.
Abstract: This rule will address changes to the 2020 Final Rule
implementing section 1557 of the Patient Protection and Affordable Care
Act (PPACA). Section 1557 of PPACA prohibits discrimination on the
basis of race, color, national origin, sex, age, or disability under
any health program or activity, any part of which is receiving Federal
financial assistance, including credits, subsidies, or contracts of
insurance, or under any program or activity that is administered by an
Executive Agency, or any entity established under title l of the PPACA.
Statement of Need: The Biden-Harris Administration has made
advancing health equity and nondiscrimination in health care a
cornerstone of its policy agenda. The current section 1557 implementing
regulation significantly curtails the scope of application of section
1557 protections and creates uncertainty and ambiguity as to what
constitutes prohibited discrimination in covered health programs and
activities. Issuance of a revised section 1557 implementing regulation
is important because it would provide clear and concise regulations
that are consistent with the statutory text and protect historically
marginalized communities as they seek access to health programs and
activities.
Summary of Legal Basis: The Secretary of the Department is
statutorily authorized to promulgate regulations to implement section
1557. 42 U.S.C. 18116(c). The current section 1557 Final Rule is
pending litigation.
Alternatives: The Department has considered the alternative of
maintaining the section 1557 implementing regulation in its current
form; however, the Department believes it is appropriate to undertake
rulemaking given the Administration's commitment to advancing equity
and access to health care and in light of the issues raised in
litigation challenges to the current rule.
Anticipated Cost and Benefits: In enacting section 1557 of the ACA,
Congress recognized the benefits of equal access to health services and
health insurance that all individuals should have, regardless of their
race, color, national origin, sex, age, or disability. The Department
anticipates that this rulemaking will result in significant benefits
that are difficult to quantify, namely by providing clear guidance to
the covered entity community regarding requirements to administer their
health programs and activities in a non-discriminatory manner. In turn,
the Department anticipates cost savings as individuals are able to
access a range of health care services that will result in decreased
health disparities among historically marginalized groups and increased
health benefits. The Department estimates annualized costs over a 5-
year time horizon of about $551 million or $560 million; however, it is
important to recognize that this rule applies pre-existing
nondiscrimination requirements in Federal civil rights laws to various
entities, the great majority of which have been covered by these
requirements for years.
Risks: To be determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/04/22 87 FR 47751
NPRM Comment Period End............. 10/03/22 .......................
Final Action........................ 03/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State.
URL For More Information: https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html.
URL For Public Comments: https://www.regulations.gov/document/HHS-OS-2022-0012-0001.
Agency Contact: Dylan Nicole De Kervor, Senior Advisor to the
Director, Department of Health and Human Services, Office for Civil
Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202
240-3110, Email: [email protected]">1557[email protected].
Related RIN: Related to 0945-AA02, Related to 0945-AA11
RIN: 0945-AA17
[[Page 11027]]
HHS--OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION
TECHNOLOGY (ONC)
Proposed Rule Stage
53. ONC Health IT Certification Program Updates, Health Information
Network Attestation Process for the Trusted Exchange Framework and
Common Agreement, and Enhancements To Support Information Sharing
[0955-AA03]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 42 U.S.C.
300jj-19a; 42 U.S.C. 300jj-52; 5 U.S.C. 552; Pub. L.114-255; Pub. L.
116-260
CFR Citation: 45 CFR 170; 45 CFR 171; 45 CFR 172.
Legal Deadline: Final, Statutory, December 13, 2017, Conditions of
certification and maintenance of certification. Final, Statutory, July
24, 2019, Publish a list of the health information networks that have
adopted the common agreement and are capable of trusted exchange
pursuant to the common agreement.
Abstract: The rulemaking implements certain provisions of the 21st
Century Cures Act, including: the Electronic Health Record Reporting
Program condition and maintenance of certification requirements under
the ONC Health IT Certification Program; a process for health
information networks that voluntarily adopt the Trusted Exchange
Framework and Common Agreement to attest to such adoption of the
framework and agreement; and enhancements to support information
sharing under the information blocking regulations. The rulemaking
would also include proposals for new standards and certification
criteria under the Certification Program related to the United States
Core Data for Interoperability, real-time benefit tools, electronic
prior authorization, and potentially other revisions to the
Certification Program.
Statement of Need: The rulemaking would implement certain
provisions of the 21st Century Cures Act, including: the Electronic
Health Record (EHR) Reporting Program condition and maintenance of
certification requirements under the (Certification Program); a process
for health information networks that voluntarily adopt the Trusted
Exchange Framework and Common Agreement to attest to such adoption of
the framework and agreement; and enhancements to support information
sharing under the information blocking regulations. The rulemaking
would also include proposals for new standards and certification
criteria under the Certification Program related to the United States
Core Data for Interoperability, real-time benefit tools, and electronic
prior authorization. These proposals would fulfill statutory
requirements, provide transparency, advance interoperability, and
support the access, exchange, and use of electronic health information.
Transparency regarding health care information and activities as well
as the interoperability and electronic exchange of health information
are central to the efforts of the Department of Health and Human
Services to enhance and protect the health and well-being of all
Americans.
Summary of Legal Basis: The provisions would be implemented under
the authority of the Public Health Service Act, as amended by the
HITECH Act and the 21st Century Cures Act.
Alternatives: ONC will consider different options and measures to
improve transparency, and the interoperability and access to electronic
health information so that the benefits to providers, patients, and
payers are maximized and the economic burden to health IT developers,
providers, and other stakeholders is minimized.
Anticipated Cost and Benefits: The majority of costs for this
proposed rule would be incurred by health IT developers in terms of
meeting new requirements and continual compliance with the EHR
Reporting Program condition and maintenance of certification
requirements. We also expect that implementation of new standards and
information sharing requirements may also account for some costs. We
expect that through implementation and compliance with the regulations,
the market (particularly patients, payers, and providers) will benefit
greatly from increased transparency, interoperability, and streamlined,
lower cost access to electronic heath information.
Risks: At this time, ONC has not been able to identify any
substantial risks that would undermine likely proposals in the proposed
rule. ONC will continue to consider and deliberate regarding any
identified potential risks and will be sure to identify them for
stakeholders and seek comment from stakeholders during the comment
period for the proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Agency Contact: Michael Lipinski, Director, Regulatory & Policy
Affairs Division, Department of Health and Human Services, Office of
the National Coordinator for Health Information Technology, Mary E.
Switzer Building, 330 C Street SW, Washington, DC 20201, Phone: 202
690-7151, Email: [email protected].
RIN: 0955-AA03
HHS--ONC
54. Establishment of Disincentives for Health Care Providers
Who Have Committed Information Blocking [0955-AA05]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj-52; 42 U.S.C. 1315a; 42 U.S.C.
1395jjj; 42 U.S.C. 1395ww; 42 U.S.C. 1395f; 42 U.S.C. 1395w-4; 42
U.S.C. 1395yy; 42 U.S.C. 1395rr; 42 U.S.C. 1395f; 42 U.S.C. 1395l; 42
U.S.C. 195fff
CFR Citation: 45 CFR 171; 42 CFR 495; 42 CFR 413; 42 CFR 41.
Legal Deadline: None.
Abstract: The rulemaking implements certain provisions of the 21st
Century Cures Act to establish appropriate disincentives for health
care providers determined by the Inspector General to have committed
information blocking. Consistent with the 21st Century Cures Act, the
rulemaking establishes a first set of disincentives using HHS
authorities under applicable Federal law, including authorities
delegated to the Centers for Medicare & Medicaid Services, and includes
related policies necessary to implement these provisions.
Statement of Need: The rulemaking would implement a provision of
the 21st Century Cures Act which requires OIG to refer health care
providers that OIG determines to have committed information blocking to
the appropriate agency to be subject to appropriate disincentives using
authorities under applicable Federal law, as the Secretary sets forth
through notice and comment rulemaking. Release of the proposed rule is
needed to implement this critical component of the Cures Act and ensure
effective enforcement of information blocking rules.
Summary of Legal Basis: The provisions would be implemented under
the authority of the Public Health
[[Page 11028]]
Service Act, as amended by the 21st Century Cures Act.
Alternatives: ONC will consider different available authorities
under which appropriate disincentives could be established to minimize
regulatory burden for health care providers.
Anticipated Cost and Benefits: The costs of this proposed rule
would be minimal. Investigated parties may incur some costs in response
to an OIG investigation or enforcement action by an HHS agency, however
this would depend on the frequency of prohibited conduct. The expected
benefits of the regulation are deterring information blocking conduct
that interferes with effective health information exchange and
negatively impacts many important aspects of health care, including
patient access, duplicative testing and costs, and the availability and
quality of care.
Risks: We anticipate that health care providers will express
concern with the potential complexity of the approach (i.e., the
application of a range of disincentives based on available authorities)
as compared to a range of civil monetary penalties or fines. ONC will
continue to consider additional potential risks, identify them for
stakeholders, and seek comment from stakeholders during the comment
period for the proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Alex Baker, Federal Policy Branch Chief, Department
of Health and Human Services, Office of the National Coordinator for
Health Information Technology, 330 C Street SW, 7th Fl., Washington, DC
20201, Phone: 202 260-2048, Email: [email protected].
RIN: 0955-AA05
HHS--ONC
55. Patient Engagement, Information Sharing, and Public Health
Interoperability [0955-AA06]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 42 U.S.C.
300jj-19a; 42 U.S.C. 300jj-52; 5 U.S.C. 552; Pub. L., 114-255
CFR Citation: 45 CFR 170; 45 CFR 171.
Legal Deadline: None.
Abstract: The rulemaking builds on policies adopted in the 21st
Century Cures Act: Interoperability, Information Blocking, and the ONC
Health IT Certification final rule (85 FR 25642) and included in the
Health Information Technology: ONC Health IT Certification Program
Updates, Health Information Network Attestation Process for the Trusted
Exchange Framework and Common Agreement, and Enhancements to Support
Information Sharing proposed rule (0955-AA03). The rulemaking advances
electronic health information sharing through proposals for: standards
adoption; the certification of health IT to support expanded uses of
application programming interfaces (APIs), such as electronic prior
authorization, patient engagement, and interoperable public health
exchange; and supporting patient engagement and other information
sharing principles under the information blocking regulations.
Statement of Need: The rulemaking builds on policies adopted in the
21st Century Cures Act: Interoperability, Information Blocking, and the
ONC Health IT Certification final rule (85 FR 25642) and included in
the Health Information Technology: ONC Health IT Certification Program
Updates, Health Information Network Attestation Process for the Trusted
Exchange Framework and Common Agreement, and Enhancements to Support
Information Sharing proposed rule (0955-AA03). The rulemaking is needed
to advance electronic health information sharing through proposals for:
standards adoption; the certification of health IT to support expanded
uses of application programming interfaces (APIs), such as electronic
prior authorization, patient engagement, and interoperable public
health exchange; and supporting patient engagement and other
information sharing principles under the information blocking
regulations.
Summary of Legal Basis: The regulatory proposals would be
implemented under the authority of the Public Health Service Act, as
amended by the HITECH Act and the 21st Century Cures Act.
Alternatives: ONC will consider different options to improve
electronic health information interoperability and sharing so that the
benefits to providers, patients, and payers are maximized and the
economic burden to health IT developers, providers, and other
stakeholders is minimized.
Anticipated Cost and Benefits: The majority of costs for this
proposed rule would be incurred by health IT developers in terms of
meeting new requirements. We also expect that implementation of new
standards for interoperability and information sharing requirements may
account for some costs. We expect that through implementation and
compliance with the regulations, the market (particularly patients,
payers, and providers) will benefit greatly from improved
interoperability and the access, exchange, and use of electronic heath
information.
Risks: At this time, ONC has not been able to identify any
substantial risks that would undermine likely proposals in the proposed
rule. ONC will continue to consider and deliberate regarding any
potential risks and will be sure to identify them for stakeholders and
seek comment from stakeholders during the comment period for the
proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Agency Contact: Michael Lipinski, Director, Regulatory & Policy
Affairs Division, Department of Health and Human Services, Office of
the National Coordinator for Health Information Technology, Mary E.
Switzer Building, 330 C Street SW, Washington, DC 20201, Phone: 202
690-7151, Email: [email protected].
RIN: 0955-AA06
HHS--SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA)
Proposed Rule Stage
56. Medications for the Treatment of Opioid Use Disorder [0930-AA39]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 823(g)(1)
CFR Citation: 42 CFR 8.
Legal Deadline: None.
Abstract: The Substance Abuse and Mental Health Services
Administration (SAMHSA) will revise 42 CFR part 8 to make permanent
some regulatory flexibilities for Opioid Treatment Programs (OTPs)
granted under the COVID-19 Public Health Emergency (PHE), and to expand
access to care for people with Opioid Use Disorder (OUD). Specifically,
SAMHSA will propose making permanent those flexibilities pertaining to
unsupervised
[[Page 11029]]
doses of methadone and also initiation of buprenorphine via
telemedicine. To expand access to care, SAMHSA will also review
admission criteria, particularly rules that may limit timely access to
treatment in an OTP. To achieve this, sections of 42 CFR part 8 will
require updating. SAMHSA's changes will impact roughly 1900 opioid
treatment programs and state opioid treatment authorities.
Statement of Need: These proposed changes will help facilitate
access to Medications for Opioid Use Disorder (MOUD) in SAMHSA-
regulated opioid treatment programs (https://www.samhsa.gov/medication-assisted-treatment/become-accredited-opioid-treatment-program).
Research and stakeholder feedback indicate that flexibilities granted
under the COVID-19 PHE have been well received by treatment programs
and patients. There are very few reports of diversion or overdose, and
the flexibilities have been shown to facilitate patient engagement in
activities, such as employment, that support recovery. Moreover, those
with limited access to transportation benefit from these flexibilities
since they are not required to attend the OTP as frequently. In this
way, making permanent the methadone extended take home flexibility and
buprenorphine initiation via telehealth flexibility will facilitate
treatment engagement. To further support this and to help surmount
increasing mortality and morbidity due to the growing fentanyl-driven
overdose crisis, it is necessary to review OTP admission criteria. This
will further expand access to care.
Summary of Legal Basis: The current OTP flexibilities allow OTPs to
operate in a manner that is otherwise inconsistent with existing OTP
regulations, and therefore, a permanent extension of such exemptions
would effectively revise the OTP regulations. If such action is pursued
without rulemaking, it could be interpreted as inconsistent with
SAMHSA's exemption authority under 42 CFR 8.11(h) and the
Administrative Procedures Act, which requires agencies to go through
notice and comment rulemaking before establishing legally binding
rules. Therefore, incorporating the OTP flexibilities at issue into 42
CFR part 8 through rulemaking is the optimal approach for making the
OTP flexibilities permanent.
Alternatives: Congressional action; allowing the flexibilities to
lapse.
Anticipated Cost and Benefits: This change will help facilitate
access to opioid use disorder treatment in SAMHSA-regulated OTPs.
Programs have already incorporated COVID-19 flexibilities into practice
and have systems in place that support their delivery in a cost
effective, safe, and patient centered manner. This proposed rule is not
expected to impart a cost to patients. In fact, the proposed rule
allows patients to more readily engage in employment and necessary
daily activities. This supports patient workforce participation, income
generation, and also recovery. Further to this, expanded access will
potentially limit the long-term effects of opioid misuse among those
seeking rapid access to treatment.
Risks: Patients seeking extended take-home doses of methadone or
who have been reviewed via telehealth for initiation of buprenorphine
should still be required to have an in-person visit at the OTP at
intermittent intervals. Without this provision, there is risk of
patients receiving a lower standard of care and increased risk of
diversion of medications.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: State.
Agency Contact: Dr. Neeraj Gandotra, Chief Medical Officer,
Department of Health and Human Services, Substance Abuse and Mental
Health Services Administration, 5600 Fishers Lane, 18E67, Rockville, MD
20857, Phone: 202 823-1816, Email: [email protected].
RIN: 0930-AA39
HHS--CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
Final Rule Stage
57. Control of Communicable Diseases; Foreign Quarantine [0920-AA75]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265
CFR Citation: 42 CFR 71.
Legal Deadline: None.
Abstract: This rulemaking amends current regulation to enable CDC
to require airlines to collect and provide to CDC certain data elements
regarding passengers and crew arriving from foreign countries under
certain circumstances.
Statement of Need: In order to control the introduction,
transmission, and spread of communicable diseases such as COVID-19 into
the United States, the collection of traveler contact information helps
ensure that CDC and state and local health authorities are able to
identify and locate persons arriving in, or transiting through, the
United States from a foreign country who may have been exposed to a
communicable disease abroad.
Summary of Legal Basis: The Public Health Service Act (42 U.S.C.
264 and 268) authorizes the Secretary of the Department of Health and
Human Services to make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries into the United States, or from one State or
possession into any other State or possession. Regulations that
implement federal quarantine authority are currently promulgated in 42
CFR parts 70 and 71. CDC's authority for collecting these data fields
is contained in 42 CFR 71.4.
Alternatives: The transmission of disease, as seen during the
COVID-19 pandemic, has the potential to lead to thousands or millions
of deaths in addition to the significant healthcare and economic costs.
Follow-up with passengers arriving from foreign countries who may be
infectious or exposed to a communicable disease is critical. The
alternative to collecting traveler contact information before their
flight is to collect the information from airlines following the
passenger's flight. When this was done in the past, some airlines took
several days to respond to a single request if the information was
available. In addition, there is significant time and labor required
for CDC to obtain additional information from federal databases and
process the received information into a format suitable for
distribution to state and local health authorities in the United
States. As a result, obtaining contact information after a flight,
assuming that information is available, can lead to a delay of several
days before health authorities can start contacting potentially exposed
travelers. This time delay allows for travelers to be lost to follow-up
or become symptomatic or infectious. The time required and costs
incurred under this alternative increase exponentially with multiple
post-flight manifest requests to airlines.
Anticipated Cost and Benefits: The annual, ongoing costs to collect
traveler contact information, in the form of airline and travel agency
staff time and passenger time, are estimated to be approximately $285
million. This does not include the initial costs for updating IT
systems and employee training, which have already been incurred. The
costs to the government are minimal, as
[[Page 11030]]
the vast majority of passenger information that is being collected is
transmitted to the government via established data systems that are
already in use for other purposes.
The benefits to this rulemaking include rapid follow-up by public
health authorities with passengers who may be infectious or exposed to
a communicable disease, resulting in less spread and transmission of
disease into and throughout the United States, helping to prevent
public health and economic costs. The availability of passenger contact
data may be used by public health authorities to slow the introduction
and transmission of novel infectious diseases, including new variants
of the SARS-CoV-2 virus, which causes COVID-19 disease.
Risks: The risk to not collecting this information is that CDC
would have to revert back to previous ways of obtaining this
information for public health follow up. Some of those methods were
time intensive and resulted in delays in follow up.
The risk, although minimal, in collecting this information is that
airlines and international passengers often do not want to comply (or
may not want to comply) with the requirement. To date, however, CDC has
found instances of noncompliance have been very limited.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule Effective........ 02/07/20
Interim Final Rule.................. 02/12/20 85 FR 7874
Interim Final Rule Comment Period 03/13/20
End.
Final Action........................ 11/00/23
------------------------------------------------------------------------
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: Ashley C. Altenburger JD, Public Health Analyst,
Department of Health and Human Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307,
Phone: 800 232-4636, Email: [email protected].
RIN: 0920-AA75
HHS--CDC
58. World Trade Center Health Program; Addition of Uterine Cancer to
the List of WTC-Related Health Conditions [0920-AA81]
Priority: Other Significant.
Legal Authority: Pub. L. 111-347; Pub. L. 114-113
CFR Citation: 42 CFR 88.15.
Legal Deadline: NPRM, Statutory, February 28, 2022.
Authorizing statute requires publication of a rulemaking in the
Federal Register not later than 90 days after receipt of advisory
committee recommendation.
Abstract: With this rulemaking, HHS/CDC proposes to add uterine
cancer to the List of WTC-Related Health Conditions.
Statement of Need: Uterine cancer is the only type of cancer not
included on the List of WTC-Related Health Conditions (List) eligible
for coverage by the WTC Health Program. Following requests from WTC
responders and survivors, as well as a letter from five WTC Health
Program Clinical Centers of Excellence requesting the addition of
uterine cancer to the List, the Program reviewed the available
scientific evidence of an association between uterine cancer and 9/11
exposures in accordance with the WTC Health Program's Policy and
Procedures for Adding Cancers to the List of WTC-Related Health
Conditions. The disproportionately low representation of women in the
most studied cohorts of exposed responders makes it unlikely that a
definitive association between toxic exposure arising from the
September 11, 2001, terrorist attacks and the occurrence of uterine
cancer will be identified during the lifetimes of most WTC Health
Program members.
The Administrator of the WTC Health Program exercised discretion to
seek a recommendation from the Program's Scientific/Technical Advisory
Committee (STAC) and asked the STAC to review the available scientific
evidence concerning potential associations between 9/11 exposures and
uterine cancer. During public meetings, the STAC considered public
comments and deliberated on whether there is a reasonable basis to
recommend the addition of uterine cancer to the List, ultimately
providing the Administrator with its recommendation and rationale for
the addition. Based on the STAC's recommendation and the Program's
evaluation of the available scientific literature, the Administrator
determined that there is a sufficient evidentiary basis to propose the
addition of uterine cancer to the List. This action will promote equity
for Program members who are found to have WTC-related uterine cancer.
Summary of Legal Basis: Title I of the James Zadroga 9/11 Health
and Compensation Act of 2010 amended the Public Health Service (PHS)
Act to establish the WTC Health Program within HHS. See 42 U.S.C. 300mm
to 300mm61. The WTC Health Program provides medical monitoring and
treatment benefits to eligible responders to the September 11, 2001,
terrorist attacks in New York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders), and eligible survivors in the
New York City disaster area (survivors). Treatment is available under
the Program for specified health conditions included on the List.
Section 3312(a)(6) of the PHS Act requires the Administrator of the WTC
Health Program to conduct rulemaking to propose the addition of a
health condition to the List codified in 42 CFR 88.15.
Alternatives: If the WTC Health Program did not add uterine cancer
to the List of WTC-Related Health Conditions, current and future WTC
Health Program members who have or develop uterine cancer likely
related to 9/11 exposures will not be eligible to receive treatment
services from the Program.
Anticipated Cost and Benefits: This final rulemaking is estimated
to cost the WTC Health Program between $1,718,691 and $3,617,447 per
annum for 2022-2025. Due to the implementation of provisions of the
Patient Protection and Affordable Care Act and as required under the
authorizing statute for the WTC Health Program, all of the members and
future members are assumed to have or have access to medical insurance
coverage other than through the WTC Health Program. Therefore, all
treatment costs to be paid by the WTC Health Program are considered
transfer payments. This final rulemaking will not impose costs on
Program members or any other interested party.
WTC Health Program members with certified WTC-related uterine
cancer are expected to experience better treatment outcomes with
Program physicians as compared to receiving care outside of the
Program. Members may experience higher survival rates compared with
those not enrolled and have improved access to timely care, which is
associated with improved treatment outcomes.
Risks: The WTC Health Program may be perceived as a policy decision
as a result of this rulemaking because the
[[Page 11031]]
science informing proposed additions to the List is limited by
incomplete information on 9/11 exposures, health outcomes, and the
relationships they share. For example, the exposures experienced by the
responders and survivors on and after September 11, 2001 were not
measured and can only be estimated. Also, there are relatively few
women in the 9/11-exposed populations; therefore, studies lack the
statistical power needed to observe a causal association among women
with a high degree of certainty. Given incomplete information, some may
argue against the sufficiency of the science supporting the addition of
uterine cancer to the List.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/10/22 87 FR 27961
NPRM Comment Period End............. 06/24/22 .......................
Final Action........................ 01/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Agency Contact: Rachel Weiss, Public Health Analyst, Department of
Health and Human Services, Centers for Disease Control and Prevention,
1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226, Phone: 404 498-
2500, Email: [email protected].
RIN: 0920-AA81
HHS--FOOD AND DRUG ADMINISTRATION (FDA)
Proposed Rule Stage
59. Biologics Regulation Modernization [0910-AI14]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 262; 21 U.S.C. 301, et seq.
CFR Citation: 21 CFR 601.
Legal Deadline: None.
Abstract: FDA's biologics regulations will be updated to clarify
existing requirements and procedures related to Biologic License
Applications and to promote the goals associated with FDA's
implementation of the abbreviated licensure pathway created by the
Biologics Price Competition and Innovation Act of 2009.
Statement of Need: As biologics regulations were primarily drafted
in the 1970s, before passage of the BPCI Act, the regulations need to
be updated and modernized to account for the existence of biosimilar
and interchangeable biological products. The intent of this rulemaking
is to make high priority updates to FDA's biologics regulations with
the goals of (1) providing enhanced clarity and regulatory certainty
for manufacturers of both originator and biosimilar/interchangeable
products and (2) helping prevent the gaming of FDA regulatory
requirements to prevent or delay competition from biosimilars and
interchangeable products.
Summary of Legal Basis: FDA's authority for this rule derives from
the biological product provisions in section 351 of the PHS Act (42
U.S.C. 262), and the provisions of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 301, et seq.) applicable to biological
products.
Alternatives: FDA would continue to rely on guidance and one-on-one
communications with sponsors through formal meetings and correspondence
to provide clarity on existing requirements and procedures related to
Biologic License Applications, increasing the risk of potential
confusion and burden.
Anticipated Cost and Benefits: This proposed rule would impose
compliance costs on affected entities to read and understand the rule
and to provide certain information relevant to the regulation. The
provisions in this proposed rule would reduce regulatory uncertainty
for manufacturers of originator and biosimilar and interchangeable
products. This reduction of uncertainty may lead to time-savings to
industry and cost-savings to government due to better organized and
more complete BLAs and increased procedural clarity and predictability.
Risks: None.
Timetable:
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Action Date FR Cite
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NPRM................................ 10/00/23 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Sandra Benton, Senior Policy Coordinator,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 22, Room 1132, Silver Spring, MD
20993, Phone: 301 796-1042, Email: [email protected].
RIN: 0910-AI14
HHS--FDA
60. Certifications Concerning Imported Foods [0910-AI66]
Priority: Other Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 21 U.S.C. 381; 21 U.S.C. 371(b); 42 U.S.C. 243; 42
U.S.C. 264; 42 U.S.C. 271; . . .
CFR Citation: 21 CFR 1, Subpart F.
Legal Deadline: None.
Abstract: This regulation, if finalized, will help prevent
potentially harmful imported foods from reaching consumers and thereby
improve the safety of the U.S. food supply by allowing the agency to
require, as a condition of importation of food with known safety risk,
a certification or such other assurances as the Agency determines
appropriate, that imported food complies with U.S food safety
requirements.
Statement of Need: Imported food is increasingly implicated in U.S.
foodborne illness outbreaks. These illnesses emphasize the importance
of ensuring imported food meets applicable requirements of the Act.
Historically, FDA has relied on its staff to detect safety problems
with imported food by intercepting and examining food products when
they are offered for import into the United States or by performing
inspections of foreign facilities that produce food for export to the
United States. This rule, if finalized, would establish requirements
for implementing import certification as a condition of granting
admission to an article of food imported into the United States,
pursuant to section 801(q) of the FD&C Act. We anticipate that this
regulation, if finalized, will help prevent potentially harmful
imported foods from reaching consumers and thereby improve the safety
of the U.S. food supply.
Summary of Legal Basis: Section 303 of FSMA, Authority to Require
Import Certifications for Food, amended section 801 of the FD&C Act (21
U.S.C. 381) to create a new subsection (q) entitled, Certifications
Concerning Imported Foods. Section 801(q) gives FDA authority to
require import certification based on the risk of the food. FDA also
derives authority for these proposed requirements from section 701(b)
of the FD&C Act (21 U.S.C. 371(b)), which authorizes the Secretaries of
Treasury and Health and Human Services to jointly prescribe regulations
for the efficient enforcement of section 801 of the FD&C Act.
Additionally, sections 311, 361, and 368 of the Public Health Service
Act (PHS Act) (42 U.S.C. 243, 264, and 271, respectively), which relate
[[Page 11032]]
to communicable disease, provide FDA with authority to make and enforce
such regulations as in FDA's judgment are necessary to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries into the States or possessions, or from one State or
possession into any other State or possession (see section 361(a) of
the PHS Act) (42 U.S.C. 264(a)).
Alternatives: None.
Anticipated Cost and Benefits: The primary estimate for annualized
costs is $74.3 million, including costs from third-party audits,
foreign government inspections, and foreign government certification
associated with complying with an import certification requirement.
The primary estimate for annualized benefits is $109.7 million,
including food safety benefits to consumers, cost savings from reduced
transit and storage time, and cost savings from reduced food testing.
Risks: During 1996-2014, 195 outbreaks with 10,685 associated
illnesses were reported where the implicated food was imported into the
U.S., representing an increasing percentage of reported outbreaks
during that timeframe. These illnesses underscore the importance of
ensuring imported food meets applicable requirements of the FD&C Act.
This rule, if finalized, would implement a risk-based approach to
requiring import certification for food as a condition of
admissibility. FDA would obtain assurances that imported food meets
applicable requirements of the FD&C Act and implementing regulations
before the food is offered for import into the U.S. This rule is
intended to protect public health by strengthening FDA's import
oversight activities for foods and preventing unsafe foods from
reaching domestic markets.
Timetable:
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Action Date FR Cite
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NPRM................................ 04/00/23 .......................
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Regulatory Flexibility Analysis Required: No.
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: Peter Fox, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, 12420 Parklawn Drive,
ELEM, RM 41416, Rockville, MD 20857, Phone: 240 402-1857, Email:
[email protected].
RIN: 0910-AI66
HHS--FDA
61. Use of Salt Substitutes To Reduce the Sodium Content in
Standardized Foods [0910-AI72]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 336; 21
U.S.C. 346; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e
CFR Citation: 21 CFR 130; 21 CFR 131; 21 CFR 133; 21 CFR 136; 21
CFR 155; . . .
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) is proposing to
amend its regulations to permit the use of salt substitutes in
standardized foods in which salt (sodium chloride) is a required or
optional ingredient. The proposed rule, if finalized, would support
industry efforts to reduce sodium content in standardized foods and
improve dietary patterns by helping to reduce consumer sodium
consumption.
Statement of Need: FDA seeks to improve dietary patterns in the
United States to help reduce the burden of diet-related chronic
diseases and advance health equity. We are committed to accomplishing
this by, in part, creating a healthier food supply for all. One way FDA
is working towards this goal is by helping to reduce sodium across the
food supply.
FDA is proposing to amend 80 standards of identity (SOI) that
include salt as a required or optional ingredient to allow the use of
salt substitutes. Salt substitutes are ingredients that can help to
reduce sodium in the food supply. FDA is proposing to permit the use of
salt substitutes to reduce the sodium content in standardized foods.
Most SOI regulations that include salt as a required or optional
ingredient do not allow the use of salt substitutes. Therefore, food
manufacturers are currently precluded from using salt substitutes in
the production of these standardized foods. The proposed rule does not
identify specific salt substitutes, but rather, proposes a broad
definition to provide flexibility and facilitate industry innovation.
The proposed rule would permit the use of salt substitutes across
80 SOI that require salt as an ingredient or provide for salt as an
optional ingredient. In addition, the proposed rule would update the
incorporation by reference (IBR) information of several SOI to refer to
the most recent versions of the IBR materials and to provide up-to-date
contact information for obtaining the IBR materials. The proposed rule
would also make technical amendments to correct typographical errors in
some SOI regulations.
Summary of Legal Basis: FDA is issuing this proposed rule under
sections 201, 401, 402, 409, and 701 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 321, 341, 342, 348, 371). These
sections authorize FDA to issue regulations establishing a reasonable
definition and standard of identity to promote honesty and fair dealing
in the interest of consumers; define food additives, provide
authorizations and exemptions from regulation as a food additive, and
allow the agency to issue regulations for the efficient enforcement of
the FD&C Act.
Alternatives: The rule is a voluntary or permitting rule with no
regulatory costs. Therefore, we did not consider alternatives designed
to reduce the regulatory impact.
Anticipated Cost and Benefits: Voluntary or permitting rules
generate potential for social benefits that depend on voluntary
behavior for their realization. Being voluntary, they do not generate
regulatory costs. Net social costs are possible if the newly allowed
voluntary behavior generates net social costs, in which case we should
not have permitted that behavior. In this case, we can identify only a
potential social benefit. However, the size of any actually occurring
benefit is unknown. Because we cannot rule out economic significance,
we set the primary estimated annualized benefits at the minimum that
would make the rule economically significant, which is $165 M. That
social benefit is calculated net of the cost of the voluntary activity
that generates those benefits. We set the uncertainty range to give
that figure as the mean, so it runs from $0 to $330 M.
Risks: There are no known risks.
Timetable:
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Action Date FR Cite
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NPRM................................ 03/00/23 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Agency Contact: Jeanmaire Hryshko, Lead Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, 5001 Campus
[[Page 11033]]
Drive, HFS-265, College Park, MD 20740, Phone: 240 402-2371, Email:
[email protected].
RIN: 0910-AI72
HHS--FDA
62. Tobacco Product Standard for Nicotine Level of Certain Tobacco
Products [0910-AI76]
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 21 U.S.C. 387g
CFR Citation: 21 CFR 1160.
Legal Deadline: None.
Abstract: The proposed rule is a tobacco product standard that
would establish a maximum nicotine level in cigarettes and certain
other finished tobacco products.
Statement of Need: Each year, 480,000 people die prematurely from a
smoking-attributed disease, making tobacco use the leading cause of
preventable disease and death in the United States. Nearly all these
adverse health effects are ultimately the result of addiction to the
nicotine in combusted tobacco products, leading to repeated exposure to
toxicants from those products. Nicotine is powerfully addictive. The
U.S. Surgeon General has reported that 87 percent of adult smokers
start smoking before age 18, and half of adult smokers become addicted
before age 18. This proposed rule is a tobacco product standard that
would establish a maximum nicotine level in cigarettes and certain
other finished tobacco products. Because tobacco-related harms
primarily result from addiction to products that repeatedly expose
users to toxins, FDA would take this action to reduce addictiveness of
certain tobacco products, thus giving addicted users a greater ability
to quit. This product standard would also help to prevent experimenters
(mainly youth) from initiating regular use, and, therefore, from
becoming regular smokers. The proposed product standard is anticipated
to benefit the population as a whole, while also advancing health
equity by addressing disparities associated with cigarette smoking,
dependence, and cessation.
Summary of Legal Basis: Section 907 of the FD&C Act authorizes the
adoption of tobacco product standards if the Secretary finds that a
tobacco product standard is appropriate for the protection of public
health, and includes authority related to provisions for nicotine
yields in tobacco product standards.
Alternatives: In addition to the costs and benefits of the product
standard as proposed, FDA plans to assess the costs and benefits of a
different effective date for the rule and the impact of including
additional tobacco products in the product standard.
Anticipated Cost and Benefits: The anticipated benefits of the
product standard include benefits from reduced death and disease
resulting from decreased tobacco use among adult consumers, reduced
death and disease from secondhand smoke, and reduced death and disease
among youth who are deterred from initiating under the product
standard. The qualitative benefits of the proposed rule include impacts
such as reduced illness and increased productivity for smokers and
nonsmokers, as well as reduced smoking-related fires, cigarette litter,
and other environmental impacts.
The proposed rule is expected to generate compliance costs on
affected entities, such as one-time costs to read and understand the
rule and alter manufacturing and importing practices; and costs to some
consumers, such as search and temporary withdrawal costs.
Risks: None.
Timetable:
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Action Date FR Cite
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NPRM................................ 10/00/23 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal, Local, State, Tribal.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
Agency Contact: Courtney Smith, Senior Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, Document Control Center Building 71, Room
G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877
287-1373, Fax: 877 287-1426, Email: [email protected].
RIN: 0910-AI76
HHS--FDA
Final Rule Stage
63. Mammography Quality Standards Act [0910-AH04]
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e);
42 U.S.C. 263b
CFR Citation: 21 CFR 900.
Legal Deadline: None.
Abstract: FDA is amending its regulations governing mammography.
The amendments will update the regulations issued under the Mammography
Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and
Cosmetic Act (FD&C Act). FDA is taking this action to address changes
in mammography technology and mammography processes that have occurred
since the regulations were published in 1997 and to address breast
density reporting to patient and healthcare providers.
Statement of Need: FDA is updating the mammography regulations that
were issued under the Mammography Quality Standards Act of 1992 (MQSA)
and the FD&C Act. FDA is taking this action to address changes in
mammography technology and mammography processes.
FDA is also updating to modernize the regulations by incorporating
current science and mammography best practices, including addressing
breast density reporting to patients and healthcare providers. These
updates are intended to improve the delivery of mammography services.
Summary of Legal Basis: The MQSA (Pub. L. 102-539) is codified
under the Public Health Service (PHS) Act (42 U.S.C. 263b; section 354
of the PHS Act). Under the MQSA, all mammography facilities, except
facilities of the Department of Veterans Affairs, must be accredited by
an approved accreditation body and certified by FDA (or an approved
State certification agency) to provide mammography services (42 U.S.C.
263b(b)(1), (d)(1)(iv)). FDA is amending the mammography regulations
(set forth in part 900 (21 CFR part 900)) under section 354 of the PHS
Act (42 U.S.C. 263b), and sections of the FD&C Act (sections 519, 537,
and 704(e); 21 U.S.C. 360i, 360nn, and 374(e)).
Alternatives: The Agency will consider different options so that
the health benefits to patients are maximized and the economic burdens
to mammography facilities are minimized.
Anticipated Cost and Benefits: The benefits and costs associated
with this final rule include qualitative benefits related to reduced
mortality, morbidity and breast cancer treatment costs resulting from
the breast density reporting requirements. Additional benefits that we
are not able to quantify include improvements in the accuracy of
mammography by improving quality control and strengthening the medical
audit, and effects on morbidity.
Risks: None.
[[Page 11034]]
Timetable:
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Action Date FR Cite
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NPRM................................ 03/28/19 84 FR 11669
NPRM Comment Period End............. 06/26/19 .......................
Final Rule.......................... 12/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Laurie Sternberg, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 66, Room 5517, Silver Spring, MD 20993,
Phone: 240 402-0425, Email: [email protected].
RIN: 0910-AH04
HHS--FDA
64. Nonprescription Drug Product With an Additional Condition for
Nonprescription Use [0910-AH62]
Priority: Other Significant.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 352; 21 U.S.C. 355; 21
U.S.C. 371; 42 U.S.C. 262; 42 U.S.C. 264; . . .
CFR Citation: 21 CFR 201.67; 21 CFR 314.56; 21 CFR 314.81; 21 CFR
314.125; 21 CFR 314.127.
Legal Deadline: None.
Abstract: The final rule is intended to increase access to
nonprescription drug products. The final rule would establish
requirements for a drug product that could be marketed as a
nonprescription drug product with an additional condition that an
applicant must implement to ensure appropriate self-selection,
appropriate actual use, or both by consumers.
Statement of Need: Currently, nonprescription drug products are
limited to drugs that can be labeled with sufficient information for
consumers to appropriately self-select and use the drug product. For
certain drug products, limitations of labeling present challenges for
adequate communication of information needed for consumers to
appropriately self-select or use the drug product without the
supervision of a healthcare practitioner. FDA is finalizing regulations
that would establish the requirements for a drug product that could be
marketed as a nonprescription drug product with an additional condition
that an applicant must implement to ensure appropriate self-selection,
appropriate actual use or both by consumers.
Summary of Legal Basis: FDA's revisions to the regulations
regarding labeling and applications for nonprescription drug products
labeling are authorized by the FD&C Act (21 U.S.C. 321 et seq.) and by
the Public Health Service Act (42 U.S.C. 262 and 264).
Alternatives: FDA evaluated various requirements for new drug
applications to assess flexibility of nonprescription drug product
design through drug labeling for appropriate self-selection and
appropriate use.
Anticipated Cost and Benefits: The benefits of the final rule would
include increased consumer access to drug products and reduced access
costs to these products as compared to their prescription alternatives.
Benefits to industry would arise from the flexibility in drug product
approval and the potential expansion of market revenue. Other benefits
would include a reduction in repetitive meetings with industry and the
Agency regarding this approval pathway. In addition, private and
government-sponsored drug coverage plans may experience cost savings.
Although applicants would incur the costs to develop and submit an
application for a nonprescription drug with an ACNU, they would likely
submit applications only when they expect that the profits from the
approval would exceed the costs of the application. Lastly, we
anticipate one-time costs of reading and understanding the rule that
potential applicants would incur.
Risks: None.
Timetable:
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Action Date FR Cite
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NPRM................................ 06/28/22 87 FR 38313
NPRM Comment Period End............. 10/26/22 .......................
Final Rule.......................... 10/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Chris Wheeler, Supervisory Project Manager,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD
20993, Phone: 301 796-0151, Email: [email protected].
RIN: 0910-AH62
HHS--FDA
65. Tobacco Product Standard for Characterizing Flavors in Cigars
[0910-AI28]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect State, local or tribal
governments and the private sector.
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21
U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . .
CFR Citation: 21 CFR 1166.
Legal Deadline: None.
Abstract: This rule is a tobacco product standard that would
prohibit characterizing flavors (other than tobacco) in all cigars. We
are taking this action with the intention of reducing the tobacco-
related death and disease associated with cigar use. Evidence shows
that flavored tobacco products appeal to youth and also shows that
youth may be more likely to initiate tobacco use with such products.
Characterizing flavors in cigars, such as strawberry, grape, orange,
and cocoa, enhance taste and make these products easier to use. Over a
half million youth in the United States use flavored cigars, placing
these youth at risk for cigar-related death and disease.
Statement of Need: The Federal Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act), authorizes FDA to adopt tobacco product
standards under section 907 if the Secretary finds that a tobacco
product standard is appropriate for the protection of the public
health. This product standard will prohibit characterizing flavors
(other than tobacco) in all cigars. Characterizing flavors in cigars,
such as strawberry, grape, cocoa, and fruit punch, increase appeal and
make the cigars easier to use, particularly among youth and young
adults. This product standard will reduce the appeal of cigars,
particularly to youth and young adults, and thereby decrease the
likelihood of experimentation, development of nicotine dependence, and
progression to regular use. This product standard will improve public
health by increasing the likelihood of cessation among existing cigar
smokers; this product standard will also improve health outcomes within
groups that experience disproportionate levels of tobacco use,
including certain vulnerable populations.
Summary of Legal Basis: Section 907 of the FD&C Act authorizes the
adoption of tobacco product standards if the Secretary finds that a
tobacco product
[[Page 11035]]
standard is appropriate for the protection of public health. Section
907 also authorizes FDA to include in a product standard a provision
that restricts the sale and distribution of a tobacco product to the
extent that it may be restricted by a regulation under section 906(d)
of the FD&C Act. Section 906(d) of the FD&C Act authorizes the
Secretary to issue regulations requiring restrictions on the sale and
distribution of a tobacco product, including restrictions on the access
to, and the advertising and promotion of, the tobacco product, if the
Secretary determines that such regulation would be appropriate for the
protection of the public health. Section 701(a) of the FD&C Act
authorizes the promulgation of regulations for the efficient
enforcement of the FD&C Act.
Alternatives: In addition to the costs and benefits of the product
standard, FDA will assess the costs and benefits of, among other
things, a different effective date for the rule, and including pipe
tobacco in the product standard.
Anticipated Cost and Benefits: The anticipated benefits of the
product standard include those coming from reduced death and disease
that are the result of cigar use among adult cigar smokers, reduced
death and disease from secondhand smoke, and reduced death and disease
among youth who are deterred from initiating under the product
standard.
Risks: None.
Timetable:
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Action Date FR Cite
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ANPRM............................... 03/21/18 83 FR 12294
ANPRM Comment Period End............ 07/19/18 .......................
NPRM................................ 05/04/22 87 FR 26396
NPRM Comment Period Extended........ 06/21/22 87 FR 36786
NPRM Comment Period End............. 07/05/22 .......................
NPRM Comment Period Extended End.... 08/02/22 .......................
Final Rule.......................... 08/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal, Local, State, Tribal.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
Agency Contact: Nathan Mease, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Center for Tobacco Products, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AI28
HHS--FDA
66. Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption Relating to Agricultural Water [0910-
AI49]
Priority: Other Significant.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21
U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C.
271; . . .
CFR Citation: 21 CFR 112.
Legal Deadline: None.
Abstract: This rulemaking would revise certain requirements for
agricultural water in the Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption (produce safety)
regulation for covered produce other than sprouts.
Statement of Need: Agricultural water can be a major conduit of
pathogens that can contaminate produce. Recent produce outbreaks
potentially linked to agricultural water have emphasized the importance
of ensuring that FDA's agricultural water standards are workable across
the diversity of domestic and foreign farms and account for the variety
of factors that impact water sources and uses. FDA plans to amend its
produce safety regulation to address concerns about the practical
challenges of implementing certain agricultural water requirements,
while protecting the public health.
Summary of Legal Basis: FDA's authority for issuing this rule is
provided by sections 402, 419, and 701(a) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 342, 350h, and 371(a)) and
sections 311, 361, and 368 of the Public Health Service Act (PHS Act)
(42 U.S.C. 243, 264, and 271).
Specifically, this rulemaking would amend certain agricultural
water requirements in the produce safety regulation, codified at 21 CFR
part 112, and issued under the following authorities: Section
419(c)(1)(A) of the FD&C Act (21 U.S.C. 350h(c)(1)(A)) authorizes FDA
to establish science-based minimum standards for the safe production
and harvesting of those types of fruits and vegetables that are raw
agricultural commodities for which such standards minimize the risk of
serious adverse health consequences or death. Section 419(c)(1)(B) of
the FD&C Act (21 U.S.C. 350h(c)(1)(B)) further requires that these
minimum standards provide sufficient flexibility to be practicable for
all sizes and types of businesses. Section 402(a)(3) of the FD&C Act
(21 U.S.C. 342(a)(3)) provides that a food is adulterated if it
consists in whole or in part of any filthy, putrid, or decomposed
substance, or if it is otherwise unfit for food. Section 402(a)(4) of
the FD&C Act (21 U.S.C. 342(a)(4)) provides that a food is adulterated
if it has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may
have been rendered injurious to health. Additionally, section 701(a) of
the FD&C Act (21 U.S.C. 371(a)) grants the authority to promulgate
regulations for the efficient enforcement of the FD&C Act. Sections
311, 361, and 368 of the PHS Act (21 U.S.C. 243, 264, and 271), provide
authority for FDA to issue regulations to prevent the spread of
communicable diseases from one State to another.
Alternatives: None.
Anticipated Cost and Benefits: FDA anticipates costs associated
with complying with the proposed water risk assessment provisions for
non-sprout covered produce.
This final rule would generate unquantified benefits stemming from
increasing flexibility and addressing practical implementation
challenges associated with certain agricultural water provisions in the
produce safety regulation and quantified benefits resulting from fewer
illnesses caused by pre-harvest agricultural water.
Risks: In a 2019 Report, the Interagency Food Safety Analytics
Collaboration (IFSAC) estimated that produce commodities cause 65
percent of foodborne E. coli O157 illnesses and over 40 percent of
foodborne Salmonella illnesses. Agricultural water can be a major
conduit for produce contamination. This rule is intended to address the
practical implementation challenges of certain agricultural water
requirements, while protecting public health by setting forth standards
to minimize the risk of serious adverse health consequences or death,
including those reasonably necessary to prevent the introduction of
known or reasonably foreseeable biological hazards into or onto
produce, and provide reasonable assurances that the produce is not
adulterated on account of those hazards.
Timetable:
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Action Date FR Cite
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NPRM................................ 12/06/21 86 FR 69120
[[Page 11036]]
NPRM Comment Period End............. 04/05/22 .......................
Supplemental NPRM................... 07/19/22 87 FR 42973
Supplemental NPRM Comment Period End 09/19/22 .......................
Final Rule.......................... 10/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Samir Assar, Supervisory Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Safety,
5001 Campus Drive, College Park, MD 20740, Phone: 240 402-1636, Email:
[email protected].
RIN: 0910-AI49
HHS--FDA
67. Tobacco Product Standard for Menthol in Cigarettes [0910-AI60]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect State, local or tribal
governments and the private sector.
Legal Authority: 21 U.S.C. 387g; 21 U.S.C 371; 21 U.S.C 387f
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This final rule is a tobacco product standard to prohibit
the use of menthol as a characterizing flavor in cigarettes.
Statement of Need: The Federal Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act), authorizes FDA to adopt tobacco product
standards under section 907 if the Secretary finds that a tobacco
product standard is appropriate for the protection of the public
health. This product standard would prohibit menthol as a
characterizing flavor in cigarettes. The standard would reduce the
appeal of cigarettes, particularly to youth and young adults, and
thereby decrease the likelihood that nonusers who would otherwise
experiment with menthol cigarettes would progress to regular cigarette
smoking. In addition, the tobacco product standard would improve the
health and reduce the mortality risk of current menthol cigarette
smokers by decreasing cigarette consumption and increasing the
likelihood among current menthol cigarette smokers, the tobacco product
standard is likely to improve the health of current menthol cigarette
smokers by decreasing consumption and increasing the likelihood of
cessation.
Summary of Legal Basis: Section 907 of the FD&C Act authorizes the
adoption of tobacco product standards if the Secretary finds that a
tobacco product standard is appropriate for the protection of public
health.
Alternatives: In addition to the costs and benefits of the rule,
FDA will assess the costs and benefits of extending the effective date
of the rule, creating a process by which some products may apply for an
exemption or variance from the product standard, and prohibiting
menthol as an intentional additive in cigarette products rather than
prohibiting menthol as a characterizing flavor.
Anticipated Cost and Benefits: The rule is expected to generate
compliance costs on affected entities, such as one-time costs to read
and understand the rule and alter manufacturing/importing practices.
The quantified benefits of the rule stem from improved health and
diminished exposure to tobacco smoke for users of cigarettes from
decreased experimentation, progression to regular use, and consumption
of menthol cigarettes. The qualitative benefits of the rule include
impacts such as reduced illness for smokers and non-smokers.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/24/13 78 FR 44484
ANPRM Comment Period End............ 09/23/13 .......................
NPRM................................ 05/04/22 87 FR 26454
NPRM Comment Period Extended........ 06/21/22 87 FR 36786
NPRM Comment Period End............. 07/05/22 .......................
NPRM Comment Period Extended End.... 08/02/22 .......................
Final Rule.......................... 08/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal, Local, State, Tribal.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
Agency Contact: Beth Buckler, Senior Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AI60
HHS--CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
Proposed Rule Stage
68. Provider Nondiscrimination Requirements for Group Health Plans and
Health Insurance Issuers in the Group and Individual Markets (CMS-9910)
[0938-AU64]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 116-260, Division BB, title I; 42 U.S.C.
300gg-5(a)
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory, January 1, 2022, Statutory
Deadline for Issuing a Proposed Rule.
Abstract: This proposed rule would implement section 108 of the No
Surprises Act.
Statement of Need: Not yet determined.
Summary of Legal Basis: The Department of Health and Human Services
regulations are adopted pursuant to the authority contained in sections
2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS
Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as
amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet determined.
Risks: Not yet determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal, State.
Federalism: Undetermined.
Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation
Division, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Consumer Information and Insurance
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301
492-4106, Email: [email protected].
RIN: 0938-AU64
[[Page 11037]]
HHS--CMS
69. Short-Term Limited Duration Insurance; Update (CMS-9904) [0938-
AU67]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111-148, title I
CFR Citation: 45 CFR 144; 45 CFR 146; 45 CFR 148.
Legal Deadline: None.
Abstract: This rule would propose amendments to the definition of
`short-term, limited-duration insurance' under section 2791(b)(5) of
the Public Health Service Act. The rule's proposals would be designed
to ensure this type of coverage does not undermine the Affordable Care
Act, including its protections for people with pre-existing conditions,
the Health Insurance Exchanges, or the individual, small group, or
large group markets for health insurance in the United States.
Statement of Need: Not yet determined.
Summary of Legal Basis: The Department of Health and Human Services
regulations are adopted pursuant to the authority contained in sections
2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS
Act (42 U.S.C. 300gg-300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-
300gg-139), as amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet determined.
Risks: Not yet determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal.
Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation
Division, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Consumer Information and Insurance
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301
492-4106, Email: [email protected].
RIN: 0938-AU67
HHS--CMS
70. Assuring Access to Medicaid Services (CMS-2442) [0938-AU68]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 1302
CFR Citation: 42 CFR 438; 42 CFR 447.
Legal Deadline: None.
Abstract: This rule proposes to address elements related to
assuring access in Medicaid and/or the Children's Health Insurance
Program (CHIP). These elements could include processes that support the
implementation of a comprehensive access strategy as well as payment
processes, such as those related to specific payment systems.
Statement of Need: In order to assure equitable access to health
care for all Medicaid and CHIP beneficiaries across all delivery
systems, access regulations need to be multi-factorial and focus beyond
payment rates. Barriers to accessing health care services can be as
heterogeneous as Medicaid and CHIP populations which can be measured
through provider availability and provider accessibility to realized or
perceived access barriers which can be measured through utilization and
satisfaction with services. CMS is developing a comprehensive access
strategy that will address not only Fee-For-Service (FFS) payment, but
also access in managed care and Home and Community-Based Services
(HCBS).
Summary of Legal Basis: There are no broad access requirements
specified in the statute beyond payment: section 1902(a)(30)(A) of the
Act requires states to ``assure that payments are consistent with
efficiency, economy, and quality of care and are sufficient to enlist
enough providers so that care and services are available under the plan
at least to the extent that such care and services are available to the
general population in the geographic area.''
Alternatives: In developing the policies contained in this rule, we
will consider numerous alternatives to the presented proposals,
including maintaining existing requirements. These alternatives will be
described in the rule.
Anticipated Cost and Benefits: This proposed rule would be expected
to result in potential costs for states to come into and remain in
compliance. Estimates for associated costs are unknown at this time and
may vary by state. Information about anticipated costs will be included
in the proposed rule.
Risks: Risks of the proposals in this rule are still under
development and will be included in the published rule for comment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: State.
Federalism: Undetermined.
Agency Contact: Karen Llanos, Director, Medicaid Innovation
Accelerator Program and Strategy Support, Department of Health and
Human Services, Centers for Medicare & Medicaid Services, Center for
Medicaid and CHIP Services, MS: S2-04-28, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-9071, Email:
[email protected].
RIN: 0938-AU68
HHS--CMS
71. Transitional Coverage for Emerging Technologies (CMS-3421) [0938-
AU86]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 263a; 42 U.S.C. 405(a); 42 U.S.C. 1302;
42 U.S.C. 1320b-12; . . .
CFR Citation: 42 CFR 405.
Legal Deadline: None.
Abstract: This proposed rule would establish the criteria for an
expedited coverage pathway to provide Medicare beneficiaries with
faster access to innovative and beneficial technologies. This pathway
would build off of prior initiatives, including coverage with evidence
development. The proposed rule will meet the following principles
previously published by CMS:
(1) Manufacturers may enter the process on a voluntary basis. This
process will be limited to medical devices that fall within the
Medicare statute and that are relevant to the Medicare population.
(2) CMS may conduct early evidence review (before the device
secures FDA marking authorization) and discuss with the manufacturer
the best Medicare coverage pathway, depending upon the strength of the
evidence collected.
(3) At the manufacturer's request, CMS may initiate the coverage
process before FDA market authorization, which could require developing
an additional evidence development plan and confirming that there are
appropriate safeguards and protections for Medicare beneficiaries.
(4) If CMS determines that further evidence development is the best
coverage pathway, the agency would explore how to reduce the burden on
manufactures, clinicians and patients
[[Page 11038]]
while maintaining rigorous evidence requirements.
Statement of Need: This rule is necessary to codify the Coverage
with Evidence Development (CED) coverage pathway in regulation and aims
to incresase predictability, transparency, and timeliness of
Transitional Coverage for Emerging Technologies (TCET).
Summary of Legal Basis: This rule would be proposed under the
authority of sections 1862(a)(1)(A) and 1862(a)(1)(E) of the Social
Security Act.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet determined.
Risks: Not yet determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, State.
Federalism: Undetermined.
Agency Contact: Lori Ashby, Senior Technical Advisor, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6322, Email:
[email protected].
RIN: 0938-AU86
HHS--CMS
72. Interoperability and Prior Authorization for MA Organizations,
Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers,
MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057) [0938-
AU87]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1395hh
CFR Citation: 42 CFR 422; 42 CFR 431; 42 CFR 435; 42 CFR 438; . . .
Legal Deadline: None.
Abstract: This proposed rule would place new requirements on
Medicare Advantage (MA) organizations, Medicaid managed care plans,
Children's Health Insurance Program (CHIP) managed care entities, state
Medicaid and CHIP fee-for-service (FFS) programs, and Qualified Health
Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to
improve the electronic exchange of health care data and streamline
processes related to prior authorization, while continuing CMS' drive
toward interoperability, and reducing burden in the health care market.
This proposed rule would also add a new measure for eligible hospitals
and critical access hospitals under the Medicare Promoting
Interoperability Program and for Merit-based Incentive Payment System
(MIPS) eligible clinicians under the Promoting Interoperability
performance category of MIPS. These policies taken together would play
a key role in reducing overall payer and provider burden and improving
patient access to health information.
Statement of Need: The proposed changes further support CMS'
efforts to improve the electronic exchange of healthcare data and
streamline processes related to prior authorization, while continuing
CMS' drive toward interoperability in the healthcare market. The
proposals in this rule build on the foundation we laid out in the CMS
Interoperability and Patient Access final rule to move the healthcare
system toward increased interoperability and reduced burden by
proposing to enhance the data sharing capabilities of impacted payers
and providers through the use of innovative technologies. The proposals
also empower patients by making health-related data more easily
available through standards-based technology.
Summary of Legal Basis: This rule addresses multiple sections of
the Social Security Act, as well as Executive Order 13985, Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government.
Alternatives: We carefully considered alternatives to the policies
we are proposing in this rule and concluded that none of the
alternatives would adequately or immediately begin to address the
critical issues related to patient access to health information and
interoperability or help to address the processes that contribute to
payer, provider, and patient burden. Alternatives considered will be
included in the proposed rule.
Anticipated Cost and Benefits: We believe that the proposed
policies, if finalized, would result in some financial burdens for
impacted payers and providers. We have weighed these potential burdens
against the potential benefits, and believe the potential benefits
outweigh any potential costs. We anticipate the long-term savings to be
significant. As we move toward publication, estimates of costs and
benefits will be included in the proposed rule.
Risks: Risks of the proposals in this rule are still under
development and will be included in the published rule for comment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal, State.
Agency Contact: Alexandra Mugge, Director & Deputy Chief Health
Informatics Officer, Health Informatics and Interoperability Group,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of Burden Reduction and Health Informatics,
MS: C5-02-00, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410
786-4457, Email: [email protected].
RIN: 0938-AU87
HHS--CMS
73. Medicare and Medicaid Program Integrity (CMS-6084) [0938-AU90]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
CFR Citation: 42 CFR 400; 42 CFR 402; 42 CFR 405; 42 CFR 406; . . .
Legal Deadline: None.
Abstract: This proposed rule includes provisions that would promote
payment accuracy and efficiency and help CMS identify and deter fraud,
waste, and abuse in a timely, effective manner, enabling the Agency to
protect the Medicare and Medicaid programs and the Children's Health
Insurance Program (CHIP). This rule would implement portions of section
6101(a) of the Patient Protection and Affordable Care Act (Affordable
Care Act), which require the disclosure of certain ownership,
managerial, and other information regarding Medicare skilled nursing
facilities (SNFs) and Medicaid nursing facilities.
Statement of Need: This rule is necessary to strengthen CMS's
program integrity efforts across Medicare, Medicaid, and the CHIP and
increase transparency and accountability.
Summary of Legal Basis: The proposals included in this rule will
address several sections of title XVIII of the Social Security Act.
Alternatives: Alternatives considered will be described in the
rule.
Anticipated Cost and Benefits: As many of the provisions to be
included in this rule are still under development, it is not possible
at this time to provide cost and benefit estimates. As it is
[[Page 11039]]
developed further, such estimates will be included in the proposed
rule.
Risks: The proposed provisions included in this rule would address
a number of program integrity vulnerabilities. Risks of the proposals
are still under development and will be included in the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal, State.
Federalism: Undetermined.
Agency Contact: John Spiegel, Senior Advisor, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Center
for Program Integrity, MS: AR-19-15, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-1909, Email:
[email protected].
RIN: 0938-AU90
HHS--CMS
74. Culturally Competent and Person-Centered Requirements To Increase
Access to Care and Improve Quality for All (CMS-3418) [0938-AU91]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 1821; 42 U.S.C 1832(a)(2)(F)(I); 42
U.S.C. 1861(dd)(1); 42 U.S.C. 1905(a)
CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 441; . . .
Legal Deadline: None.
Abstract: The proposed rule would establish culturally competent
and person-centered requirements for all provider and supplier types
that participate in Medicare and Medicaid programs. These requirements
revise the Conditions of Participations/Conditions for Coverage (CoPss/
CfCs) pertaining to governance, patient/resident/client rights (such as
nondiscrimination and accessibility), clinical quality standards,
quality assessment and performance improvement, staff training,
discharge planning, and care planning in an effort to increase quality
and improve access to health care. These proposals also include
additional requirements for transplant programs, organ procurement
organizations, and end-stage renal disease facilities that would
advance equity and reduce disparities in organ transplantation and
organ donation.
Statement of Need: This rule would advance health equity, increase
access to care, improve quality of care, and reduce health disparities
for all individuals. The proposals are in accordance with Executive
Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and
Support for Underserved Communities through the Federal Government,
Preventing and Combating Discrimination on the Basis of Gender Identity
or Sexual Orientation, Ensuring an Equitable Pandemic Response and
Recovery, and on Advancing Equity, Justice, and Opportunity for Asian
Americans, Native Hawaiians, and Pacific Islanders, respectively.
Despite the existence of Federal civil rights laws, disparities in care
still persist. Revising the CoPs/CfCs by adding culturally competent
and person-centered requirements will incentivize providers to address
disparities that exist within their facilities by requiring specific
actions or face a noncompliance determination that may affect their
participation status in the Medicare and Medicaid programs.
Discrimination, or even the fear of discriminatory behavior by
healthcare providers, negatively impacts a patient's health and safety
and health outcomes, and presents barriers to accessing quality health
care. The establishment of culturally competent and person-centered
requirements are a necessary step to protect an individual's health and
safety. The provisions of this rule would help ensure that everyone has
a fair and just opportunity to attain their optimal health regardless
of race, ethnicity, disability, sexual orientation, gender identity,
socioeconomic status, geography, preferred language, or other factors
that affect access to care and health outcomes. Further, culturally
competent and person-centered focused health and safety requirements
could lead to improved access to care, improved quality of care, and
better health outcomes for all.
Summary of Legal Basis: The statutory authority to revise the
health and safety standards for Medicare and Medicaid participating
providers and suppliers is contained within Section 1102 (42 U.S.C.
1302) of the Social Security Act. In addition, this rule revises the
health and safety regulations to advance health equity and reduce
disparities for all individuals in accordance with Executive Orders
13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support
for Underserved Communities through the Federal Government, Preventing
and Combating Discrimination on the Basis of Gender Identity or Sexual
Orientation, Ensuring an Equitable Pandemic Response and Recovery, and
on Advancing Equity, Justice, and Opportunity for Asian Americans,
Native Hawaiians, and Pacific Islanders, respectively.
Alternatives: In developing the policies contained in this rule, we
considered numerous alternatives to the presented proposal. These
alternatives will be included in the proposed rule.
Anticipated Cost and Benefits: The provisions in this rule aim to
advance health equity, increase access to care, improve quality of
care, and reduce health disparities for all individuals. This
regulation will ultimately remove barriers to access health care,
ensure that all individuals have equitable care, and improve quality of
care for all. As we move toward publication, estimates of the cost and
benefits of these provisions will be included in the rule.
Risks: This action furthers the goals of the Executive Orders on
Advancing Racial Equity and Support for Underserved Communities Through
the Federal Government (E.O. 13985), Executive Order on Preventing and
Combating Discrimination on the Basis of Gender Identity or Sexual
Orientation (E.O. 13988), Executive Order on Ensuring an Equitable
Pandemic Response and Recovery (E.O. 13995), and Executive Order on
Advancing Equity, Justice, and Opportunity for Asian Americans, Native
Hawaiians, and Pacific Islanders (E.O. 14301). While there may be some
risks associated with an increased burden on providers as a result of
these regulations, we believe benefits related to addressing the
challenges that historically underserved populations (those that have
been subject to racism, discrimination, or systemic disadvantage) face
when accessing and receiving care from a health care organization,
would far outweigh any risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, State.
Agency Contact: Alpha-Banu Wilson, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8687, Email: [email protected].
RIN: 0938-AU91
[[Page 11040]]
HHS--CMS
75. Mental Health Parity and Addiction Equity Act and the Consolidated
Appropriations Act, 2021 (CMS-9902) [0938-AU93]
Priority: Other Significant.
Legal Authority: Pub. L. 116-260, Division BB, title II; Pub. L.
110-343, secs. 511 to 512
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule would propose amendments to the final rules
implementing the Mental Health Parity and Addiction Equity Act. The
amendments would clarify plans' and issuers' obligations under the law,
promote compliance with MHPAEA, and update requirements taking into
account experience with MHPAEA in the years since the rules were
finalized as well as amendments to the law recently enacted as part of
the Consolidated Appropriations Act, 2021.
Statement of Need: There have been a number of legislative
enactments related to MHPAEA since issuance of the 2014 final rules,
including the 21st Century Cures Act, the Support Act, and the
Consolidated Appropriations Act, 2021. This rule would propose
amendments to the final rules and incorporate examples and
modifications to account for this legislation and previously issued
guidance.
Summary of Legal Basis: The Department of Health and Human Services
regulations are adopted pursuant to the authority contained in sections
2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS
Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as
amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet determined.
Risks: Not yet determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal, State.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation
Division, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Consumer Information and Insurance
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301
492-4106, Email: [email protected].
RIN: 0938-AU93
HHS--CMS
76. Coverage of Certain Preventive Services Under the Affordable Care
Act (CMS-9903) [0938-AU94]
Priority: Other Significant.
Legal Authority: Pub. L. 111-148, sec. 1001
CFR Citation: 45 CFR 147; 45 CFR 156.
Legal Deadline: None.
Abstract: This rule would propose amendments to the final rules
regarding religious and moral exemptions and accommodations regarding
coverage of certain preventive services under title I of the Patient
Protection and Affordable Care Act.
Statement of Need: Not yet determined.
Summary of Legal Basis: The Department of Health and Human Services
regulations are adopted pursuant to the authority contained in sections
2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS
Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as
amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet determined.
Risks: Not yet determined.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State.
Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation
Division, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Consumer Information and Insurance
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301
492-4106, Email: [email protected].
RIN: 0938-AU94
HHS--CMS
77. Contract Year 2024 Changes to the Medicare Advantage, Medicare
Prescription Drug Benefit, Medicare Cost Plan Programs, Medicare
Overpayment Provisions of the Affordable Care Act, and PACE (CMS-4201)
[0938-AU96]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 115-271
CFR Citation: 42 CFR 422; 42 CFR 423.
Legal Deadline: None.
Abstract: This proposed rule would implement changes to strengthen
and improve the Medicare Advantage (Part C) and prescription drug (Part
D) programs. It also proposes changes to the Medicare Cost Plan
Program, Medicare Parts A, B, C, and D Overpayment Provisions of the
Affordable Care Act, and Programs of All-Inclusive Care (PACE).
Statement of Need: This rule is necessary to make revisions to the
Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part
D), and PACE regulations to implement changes related to Star Ratings,
medication therapy management, marketing and communications, health
equity, provider directories, prior authorization, passive enrollment,
network adequacy, identification of overpayments, formulary changes,
and other programmatic areas. This proposed rule would also codify
regulations implementing Section 118 of the Consolidated Appropriations
Act of 2021 and includes a large number of provisions that would codify
existing sub-regulatory guidance in the Part C, Part D, and PACE
programs. This proposed rule would also amend the existing regulations
for Medicare Parts A, B, C, and D regarding the standard for an
identified overpayment.
Summary of Legal Basis: This rule addresses multiple sections of
the Social Security Act, the Bipartisan Budget Act of 2018, the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities (SUPPORT) Act, and the
Consolidated Appropriations Act of 2021.
Alternatives: This rule implements provisions that require public
notice and comment and are necessary for the upcoming contract year. We
continue to explore alternatives as we develop the rule.
Anticipated Cost and Benefits: As we move toward publication,
estimates of costs and benefits will be included in the proposed rule.
[[Page 11041]]
Risks: Risks of the proposals in this rule are still under
development and will be included in the published rule for comment.
Timetable:
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Action Date FR Cite
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NPRM................................ 12/00/22 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Agency Contact: Christian Bauer, Director, Division of Part D
Policy, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C1-26-16, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6043, Email:
[email protected].
Related RIN: Related to 0938-AV01
RIN: 0938-AU96
HHS--CMS
78. FY 2024 Skilled Nursing Facility (SNFs) Prospective
Payment System and Consolidated Billing and Updates to the Value-Based
Purchasing and Quality Reporting Programs (CMS-1779) [0938-AV02]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C 1395hh; 42 U.S.C. 1302
CFR Citation: 42 CFR 413.
Legal Deadline: Final, Statutory, October 1, 2023, By statute, rule
must be effective by October 1 annually.
Abstract: This annual proposed rule would update the payment rates
used under the prospective payment system for SNFs for fiscal year
2024. The rule also includes proposals for the SNF Quality Reporting
Program (QRP) and for the Skilled Nursing Facility Value-Based
Purchasing (VBP) Program that will affect Medicare payment to SNFs. In
addition, this rule also proposes to establish new minimum staffing
requirements that facilities must meet to ensure safe and quality care.
Statement of Need: This proposed rule would update the SNF
prospective payment rates as required under the Social Security Act
(the Act). The Act requires the Secretary to provide, before the August
1 that precedes the start of each FY, the unadjusted Federal per diem
rates, the case-mix classification system, and the factors to be
applied in making the area wage adjustment.
Summary of Legal Basis: In accordance with sections
1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of the Act, the Federal rates in
this proposed rule would reflect an update to the rates that we
published in the SNF PPS final rule for FY 2023. These changes would be
applicable to services furnished on or after October 1, 2023.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for FY 2024.
Risks: None. The rule is necessary for SNF services to be paid
appropriately.
Timetable:
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Action Date FR Cite
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NPRM................................ 04/00/23 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Tammy Luo, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare, MS: C5-06-17, 7500 Security Boulevard, Baltimore,
MD 21244, Phone: 410 786-4325, Email: [email protected].
RIN: 0938-AV02
HHS--CMS
Final Rule Stage
79. Streamlining the Medicaid and CHIP Application, Eligibility
Determination, Enrollment, and Renewal Processes (CMS-2421) [0938-AU00]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302
CFR Citation: 42 CFR 431; 42 CFR 435; 42 CFR 457.
Legal Deadline: None.
Abstract: This final rule streamlines eligibility and enrollment
processes for all Medicaid and Children's Health Insurance Program
(CHIP) populations and creates new enrollment pathways to maximize
enrollment and retention of eligible individuals.
Statement of Need: Since the implementation of the Affordable Care
Act (ACA), CMS has made improvements in streamlining the Medicaid and
CHIP application, eligibility determination, enrollment, and renewal
processes. Simplifying enrollment in Medicaid and CHIP coverage is a
foundational step in efforts to address health disparities for low-
income individuals. However, gaps remain in States' ability to
seamlessly process beneficiaries' eligibility and enrollment in order
to maximize coverage. This rule will provide States with the tools they
need to reduce unnecessary barriers to enrollment in Medicaid and CHIP
and to keep eligible beneficiaries covered.
Summary of Legal Basis: This rule responds to the January 28, 2021,
Executive Order on Strengthening Medicaid and the Affordable Care Act.
It addresses components of title XIX and title XXI of the Social
Security Act and several sections of the Patient Protection and
Affordable Care Act (Pub. L. 111-148) and the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised
several provisions of the Patient Protection and Affordable Care Act.
Alternatives: In developing the policies contained in this rule, we
considered numerous alternatives to the presented proposals, including
maintaining existing requirements. These alternatives will be described
in the rule.
Anticipated Cost and Benefits: The provisions in this rule will
streamline Medicaid and CHIP enrollment processes and ensure that
eligible beneficiaries can maintain coverage. While states and the
Federal Government may incur some initial costs to implement these
changes, this rule aims to reduce administrative barriers to
enrollment, which is expected to reduce administrative costs over time.
The provisions in this rule are designed to increase access to
affordable health coverage, and we believe that the benefits will
justify any costs. Additionally, through clear and consistent
requirements for the timely renewal of eligibility for all
beneficiaries, this rule promotes program integrity, thereby protecting
taxpayer funds at both the state and federal levels. As we move toward
publication, estimates of the cost and benefits of these provisions
will be included in the rule.
Risks: We anticipate that the provisions of this rule will further
the administration's goal of strengthening Medicaid and making high-
quality health care accessible and affordable for every American. At
the same time, through clear and consistent requirements for conducting
regular renewals of eligibility, acting on changes reported by
beneficiaries and maintaining thorough recordkeeping on these
activities, this rule will reduce the risk of improper payments.
Timetable:
[[Page 11042]]
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Action Date FR Cite
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NPRM................................ 09/07/22 87 FR 54760
NPRM Comment Period End............. 11/07/22 .......................
Final Action........................ 11/00/23 .......................
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Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Local, State.
Agency Contact: Sarah Delone, Deputy Director, Children and Adults
Health Programs Group, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Center for Medicaid and CHIP
Services, MS: S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244,
Phone: 410 786-5647, Email: [email protected].
RIN: 0938-AU00
HHS--ADMINISTRATION FOR CHILDREN AND FAMILIES (ACF)
Proposed Rule Stage
80. Foster Care Legal Representation [0970-AC89]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: sec. 474(a)(3) of the Social Security Act; sec.
1102 of the Social Security Act
CFR Citation: 45 CFR 1356.60(c).
Legal Deadline: None.
Abstract: This regulation proposes to allow a title IV-E agency to
claim Federal financial participation for the administrative cost of
providing independent legal representation to a child who is either a
candidate for foster care or in foster care, and his/her parent to
prepare for and participate in judicial determinations in foster care
and other related civil legal proceedings.
Statement of Need: Allowing title IV-E agencies to claim Federal
reimbursement for independent legal representation in legal proceedings
that are necessary to carry out the requirements in the agency's title
IV-E plan, including civil proceedings, may help prevent the need to
remove a child from the home or, for a child in foster care, achieve
permanency faster. Research demonstrates that some of the circumstances
bringing families into contact with the child welfare system (poverty,
educational neglect, inadequate housing, failure to provide adequate
nutrition, and failure to safeguard mental health due to domestic
violence) can be addressed before a child enters foster care by
providing legal representation early in foster care legal proceedings
and in civil legal matters. When children are removed from the home,
studies show having access to legal representation for civil legal
issues earlier in a case can improve the rate of reunification, nearly
double the speed to legal guardianship or adoption, and result in more
permanent outcomes for children and families.
Summary of Legal Basis: Section 474(a)(3) of the Act authorizes
Federal reimbursement for title IV-E administrative costs, which are
defined as costs found necessary by the Secretary for the provision of
child placement services and for the proper and efficient
administration of the State [title IV-E] plan. Section 1102 of the Act
authorizes the Secretary to publish regulations, not inconsistent with
the Act, as may be necessary for the efficient administration of the
functions with which the Secretary is responsible under the Act.
Alternatives: If this NPRM is not published, agencies may only
continue to claim FFP for administrative costs of independent legal
representation provided by attorneys representing children in title IV-
E foster care, children who are candidates for title IV-E foster care,
and the child's parents in all stages of foster care legal proceedings,
but not in other civil proceedings (See Child Welfare Policy Manual
(CWPM) 8.1B #30, 31 and 32).
Anticipated Cost and Benefits: This final rule impacts state and
tribal title IV-E (child welfare) agencies. ACF estimates that the
proposed regulatory change would cost the federal government $2,731
billion in FFP over 10 years. This proposal does not impose a burden or
cost on the title IV-E agency. The title IV-E agency has discretion to
provide allowable independent legal representation to families.
Risks: None.
Timetable:
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Action Date FR Cite
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NPRM................................ 01/00/23 .......................
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kathleen McHugh, Director, Division of Policy,
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human
Services, Administration for Children and Families, 330 C Street SW,
Room 3411, Washington, DC 20201, Phone: 202 401-5789, Fax: 202 205-
8221, Email: [email protected].
RIN: 0970-AC89
HHS--ACF
81. Separate Licensing Standards for Relative or Kinship Foster Family
Homes [0970-AC91]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 620 et seq.; 42 U.S.C. 670 et seq.; 42
U.S.C. 1302
CFR Citation: 45 CFR 1355.20.
Legal Deadline: None.
Abstract: This regulation proposes to allow title IV-E agencies to
adopt separate licensing standards for relative or kinship foster
family homes.
Statement of Need: Currently, the regulation provides that in order
to claim title IV-E, all foster family homes must meet the same
licensing standards, regardless of whether the foster family home is a
relative or non-relative placement. This Notice of Proposed Rulemaking
(NPRM) allows a title IV-E agency to adopt licensing or approval
standards for all relative foster family homes that are different from
the licensing standards used for non-related foster family homes.
Summary of Legal Basis: This NPRM is published under the authority
granted to the Secretary of Health and Human Services by section 1102
of the Social Security Act (Act), 42 U.S.C. 1302. Section 1102 of the
Act authorizes the Secretary to publish regulations, not inconsistent
with the Act, as may be necessary for the efficient administration of
the functions for which the Secretary is responsible pursuant to the
Act. Section 472 of the Act authorizes federal reimbursement for a FCMP
for an otherwise eligible child when the child is placed in a fully
licensed or approved foster family home.
Alternatives: There are no satisfactory alternatives to publishing
this NPRM. This change cannot be made in sub-regulatory guidance.
Anticipated Cost and Benefits: This NPRM impacts state and tribal
title IV-E agencies and does not impose a burden. The title IV-E agency
has discretion to develop separate licensing standards for relatives
and non-relatives and if they do so, they may claim title IV-E funding.
ACF estimates that the proposed regulatory change would cost the
Federal Government $3.085 billion in title IV-E foster care federal
financial participation over 10 years.
Risks: None.
Timetable:
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Action Date FR Cite
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NPRM................................ 01/00/23 .......................
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Regulatory Flexibility Analysis Required: No.
[[Page 11043]]
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kathleen McHugh, Director, Division of Policy,
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human
Services, Administration for Children and Families, 330 C Street SW,
Room 3411, Washington, DC 20201, Phone: 202 401-5789, Fax: 202 205-
8221, Email: [email protected].
RIN: 0970-AC91
HHS--ACF
82. Unaccompanied Children Program Foundational Rule [0970-AC93]
Priority: Other Significant.
Legal Authority: sec. 462 of the Homeland Security Act (6 U.S.C.
279)
CFR Citation: 45 CFR 410.
Legal Deadline: None.
Abstract: This rule would establish the regulatory framework for a
variety of activities currently conducted by the Office of Refugee
Resettlement's Unaccompanied Children (UC) Program. The rule would
target activities currently mandated under the Flores Settlement
Agreement (FSA), and it would further strengthen and codify additional
protections and service provisions for unaccompanied children.
Statement of Need: Historically, the UC Program has operated
largely without authorizing regulations enacted under the
Administrative Procedures Act or subject to notice-and-comment
rulemaking. Instead, virtually all ORR policies and procedures are
contained in an ORR Policy Guide, and more recently, official ORR Field
Guidance.
The UC Program is currently subject to the FSA, a consent decree
which was first agreed to on January 28, 1997, in the United States
District Court for the Central District of California. The court
continues to supervise the agreement, which, based on a subsequent
amendment, cannot terminate until 45 days after the agency publishes
rules implementing the agreement.
At this time, ORR seeks to promulgate a new UC Program Foundational
Rule, which will govern ORR activities that are currently governed by
the FSA along with the federal statutes concerning the UC program, and
address additional areas not contemplated in 1997 when the FSA was
instituted.
It is important to note that this rule will codify new and vital
protections for all children in ORR care, most of which currently are
only provided in ORR policies and procedures. Upon promulgation of the
final UC Program Foundational Rule, ORR will seek to terminate the FSA.
The long-term goal is for ORR to codify FSA requirements and provide
programmatic enhancements that will result in better and more durable
protections for all children in ORR care, including greater
transparency of ORR policies.
Summary of Legal Basis: ORR has broad statutory authority
concerning the care and custody of UC through the Homeland Security Act
of 2002 (HSA), 6 U.S.C. 279, and the William Wilberforce Trafficking
Victims Protection Reauthorization Act of 2008 (TVPRA), 8 U.S.C. 1232.
Alternatives: The agency could choose to not issue regulations and
continue to be governed by the FSA. However, as noted above, although
the FSA provides important protections, it was never intended to
permanently govern the program, and regulations are needed to codify
enhancements that will result in better and more durable protections
for all children in ORR care.
Anticipated Cost and Benefits: ORR anticipates new costs associated
with this rule particularly those associated with staffing increases
(e.g., related to administrative hearings as part of due process
protections) and will work to estimate the costs based on updated
staffing requirements, costs associated with promulgation of the
federal rule, and any other associated costs.
Risks: No programmatic risks are anticipated.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses, Organizations.
Government Levels Affected: None.
Agency Contact: Toby Biswas, Senior Supervisory Policy Counsel,
Department of Health and Human Services, Administration for Children
and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 555-
4440, Email: [email protected].
RIN: 0970-AC93
HHS--ACF
83. Federal Licensing of Office of Refugee Resettlement Facilities
[0970-AC94]
Priority: Other Significant.
Legal Authority: sec. 462 of the Homeland Security Act (6 U.S.C.
279)
CFR Citation: 45 CFR 412.
Legal Deadline: None.
Abstract: This rule would provide the regulatory framework for new
Federal licensing of shelter care providers for unaccompanied children.
This framework would be used when State governments do not provide
State licensing for such providers under certain circumstances. The new
office created to manage the Federal licensing will be proposed to be
located within the Administration for Children and Families, but not
within the Office of Refugee Resettlement.
Statement of Need: ORR's Unaccompanied Children (UC) Program is
responsible for the administration of childcare shelters that provide
care to UC arriving in the United States, prior to being placed with
vetted sponsors. As of December 2021, ORR supports over 250 licensed
care provider shelters in 25 states under approximately 150 separate
grants between ORR and its network of care providers.
In addition, the Flores Settlement Agreement (FSA) generally
requires that UC be placed in a state-licensed shelters subject to
certain exceptions and expresses a specific preference for placements
in geographic locations in which a majority of children are
apprehended. Critically, none of ORR's authorizing statutes mandate
placement in state-licensed shelters.
ORR has cultivated a large network of state-licensed shelters and
developed close, cooperative relationships with many of the partner
states that oversee and enforce their own licensing processes for ORR
care providers. Accordingly, ORR has not attempted to fulfill all of
the functions of, nor provide the services typically performed by,
state agencies involved in the licensure and oversight of child care
facilities with respect to compliance with state licensing
requirements, such as conducting facility inspections, facilitating and
processing background checks, and investigating child abuse/neglect
allegations.
Recent actions by Texas and Florida to restrict or exempt from
state licensure of ORR UC care provider facilities have required ORR to
re-evaluate how to continue providing care for UC consistent with the
FSA's expectation that children be placed in state-licensed shelters in
those states, which represent a significant proportion of ORR's overall
UC bed space. ACF has determined that the HSA's and TVPRA's broad grant
of authority to ORR to manage the care and custody of UC authorizes the
Department of Health and Human Services (HHS) to federally license
shelters that house UC where states abdicate their traditional
licensing responsibilities. This authority has been further delegated
to ACF. ACF believes this change is necessary because
[[Page 11044]]
additional states have recently taken steps to sever ORR grantees'
access to state licensure through executive action. ACF has determined
that implementing federal licensure in these states can substantively
address concerns underlying the FSA's requirement that UC shelters be
state licensed (e.g. establishment and monitoring of facility standards
not addressed by ORR policies, by authorities that are independent of
ORR).
To continue serving UC and maintain quality of care in states that
have restricted the availability of licensure to UC care providers, ORR
has determined that the most effective response is for HHS, through
ACF, to develop federal licensing standards for its care provider
facilities under certain circumstances.
ORR will propose that this function be carried out by the proposed
Office of Residential Licensure for Unaccompanied Children (ORLUC), to
sit within ACF but independent of ORR. That office would oversee the
issuance of licensing standards, implement monitoring, and oversee
associated processes including federal license revocations.
Summary of Legal Basis: ORR has broad statutory authority
concerning the care and custody of UC through the Homeland Security Act
of 2002 (HSA), 6 U.S.C. 279, and the William Wilberforce Trafficking
Victims Protection Reauthorization Act of 2008 (TVPRA), 8 U.S.C. 1232.
Alternatives: If this rule is not issued, ACF will lack the legal
authority to issue licenses and enforce licensing requirements in
states that have acted to restrict the availability of licensure to
organizations funded by ORR to carry out the UC program. This would
limit ACF's ability to ensure the safety and well-being of children in
its care, and to comply with the intent of the FSA.
Anticipated Cost and Benefits: The proposed regulations would
result in costs to federal licensees, prospective federal licensees,
ORR, and to ACF in implementing the proposed federal licensure program.
Based on ACF's analysis, costs associated with the proposed regulations
range from approximately $153 to $220 per licensee for submitting
licensure applications and corrective action plans, as necessary. In
addition, ACF conducted a regulatory impact analysis to assess costs
associated with other requirements in the proposed rule such as
updating policy and/or training staff, hiring additional staff, and
implementing facility changes. At this time, ACF lacks the ability to
estimate the potential costs specific to potentially affected care
providers, especially with regard to changes to facilities. Therefore,
ACF is required to make assumptions general to all prospective federal
licensees in implementing any necessary changes. On average, ACF
estimates that updates to affected facility policies or staff training
will cost licensees between $17.32 and $34.68 per childcare worker.
Should a federal licensee need to hire additional staff in order to
come into compliance with federal licensure standards, ACF estimates
the average cost to be $36,361 per year per worker.
The proposed rule would also result in associated federal costs of
the establishment and operation of ORLUC. Based on ACF's analysis, the
federal costs associated with the proposed regulations would be
approximately $6.4 million in the first fiscal year once they are
finalized. ACF also notes that many potential federal licensees
discussed in this proposed rule are ACF grantees and the costs of
maintaining compliance with licensing requirements are allowable costs
to grant awards under the Basic Considerations for cost provisions at
45 CFR part 75, sections 403 through 405, if that the costs are
reasonable, necessary, ordinary, treated consistently, and are
allocable to the award. Additional costs associated with the policies
discussed in this proposed rule that were not budgeted, and cannot be
absorbed within existing budgets, would be allowable for the grant
recipient to submit a request for supplemental funds to cover the
costs, and may therefore result in additional federal costs.
Risks: No programmatic risks are anticipated.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23 .......................
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Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses, Organizations.
Government Levels Affected: None.
Agency Contact: Toby Biswas, Senior Supervisory Policy Counsel,
Department of Health and Human Services, Administration for Children
and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 555-
4440, Email: [email protected].
RIN: 0970-AC94
HHS--ACF
84. Strengthening TANF as a Safety Net and Work Program [0970-
AC97]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 609
CFR Citation: 45 CFR 260.
Legal Deadline: None.
Abstract: This rule would strengthen the Temporary Assistance for
Needy Families (TANF) program as a safety net and a work preparation
program, make changes to allowable uses of TANF funds, improve work
program effectiveness, and reduce administrative burden. The rule
responds to the President's Executive Order on Advancing Racial Equity
and Support for Underserved Communities Through the Federal Government,
as well as the Biden-Harris Administration's priority to build a bridge
towards economic recovery. The rule aims to increase support for
families with the greatest needs and the services most integral to the
safety net, including cash assistance, and help to reduce racial
inequities across states. Additionally, the rule aims to help states to
tailor effective workforce services to the needs of each family and
reduce administrative burden.
Statement of Need: In fiscal year (FY) 2020, combined federal TANF
and state maintenance-of-effort (MOE) expenditures and transfers
totaled $31.6 billion. Of that amount only 22 percent was spent on
basic assistance, compared to 71 percent in FY 1997. As a result, TANF
currently serves less than 25 percent of eligible families across the
country, as compared to 1997 when TANF served almost 70 percent of
eligible families. States in which the lowest proportion of families in
poverty receive cash benefits also have proportionally larger shares of
Black and Latinx children. The rule aims to address these shortcomings
and would align with the Administration's efforts to address equity,
focus on upstream preventions, and increase opportunities for economic
mobility for low-income families. The NPRM may consider changes around
use of funds, eligible families, state MOE spending, and work
flexibilities.
Summary of Legal Basis: The proposed regulations will relate to
allowable spending, eligible work activities and penalties, and
administrative simplification. The NPRM would be issued under the
Secretary's authority to issue regulations where Congress has charged
the Department with enforcing penalties, 42 U.S.C. 609.
Alternatives: Without these regulatory changes around allowable
uses of funds, states will continue to underinvest in services most
integral to the safety net, including cash assistance, and supports for
families with the greatest needs. Without regulatory changes to improve
work program effectiveness, states will
[[Page 11045]]
have less flexibility to tailor employment and training services to the
needs of each family. Lastly, in the absence of these regulatory
changes, states will not experience any relief in their administrative
burden to operate the TANF program.
Anticipated Cost and Benefits: This NPRM imposes no costs on the
federal government nor does it change overall funding amounts or
spending requirements for states, territories, and tribes, as TANF is a
fixed block grant. We anticipate a benefit in the transfer of funding
toward critical supports to families experiencing economic hardships.
Risks: While we expect more low-income families to receive TANF
benefits and receive more effective work-related services, this action
may result in states having to increase their own spending to fund
activities previously funded by federal TANF dollars or previously
counted as state MOE spending.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23 .......................
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Deborah List, Associate Deputy Director, Office of
Family Assistance, Department of Health and Human Services,
Administration for Children and Families, 330 C Street SW, Washington,
DC 20201, Phone: 202 401-5488, Email: [email protected].
RIN: 0970-AC97
HHS--ACF
85. Adoption and Foster Care Analysis and Reporting System
(AFCARS) [0970-AC98]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 679
CFR Citation: 45 CFR 1355.41 et seq.
Legal Deadline: None.
Abstract: To ensure equitable treatment of all children and youth
in child welfare, including Native American and LGBTQ+ children and
youth, this rule will propose to require title IV-E agencies to collect
and report for AFCARS additional information related to youth, foster
parents, adoptive parents, and legal guardians. AFCARS data is used for
planning, technical assistance, discretionary service grants, and
research and evaluation, all with the goal of reducing entry into and
improving outcomes of children in foster care.
Statement of Need: This NPRM is consistent with the
Administration's priority of advancing equity for those historically
underserved and adversely affected by persistent poverty and
inequality. Native and LGBTQI+ children are over-represented
populations in the child welfare system; however, the experiences of
LGBTQI+ children in foster care and Native children are not fully
captured in current child welfare data systems. As such, adding sexual
orientation and ICWA data elements removed from the 2020 rule would
make the experiences of these children more visible and may provide
better insight into the trajectory of LGBTQI+ and Native children in
foster care. It will also provide avenues for collaboration between
states and tribes, in areas such as technical assistance, training and
resource allocation that would be informed by the additional ICWA data
elements. We anticipate that this is a critical step in addressing the
needs of this population, and also will assist title IV-E agencies in
recruiting and training foster care providers in meeting the needs of
these youth. We will also consider potentially adding other elements
that were removed by a May 2020 AFCARS Final Rule, such as health and
education data.
Summary of Legal Basis: AFCARS is authorized by section 479 of the
Social Security Act (the Act), which mandates that the Department of
Health and Human Services (HHS) regulate a data collection system for
national adoption and foster care data. Section 474(f) of the Act
requires HHS to impose penalties for non-compliant AFCARS data. Section
1102 of the Act authorizes the Secretary to publish regulations, not
inconsistent with the Act, as may be necessary for the efficient
administration of the functions with which the Secretary is responsible
under the Act.
Alternatives: If this NPRM is not published, title IV-E agencies
are required to report to AFCARS (beginning 10/1/22 under the 2020
final rule) related to ICWA: the child's tribal membership and name of
Tribe; tribal membership for the child's the parents, foster parents,
adoptive parents, and legal guardians; whether the state made inquiries
if the child is an Indian child as defined in ICWA; whether ICWA
applies for the child and if yes, the date that the state was notified
by the Indian tribe or state or tribal court that ICWA applies; and
whether the child's tribe(s) was sent legal notice. Title IV-E agencies
are not required to report on sexual orientation in AFCARS currently.
Anticipated Cost and Benefits: There will be new state/tribe and
federal costs associated with requiring title IV-E agencies to report
additional AFCARS data elements, and the cost is contingent on the
scope of the NPRM.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/23 .......................
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Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Agency Contact: Kathleen McHugh, Director, Division of Policy,
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human
Services, Administration for Children and Families, 330 C Street SW,
Room 3411, Washington, DC 20201, Phone: 202 401-5789, Fax: 202 205-
8221, Email: [email protected].
RIN: 0970-AC98
HHS--ACF
86. Modification of the Tribal Non-Federal Share Requirement
[0970-AC99]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 655(f)
CFR Citation: 45 CFR 309; 45 CFR 310.
Legal Deadline: None.
Abstract: This rule would modify the non-Federal share of program
expenditures requirement, including the 90/10 and 80/20 cost sharing
rates, for Tribal child support enforcement programs.
Statement of Need: The requirement to provide the non-Federal share
of program expenditures has been a longstanding issue for Tribal child
support enforcement programs. It limits growth, causes disruptions, and
creates instability. Modifying the non-Federal share requirement
prevents existing Tribal child support enforcement programs from
closing. It implements guidance provided by the Secretary that the
match rate would be revised if it were disruptive and imposed hardship
(see 65 Fed Reg. at 50823). It also removes a major barrier that
hinders prospective Tribes and Tribal organizations from administering
a Tribal child support enforcement program. Most importantly, it
ensures the opportunity for Tribal families to
[[Page 11046]]
receive child support services that reflect and affirm their Tribal
cultures and traditions, promote parental responsibility, create
financial stability, and lift Tribal families out of poverty. In FY
2020, Tribal child support enforcement programs collected $58 million
in child support payments and 96 percent went to families.
Summary of Legal Basis: Section 455(f) of the Social Security Act
(the Act) requires the Secretary to issue regulations governing the
grants to Tribes and Tribal organizations operating child support
enforcement programs. Additionally, section 1102 of the Act authorizes
the Secretary to publish regulations, not inconsistent with the Act, as
may be necessary for the efficient administration of the functions with
which the Secretary is responsible under the Act.
Alternatives: If the NPRM is not published, many Tribal child
support enforcement programs will continue to reduce services, delay
filling vacancies, forgo system upgrades, and operate at a limited
capacity so that they can meet the non-Federal share of program
expenditures. Some Tribal child support enforcement programs will
continue to face the danger of closing and may eventually be forced to
close. Additionally, many prospective Tribes and Tribal organizations
will be unable to apply for funding to operate a Tribal child support
enforcement program due to the non-Federal share requirement.
Anticipated Cost and Benefits: ACF estimates that a modification to
the regulation will result in increased costs to the Federal government
but will also result in additional tribal child support programs added
to serve children and families.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Chad Sawyer, Senior Policy Specialist, Department
of Health and Human Services, Administration for Children and Families,
330 C Street SW, Washington, DC 20201, Phone: 202 774-2323, Email:
[email protected].
RIN: 0970-AC99
HHS--ACF
Final Rule Stage
87. ANA Non-Federal Share Emergency Waivers [0970-AC88]
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 2991b
CFR Citation: 45 CFR 1336.
Legal Deadline: None.
Abstract: This regulation proposes to streamline the process for
Administration for Native Americans (ANA) grant program applicants to
request a waiver for non-federal share for the 20 percent match
required by statute for ANA grants. The regulation will also propose
the ability for current grantees to request an emergency waiver for the
non-federal share match.
Statement of Need: The Native American Programs Act of 1974 (NAPA),
as amended, requires projects awarded funding through sections 803,
804, and 805 provide a 20 percent match of the total cost of the
project, unless a waiver is obtained through objective criteria as
outlined in ANA's regulations. The current regulations outline the
requirements and criteria for applicants to request a waiver for non-
federal share (NFS) at 45 CFR part 1336.50 at the time of application
for a new or continuation award. The COVID-19 pandemic had a
detrimental impact on the economies and financial resources of ANA's
Native American recipients, most of whom had to close their borders to
protect their citizens. Many tribal enterprises were forced to close,
and tourism revenues became non-existent. Partnerships and vendors were
no longer able to contribute previously committed resources for NFS.
During this time, many recipients grew concerned that they would be
unable to fully meet their NFS of their grant award. ANA explored the
possibility of providing emergency NFS waivers to ANA grantees.
Unfortunately, ANA learned that it does not currently have the
authority to issue emergency NFS waivers, as neither emergency waiver
authority nor a process to approve such requests exists in ANA's
regulations. Current regulations require waiver requests to be
submitted at the time of application or during the non-competitive
continuation process. This request to update ANA's regulation would
provide a new provision for recipients to request an emergency NFS
waiver in the event of a natural or man-made emergency such as a public
health pandemic.
Summary of Legal Basis: The Native American Programs Act of 1974
(NAPA), as amended, requires projects awarded funding through sections
803, 804, and 805 provide a 20 percent match of the cost of the
project, unless a waiver is obtained through objective criteria as
outlined in ANA's regulations. Current regulations outline the
requirements and criteria to request a waiver at 45 CFR part 1336.50 at
the time of application for a new or continuation award. However, there
is no existing regulations or criteria to provide an emergency waiver
for NFS to recipients experience a natural or man-made disaster or
public health emergency such as COVID-19.
Alternatives: The alternative would be to not offer the emergency
waiver.
Anticipated Cost and Benefits: There are no known costs to the
program by issuing this rule. This final rule is responsive to the
President's Executive Order 13995 (Ensuring an Equitable Pandemic
Response and Recovery) and Executive Order 14002 (Economic Relief
Related to the COVID-19 Pandemic), as well as responsive to the needs
of Native American communities. Existing regulations state that ANA
must determine that approval of an NFS waiver will not prevent the
award of other grants at levels it believes are desirable for the
purposes of the program. Approval of this emergency waiver regulation
will also decrease the potential audit findings of entities not meeting
the required NFS. In addition, it reduces further harm to recipients
that are impacted by an emergency situation, which caused unforeseen
and additional financial hardships.
Risks: There are no known risks to the program by issuing this
rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/07/21 86 FR 69215
NPRM Comment Period End............. 02/07/22 .......................
Final Action........................ 04/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Mirtha Beadle, Senior Policy Advisor, Department of
Health and Human Services, Administration for Children and Families,
330 C Street SW, Washington, DC 20201, Phone: 202 401-6506, Email:
[email protected].
RIN: 0970-AC88
[[Page 11047]]
HHS--ADMINISTRATION FOR COMMUNITY LIVING (ACL)
Proposed Rule Stage
88. Older Americans Act, Titles III, VI, and VII [0985-AA17]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 3001 et seq.
CFR Citation: 45 CFR 1321 to 1324.
Legal Deadline: None.
Abstract: The proposed rule would amend the regulations
implementing programs under the Older Americans Act (OAA) (42 U.S.C.
3001 et seq.): 45 CFR part 1321 (Grants to State and Community Programs
on Aging); 45 CFR part 1322 (Grants to Indian Tribes for Support and
Nutrition Services); 45 CFR part 1323 (Grants for Supportive and
Nutritional Services to Older Hawaiian Natives); and 45 CFR part 1324
(Allotments for Vulnerable Elder Rights Protection Activities,
including Subpart A State Long-Term Care Ombudsman Program). The
proposed rule would make revisions to these regulations to align with
the OAA as reauthorized in 2020. Current OAA regulations are more than
30 years old (issued in 1988), other than portions of 45 CFR part 1321
and 1324 regarding the State Long-Term Care Ombudsman Program, which
were issued in 2015.
Statement of Need: The proposed rule would make important revisions
to these regulations following the reauthorization of the Act in 2020.
The majority of the current regulations associated with this Act are
more than 30 years old, so updates to these regulations will allow for
an overall alignment of regulations with current statutory language,
related regulatory language and circumstances in the field. These
regulations also provide an important opportunity to advance equity in
the OAA programs as envisioned by the statute and consistent with
current executive orders.
Summary of Legal Basis: Development, promulgation and
implementation of regulations for OAA programs have been and will be
carried out consistently with the statute. This particular regulatory
action is not required by the reauthorization of the statute or court
order.
Alternatives: ACL considers sub-regulatory guidance, information
and education outreach, and voluntary approaches as alternatives to
regulatory action. None of these alternatives are the appropriate
option for promulgating and administering the provisions that will be
included in the regulations consistent with statute. Economic
incentives and instruments are not an option.
Anticipated Cost and Benefits: To be determined. A regulatory
impact analysis is concurrently underway.
Risks: These regulations would update past and establish new
regulatory provisions consistent with the reauthorization of the OAA in
2020. Promulgating this NPRM and obtaining public feedback in order to
issue a new final rule will result in decreased risk for administering
agencies at the federal, state and local level in ensuring the
administration of the OAA programs consistent with the statute, and in
also supporting the statute's purpose of reducing the risk of injury,
disease, disability and institutional placement of older adults.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Request for Information (RFI)....... 05/06/22 87 FR 27160
Request for Information Comment 06/06/22
Period End.
NPRM................................ 06/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State, Tribal.
Agency Contact: Richard Nicholls, Chief of Staff and Executive
Secretary, Department of Health and Human Services, Administration for
Community Living, 330 C Street SW, Room 1004B, Washington, DC 20201,
Phone: 202 795-7415, Fax: 202 205-0399, Email:
[email protected].
RIN: 0985-AA17
HHS--ACL
89. Adult Protective Services Functions and Grant Programs
[0985-AA18]
Priority: Other Significant.
Legal Authority: Elder Justice Act (SSA sec. 2042. [42 U.S.C.
1397m-1] (a) Secretarial Responsibilities)
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The proposed rule would create federal regulations for
Adult Protective Services (APS) programs as authorized by the Elder
Justice Act. APS programs were originally recognized by federal law in
1975 under title XX of the Social Security Act via the Social Services
Block Grant (SSBG). States have wide discretion whether to allocate any
funding to APS via the SSBG program, and there are no regulations
pertaining to APS under SSBG. Since 1975, all 50 states, the District
of Columbia, and four territories have developed APS programs in
accordance with local needs, structures, and laws. Historic investments
through the Coronavirus Relief and Response Supplemental Appropriations
Act (CRRSA) and the American Rescue Plan Act (ARPA) provided the very
first funding for APS program formula funding to states as authorized
by the Elder Justice Act (EJA). These regulations would promote an
effective APS response across the country so that all older adults and
adults with disabilities, regardless of the state or jurisdiction in
which they live, have similar protections and service delivery from APS
systems.
Statement of Need: The proposed rule would create federal
regulations for Adult Protective Services (APS) programs as authorized
by the Elder Justice Act (EJA). These regulations are critical in
establish consistent national requirements and standards for EJA APS
program formula funding to states.
Summary of Legal Basis: Development, promulgation and
implementation of this regulation will be carried out consistently with
the statute; however, this regulatory action is not required by the
statute or a court order.
Alternatives: ACL considers sub-regulatory guidance, information
and education outreach, and voluntary approaches as alternatives to
regulatory action. Prior to the availability of appropriations for
formula funding for this program ACL utilized guidance and voluntary
approach for the establishment of a national data system and in
supporting the establishment and dissemination of program best
practices. However, now that federal funding is available to all states
and territories, none of these alternatives are the appropriate option
for promulgating and administering the provisions that will be included
in the regulations consistent with statute. Economic incentives and
instruments are not an option.
Anticipated Cost and Benefits: To be determined. A regulatory
impact analysis is concurrently underway.
Risks: These regulations would establish first ever regulations for
APS programs consistent with the Elder Justice Act passed in 2010.
Promulgating this NPRM and obtaining public feedback in order to issue
a new final rule will result in decreased risk for administering
agencies at the federal, state and local level in ensuring the
administration of appropriations for APS programs consistent with the
statute, and in also supporting the
[[Page 11048]]
statute's programmatic purpose of detecting, preventing and reducing
the abuse, neglect and exploitation of adults, including older adults.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: State.
Agency Contact: Richard Nicholls, Chief of Staff and Executive
Secretary, Department of Health and Human Services, Administration for
Community Living, 330 C Street SW, Room 1004B, Washington, DC 20201,
Phone: 202 795-7415, Fax: 202 205-0399, Email:
[email protected].
RIN: 0985-AA18
BILLING CODE 4150-03-P
DEPARTMENT OF HOMELAND SECURITY (DHS)
Fall 2022 Statement of Regulatory Priorities
The Department of Homeland Security (DHS or Department) was
established in 2003 pursuant to the Homeland Security Act of 2002,
Public Law 107-296. The DHS mission statement provides the following:
``With honor and integrity, we will safeguard the American people, our
homeland, and our values.''
DHS was created in the aftermath of the horrific attacks of 9/11,
and its distinctive mission is defined by those words. The phrase
``homeland security'' refers to the security of the American people,
the homeland (understood in the broadest sense), and the nation's
defining values. A central part of the mission of protecting ``our
values'' includes fidelity to law and the rule of law, reflected above
all in the Constitution of the United States, and also in statutes
enacted by Congress, including the Administrative Procedure Act. That
commitment is also associated with a commitment to individual dignity.
Among other things, the attacks of 9/11 were attacks on that value as
well.
The regulatory priorities of DHS are founded an insistence on the
rule of law--and also on a belief that individual dignity, symbolized
and made real by the opening words of the Constitution (``We the
People''), the separation of powers, and the Bill of Rights (including
the Due Process Clause), helps to define our mission.
Fulfilling that mission requires the dedication of more than
240,000 employees in jobs that range from aviation and border security
to emergency response, from cybersecurity analyst to chemical facility
inspector, from the economist seeking to identify the consequences of
our actions to the scientist and policy analyst seeking to make the
nation more resilient against flooding, drought, extreme heat, and
wildfires. Our duties are wide-ranging, but our goal is clear: keep
America safe.
There are six overarching homeland security missions that make up
DHS's strategic plan: (1) Counter terrorism and homeland security
threats; (2) secure U.S. borders and approaches; (3) secure cyberspace
and critical infrastructure; (4) preserve and uphold the Nation's
prosperity and economic security; (5) strengthen preparedness and
resilience (including resilience from risks actually or potentially
aggravated by climate change); and (6) champion the DHS workforce and
strengthen the Department. See also 6 U.S.C. 111(b)(1) (identifying the
primary mission of the Department).
In promoting these goals, we attempt to evaluate our practices by
reference to evidence and data, and to improve them in real time. We
also attempt to deliver our multiple services in a way that, at once,
protects the American people and does not impose excessive or
unjustified barriers and burdens on those who use them.
In achieving those goals, we are committed to public participation
and to listening carefully to the American people (and to noncitizens
as well). We are continually strengthening our partnerships with
communities, first responders, law enforcement, and Government
agencies--at the Federal, State, local, tribal, and international
levels. We are accelerating the deployment of science, technology, and
innovation in order to make America more secure against risks old and
new--and to perform our services better. We are becoming leaner,
smarter, and more efficient, ensuring that every security resource is
used as effectively as possible. We are reducing administrative burdens
and simplifying our processes. For a further discussion of our mission,
see the DHS website at https://www.dhs.gov/mission.
The regulations we have summarized below in the Department's Fall
2022 regulatory plan and agenda support the Department's mission. We
are committed to continuing evaluation of our regulations, consistent
with Executive Order 13563, and Executive Order 13707, and in a way
that improves them over time. These regulations will improve the
Department's ability to accomplish its mission. Also, these regulations
address legislative initiatives such as the ones found in the
Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11
Act) and the FAA Extension, Safety, and Security Act of 2016.
We emphasize here our commitments (1) To fidelity to law; (2) to
treating people with dignity and respect; (3) to increasing national
resilience against multiple risks and hazards, including those actually
or potentially associated with climate change; (4) to modernization of
existing requirements; and (5) to reducing unjustified barriers and
burdens, including administrative burdens.
DHS strives for organizational excellence and uses a centralized
and unified approach to managing its regulatory resources. The Office
of the General Counsel manages the Department's regulatory program,
including the agenda and regulatory plan. In addition, DHS senior
leadership reviews each significant regulatory project in order to
ensure that the project fosters and supports the Department's mission.
The Department is committed to ensuring that all of its regulatory
initiatives are aligned with its guiding principles to remain faithful
to law, protect civil rights and civil liberties, integrate our
actions, listen to those affected by our actions, build coalitions and
partnerships, develop human resources, innovate, and be accountable to
the American public.
DHS is strongly committed to the principles described in Executive
Orders 13563 and 12866 (as amended). Both Executive Orders direct
agencies to assess the costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits. Executive Order 13563 emphasizes
the importance of quantifying both costs and benefits, of reducing
costs, of harmonizing rules, and of promoting flexibility. Executive
Order 13563 explicitly draws attention to human dignity and to equity.
Finally, the Department values public involvement in the
development of its regulatory plan, agenda, and regulations. It is
particularly concerned with the impact its regulations have on small
businesses and startups, consistent with its commitment to promoting
economic growth. DHS is also concerned to ensure that its regulations
are equitable, and that they do not have unintended or adverse effects
on (for example) women,
[[Page 11049]]
disabled people, people of color, or the elderly. Its general effort to
modernize regulations, and to remove unjustified barriers and burdens,
is meant in part to avoid harmful effects on small businesses,
startups, and disadvantaged groups of multiple sorts. DHS and its
components continue to emphasize the use of plain language in our
regulatory documents to promote a better understanding of regulations
and to promote increased public participation in the Department's
regulations. We want our regulations to be transparent and
``navigable,'' so that people are aware of how to comply with them (and
in a position to suggest improvements).
The Fall 2022 regulatory plan for DHS includes regulations from
multiple DHS components, including the Federal Emergency Management
Agency (FEMA), U.S. Citizenship and Immigration Services (USCIS), the
U.S. Coast Guard (the Coast Guard), U.S. Customs and Border Protection
(CBP), Transportation Security Administration (TSA), U.S. Immigration
and Customs Enforcement (ICE), and the Cybersecurity and Infrastructure
Security Agency (CISA). We next describe the regulations that comprise
the DHS fall 2022 regulatory plan.
Federal Emergency Management Agency
The Federal Emergency Management Agency (FEMA) is the government
agency responsible for helping people before, during, and after
disasters. FEMA supports the people and communities of our Nation by
providing experience, perspective, and resources in emergency
management. FEMA is particularly focused on national resilience in the
face of the risks of flooding, drought, extreme heat, and wildfire; it
is acutely aware that these risks, and others, are actually or
potentially aggravated by climate change. FEMA seeks to ensure, to the
extent possible, that changing weather conditions do not mean a more
vulnerable nation. FEMA is also focused on individual equity, and it is
aware that administrative burdens and undue complexity might produce
inequitable results in practice.
Consistent with President Biden's Executive Order on Climate
Related Financial Risk (Executive Order 14030), FEMA will propose a
regulation titled National Flood Insurance Program: Standard Flood
Insurance Policy, Homeowner Flood Form. The National Flood Insurance
Program (NFIP), established pursuant to the National Flood Insurance
Act of 1968, is a voluntary program in which participating communities
adopt and enforce a set of minimum floodplain management requirements
to reduce future flood damages. Property owners in participating
communities are eligible to purchase NFIP flood insurance. This
proposed rule would revise the Standard Flood Insurance Policy by
adding a new Homeowner Flood Form and five accompanying endorsements.
The new Homeowner Flood Form would replace the Dwelling Form as a
source of coverage for homeowners of one-to-four family residences.
Together, the new Form and endorsements would more closely align with
property and casualty homeowners' insurance and provide increased
options and coverage in a more user-friendly and comprehensible format.
FEMA will also propose a regulation titled Individual Assistance
Program Equity to further align with Executive Order 13985, Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government. FEMA will propose to amend its Individual
Assistance (IA) regulations to increase equity and ease of entry to the
IA Program. To provide a full opportunity for underserved communities
to participate in the program, FEMA will propose to amend application
of ``safe, sanitary, and functional'' for the Individuals and
Households Program Home Repair assistance; re-evaluate the requirement
to apply for a Small Business Administration loan prior to receipt of
certain types of Other Needs Assistance; add eligibility criteria for
its Serious Needs and Displacement Assistance; amend its requirements
for Continued Temporary Housing Assistance; re-evaluate its approach to
insurance proceeds; and amend its appeals process. FEMA will also
propose revisions to reflect changes to statutory authority that have
not yet been implemented in regulation, to include provisions for
utility and security deposit payments, lease and repair of multi-family
rental housing, child care assistance, maximum assistance limits, and
waiver authority. Finally, FEMA will propose allowing self-employed
individuals to receive assistance for essential tools under Other Needs
Assistance, allowing certain home repair accessibility-related items,
and allowing the reopening of the registration period when the
President adds new counties to the major disaster declaration.
In addition, FEMA will propose a regulation titled Update of FEMA's
Public Assistance Regulations. FEMA proposes to revise its Public
Assistance program regulations to reflect current statutory authorities
and implement program improvements. The proposed rule would incorporate
changes brought about by amendments to the Robert T. Stafford Disaster
Relief and Emergency Assistance Act. FEMA is also proposing
clarifications and corrections to improve the efficiency and
consistency of the Public Assistance program.
Additionally, FEMA will propose a regulation titled Updates to
Floodplain Management and Protection of Wetlands Regulations consistent
with President Biden's Executive Order on Climate Related Financial
Risk (Executive Order 14030). FEMA proposes to amend its existing
regulations to incorporate amendments that have been made to Executive
Order 11988 and the Federal Flood Risk Management Standard (FFRMS). The
FFRMS is a flexible framework allowing agencies to choose among three
approaches to define the floodplain and corresponding flood elevation
requirements for federally funded projects. Existing regulations
describe FEMA's process for determining whether the proposed location
for an action falls within a floodplain and how to complete the action
in the floodplain, in light of the risk of flooding. The proposed rule
would change how FEMA defines a floodplain with respect to certain
actions. Additionally, under the proposed rule, FEMA would use natural
systems, ecosystem process, and nature-based approaches, where
practicable, when developing alternatives to locating the proposed
action in the floodplain.
Finally, FEMA continues to engage with the public related to its
floodplain management standards. On October 12, 2021, FEMA issued a
Request for Information to receive the public's input on revising the
NFIP's floodplain management standards for land management and use
regulations to better align with the current understanding of flood
risk and flood risk reduction approaches. FEMA's authority under the
National Flood Insurance Act requires the agency to, from time to time,
develop comprehensive criteria designed to encourage the adoption of
adequate State and local measures. The agency is reviewing potential
actions to better align the NFIP minimum floodplain management
standards with FEMA's current understanding of flood risk, flood
insurance premium rates, and risk reduction approaches to make
communities safer, stronger, and more resilient to increased flooding.
FEMA is considering revisions to the minimum standards to better
protect people and property in a nuanced manner that balances community
needs with the
[[Page 11050]]
national scope of the NFIP while also incorporating opportunities for
improving resilience in communities that have been historically
underserved. FEMA is also considering revisions to the minimum
standards that would advance the conservation of threatened and
endangered species and their habitat. In response to a separate Request
for Information, FEMA is also reviewing ways to further promote
enhanced resilience efforts through the Community Rating System.
United States Citizenship and Immigration Services
U.S. Citizenship and Immigration Services (USCIS) is the government
agency that administers the nation's lawful immigration system,
safeguarding its integrity and promise by efficiently and fairly
adjudicating requests for immigration benefits with integrity and
respect for all we serve. To the extent permitted by law, USCIS is
committed to meeting the economic needs of U.S. employers, reducing
unnecessary barriers to legal immigration, increasing access to legally
authorized immigration benefits, and reinvigorating the size and scope
of humanitarian relief. In the coming year, USCIS intends to pursue
several regulatory actions that support these goals while balancing
this work with our fiscal stability goals.
Employment Issues, Economic Needs, and Lawful Pathways. USCIS is
focused on promulgating policies that are responsive to the needs of
the U.S. economy and U.S. employers, while providing lawful pathways to
work in the United States and also protecting the rights of both U.S.
and noncitizen workers. USCIS will propose a rule to modernize and
reform the H-2A and H-2B programs. The proposed rule will incorporate
necessary program efficiencies and meet the legitimate needs of U.S.
employers; it will include provisions designed to protect against the
exploitation or other abuse of H-2A and H-2B workers. (Modernization
and Reform of the H-2 Programs.)
Improvements to the Overall Immigration System. USCIS will propose
adjustments to certain immigration and naturalization benefit request
fees (after performing the required biennial fee review) to ensure that
fees recover full costs borne by USCIS. In doing so, USCIS will adhere
to the ideals of removing unjustified barriers and promoting access to
the immigration system (to promote, among other things, economic needs
and economic growth); improving and expanding naturalization
processing; and implementing the administration's humanitarian
priorities. (USCIS Fee Schedule and Changes to Certain Other
Immigration Benefit Request Requirements.) In addition, USCIS plans to
take steps to reform the regulations governing the adjustment of status
to lawful permanent residence to improve the efficiency and
administration of that program. USCIS will propose a rule that updates
outdated regulations, reduces the potential for visa retrogression, and
promotes the efficient use of immediately available immigrant visas.
(Improving the Regulations Governing the Adjustment of Status to Lawful
Permanent Residence and Related Immigration Benefits.) Lastly, USCIS
will propose a rule to clarify and update eligibility requirements
governing citizenship and naturalization. (Citizenship and
Naturalization and Other Related Flexibilities.)
Humanitarian Relief. USCIS will propose reforms to the U
nonimmigrant visa classification. The U nonimmigrant status is for
noncitizen victims of certain qualifying criminal activities, and their
eligible family members, who have been, are, or are likely to be
helpful in the investigation or prosecution of those crimes. To
streamline the procedures and enhance operational efficiency, USCIS
will propose a rule to update eligibility, procedural and filing
requirements governing U nonimmigrant status, and adjustment of status
for those nonimmigrants. (Victims of Qualifying Criminal Activities;
Eligibility Requirements for U Nonimmigrant Status and Adjustment of
Status). In addition, USCIS will propose a rule to update the
regulations governing self-petitions in cases where the noncitizen has
been subjected to battery or extreme cruelty by their U.S. citizen
spouse, parent, son, or daughter, or lawful permanent resident spouse
or parent. USCIS will also propose to update the regulations to align
with statutory updates made as a result of subsequent reauthorizations
of the Violence Against Women Act. (Relief Under the Violence Against
Women Act of 1994 and Subsequent Legislation.)
Asylum Reforms. USCIS is focused on pursuing regulations to
strengthen, rebuild, and (where appropriate) streamline the asylum
system, consistent with law and mission imperatives. For example, USCIS
and DOJ will take steps to remove regulatory provisions that are
currently enjoined (Bars to Asylum Eligibility and Related Procedures),
propose updates to clarify eligibility for asylum and withholding of
removal (Particular Social Group and Related Definitions and
Interpretations for Asylum and Withholding of Removal), and propose
modifications or withdrawal of other asylum-related regulatory
provisions (Security Bars and Processing).
United States Coast Guard
The 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 in U.S. ports and waterways.
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 with
maritime stakeholders. Consistent standards of universal application
and enforcement, which encourage safe, efficient, and responsible
maritime commerce, are vital to the success of the maritime industry.
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 modern maritime environment. 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. These goals include protection against the risks
associated with climate change, and the Coast Guard seeks to obtain
scientific information to assist in that task, while also acting to
promote resilience and adaptation.
The Coast Guard highlights the following regulatory actions:
[[Page 11051]]
Cybersecurity in the Marine Transportation System. The Coast Guard
is proposing to update its maritime security regulations by adding
cybersecurity requirements to existing regulations. This proposed
rulemaking is part of an ongoing effort to address emerging
cybersecurity risks and threats to maritime security by including
additional security requirements to safeguard the marine transportation
system.
Shipping Safety Fairways Along the Atlantic Coast. The Coast Guard
published an ANPRM on June 19, 2020. The Coast Guard is reviewing
comments to help develop a proposed rule that would establish shipping
safety fairways along the Atlantic Coast of the United States. Fairways
are marked routes for vessel traffic. They facilitate the direct and
unobstructed transit of ships. The proposed fairways will be based on
studies about vessel traffic along the Atlantic Coast. The Coast Guard
is taking this action to ensure that obstruction-free routes are
preserved to and from U.S. ports and along the Atlantic coast and to
reduce the risk of collisions, allisions and grounding, as well as
alleviate the chance of increased time and expenses in transit.
MARPOL Annex VI; Prevention of Air Pollution From Ships. The Coast
Guard is proposing regulations to carry out the provisions of Annex VI
of the MARPOL Protocol, which is focused on the prevention of air
pollution from ships. The Act to Prevent Pollution from Ships has
already given direct effect to most provisions of Annex VI, and the
Coast Guard and the Environmental Protection Agency have carried out
some Annex VI provisions through previous rulemakings. This proposed
rulemaking would fill gaps in the existing framework for carrying out
the provisions of Annex VI. Chapter 4 of Annex VI contains shipboard
energy efficiency measures that include short-term measures reducing
carbon emissions linked to climate change. This proposed rulemaking
would apply to U.S.-flagged ships. It would also apply to foreign-
flagged ships operating either in U.S. navigable waters or in the U.S.
Exclusive Economic Zone.
United States Customs and Border Protection
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 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 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
importation of goods into the United States 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 mission, CBP's goal is to facilitate the
processing of legitimate trade and travel efficiently without
compromising security. Consistent with its primary mission of homeland
security, CBP intends to issue several regulations that are intended to
improve security at our borders and ports of entry. During the upcoming
year, CBP will also work on various projects to streamline CBP
processing, reduce duplicative processes, reduce various burdens on the
public, and automate various paper forms. CBP highlights one those
projects below.
Advance Passenger Information System: Electronic Validation of
Travel Documents. CBP intends to amend current Advance Passenger
Information System (APIS) regulations to incorporate additional carrier
requirements that would further enable CBP to determine whether each
passenger is traveling with valid, authentic travel documents prior to
the passenger boarding the aircraft. The proposed regulation would
require commercial air carriers to receive a second message from CBP
that would state whether CBP matched the travel documents of each
passenger to a valid, authentic travel document recorded in CBP's
databases. The proposed regulation would also require air carriers to
transmit additional data elements regarding contact information through
APIS for all commercial aircraft passengers arriving in the United
States to support border operations and national security. CBP expects
that the collection of these elements would enable CBP to further
support the Center for Disease Control and Prevention's mission in
monitoring and tracing the contacts for persons involved in health
incidents. This action will result in time savings to passengers and
cost savings to CBP, carriers, and the public.
In addition to the regulations that CBP issues to promote DHS's
mission, CBP issues regulations related to the mission of the
Department of the Treasury. Under section 403(1) of the Homeland
Security Act of 2002, the former-U.S. Customs Service, including
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 and the Border Patrol and transferred into CBP.
The Department of the Treasury retained certain regulatory authority of
the U.S. Customs Service relating to customs revenue function. In the
coming year, CBP expects to continue to issue regulatory documents that
will facilitate legitimate trade and implement trade benefit programs.
For a discussion of CBP regulations regarding the customs revenue
function, see the regulatory plan of the Department of the Treasury.
Transportation Security Administration
The Transportation Security Administration (TSA) protects the
Nation's transportation systems to ensure freedom of movement for
people and commerce. TSA applies an intelligence-driven, risk-based
approach to all aspects of its mission. This approach results in layers
of security to mitigate risks effectively and efficiently. In the
coming fiscal year, TSA is prioritizing the following actions that are
required to meet statutory mandates or that are necessary for national
security.
Enhancing Surface Cyber Risk Management. TSA intends to issue a
rulemaking that will permanently codify critical cybersecurity
requirements for pipeline and rail modes of transportation. On January
28, 2021, the President issued the National Security Memorandum on
Improving Cybersecurity for Critical Infrastructure Controls Systems.
Consistent with this priority of the Administration and in response to
the ongoing cybersecurity threat to surface transportation systems, TSA
issued security directives to owners and operators of TSA-designated
critical pipeline systems and facilities,
[[Page 11052]]
and higher-risk rail operations (freight, passenger, and mass transit)
to implement several urgently needed protections against cyber
intrusions. Through these directives, TSA has imposed measures to
report cybersecurity incidents; designate a cybersecurity coordinator;
review current cybersecurity measures; identify and report any gaps and
related remediation measures to address cyber-related risks; implement
specific mitigation measures to protect against cyber-attacks; develop
and implement a cybersecurity incident response plan; and develop an
assessment program to proactively address and audit cybersecurity
measures. TSA is committed to enhancing and sustaining cybersecurity
for all modes of transportation and intends to issue a rulemaking that
may codify these and other requirements.
Vetting of Certain Surface Transportation Employees. Consistent
with the Implementing Recommendations of the 9/11 Commission Act of
2007, TSA will propose a rule requiring security threat assessments for
security coordinators and other frontline employees of certain public
transportation agencies (including rail mass transit and bus systems),
railroads (freight and passenger), and over-the-road bus owner/
operators. The NPRM will also propose provisions to implement TSA's
statutory requirement to recover its cost of vetting through user fees.
While many stakeholders conduct background checks on their employees,
their actions are limited based upon the data they can access. Through
this rule, TSA will be able to conduct a more thorough check against
terrorist watch-lists of individuals in security-sensitive positions.
Flight Training Security Program. TSA published an interim final
rule in 2004 related to flight schools. The IFR requires flight schools
to notify TSA when noncitizens, and other individuals designated by
TSA, apply for flight training or recurrent training. TSA subsequently
issued exemptions and interpretations in response to comments on the
IFR and questions raised during operation of the program since 2004.
TSA published a notice reopening the comment period on May 18, 2018.
Based on the comments and questions received, TSA is finalizing the
rule with modifications that may include changing the frequency of
security threat assessments from a high-frequency event-based interval
to a time-based interval, clarify the definitions and other provisions
of the rule, and enable industry to use TSA-provided electronic
recordkeeping systems for all documents required to demonstrate
compliance with the rule. These and other changes would provide
significant cost-savings to the industry and individuals seeking flight
training while also enhancing security.
Amending Vetting Requirements for Employees With Access to a
Security Identification Display Area. The FAA Extension, Safety, and
Security Act of 2016 mandates that TSA consider modifications to the
list of disqualifying criminal offenses and criteria, develop a waiver
process for approving the issuance of credentials for unescorted
access, and propose an extension of the look back period for
disqualifying crimes. Based on these requirements, and current
intelligence pertaining to the ``insider threat,'' TSA will propose a
rule to revise current vetting requirements to enhance eligibility
requirements and disqualifying criminal offenses for individuals
seeking or having unescorted access to any Security Identification
Display Area of an airport.
United States Immigration and Customs Enforcement
U.S. Immigration and Customs Enforcement (ICE) is the principal
criminal investigative arm of DHS and one of the three Department
components charged with the criminal and civil enforcement of the
Nation's immigration laws. Its 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 the coming fiscal year, ICE
will focus rulemaking efforts on regulations pertaining to processing
improvements, including the rules mentioned below.
Immigration Bond Notifications and Electronic Service. ICE is
revising regulations that authorize the means to serve decisions and
other notices in-person or by mail, to include electronic and other
means of service. This rule is consistent with Executive Order 14058,
which directs agencies to take actions that improve service delivery
and customer experience by decreasing administrative burdens, enhancing
transparency, and improving the efficiency and effectiveness of
government. Current regulations limit ICE to serve documents in-person,
or by certified, registered, or ordinary mail, which is time consuming,
inefficient, and unreliable. This interim final rule would enable ICE
to issue and serve certain notices, decisions, and other documents
electronically to noncitizens, parties, attorneys, or other persons of
interest who voluntarily opt-in to be served electronically. The intent
is to improve convenience, transparency, and provide quicker
information and communication to both the public and the government.
Optional Alternative to the Physical Examination Associated With
Employment Eligibility Verification (Form I-9). In August of 2022, ICE
published a proposed rule that would revise employment eligibility
verification regulations to allow the Secretary to authorize
alternative document examination procedures in certain circumstances or
with respect to certain employer. As explained in the rule, future
exercises of such authority may reduce burdens on employers and
employees while maintaining the integrity of the employment
verification process. DHS will complete this rulemaking following
review of public comments received. This rulemaking is consistent with
Executive Order 14058, which directs agencies to take actions that
improve service delivery and customer experience by decreasing
administrative burdens, enhancing transparency, and improving the
efficiency and effectiveness of government.
Cybersecurity and Infrastructure Security Agency
The Cybersecurity and Infrastructure Security Agency (CISA) is
responsible for leading the national effort to develop cybersecurity
and critical infrastructure security programs, operations, and
associated policy to enhance the security and resilience of physical
and cyber infrastructure.
Ammonium Nitrate Security Program. This rule implements a 2007
amendment to the Homeland Security Act. The amendment requires DHS to
``regulate the sale and transfer of ammonium nitrate facility . . . to
prevent the misappropriation or use of ammonium nitrate in an act of
terrorism.'' CISA published an Notice of Proposed Rulemaking in 2011.
CISA is planning to issue a Supplemental Notice of Proposed Rulemaking.
Chemical Facility Anti-Terrorism Standards (CFATS). This rule would
update CFATS' Risk Based Performance Standards to enhance cybersecurity
requirements, modify the counting rules associated with release-
flammable chemicals, remove release-explosive chemicals, and adjust the
Screening Threshold Quantities of Appendix A to account for the updated
risk analysis methodology. CISA previously invited public comment on an
Advance Notice of Proposed Rulemaking (ANPRM)
[[Page 11053]]
during August 2014 for potential revisions to the CFATS regulations.
The ANPRM provided an opportunity for the public to provide
recommendations for possible program changes. In June 2020, CISA
published for public comment a retrospective analysis of the CFATS
program. And in January 2021, CISA invited additional public comment
through an ANPRM concerning the removal of certain explosive chemicals
from CFATS. CISA intends to address many of the subjects raised in both
ANPRMs and the retrospective analysis in this regulatory action,
including potential updates to CFATS cybersecurity requirements and
Appendix A to the CFATS regulations. CISA is planning to issue a notice
of proposed rulemaking.
A more detailed description of the priority regulations that
comprise the DHS regulatory plan follows
DHS--U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)
Proposed Rule Stage
90. Victims of Qualifying Criminal Activities; Eligibility Requirements
for U Nonimmigrant Status and Adjustment of Status [1615-AA67]
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8
U.S.C. 1101 (note); 8 U.S.C. 1102; Pub. L. 113-4
CFR Citation: 8 CFR 214; 8 CFR 274a; 8 CFR 103; 8 CFR 299.
Legal Deadline: None.
Abstract: This proposed rule would clarify and update eligibility,
procedural, and filing requirements for U nonimmigrant status (commonly
known as the ``U'' visa) and adjustment of status for U nonimmigrants.
U nonimmigrant status is for noncitizen victims of certain qualifying
criminal activities who have been, are being, or are likely to be
helpful in the investigation or prosecution of those crimes and
eligible family members. There is a statutory limit of 10,000 U visas
per year for principal petitioners. DHS published an interim final rule
in 2007 (72 FR 53013) to establish the procedures to be followed in
order to petition the U nonimmigrant status and published an interim
final rule in 2008 (73 FR 75540) to establish the procedures for
applying for adjustment of status as a U nonimmigrant, and this rule
would address relevant comments and stakeholder feedback received since
publication of those interim final rules, as well as update the
regulations for changes in legislation.
Statement of Need: This regulation is necessary to allow noncitizen
victims of certain crimes to petition for U nonimmigrant status and to
adjust status to that of a lawful permanent resident. The U
classification is for noncitizen victims of certain qualifying criminal
activities who have been, are being, or are likely to be helpful in the
investigation or prosecution of those crimes. This rule would address
the eligibility requirements that must be met for classification as a U
nonimmigrant and implements statutory amendments to these requirements,
streamlines the procedures to petition for U nonimmigrant status,
provides evidentiary guidance to assist in the petition process, and
clarifies adjustment of status requirements.
Summary of Legal Basis: This regulation is necessary to allow
noncitizen victims of certain crimes to petition for U nonimmigrant
status and to adjust status to that of a lawful permanent resident. The
U classification is for noncitizen victims of certain qualifying
criminal activities who have been, are, or are likely to be helpful in
the investigation or prosecution of those crimes. This rule would
address the eligibility requirements that must be met for
classification as a U nonimmigrant and implements statutory amendments
to these requirements, streamlines the procedures to petition for U
nonimmigrant status, provides evidentiary guidance to assist in the
petition process, and clarifies adjustment of status requirements.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
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Interim Final Rule.................. 09/17/07 72 FR 53013
Interim Final Rule Effective........ 10/17/07
Interim Final Rule Comment Period 11/17/07
End.
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: Transferred from RIN 1115-AG39.
URL For More Information: www.regulations.gov.
URL For Public Comments: www.regulations.gov.
Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian
Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and
Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD
20746, Phone: 240 721-3000.
RIN: 1615-AA67
DHS--USCIS
91. Improving the Regulations Governing the Adjustment of Status to
Lawful Permanent Residence and Related Immigration Benefits [1615-AC22]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103(a); 8 U.S.C. 1153 to
1155; 8 U.S.C 1160; 8 U.S.C 1254a; 8 U.S.C. 1255 and 1324a; . . .
CFR Citation: 8 CFR 204.5; 8 CFR 204.12; 8 CFR 205.1; 8 CFR 209.1;
8 CFR 209.2; 8 CFR 244.15; 8 CFR 245.1; 8 CFR 245.2; 8 CFR 245.5; 8 CFR
245.11; 8 CFR 245.15; 8 CFR 245.18; 8 CFR 249.2; 8 CFR 264.2; 8 CFR
274a.12; . . .
Legal Deadline: None.
Abstract: The Department of Homeland Security (DHS) proposes to
amend its regulations governing adjustment of status to lawful
permanent residence in the United States. The proposed changes include
permitting concurrent filing of a visa petition and the application for
adjustment of status for the employment-based 4th preference (certain
special immigrants) category, including religious workers; permitting
the transfer of underlying basis of a pending adjustment of status
application; amending the definition relating to ineligibilities under
section 245(c) of the INA; changing the age calculation under the Child
Status Protection Act; and authorizing employment authorization for
certain derivative beneficiaries waiting for immigrant visa
availability when they present compelling circumstances. DHS also
proposes to amend the regulations relating to temporary protected
status and travel authorization and the impact on the adjustment of
status eligibility. The intent of these proposed changes is to reduce
processing times, improve the quality of inventory data provided to
partner agencies, reduce the potential for visa retrogression, and
promote the efficient use of immediately available immigrant visas.
Statement of Need: This rulemaking is necessary to address outdated
regulations and to improve the efficiency and the administration of the
adjustment of status of immigrants to
[[Page 11054]]
lawful permanent residence in the United States, improve the quality of
inventory data that DHS provides to agencies, reduce the potential for
visa retrogression, and promote the efficient use of immediately
available immigrant visas. This proposed rule would revise travel
authorization regulations for temporary protected status beneficiaries
and clarify the impact on adjustment of status eligibility. This rule
also changes eligibility requirements for certain classifications for
what constitutes compelling circumstances for employment authorization.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Mark Phillips, Residence and Naturalization
Division Chief, Department of Homeland Security, U.S. Citizenship and
Immigration Services, Office of Policy and Strategy, 5900 Capital
Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240
721-3000.
RIN: 1615-AC22
DHS--USCIS
92. Particular Social Group and Related Definitions and Interpretations
for Asylum and Withholding of Removal [1615-AC65]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 8 U.S.C. 1101(a)(42); 8 U.S.C. 1158; 8 U.S.C.
1225; 8 U.S.C. 1231 and 1231 (note); E.O. 14010; 86 FR 8267 (Feb. 2,
2021)
CFR Citation: 8 CFR 2; 8 CFR 208; 8 CFR 1208.
Legal Deadline: None.
Abstract: This rule proposes to amend Department of Homeland
Security (DHS) and Department of Justice (DOJ) (collectively, ``the
Departments'') regulations that govern eligibility for asylum and
withholding of removal. The amendments focus on portions of the
regulations that deal with the definitions of membership in a
particular social group and the interpretation of various other
elements of eligibility for asylum, including some that are often
determinative in particular social group claims, such as the
requirements for failure of State protection, and determinations about
whether persecution is on account of a protected ground. The rule will
also propose to modify or rescind portions of the Procedures for Asylum
and Withholding of Removal; Credible Fear and Reasonable Fear Review
final rule (RINs 1125-AA94 and 1615-AC42). This rule is consistent with
Executive Order 14010 of February 2, 2021, which directs the
Departments to promulgate joint regulations, consistent with applicable
law, addressing the circumstances in which a person should be
considered a member of a particular social group.
Statement of Need: The Departments propose this rule to clarify
standards governing numerous elements of eligibility for asylum,
withholding of removal under section 241(b)(3) of the Immigration and
Nationality Act, and protection from removal under the regulations that
implement U.S. obligations in immigration cases under Article 3 of the
Convention Against Torture and Other Cruel, Inhuman or Degrading
Treatment or Punishment. The rule proposes to rescind certain
provisions of the Procedures for Asylum and Withholding of Removal;
Credible Fear and Reasonable Fear Review final rule, which had
addressed many of the same issues. See 85 FR 80274. The previous rule
was the subject of multiple suits challenging the rule on numerous
procedural and substantive grounds, and was preliminarily enjoined
before it became effective. Pangea Legal Servs. v. U.S. Dep't of
Homeland Sec., 512 F. Supp. 3d 966, 977 (N.D. Cal. 2021). In some
circumstances the Departments have decided to republish changes made in
the Global Asylum Rule without amendment. The purpose of doing so is to
remedy any alleged procedural deficiencies with the enactment of those
provisions. In other instances, the Departments now propose different
provisions with the goal of adopting clearer and simpler analyses that
would reduce burdens on adjudicators and applicants, and result in more
consistent and accurate adjudications. The Departments believe that the
existing standards governing these issues have become confusing, overly
complex, and subject to inconsistent interpretations among adjudicators
and across federal circuit courts on numerous issues. The Departments
propose this rule to rectify these problems.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
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: Rena Cutlip-Mason, Chief, Division of Humanitarian
Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and
Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD
20746, Phone: 240 721-3000.
Related RIN: Related to 1615-AC42, Related to 1125-AB13, Related to
1125-AA94
RIN: 1615-AC65
DHS--USCIS
93. U.S. Citizenship and Immigration Services Fee Schedule and Changes
to Certain Other Immigration Benefit Request Requirements [1615-AC68]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 8 U.S.C. 1356(m), (n)
CFR Citation: 8 CFR 103; 8 CFR 106.
Legal Deadline: None.
Abstract: DHS will propose to adjust the fees charged by U.S.
Citizenship and Immigration Services (USCIS) for immigration and
naturalization benefit requests. On August 3, 2020, DHS adjusted the
fees USCIS charges for immigration and naturalization benefit requests,
imposed new fees, revised certain fee waiver and exemption policies,
and changed certain application requirements via the rule ``USCIS Fee
Schedule & Changes to Certain Other Immigration Benefit Request
Requirements.'' DHS has been preliminarily enjoined from implementing
that rule by court order. This rule would rescind and replace the
changes made by the August 3, 2020, rule and establish new USCIS fees
to recover USCIS operating costs.
Statement of Need: USCIS projects that its costs of providing
immigration adjudication and naturalization services will exceed the
financial resources
[[Page 11055]]
available to it under its existing fee structure. DHS proposes to
adjust the USCIS fee structure to ensure that USCIS recovers the costs
of meeting its operational requirements.
The CFO Act requires each agency's chief financial officer to
``review, on a biennial basis, the fees, royalties, rents, and other
charges imposed by the agency for services and things of value it
provides, and make recommendations on revising those charges to reflect
costs incurred by it in providing those services and things of value.''
Summary of Legal Basis: INA 286(m) and (n), 8 U.S.C. 1356(m) and
(n), authorize the Attorney General and Secretary of Homeland Security
to recover the full cost of providing immigration adjudication and
naturalization services by establishing and collecting fees deposited
into the Immigration Examinations Fee Account.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations.
Government Levels Affected: None.
Agency Contact: Kika Scott, Chief Financial Officer, Department of
Homeland Security, U.S. Citizenship and Immigration Services, 5900
Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone:
240 721-3000.
RIN: 1615-AC68
DHS--USCIS
94. Bars to Asylum Eligibility and Related Procedures [1615-AC69]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Homeland Security Act of 2002, Pub. L. 107-296,
116 Stat. 2135, sec. 1102, as amended; 8 U.S.C. 1103(a)(1); 8 U.S.C.
1103(a)(3); 8 U.S.C. 1103(g); 8 U.S.C. 1225(b); 8 U.S.C. 1231(b)(3) and
1231 (note); 8 U.S.C. 1158
CFR Citation: 8 CFR 208; 8 CFR 235; 8 CFR 1003; 8 CFR 1208; 8 CFR
1235.
Legal Deadline: None.
Abstract: In 2020, the Department of Homeland Security and
Department of Justice (collectively, the Departments) published final
rules amending their respective regulations governing bars to asylum
eligibility and procedures, including the Procedures for Asylum and
Bars to Asylum Eligibility (RINs 1125-AA87 and 1615-AC41), 85 FR 67202
(Oct. 21, 2020), and Asylum Eligibility and Procedural Modifications
(RINs 1125-AA91 and 1615-AC44), 85 FR 82260 (Dec. 17, 2020), final
rules. The Departments will propose to modify or rescind the regulatory
changes promulgated in these two final rules consistent with Executive
Order 14010 (Feb. 2, 2021).
Statement of Need: The Departments are reviewing these regulations
in light of the issuance of Executive Order 14010 and Executive Order
14012. This rule is needed to restore and strengthen the asylum system
and to address inconsistencies with the goals and principles outlined
in Executive Order 14010 and Executive Order 14012.
Anticipated Cost and Benefits: The Departments are currently
considering the specific cost and benefit impacts of the proposed
provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian
Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and
Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD
20746, Phone: 240 721-3000.
Related RIN: Related to 1125-AA87, Split from 1615-AC41, Related to
1125-AA91, Related to 1615-AC44, Related to 1125-AB12
RIN: 1615-AC69
DHS--USCIS
95. Modernization and Reform of the H-2 Programs [1615-AC76]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 8 U.S.C. 1103(a)(3); 8 U.S.C.
1001(a)(15)(H)(ii)(a) and (b); 8 U.S.C. 1184(a), (c) and (g)
CFR Citation: 8 CFR 214; 8 CFR 274a.
Legal Deadline: None.
Abstract: DHS plans to issue a notice of proposed rulemaking that
will modernize and reform the H-2A and H-2B nonimmigrant worker
programs. DHS will propose to incorporate policies that produce program
efficiencies, address current aspects of the program that may
unintentionally result in exploitation or other abuse of persons
seeking to come to this country as H-2A and H-2B workers, build upon
existing protections against prohibited payments or other assessment of
fees and/or salary deductions by H-2A and H-2B workers in connection
with recruitment and/or employment, and otherwise add protections for
workers. This rule would not revise the temporary labor certification
process or the regulations contained in 20 CFR part 655 or 29 CFR part
501 and 503.
Statement of Need: This rulemaking is needed to enhance protections
for workers and better ensure the integrity of the H-2A and H-2B
programs. In addition, this proposed rule is necessary to improve H-2
program efficiencies and remove certain barriers to program access.
Summary of Legal Basis: The Immigration and Nationality Act (INA)
charges the Secretary of Homeland Security with the administration and
enforcement of the immigration laws and provides that the Secretary
shall establish such regulations and perform such other acts as he
deems necessary for carrying out his authority under the INA. See INA
section 103(a)(1),(3), 8 U.S.C. 1103(a)(1), (3). In addition, the
Homeland Security Act of 2002, also charges the Secretary with
establishing and administering rules governing the granting of visas or
other forms of permission to enter the United States to individuals who
are not a citizen, or an alien lawfully admitted for permanent
residence in the United States. See Public Law 107-296, 116 Stat. 2135,
6 U.S.C. 202(4). With respect to nonimmigrants in particular, the INA
provides that the admission to the United States of any alien as a
nonimmigrant shall be for such time and under such conditions as the
Secretary may by regulations prescribe. See INA section 214(a)(1), 8
U.S.C. 1184(a)(1). The INA also tasks DHS with approving petitions
filed by the importing employers of nonimmigrants, including those in
the H nonimmigrant visa classification, before a nonimmigrant visa may
be granted. See INA section 214(c)(1), 8 U.S.C. 1184(c)(1).
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
[[Page 11056]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Charles Nimick, Chief, Business and Foreign Workers
Division, Office of Policy and Strategy, Department of Homeland
Security, U.S. Citizenship and Immigration Services, 5900 Capital
Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240
721-3000.
RIN: 1615-AC76
DHS--USCIS
96. Citizenship and Naturalization and Other Related
Flexibilities [1615-AC80]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: sec. 102 of the Homeland Security Act of 2002; 6
U.S.C. 112(a)(3); 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1151; 8 U.S.C.
1153; 8 U.S.C. 1154; 8 U.S.C. 1159; 8 U.S.C. 1182; 8 U.S.C. 1255; 8
U.S.C. 1401; 8 U.S.C. 1409; 8 U.S.C. 1421; 8 U.S.C. 1423; 8 U.S.C.
1427; 8 U.S.C. 1429 to 1431; 8 U.S.C. 1433; 8 U.S.C. 1435; 8 U.S.C.
1438 to 1440; 8 U.S.C. 1443; 8 U.S.C. 1445 to 1449; 8 U.S.C. 1452; 8
U.S.C. 1454; 8 U.S.C. 1481
CFR Citation: 8 CFR 1.2; 8 CFR 103; 8 CFR 106; 8 CFR 204; 8 CFR
209; 8 CFR 245; 8 CFR 300; 8 CFR 306; 8 CFR 312; 8 CFR 316; 8 CFR 318;
8 CFR 319; 8 CFR 320; 8 CFR 322; 8 CFR 324; 8 CFR 329; 8 CFR 333; 8 CFR
334; 8 CFR 335; 8 CFR 336; 8 CFR 337; 8 CFR 338; 8 CFR 339; 8 CFR 341;
8 CFR 343a; 8 CFR 349; . . .
Legal Deadline: None.
Abstract: The Department of Homeland Security (DHS) will propose to
amend its regulations governing citizenship and naturalization. This
includes clarifying the testing requirements, updating eligibility
requirements, and proposing amendments to clarify definitions. DHS will
also propose removing certain outdated provisions and amending other
provisions to align with current statutory framework, such as updating
the adoption-related regulatory provisions consistent with the
Intercountry Adoption Universal Accreditation Act of 2012.
Statement of Need: These proposed changes, some of which were
requested by the public, are needed to improve the efficiency,
effectiveness, accessibility, uniformity, and consistency of
adjudications.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Mark Phillips, Residence and Naturalization
Division Chief, Department of Homeland Security, U.S. Citizenship and
Immigration Services, Office of Policy and Strategy, 5900 Capital
Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240
721-3000.
RIN: 1615-AC80
DHS--USCIS
97. Relief Under the Violence Against Women Act of 1994 and
Subsequent Legislation [1615-AC81]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 8.U.S.C. 1103; 8 U.S.C. 1154; 8 U.S.C. 1155; 8
U.S.C. 1182; 8 U.S.C. 1183a; 8 U.S.C. 1186; 8 U.S.C. 1324a; 8 U.S.C.
1225; 8 U.S.C. 1255; . . .
CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 205; 8 CFR 213a; 8 CFR
216; 8 CFR 245; 8 CFR 274a; . . .
Legal Deadline: None.
Abstract: This proposed rule would amend regulations governing
self-petitions for immigrant classification and related relief
available to certain spouses, children, and parents who have been
subjected to battery or extreme cruelty by their U.S. citizen spouses,
parents, sons, or daughters, or lawful permanent resident spouses or
parents. DHS also proposes to amend regulations governing petitions to
remove conditions on permanent residence in which conditional permanent
residents (CPR) request a waiver of the joint filing requirement due to
battery or extreme cruelty by their U.S. citizen or lawful permanent
resident (LPR) spouses or parents.
Statement of Need: The Violence Against Women Act of 1994 (VAWA)
provides noncitizens who have been abused by their U.S. citizen or
lawful permanent resident relative the ability to independently
petition for themselves for immigrant classification without the
abuser's knowledge, consent, or participation in the immigration
process. Current VAWA regulations, which were codified to implement the
Immigration Act of 1990 and the Violence Against Women Act of 1994,
were published in the Federal Register on May 16, 1991, and March 26,
1996. Subsequently, Congress has reauthorized VAWA through the Victims
of Trafficking and Violence Protection Act of 2000, the Violence
Against Women and Department of Justice Reauthorization Act of 2005 and
the Violence Against Women and Department of Justice Reauthorization
Act of 2005 Technical Amendments, and the Violence Against Women
Reauthorization Act of 2013. This rule is necessary to update USCIS
regulations to comport with these subsequent reauthorizations of VAWA.
The amendments contained in this proposed rule would reflect the
subsequent legislative enactments and incorporate current USCIS policy.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian
Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and
Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD
20746, Phone: 240 721-3000.
RIN: 1615-AC81
DHS--USCIS
Final Rule Stage
98. Security Bars and Processing [1615-AC57]
Priority: Other Significant.
Legal Authority: Illegal Immigration Reform and Immigrant
Responsibility Act of 1996 (``IIRIRA''), Pub. L. 104-208, 110 Stat.
3009, sec. 604(a) (codified at INA 208(b)(2)(C), 8 U.S.C.
1158(b)(2)(C)); INA 241(b)(3)(B), 8 U.S.C. 1231(b)(3)(B); Foreign
Affairs
[[Page 11057]]
Reform and Restructuring Act (``FARRA''), Pub. L. 105-277, 112 Stat.
2681-822, sec. 2242 (1998); INA 235(b), 8 U.S.C. 1225(b)
CFR Citation: 8 CFR 208; 8 CFR 1208.
Legal Deadline: None.
Abstract: On December 23, 2020, DHS and the DOJ (collectively, the
Departments) published a final rule to clarify that the danger to the
security of the United States statutory bar to eligibility for asylum
and withholding of removal encompasses certain emergency public health
concerns and make certain other changes. As of December 28, 2021, the
rule's effective date was delayed to December 31, 2022. The Departments
plan to further delay the effective date and to propose modification or
withdrawal of the December 23, 2020, rule.
Statement of Need: The Departments are reviewing and reconsidering
whether the Security Bars and Processing final rule is consistent with
the goals of ensuring the safe and orderly reception and processing of
asylum seekers consistent with public health and safety, with the
additional context of the complex relationship between the Procedures
for Asylum and Withholding of Removal; Credible Fear and Reasonable
Fear Review final rule (RINs 1125-AA94 and 1615-AC42) and the Security
Bars rule. The Departments are reevaluating whether the Security Bars
rule provides the most appropriate and effective framework for
achieving its goals of mitigating the spread of communicable diseases,
including COVID-19, among certain noncitizens in the credible fear
screening process, as well as DHS personnel and the public. Based on
such reconsideration, the Departments will publish rules to delay the
effective date of the Security Bars rule and propose to modify or
withdraw the Security Bars rule.
Anticipated Cost and Benefits: DHS is currently considering the
specific cost and benefit impacts of the proposed provisions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/09/20 85 FR 41201
NPRM Comment Period End............. 08/10/20
Final Action........................ 12/23/20 85 FR 84160
Final Action Effective.............. 01/22/21
Final Rule; Delay of Effective Date. 01/25/21 86 FR 6847
Final Rule; Effective Date Delayed 03/22/21
Until.
Interim Final Rule; Delay of 03/22/21 86 FR 15069
Effective Date.
Interim Final Rule Comment Period 04/21/21
End.
Interim Final Rule Effective Date 12/31/21
Delayed Until.
Interim Final Rule; Delay of 12/28/21 86 FR 73615
Effective Date.
Interim Final Rule Comment Period 02/28/22
End.
Interim Final Rule Effective Date 12/31/22
Delayed Until.
NPRM................................ 02/00/23
Interim Final Rule; Delay of 12/00/22
Effective Date.
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL For More Information: www.regulations.gov.
URL For Public Comments: www.regulations.gov.
Agency Contact: Ashley Caudill-Mirillo, Acting Asylum Division,
Office of Refugee, Asylum, and International Operations, Department of
Homeland Security, U.S. Citizenship and Immigration Services, 5900
Capital Gateway Drive, Camp Springs, MD 20746, Phone: 240 721-3000.
Related RIN: Related to 1125-AB08, Related to 1615-AC69
RIN: 1615-AC57
DHS--U.S. COAST GUARD (USCG)
Proposed Rule Stage
99. Cybersecurity in the Marine Transportation System [1625-AC77]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 46 U.S.C. 70101; 46 U.S.C. 70102; 46 U.S.C. 70104;
46 U.S.C. 70124; . . .
CFR Citation: 33 CFR 101; . . .
Legal Deadline: None.
Abstract: The Coast Guard proposes to update its maritime security
regulations by adding cybersecurity requirements to existing Maritime
Security regulations in 33 CFR part 101 et seq. This proposed
rulemaking is part of an ongoing effort to address emerging
cybersecurity risks and threats to maritime security by including
additional security requirements to safeguard the marine transportation
system.
Statement of Need: The purpose of this rulemaking is to set minimum
cybersecurity requirements for vessels and facilities to safeguard the
Marine Transportation System (MTS) from cybersecurity vulnerabilities.
Summary of Legal Basis: The Coast Guard exercises the Maritime
Transportation Security Act of 2002 (MTSA) authorities of Chapter 701
of Title 46 of the U.S. Code. This includes the authority to promulgate
Chapter 701 regulations under 46 U.S.C. 70124. This statute provides
that the DHS Secretary may issue regulations necessary to implement
Chapter 701 of Title 46.
Anticipated Cost and Benefits: The regulatory analysis for the
proposed rule is still being developed.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Frank Strom, Chief, Systems Engineering Division
(CG-ENG-3), Department of Homeland Security, U.S. Coast Guard, Office
of Design and Engineering Standards, 2703 Martin Luther King Jr. Avenue
SE, STOP 7509, Washington, DC 20593-7509, Phone: 202 372-1375, Email:
[email protected].
RIN: 1625-AC77
DHS--USCG
100. MARPOL Annex VI; Prevention of Air Pollution From Ships [1625-
AC78]
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1903
CFR Citation: 33 CFR 151.
Legal Deadline: None.
Abstract: The Coast Guard is proposing regulations to carry out the
provisions of Annex VI of the MARPOL Protocol, which is focused on the
prevention of air pollution from ships. The Act to Prevent Pollution
from Ships has already given direct effect to most provisions of Annex
VI, and the Coast Guard and the Environmental Protection Agency have
carried out some Annex VI provisions through previous rulemakings. This
proposed rule would fill gaps in the existing framework for carrying
out the provisions of Annex VI. Chapter 4 of Annex VI contains
shipboard energy efficiency measures that include short-term measures
reducing carbon emissions linked to climate change and supports
Administration goals outlined in Executive Order 14008 titled Tackling
the Climate Crisis at Home and Abroad. This proposed rule would apply
to U.S.-flagged ships. It would also apply to
[[Page 11058]]
foreign-flagged ships operating either in U.S. navigable waters or in
the U.S. Exclusive Economic Zone.
Statement of Need: The Coast Guard is proposing regulations to
carry out the provisions of Annex VI of the MARPOL Protocol, which is
focused on the prevention of air pollution from ships. The Act to
Prevent Pollution from Ships has already given direct effect to most
provisions of Annex VI, and the Coast Guard and the Environmental
Protection Agency have carried out some Annex VI provisions through
previous rulemakings. This proposed rule would fill gaps in the
existing framework for carrying out the provisions of Annex VI and
explain how the United States has chosen to carry out certain
discretionary aspects of Annex VI. This proposed rule would apply to
U.S.-flagged ships. And it would also apply to foreign-flagged ships
operating in U.S. navigable waters or in the U.S. Exclusive Economic
Zone.
Summary of Legal Basis: Section 4 of the Act to Prevent Pollution
from Ships (Pub. L. 96-478, Oct. 21, 1980, 94 Stat 2297), as reflected
in 33 U.S.C. 1903, directs the Secretary of Homeland Security to
prescribe any necessary or desired regulations to carry out the
provisions of the MARPOL Protocol. The ``MARPOL Protocol'' is defined
in 33 U.S.C. 1901 and includes Annex VI of the International Convention
for the Prevention of Pollution from Ships, 1973.
Anticipated Cost and Benefits: USCG anticipates the costs for the
proposed rule to come primarily from additional labor for 5
requirements including overseeing surveys; developing and maintaining a
fuel-switching procedure; recording various data during each fuel
switching; developing and managing a Volatile organic compounds (VOC)
management plan; crew member to calculate and report the attained
Energy Efficient Design Index (EEDI) of the vessel, and crew member to
develop and maintain the Ship Energy Efficiency Management Plan
(SEEMP). USCG expects the proposed rule to have unquantified benefits
from reduction in fatalities and injuries due to pollutant in engine
emissions, and also reduced risk of retaliation due to breaching
international agreement.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Frank Strom, Chief, Systems Engineering Division
(CG-ENG-3), Department of Homeland Security, U.S. Coast Guard, Office
of Design and Engineering Standards, 2703 Martin Luther King Jr. Avenue
SE, STOP 7509, Washington, DC 20593-7509, Phone: 202 372-1375, Email:
[email protected].
RIN: 1625-AC78
DHS--U.S. CUSTOMS AND BORDER PROTECTION (USCBP)
Proposed Rule Stage
101. Advance Passenger Information System: Electronic Validation of
Travel Documents [1651-AB43]
Priority: Other Significant.
Legal Authority: 49 U.S.C. 44909; 8 U.S.C. 1221
CFR Citation: 19 CFR 122.
Legal Deadline: None.
Abstract: U.S. Customs and Border Protection (CBP) regulations
require commercial air carriers to electronically transmit passenger
information to CBP's Advance Passenger Information System (APIS) prior
to an aircraft's arrival in or departure from the United States. CBP
proposes to amend these regulations to incorporate additional carrier
requirements that will enable CBP to validate each passenger's travel
documents prior to the passenger boarding the aircraft. This proposed
rule would also require air carriers to transmit additional data
elements through APIS for all commercial aircraft passengers arriving
in the United States in order to support border operations and national
security. The collection of additional data elements will support the
efforts of the Centers for Disease Control, within the Department of
Health and Human Services, to monitor and contact-trace health
incidents. This rule is consistent with Executive Order 14058, which
directs agencies to take actions that improve service delivery and
customer experience by decreasing administrative burdens, enhancing
transparency, and improving the efficiency and effectiveness of
government.
Statement of Need: Current regulations require U.S. citizens and
foreign travelers entering and leaving the United States via air travel
to submit travel documents containing biographical information, such as
a passenger's name and date of birth. For security purposes, CBP
compares the information on passengers' documents to various databases
and the terrorist watch list through APIS. While in the case of
security threats CBP may require an air carrier to deny boarding to the
passenger. CBP recommends that air carriers deny boarding to those
likely to be deemed inadmissible upon arrival in the United States. To
further improve CBP's vetting processes with respect to identifying and
preventing passengers with fraudulent or improper documents from
traveling to or leaving the United States, CBP proposes to require
carriers to receive from CBP a message that would state whether CBP
matched the travel documents of each passenger to a valid, authentic
travel document prior to departure to the United States from a foreign
port or place or departure from the United States. The proposed rule
also would require carriers to submit passenger contact information
while in the United States to CBP through APIS. Submission of such
information would enable CBP to identify and interdict individuals
posing a risk to border, national, and aviation safety and security
more quickly. Collecting these additional data elements would also
enable CBP to further assist CDC to monitor and trace the contacts of
those involved in serious public health incidents upon CDC request.
Additionally, the proposed rule would allow carriers to include the
aircraft tail number in their electronic messages to CBP and make
technical changes to conform with current practice.
Anticipated Cost and Benefits: The proposed rule would result in
costs to CBP, air carriers, and passengers for additional time spent
coordinating to resolve a passenger's status should there be a security
issue upon checking in for a flight. In addition, CBP will incur costs
for technological improvements to its systems. CBP, air carriers, and
passengers would benefit from reduced passenger processing times during
customs screening. Unquantified benefits would result from greater
efficiency in passenger processing pre-flight, improved national
security, and fewer penalties for air carriers following entry denial
of a passenger.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Robert Neumann, Program Manager, Office of Field
Operations, Department of Homeland Security, U.S. Customs and Border
Protection, 1300 Pennsylvania Avenue NW, Washington, DC 20229, Phone:
202 412-2788, Email: [email protected].
[[Page 11059]]
RIN: 1651-AB43
DHS--TRANSPORTATION SECURITY ADMINISTRATION (TSA)
Prerule Stage
102. Enhancing Surface Cyber Risk Management [1652-AA74]
Priority: Other Significant.
Legal Authority: 49 U.S.C. 114
CFR Citation: 49 CFR 1570.
Legal Deadline: None.
Abstract: On July 28, 2021, the President issued the National
Security Memorandum on Improving Cybersecurity for Critical
Infrastructure Control Systems. In response to the ongoing threat to
pipeline systems, TSA used its authority under 49 U.S.C. 114 to issue
emergency security directives to owners and operators of TSA-designated
critical pipelines that transport hazardous liquids and natural gas to
implement a number of urgently needed protections against cyber
intrusions. TSA also issued security directives in the freight,
passenger, and transit-rail sectors under the same statutory authority.
TSA is committed to enhancing and sustaining industry's resilience to
cybersecurity attacks. TSA intends to issue a rulemaking that will
permanently codify critical cybersecurity requirements for pipeline and
rail modes.
Statement of Need: This rulemaking is necessary to address the
ongoing cybersecurity threat to U.S. transportation modes.
Anticipated Cost and Benefits: TSA is in the process of determining
the costs and benefits of this rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 11/30/22 87 FR 73527
ANPRM Comment Period End............ 01/17/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Agency Contact: Victor Parker, Chief, Policy Development Section,
Surface Division, Department of Homeland Security, Transportation
Security Administration, Policy, Plans and Engagement, 6595 Springfield
Center Drive, Springfield, VA 20598-6028, Phone: 571 227-3664, Email:
[email protected].
James Ruger, Chief Economist, Economic Analysis Branch-Coordination
& Analysis Division, Department of Homeland Security, Transportation
Security Administration, Policy, Plans, and Engagement, 6595
Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-
5519, Email: [email protected].
David Kasminoff, Senior Counsel, Regulations and Security
Standards, Department of Homeland Security, Transportation Security
Administration, Chief Counsel's Office, 6595 Springfield Center Drive,
Springfield, VA 20598-6002, Phone: 571 227-3583, Email:
[email protected].
RIN: 1652-AA74
DHS--TSA
Proposed Rule Stage
103. Vetting of Certain Surface Transportation Employees [1652-AA69]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Public Law 108-90, sec. 520; Pub.
L. 110-53, secs. 1411, 1414, 1512, 1520, 1522, and 1531
CFR Citation: Not Yet Determined.
Legal Deadline: Other, Statutory, August 3, 2008, Background and
immigration status check for all public transportation frontline
employees is due no later than 12 months after date of enactment.
Sections 1411 and 1520 of Public Law 110-53, Implementing
Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), (121
Stat. 266, Aug. 3, 2007), require background checks of frontline public
transportation and railroad employees not later than one year from the
date of enactment. Requirement will be met through regulatory action.
Abstract: The 9/11 Act requires vetting of certain railroad, public
transportation, and over-the-road bus employees. Also, 6 U.S.C. 469
requires TSA to collect fees to recover the costs of the vetting
services. Through this rulemaking, the Transportation Security
Administration (TSA) intends to propose the standards and procedures to
conduct the required vetting and recover costs. This regulation is
related to 1652-AA55, Security Training for Surface Transportation
Employees.
Statement of Need: Employee vetting is an important and effective
tool for averting or mitigating potential attacks by those with
malicious intent who may target surface transportation and plan or
perpetrate actions that may cause significant injuries, loss of life,
or economic disruption.
Anticipated Cost and Benefits: The vetting of freight rail, public
transportation, and over-the-road bus employees covered under the rule
will result in costs to TSA and to industry. TSA is proposing to
establish fees to recover vetting costs. TSA also anticipates ancillary
costs (e.g., updating contact information, compliance inspections)
associated with compliance with the rule. Anticipated benefits include
reducing security risks by identifying and/or mitigating potential
insider threats through vetting.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: Local.
URL For More Information: www.regulations.gov.
URL For Public Comments: www.regulations.gov.
Agency Contact: Victor Parker, Chief, Policy Development Section,
Surface Division, Department of Homeland Security, Transportation
Security Administration, Policy, Plans and Engagement, 6595 Springfield
Center Drive, Springfield, VA 20398-6028, Phone: 571 227-3664, Email:
[email protected].
James Ruger, Chief Economist, Economic Analysis Branch-Coordination
& Analysis Division, Department of Homeland Security, Transportation
Security Administration, Policy, Plans, and Engagement, 6595
Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-
5519, Email: [email protected].
Christine Beyer, Senior Counsel, Regulations and Security
Standards, Department of Homeland Security, Transportation Security
Administration, Chief Counsel's Office, 6595 Springfield Center Drive,
Springfield, VA 20598-6002, Phone: 571 227-3653, Email:
[email protected].
Related RIN: Related to 1652-AA55, Related to 1652-AA56
RIN: 1652-AA69
DHS--TSA
104. Amending Vetting Requirements for Employees With Access to a
Security Identification Display Area (SIDA) [1652-AA70]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 114-190, sec. 3405
[[Page 11060]]
CFR Citation: 49 CFR 1542.209; 49 CFR 1544.229.
Legal Deadline: Final, Statutory, January 11, 2017, Rule for
individuals with unescorted access to any Security Identification
Display Area (SIDA) due 180 days after date of enactment. Section 3405
of title III of the FAA Extension, Safety, and Security Act of 2016
(FESSA) Extension, Public Law 114-190 (130 Stat. 615, July 15, 2016),
requires the Transportation Security Administration (TSA) to revise the
regulations issued under 49 U.S.C. 44936 within 180 days after the date
of enactment.
Abstract: As required by the FESSA, TSA will propose a rule to
revise its regulations, reflecting current knowledge of insider threat
and intelligence, to enhance the eligibility requirements and
disqualifying criminal offenses for individuals seeking or having
unescorted access to any SIDA of an airport. Consistent with the
statutory mandate, TSA will consider adding to the list of
disqualifying criminal offenses and criteria, develop an appeal and
waiver process for the issuance of credentials for unescorted access,
and propose an extension of the lookback period for disqualifying
crimes. As part of TSA's reevaluation of the eligibility and redress
standards for aviation workers required by the Act, TSA is also
reevaluating the current vetting process to minimize any security risks
that may exist.
Statement of Need: Employee vetting is an important and effective
tool for averting or mitigating potential attacks by those with
malicious intent who wish to target aviation and plan or perpetrate
actions that may cause significant injuries, loss of life, or economic
disruption. Enhancing eligibility standards for airport workers will
improve transportation and national security.
Anticipated Cost and Benefits: TSA anticipates costs associated
with implementing and administering revised aspects of aviation vetting
including potential changes to the list of disqualifying criminal
offenses, the lookback period for convictions, and new waiver
eligibility. Anticipated benefits include reducing security risks
through enhanced vetting of aviation workers while also providing
greater flexibility and access through waivers as well as increased
efficiencies of the vetting process.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Kevin Knott, Branch Manager, Airports Policy
Branch-Aviation Division, Department of Homeland Security,
Transportation Security Administration, Policy, Plans, and Engagement,
6595 Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571
227-4370, Email: [email protected].
James Ruger, Chief Economist, Economic Analysis Branch-Coordination
& Analysis Division, Department of Homeland Security, Transportation
Security Administration, Policy, Plans, and Engagement, 6595
Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-
5519, Email: [email protected].
Christine Beyer, Senior Counsel, Regulations and Security
Standards, Department of Homeland Security, Transportation Security
Administration, Chief Counsel's Office, 6595 Springfield Center Drive,
Springfield, VA 20598-6002, Phone: 571 227-3653, Email:
[email protected].
Related RIN: Related to 1652-AA11
RIN: 1652-AA70
DHS--TSA
Final Rule Stage
105. Flight Training Security Program [1652-AA35]
Priority: Other Significant.
Legal Authority: 6 U.S.C. 469(b); 49 U.S.C. 114; 49 U.S.C. 44939;
49 U.S.C. 46105
CFR Citation: 49 CFR 1552.
Legal Deadline: Final, Statutory, February 10, 2004, sec. 612(a) of
Vision 100 requires the Transportation Security Administration (TSA) to
issue an interim final rule within 60 days of enactment of Vision 100.
Requires TSA to establish a process to implement the requirements of
section 612(a) of Vision 100-Century of Aviation Reauthorization Act
(Pub. L. 108-176, 117 Stat. 2490, Dec. 12, 2003) (Vision 100 Act),
including the fee provisions, not later than 60 days after the
enactment of the Act.
Abstract: An Interim Final Rule (IFR) published and effective on
September 20, 2004, transferred responsibility for the vetting of
flight school candidates from the Department of Justice to TSA, with
certain modifications to the program, as required by the Vision 100
Act. This IFR applied to training providers and to individuals who
apply for or receive flight training. Flight schools are required to
notify TSA when non-U.S. citizens, non-U.S. nationals, and other
individuals designated by TSA, apply for flight training or recurrent
flight training. TSA issued exemptions and interpretations in response
to comments on the IFR and questions raised during operation of the
program since 2004. TSA published a notice reopening the comment period
on May 18, 2018. Based on the comments and questions received, TSA is
finalizing the rule and considering modifications that would change the
frequency of security threat assessments from a high-frequency event-
based interval to a time-based interval, clarify the definitions and
other provisions of the rule, and enable industry to use TSA-provided
electronic recordkeeping systems for all documents required to
demonstrate compliance with the rule.
Statement of Need: In the years since TSA published the IFR,
members of the aviation industry, the public, and Federal oversight
organizations have identified areas where the Flight Training Security
Program (formerly the Alien Flight Student Program) could be improved.
TSA's internal procedures and processes for vetting applicants also
have advanced through technology and other enhancements. Publishing a
final rule that addresses external recommendations and aligns with
modern TSA vetting practices would streamline the Flight Training
Security Program application, vetting, and recordkeeping process for
all parties involved.
Anticipated Cost and Benefits: TSA is considering revising the
requirements of the Flight Training Security Program to reduce costs
and industry burden. One action TSA is considering is an electronic
recordkeeping platform where all flight training providers would upload
certain information to a TSA-managed website (https://fts.tsa.dhs.gov/
). Also at industry's request, TSA is considering changing the interval
for a Security Threat Assessment of each non-U.S. citizen and non-U.S.
national flight student, by eliminating the requirement for a Security
Threat Assessment for each separate training event. This change would
result in an annual savings, although there may be additional start-up
and record retention costs for the agency as a result of this revision.
The change in the interval of the Security Threat Assessment would
result in immediate cost savings to flight providers and students who
are neither U.S. citizens nor U.S. nationals without compromising the
security process.
[[Page 11061]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule; Request for 09/20/04 69 FR 56324
Comments.
Interim Final Rule Effective........ 09/20/04 .......................
Interim Final Rule; Comment Period 10/20/04 .......................
End.
Notice-Information Collection; 60- 11/26/04 69 FR 68952
Day Renewal.
Notice-Information Collection; 30- 03/30/05 70 FR 16298
Day Renewal.
Notice-Information Collection; 60- 06/06/08 73 FR 32346
Day Renewal.
Notice-Information Collection; 30- 08/13/08 73 FR 47203
Day Renewal.
Notice-Alien Flight Student Program 04/13/09 74 FR 16880
Recurrent Training Fees.
Notice-Information Collection; 60- 09/21/11 76 FR 58531
Day Renewal.
Notice-Information Collection; 30- 01/31/12 77 FR 4822
Day Renewal.
Notice-Information Collection; 60- 03/10/15 80 FR 12647
Day Renewal.
Notice-Information Collection; 30- 06/18/15 80 FR 34927
Day Renewal.
IFR; Comment Period Reopened........ 05/18/18 83 FR 23238
IFR; Comment Period Reopened End.... 06/18/18 .......................
Notice-Information Collection; 60- 07/06/18 83 FR 31561
Day Renewal.
Notice-Information Collection; 30- 10/31/18 83 FR 54761
Day Renewal.
Final Rule.......................... 03/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL For More Information: www.regulations.gov.
URL For Public Comments: www.regulations.gov.
Agency Contact: Stephanie Hamilton, Manager, Vetting Programs
Branch, Department of Homeland Security, Transportation Security
Administration, Enrollment Services & Vetting Programs, 6595
Springfield Center Drive, Springfield, VA 20598-6010, Phone: 571 227-
2851, Email: [email protected].
James Ruger, Chief Economist, Economic Analysis Branch-Coordination
& Analysis Division, Department of Homeland Security, Transportation
Security Administration, Policy, Plans, and Engagement, 6595
Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-
5519, Email: [email protected].
David Ross, Attorney-Advisor, Regulations and Security Standards,
Department of Homeland Security, Transportation Security
Administration, Chief Counsel's Office, 6595 Springfield Center Drive,
Springfield, VA 20598-6002, Phone: 571 227-2465, Email:
[email protected].
Related RIN: Related to 1652-AA61
RIN: 1652-AA35
DHS--U.S. IMMIGRATION AND CUSTOMS ENFORCEMENT (USICE)
Final Rule Stage
106. Immigration Bond Notifications and Electronic Service [1653-AA85]
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Government Paperwork Elimination Act, 44 U.S.C.
3504 note; Electronic Signatures in Global and National Commerce Act,
15 U.S.C. 7001 to 7031; 8 U.S.C. 1103(a)(3)
CFR Citation: 8 CFR 103.
Legal Deadline: None.
Abstract: DHS is revising regulations that authorize the means to
serve decisions and other notices in-person or by mail, to include
electronic and other means of service. This rule is consistent with
Executive Order 14058, which directs agencies to take actions that
improve service delivery and customer experience by decreasing
administrative burdens, enhancing transparency, and improving the
efficiency and effectiveness of government. Current regulations limit
ICE, a component of DHS, to serve documents in-person, or by certified,
registered, or ordinary mail, which is time consuming, inefficient, and
unreliable.
This interim final rule would enable ICE to issue and serve certain
notices, decisions, and other documents electronically to noncitizens,
parties, attorneys, or other persons of interest who voluntarily opt-in
to be served electronically. The intent is to improve convenience,
transparency, and provide quicker information and communication to both
the public and the government. This interim final rule would also
permit ICE to issue bond-related notifications to obligors
electronically for immigration bonds.The ICE transition to electronic
notifications for bond-related documents is part of an electronic bonds
system ICE developed to simplify the posting of bonds.
Statement of Need: This interim final rule is needed for ICE to
begin transforming from a paper environment to electronic or other
means to streamline processes and increase efficiency.
Anticipated Cost and Benefits: ICE is in the process of assessing
the anticipated impacts of this rule. This interim final rule is
expected to result in cost-savings and benefits to both the government
and private parties due to the optional electronic servicing of bond-
related notifications, including expedited delivery, improved
reliability, and other modernization features. It may impose nominal
use and familiarization costs to those who elect to create accounts and
use the system.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 10/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Agency Contact: Sharon Hageman, Deputy Assistant Director,
Department of Homeland Security, U.S. Immigration and Customs
Enforcement, 500 12th Street SW, Mail Stop 5006, Washington, DC 20536,
Phone: 202 732-6960, Email: [email protected].
RIN: 1653-AA85
DHS--USICE
107. Optional Alternative to the Physical Examination Associated With
Employment Eligibility Verification (Form I-9) [1653-AA86]
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101, 1103
CFR Citation: 8 CFR 274a.
Legal Deadline: None.
Abstract: On August 18, 2022, DHS published a proposed rule that
would revise employment eligibility verification regulations to allow
the Secretary to authorize alternative document examination procedures
in certain circumstances or with respect to certain employers. DHS
explained that future exercises of such authority may reduce burdens on
employers and employees while maintaining the integrity of the
employment verification process. DHS will complete this rulemaking
following review of public comments received. This rulemaking is
consistent with Executive Order 14058, which directs agencies to take
actions that improve service delivery and customer experience by
decreasing administrative burdens, enhancing transparency, and
improving the
[[Page 11062]]
efficiency and effectiveness of government.
Statement of Need: DHS is exploring alternative options for
examining employees' identity and employment authorization documents
because of lessons learned during the COVID-19 pandemic, and because
more employers are adopting telework and remote work arrangements as a
result of advances in technology and new work arrangements where more
employees work without physically reporting to a company location on a
regular basis.
Anticipated Cost and Benefits: DHS proposed allowing the Secretary
to authorize alternative options for document examination procedures
with respect to some or all employers when they are hired, have their
employment authorization reverified, or rehired, as part of a pilot
program, or as a temporary measure to address a public health emergency
declared by the Secretary of Health and Human Services or a national
emergency declared by the President. The rule does not itself implement
an alternative procedure to physical examination, therefore DHS is
unable to fully quantify the potential impacts due to a lack of
information about the specifics of a possible future alternative
procedure. DHS proposed changes to the Form I-9, Employment Eligibility
Verification, and its accompanying instructions that would allow
employers to indicate that alternative procedures were used (should
such alternative procedures be authorized in the future). These changes
would increase the time for employers to complete the form.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/18/22 87 FR 50786
NPRM Comment Period End............. 10/17/22 .......................
Final Rule.......................... 05/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL For More Information: http://www.regulations.gov.
URL For Public Comments: http://www.regulations.gov.
Agency Contact: Sharon Hageman, Deputy Assistant Director,
Department of Homeland Security, U.S. Immigration and Customs
Enforcement, 500 12th Street SW, Mail Stop 5006, Washington, DC 20536,
Phone: 202 732-6960, Email: [email protected].
RIN: 1653-AA86
DHS--FEDERAL EMERGENCY MANAGEMENT AGENCY (FEMA)
Proposed Rule Stage
108. National Flood Insurance Program: Standard Flood Insurance Policy,
Homeowner Flood Form [1660-AB06]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 4001 et seq.
CFR Citation: 44 CFR 61.
Legal Deadline: None.
Abstract: The National Flood Insurance Program (NFIP), established
pursuant to the National Flood Insurance Act of 1968, is a voluntary
program in which participating communities adopt and enforce a set of
minimum floodplain management requirements to reduce future flood
damages. Property owners in participating communities are eligible to
purchase NFIP flood insurance. This proposed rule would revise the
Standard Flood Insurance Policy by adding a new Homeowner Flood Form
and five accompanying endorsements.
The new Homeowner Flood Form would replace the Dwelling Form as a
source of coverage for homeowners of one-to-four family residences.
Together, the new Form and endorsements would more closely align with
property and casualty homeowners' insurance and provide increased
options and coverage in a more user-friendly and comprehensible format.
Statement of Need: The National Flood Insurance Act requires FEMA
to provide by regulation the general terms and conditions of
insurability applicable to properties eligible for flood insurance
coverage. 42 U.S.C. 4013(a). To comply with this requirement, FEMA
adopts the Standard Flood Insurance Policy (SFIP) in regulation, which
sets out the terms and conditions of insurance. See 44 CFR part 61,
Appendix A. FEMA must use the SFIP for all flood insurance policies
sold through the NFIP. See 44 CFR 61.13.
The SFIP is a single-peril (flood) policy that pays for direct
physical damage to insured property. There are currently three forms of
the SFIP: the Dwelling Form, the General Property Form, and the
Residential Condominium Building Association Policy (RCBAP) Form. The
Dwelling Form insures a one-to-four family residential building or a
single-family dwelling unit in a condominium building. See 44 CFR part
61, Appendix A(1). Policies under the Dwelling Form offer coverage for
building property, up to $250,000, and personal property up to
$100,000. The General Property Form ensures a five-or-more family
residential building or a non-residential building. See 44 CFR part 61,
Appendix A(2). The General Property Form offers coverage for building
and contents up to $500,000 each. The RCBAP Form insures residential
condominium association buildings and offers building coverage up to
$250,000 multiplied by the number of units and contents coverage up to
$100,000 per building. See 44 CFR part 61, appendix A(3). RCBAP
contents coverage insures property owned by the insured condominium
association. Individual unit owners must purchase their own Dwelling
Form policy in order to insure their own contents.
FEMA last substantively revised the SFIP in 2000. See 65 FR 60758
(Oct. 12, 2000). In 2020, FEMA published a final rule that made non-
substantive clarifying and plain language improvements to the SFIP. See
85 FR 43946 (July 20, 2020). However, many policyholders, agents, and
adjusters continue to find the SFIP difficult to read and interpret
compared to other, more modern, property and casualty insurance
products found in the private market. Accordingly, FEMA proposes to
adopt a new Homeowner Flood Form.
The new Homeowner Flood Form, which FEMA proposes to add to its
regulations at 44 CFR 61 appendix A(4), would protect property owners
in a one-to-four family residence. Upon adoption, the Homeowner Flood
Form would replace the Dwelling Form as a source of coverage for this
class of residential properties. FEMA would continue to use the
Dwelling Form to insure landlords, renters, and owners of mobile homes,
travel trailers, and condominium units. Compared to the current
Dwelling Form, the new Homeowner Flood Form would clarify coverage and
more clearly highlight conditions, limitations, and exclusions in
coverage as well as add and modify coverages and coverage options. FEMA
also proposes adding to its regulations five endorsements to accompany
the new Form: Increased Cost of Compliance Coverage, Actual Cash Value
Loss Settlement, Temporary Housing Expense, Basement Coverage, and
Builder's Risk. These endorsements, which FEMA proposes to codify at 44
CFR 61 appendices A(101)-(105), respectively, would give policyholders
the option of amending the Homeowner Flood Form to modify coverage with
a commensurate adjustment to premiums charged. Together, the Homeowner
Flood Form and accompanying endorsements would increase options
[[Page 11063]]
and coverage for owners of one-to-four family residences.
FEMA intends that this new Form will be more user-friendly and
comprehensible. As a result, the new Homeowner Flood Form and its
accompanying endorsements would provide a more personalized,
customizable product than the NFIP has offered during its 50 years. In
addition to aligning with property and casualty homeowners' insurance,
the result would increase consumer choice and simplify coverage.
Anticipated Cost and Benefits: FEMA estimates that this rulemaking
would result in an increase in transfer payments from policyholders to
FEMA and insurance providers in the form of flood insurance premiums,
and from FEMA to policyholders in the form of claims payments.
Additionally, this rulemaking would result in benefits to
policyholders, insurance providers, and FEMA, mostly through cost
savings due to increased clarity and fulfillment of customer
expectations through expanded coverage options. It would also help the
NFIP better signal risk through premiums, reduce the need for Federal
assistance, and increase resilience by enhancing mitigation efforts.
Lastly, FEMA, States, and insurance providers will incur costs for
implementation and familiarization of the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal.
Agency Contact: Christine Merk, Lead Management and Program
Analyst, Department of Homeland Security, Federal Emergency Management
Agency, Insurance Analytics and Policy Branch, 400 C Street SW,
Washington, DC 20472, Phone: 202 735-6324, Email:
[email protected].
RIN: 1660-AB06
DHS--FEMA
109. Individual Assistance Program Equity [1660-AB07]
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 5155; 42 U.S.C. 5174; 42 U.S.C. 5189a
CFR Citation: 44 CFR 206.101; 44 CFR 206.110 to 206.115; 44 CFR
206.117 to 206.119; 44 CFR 206.191.
Legal Deadline: None.
Abstract: The Federal Emergency Management Agency (FEMA) proposes
to amend its Individual Assistance (IA) regulations to increase equity
and ease of entry to the IA Program. To provide a full opportunity for
underserved communities to participate in the Program, FEMA proposes to
amend application of `safe, sanitary, and functional' for the
Individuals and Households Program (IHP) Home Repair assistance; re-
evaluate the requirement to apply for a Small Business Administration
loan prior to receipt of certain types of Other Needs Assistance (ONA);
add eligibility criteria for its Serious Needs & Displacement
Assistance; amend its requirements for Continued Temporary Housing
Assistance; re-evaluate its approach to insurance proceeds; and amend
its appeals process. FEMA also proposes revisions to reflect changes to
statutory authority that have not yet been implemented in regulation,
to include provisions for utility and security deposit payments, lease
and repair of multi-family rental housing, child care assistance,
maximum assistance limits, and waiver authority. Finally, FEMA proposes
allowing self-employed individuals to receive assistance for essential
tools under ONA, allowing certain home repair accessibility-related
items, and allowing the reopening of the registration period when the
President adds new counties to the major disaster declaration.
Statement of Need: FEMA's Individuals and Households Program (IHP)
regulations have not had a major review and update since section 206 of
the Disaster Mitigation Act of 2000 replaced the Individual and Family
Grant Assistance Program with the current IHP. Some minor changes to
Repair Assistance were completed in 2013, but Congress has passed
multiple other laws that have superseded portions of the regulations
and created other programs or forms of assistance with no supporting
regulations. FEMA proposes an update to the IHP regulations now to
bring them up to date and address other lessons learned through the
course of implementing the IHP in disasters much larger than any
previously addressed at the time the regulations were first developed.
Anticipated Cost and Benefits: FEMA estimates that this rulemaking
would result in an increase in transfer payments from FEMA and States
in the form of disaster assistance to individuals and households. It
would also result in additional costs to States for familiarization of
the rule and to FEMA and applicants for paperwork burden. The proposed
rule would ensure disaster assistance is more equitably distributed and
assist applicants to more quickly and fully recover from disasters by
expanding eligibility for, and access to, certain types of assistance.
Lastly, the rulemaking would improve clarity and align FEMA regulations
with statutory changes improving the efficiency and the consistency of
IHP assistance.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State.
Agency Contact: Kristina McAlister, Supervisory Emergency
Management Specialist (Recovery), Department of Homeland Security,
Federal Emergency Management Agency, Individual Assistance Division
Recovery Directorate, 500 C Street SW, Washington, DC 20472, Phone: 202
604-8007, Email: [email protected].
RIN: 1660-AB07
DHS--FEMA
110. Update of FEMA's Public Assistance Regulations [1660-AB09]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 5121 to 5207
CFR Citation: 44 CFR 206.
Legal Deadline: None.
Abstract: The Federal Emergency Management Agency (FEMA) proposes
to revise its Public Assistance (PA) program regulations to reflect
current statutory authorities and implement program improvements. The
proposed rule would incorporate changes brought about by amendments to
the Robert T. Stafford Disaster Relief and Emergency Assistance Act.
FEMA is also proposing clarifications and corrections to improve the
efficiency and consistency of the Public Assistance program.
Statement of Need: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act), Public Law 100-707, 102 Stat.
4689, authorizes the President to provide Federal assistance when the
severity and magnitude of an incident or threatened incident, exceeds
the affected State, local, Indian Tribal, and Territorial government's
(SLTT's) capabilities to effectively respond or recover. 42 U.S.C. 5170
and 5191. If the President declares an emergency or major disaster
authorizing the Public Assistance
[[Page 11064]]
program, FEMA may award Public Assistance grants to assist SLTTs and
certain private nonprofit (PNP) organizations so communities can
quickly respond to and recover from the major disaster or emergency.
FEMA proposes to amend its Public Assistance and Community Disaster
Loan program regulations to incorporate statutory changes that have
amended sections of the Stafford Act relating to Public Assistance and
Community Disaster Loans and to improve program administration. These
include the Post-Katrina Emergency Management Reform Act of 2006
(PKEMRA), Public Law 109-295, 120 Stat. 1394, the Security and
Accountability for Every Port Act of 2006 (SAFE Port Act), Public Law
109-347, 120 Stat. 1884, the Pets Evacuation and Transportation
Standards Act of 2006 (PETS Act), Public Law 109-308, 120 Stat. 1725,
the Sandy Recovery Improvement Act of 2013 (SRIA), Public Law 113-2,
127 Stat. 39, the Emergency Information Improvement Act of 2015, Public
Law 114-111, 129 Stat. 2240, the Bipartisan Budget Act of 2018, Public
Law 115-123, 132 Stat. 64, and the FAA Reauthorization Act of 2018,
Division D, Disaster Recovery Reform Act of 2018 (DRRA), Public Law
115-254, 132 Stat. 3438. FEMA also proposes to implement program
improvements and make clarifications and corrections to existing
regulations.
Anticipated Cost and Benefits: FEMA estimates that this rulemaking
would result in benefits to SLTTs and FEMA from improving clarity and
aligning FEMA regulations with statutory changes and current practices.
Such increased clarity and understanding would improve the efficiency
and the consistency of FEMA's PA programs. Additionally, proposed
improvements to State/Tribal administrative plans would better position
SLTTs to respond to and to recover from emergencies and disasters.
Lastly, FEMA estimates increases in costs for SLTTs due to additional
paperwork burden and familiarization of the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State, Tribal.
Agency Contact: Ana Montero, Public Assistance Division Recovery
Directorate, Department of Homeland Security, Federal Emergency
Management Agency, 500 C Street SW, Washington, DC 20472-3100, Phone:
202 646-3834, Email: [email protected].
RIN: 1660-AB09
DHS--FEMA
111. Updates to Floodplain Management and Protection of Wetlands
Regulations [1660-AB12]
Priority: Other Significant.
Legal Authority: 6 U.S.C. 101 et seq.; 42 U.S.C. 4001 et seq.; 42
U.S.C. 4321 et seq.; E.O. 11988 of May 24, 1977, 42 FR 26951, 3 CFR,
1977 Comp., p. 117; E.O. 11990 of May 24, 1977, 42 FR 26961, 3 CFR,
1977 Comp., p. 121; E.O. 13690, 80 FR 6425; E.O. 14030, 86 FR 27967
CFR Citation: 44 CFR 9.
Legal Deadline: None.
Abstract: Consistent with President Biden's Executive Order on
Climate Related Financial Risk (E.O. 14030), the Federal Emergency
Management Agency (FEMA) proposes to amend its regulations at 44 CFR
part 9 Floodplain Management and Protection of Wetlands to incorporate
amendments to Executive Order 11988 and the Federal Flood Risk
Management Standard (FFRMS). The FFRMS is a flexible framework allowing
agencies to choose among three approaches to define the floodplain and
corresponding flood elevation requirements for federally funded
projects. 44 CFR part 9 describes FEMA's process under Executive Order
11988 for determining whether the proposed location for an action falls
within a floodplain and how to complete the action in the floodplain,
in light of the risk of flooding. The proposed rule would change how
FEMA defines a floodplain with respect to certain actions.
Additionally, under the proposed rule, FEMA would use natural systems,
ecosystem process, and nature-based approaches, where practicable, when
developing alternatives to locating the proposed action in the
floodplain.
Statement of Need: The United States is experiencing increased
flooding and flood risk from changing conditions. The Federal Emergency
Management Agency (FEMA) has not made significant updates to its
regulations governing floodplain management to reflect the challenges
faced because of increased flooding and changing conditions since
initial publication in 1980. As a result, FEMA is now proposing to
amend 44 CFR part 9, Floodplain Management and Protection of Wetlands,
to implement the Federal Flood Risk Management Standard (FFRMS) and
update the agency's 8-step process. The FFRMS is a flood resilience
standard that is required for federally funded projects and provides a
flexible framework to increase resilience against flooding and help
preserve the natural values of floodplains and wetlands. A floodplain
is any land area that is subject to flooding and refers to geographic
features with undefined boundaries. 44 CFR part 9 describes the 8-step
process FEMA uses to determine whether a proposed action would be
located within or affect a floodplain, and if so, whether and how to
continue with or modify the proposed action. Executive Order 11988, as
amended, and the FFRMS changed the Executive Branch-wide guidance for
defining the floodplain with respect to federally funded projects
(i.e., actions involving the use of Federal funds for new construction,
substantial improvement, or to address substantial damage to a
structure or facility). This proposed rule would ensure that actions
subject to the FFRMS are designed to be resilient to both current and
future flood risks to minimize the impact of floods on human health,
safety, and welfare and to protect Federal investments by reducing the
risk of flood loss.
Anticipated Cost and Benefits: FEMA estimates that this rulemaking
would result in benefits to grant recipients (States, Local, Tribes,
Territories, and Individuals) and to FEMA, mostly through the reduction
in damage to properties and contents from future floods, potential
lives saved, public health and safety benefits, reduced recovery time
from floods, and increased community resilience to flooding. FEMA
estimates project cost increases for FEMA and grant recipients due to
increased elevation or floodproofing requirements of the proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State, Tribal.
Agency Contact: Portia Ross, Office of Environmental and Historic
Preservation, Department of Homeland Security, Federal Emergency
Management Agency, 400 C Street SW, Washington, DC 20472, Phone: 202
646-2741, Email: [email protected].
RIN: 1660-AB12
[[Page 11065]]
DHS--FEMA
Long-Term Actions
112. National Flood Insurance Program's Floodplain Management Standards
for Land Management & Use, & an Assessment of the Program's Impact on
Threatened and Endangered Species & Their Habitats [1660-AB11]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 4001 et seq.
CFR Citation: 44 CFR 59 to 60.
Legal Deadline: None.
Abstract: The Federal Emergency Management Agency (FEMA) issued a
Request for Information to receive the public's input on revisions to
the National Flood Insurance Program's (NFIP) floodplain management
standards for land management and use regulations. FEMA's authority
under the National Flood Insurance Act requires the agency to, from
time to time, develop comprehensive criteria designed to encourage the
adoption of adequate State and local measures. The agency is reviewing
potential actions to better align the NFIP minimum floodplain
management standards with our current understanding of flood risk,
flood insurance premium rates, and risk reduction approaches to make
communities safer, stronger, and more resilient to increased flooding.
FEMA is considering revisions to the minimum standards to better
protect people and property in a nuanced manner that balances community
needs with the national scope of the NFIP while also incorporating
opportunities for improving resilience in communities that have been
historically underserved. The agency is also reviewing ways to further
promote enhanced resilience efforts through the Community Rating System
and to strengthen NFIP compliance with Section 7 of the Endangered
Species Act.
Statement of Need: FEMA issued this Request for Information to seek
information from the public on the agency's current floodplain
management standards to ensure the agency receives public input to
inform any action to revise the NFIP minimum floodplain management
standards.
FEMA is also re-evaluating the implementation of the NFIP under the
Endangered Species Act at the national level. FEMA is reviewing
potential actions based on the comments received on this Request for
Information to better align the NFIP minimum floodplain management
standards with our current understanding of flood risk, flood insurance
premium rates, and risk reduction approaches to make communities safer,
stronger, and more resilient to increased flooding.
Anticipated Cost and Benefits: FEMA is currently considering the
cost and benefit impacts of potential proposed actions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Request for Information............. 10/12/21 86 FR 56713
Announcement of Public Meetings..... 10/28/21 86 FR 59745
Announcement of Additional Public 11/22/21 86 FR 66329
Meeting; Extension of Comment
Period.
Request for Information Comment 01/27/22
Period End..
-----------------------------------
Next Action Undetermined............ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Additional Information: Docket ID FEMA-2021-0024.
URL For More Information: http://www.regulations.gov.
URL For Public Comments: http://www.regulations.gov.
Agency Contact: Rachel Sears, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency, 400 C Street SW, Washington, DC 20472, Phone: 202
646-2977, Email: [email protected].
RIN: 1660-AB11
DHS--CYBERSECURITY AND INFRASTRUCTURE SECURITY AGENCY (CISA)
Proposed Rule Stage
113. Ammonium Nitrate Security Program [1670-AA00]
Priority: Other Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 6 U.S.C. 488 et seq.
CFR Citation: 6 CFR 31.
Legal Deadline: NPRM, Statutory, May 26, 2008, Publication of
Notice of Proposed Rulemaking. Final, Statutory, December 26, 2008,
Publication of Final Rule.
Abstract: The Cybersecurity and Infrastructure Security Agency
(CISA) is proposing a rulemaking to implement the December 2007
amendment to the Homeland Security Act titled ``Secure Handling of
Ammonium Nitrate.'' This 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.'' CISA previously issued a
Notice of Proposed Rulemaking (NPRM) on August 3, 2011. CISA is
planning to issue a Supplemental Notice of Proposed Rulemaking (SNPRM).
Statement of Need: A Federal regulation governing the sale and
transfer of ammonium nitrate is statutorily mandated. The statute
requires that purchasers of ammonium nitrate and owners of ammonium
nitrate facilities register with the Department of Homeland Security
and be vetted against the Terrorist Screening Database. The statute
further requires that information about transactions of ammonium
nitrate be recorded and kept. Given the widespread use of ammonium
nitrate in many sectors of the economy, including industrial,
agricultural, and consumer uses, the Department is exploring ways to
reduce the threat of terrorism posed by ammonium nitrate while
remaining sensitive to the impacts on the supply chain and legitimate
users.
Summary of Legal Basis: This regulation is statutorily mandated by
6 U.S.C. 488 et seq.
Anticipated Cost and Benefits: In the 2011 NPRM, CISA estimated
cost of this proposed rule would range from $300 million to $1,041
million over 10 years at a 7 percent discount rate. In the intervening
years, CISA has adjusted its approach to this rulemaking and has made
significant changes to the way we estimate the costs associated with
this SNPRM. At this time CISA is still developing the cost estimates
for and substantive contents of this SNPRM.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 10/29/08 73 FR 64280
ANPRM Correction.................... 11/05/08 73 FR 65783
ANPRM Comment Period End............ 12/29/08
NPRM................................ 08/03/11 76 FR 46908
Notice of Public Meetings........... 10/07/11 76 FR 62311
Notice of Public Meetings........... 11/14/11 76 FR 70366
NPRM Comment Period End............. 12/01/11
Notice of Availability.............. 06/03/19 84 FR 25495
Notice of Availability Comment 09/03/19
Period End.
[[Page 11066]]
Supplemental NPRM................... 09/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal, Local, State.
Federalism: This action may have federalism implications as defined
in E.O. 13132.
URL For More Information: www.regulations.gov.
URL For Public Comments: www.regulations.gov.
Agency Contact: Ryan Donaghy, Deputy Branch Chief for Chemical
Security Policy, Rulemaking, and Engagement, Department of Homeland
Security, Cybersecurity and Infrastructure Security Agency, 245 Murray
Lane SW, Mail Stop 0610, Arlington, VA 20528, Phone: 571 532-4127,
Email: [email protected].
Related RIN: Previously reported as 1601-AA52
RIN: 1670-AA00
DHS--CISA
114. Chemical Facility Anti-Terrorism Standards (CFATS) [1670-AA01]
Priority: Other Significant.
Legal Authority: 6 U.S.C. 621 to 629
CFR Citation: 6 CFR 27.
Legal Deadline: None.
Abstract: The Cybersecurity and Infrastructure Security Agency
(CISA) previously invited public comment on an Advance Notice of
Proposed Rulemaking (ANPRM) during August 2014 for potential revisions
to the Chemical Facility Anti-Terrorism Standards (CFATS) regulations.
The ANPRM provided an opportunity for the public to provide
recommendations for possible program changes. In June 2020, CISA
published for public comment a retrospective analysis of the CFATS
program. And in January 2021, CISA invited additional public comment
through an ANPRM concerning the removal of certain explosive chemicals
from CFATS. CISA intends to address many of the subjects raised in both
ANPRMs and the retrospective analysis in this regulatory action,
including potential updates to CFATS cybersecurity requirements and
Appendix A to the CFATS regulations.
Statement of Need: The Chemical Facility Anti-Terrorism Standards
(CFATS) program regulates facilities possessing large quantities of
dangerous chemicals. The particular chemicals listed and threshold
quantities were established in 2007, and were based on EPA's threshold
quantities for Hazardous Substances published under its Release
Management Program. In the 15 years since implementation of the
program, CISA has gained extensive experience in analyzing chemical
holdings and determining which facilities should be classified as high-
risk and subject to further regulation. Given its experience, CISA has
determined that it should adjust its list of regulated chemicals,
threshold quantities, and counting methods to better reflect the
security issues implicated by these chemicals. Additionally, CISA
believes that the CFATS security performance guidelines, first issued
in 2009, should be updated to better reflect lessons learned over the
past decade, including substantially updating the guidelines for
cybersecurity performance metrics.
Summary of Legal Basis: This regulation is authorized pursuant to 6
U.S.C. 621 et seq.
Alternatives: CISA considered an alternative version of this NPRM
where we updated only the performance guidance but not the chemical
listings. Additionally, we considered an alternative version where
changes to certain toxic chemical listings were omitted.
Anticipated Cost and Benefits: CISA is developing the cost and
benefits estimates for this rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 08/18/14 79 FR 48693
ANPRM Comment Period End............ 10/17/14
ANPRM............................... 01/06/21 86 FR 495
Announcement of Availability; 06/22/20 85 FR 37393
Retrospective Analysis.
Announcement of Availability; 09/21/20
Retrospective Analysis Comment
Period End.
NPRM................................ 05/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal, Local, State.
URL For More Information: www.regulations.gov.
URL For Public Comments: www.regulations.gov.
Agency Contact: Ryan Donaghy, Deputy Branch Chief for Chemical
Security Policy, Rulemaking, and Engagement, Department of Homeland
Security, Cybersecurity and Infrastructure Security Agency, 245 Murray
Lane SW, Mail Stop 0610, Arlington, VA 20528, Phone: 571 532-4127,
Email: [email protected].
Related RIN: Previously reported as 1601-AA69, Merged with 1670-
AA03
RIN: 1670-AA01
BILLING CODE 9110-9B-P
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Statement of Regulatory Priorities for Fiscal Year 2023
Introduction
The Regulatory Plan for the Department of Housing and Urban
Development (HUD) for Fiscal Year (FY) 2023 highlights two of the most
significant regulations and policy initiatives that HUD seeks to
complete during the upcoming fiscal year. As the Federal agency that
serves as the nation's housing agency, HUD is committed to addressing
the housing needs of all Americans by creating strong, sustainable,
inclusive communities, and quality affordable homes for all. As a
result, HUD plays a significant role in the lives of families and in
communities throughout America.
HUD is currently working to strengthen the housing market to
bolster the economy and protect consumers; meet the need for quality
affordable rental homes; utilize housing as a platform for improving
quality of life; build inclusive and sustainable communities free from
discrimination and transform the way HUD does business. Under the
leadership of Secretary Marcia L. Fudge, HUD is dedicated to
implementing the Administration's priorities by setting forth
initiatives related to recovery from the COVID-19 pandemic, providing
economic relief to those HUD serves, advancing racial equity and civil
rights, and tackling the climate emergency.
The rules highlighted in HUD's regulatory plan for FY 2023 reflect
HUD's efforts to continue its work in building strong and sustainable
communities, addressing the housing needs of all Americans, and
providing for equal access to housing opportunities. Additionally, HUD
notes that its Fall 2022 Semiannual Regulatory Agenda includes
additional rules that advance the Administration's priorities,
including rules to advance racial equity and civil rights and rules to
provide economic relief to homeowners and renters.
[[Page 11067]]
Floodplain Management and Protection of Wetlands; Minimum Property
Standards for Flood Hazard Exposure; Building to the Federal Flood Risk
Management Standard
On January 20, 2021, President Biden issued Executive Order 13990,
``Protecting Public Health and the Environment and Restoring Science to
Tackle the Climate Crisis,'' which declared the Administration's policy
to bolster resilience to the impacts of climate change, and which
directed all executive department and agencies to immediately commence
work to confront the climate crisis. Executive Order 14008, ``Tackling
the Climate Crisis at Home and Abroad,'' signed on January 27, 2021,
noted that it is the Administration's policy to increase resilience to
the impacts of climate change. HUD's proposed rule titled ``Floodplain
Management and Protection of Wetlands; Minimum Property Standards for
Flood Hazard Exposure; Building to the Federal Flood Risk Management
Standard'' would improve the resilience of HUD-assisted or financed
projects to the effects of climate change and natural disasters,
This proposed rule would revise HUD's regulations governing
floodplain management and the protection of wetlands to implement the
Federal Flood Risk Management Standard (FFRMS), in accordance with
Executive Order 13690 (Establishing a Federal Flood Risk Management
Standard and a Process for Further Soliciting and Considering
Stakeholder Input) (2015) and provide for greater flexibility in the
use of HUD assistance in floodways under certain circumstances. Among
other revisions, the rule would provide a process for determining the
FFRMS Floodplain that would establish a preference for the climate-
informed science approach (CISA), and it would revise HUD's floodplain
and wetland regulations to streamline them, improve overall clarity,
and modernize standards.
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
pursued in FY 2022. HUD expects that the neither the total economic
costs nor the total efficiency gains will exceed $100 million.
Elevating HUD-assisted structures located in and around the FFRMS
floodplain will lessen damage caused by flooding and avoid relocation
costs to tenants associated with temporary moves when HUD-assisted
structures sustain flood damage and are temporarily uninhabitable.
These benefits, which are realized throughout the life of HUD-assisted
structures, are offset by the one-time increase in construction costs,
borne only at the time of construction.
Statement of Need
The rule is part of HUD's commitment under HUD's 2021 Climate
Action Plan. HUD committed to completing rulemaking to update 24 CFR
part 55 of its regulations and implement FFRMS as a key component of
its plan to increase climate resilience and climate justice across the
Department, noting that low-income families and communities of color
are disproportionately impacted by climate change. Additionally, HUD
notes that affordable housing is increasingly at risk from both extreme
weather events and sea-level rise, and that coastal communities are
especially at risk.
HUD's existing regulations currently rely on Flood Insurance Rate
Maps, which are critical resources when assessing flood risk, but are
not intended to reflect changes in future flood risk influenced by a
changing climate. This rule would ensure that HUD projects are designed
with a more complete picture of a proposed project site's flood risk
over time. Building to the standards discussed in this proposed rule
would increase resiliency, reduce the risk of flood loss, minimize the
impact of floods on human safety, health, and welfare, and promote
sound, sustainable, long-term planning informed by a more accurate
evaluation of risk that takes into account possible sea level rise and
increased development associated with population growth.
Alternatives: An alternative to promulgating this rule would be to
maintain HUD's existing regulations governing floodplain management and
the protection of wetlands. However, doing so would ignore the threats
that increasing flood risks pose to life and taxpayer-funded property.
Additionally, HUD would not be in compliance with Executive Order 13960
and implementing guidance if HUD did not revise its regulations. Other
alternatives include higher additional elevation standards for HUD
projects without using a CISA approach. HUD prefers the CISA approach
because it provides a forward-looking assessment of flood risk based on
likely or potential climate change scenarios, regional climate factors,
and an advanced scientific understanding of these effects.
Risks: This rule could increase construction costs for HUD projects
where it leads to additional elevation requirements, thereby increasing
the cost of constructing affordable housing. However, these costs are
offset by the decreased damage caused by flooding a project will endure
throughout its lifetime, and the avoidance of relocation costs when
HUD-assisted structures sustain flood damage.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Proposed Rule....................... 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism Affected: No.
Energy Affected: No.
International Impacts: No.
Violence Against Women Act Reauthorization Act of 2022 (VAWA 2022)
Through this proposed rule, HUD would amend its VAWA regulations to
implement the requirements of the Violence Against Women Act (``VAWA'')
as reauthorized on March 15, 2022, under the Violence Against Women Act
Reauthorization Act of 2022 (``VAWA 2022''). These revisions will
assist in ensuring that survivors of domestic violence, dating
violence, sexual assault, and stalking (``survivors'') can access and
maintain affordable housing as well as homeless assistance services.
Specifically, HUD is focused on protecting survivors' housing rights,
enforcing VAWA's requirements and protections, and providing access to
safe, stable, and affordable housing for survivors.
This proposed rule will seek to ensure that HUD's regulatory
definitions account for the changes to VAWA's statutory definitions and
are interpreted broadly enough to include the additional acts referred
to in the VAWA 2022 reauthorization. For example, VAWA 2022 expands the
definition of ``domestic violence'' by, in part, adding (as well as
separately defining) the concepts of ``economic abuse'' and
``technological abuse''. Additionally, following the direction provided
in VAWA 2022, this proposed rule will establish VAWA compliance review
processes for VAWA-covered HUD programs (``covered housing programs''),
and further address VAWA standards of compliance and standards of
corrective actions, where compliance standards have not been met. VAWA
2022 also establishes substantive rights and protections for survivors,
including anti-retaliation and anti-coercion
[[Page 11068]]
requirements, and protections for individuals against being penalized
for seeking emergency assistance or for criminal activity where they
are a victim or otherwise not at fault. HUD has existing enforcement
mechanisms that have been used to enforce VAWA rights and protections,
but this proposed rule would provide HUD and survivors with direct
enforcement authority of VAWA's housing rights.
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
pursued in FY 2022. HUD expects that the neither the total economic
costs nor the total efficiency gains will exceed $100 million. Unlike
HUD's VAWA 2013 final rule that was published in 2016 (``VAWA 2013
rule''), which had costs that were ``primarily paperwork costs,'' this
rulemaking has fewer paperwork costs. The benefits of HUD's rulemaking
include codifying in regulation the protections that VAWA 2022 provides
to applicants and tenants of covered housing programs; strengthening
the rights of survivors accessing and living in covered housing
programs, including existing emergency transfer rights and new rights
against retaliation and prohibition and the right to report crime from
one's home; and improving and streamlining HUD's VAWA compliance
monitoring and review processes. HUD grantees are already familiar with
HUD's VAWA regulations as instituted by the 2016 final rule; this
proposed rule will largely build on that regulatory framework and
related forms and documents. HUD is also planning to publish a notice
in the Federal Register in the Fall of 2022 that will provide initial
guidance on VAWA 2022, its impact on VAWA-covered HUD programs, and
HUD's planned implementation actions. HUD believes that grantees' prior
experience with HUD's implementation of other VAWA reauthorization
legislation and HUD's advanced notice will reduce costs by helping
grantees to understand the new protections and requirements ahead of
rulemaking.
Statement of Need
The rule is needed to conform HUD regulations with statutory
standards and amendments, and to ensure consistency in application and
enforcement of VAWA protections and requirements across HUD's covered
housing programs. This proposed rule would consider HUD's VAWA 2013
rule published on November 16, 2016, and improve upon its framework and
impose less regulatory burden.
Alternatives: HUD has no alternative to implementing the provisions
of VAWA 2022. VAWA 2022 requires stakeholder consultation and
rulemaking to establish VAWA compliance review processes, and to
incorporate this process into existing compliance review processes,
where possible. Therefore, HUD does not have the discretion to choose
an alternative to rulemaking for compliance review processes. HUD has
also determined that rulemaking is needed to implement new and revised
statutory protections and requirements. Furthermore, prior VAWA
reauthorizations were implemented through rulemaking.
Risks: Previous and unfinished implementations of prior VAWA
reauthorizations have resulted in challenges for grantees. HUD must
seek to complete implementation of VAWA 2013, the Justice for All
Reauthorization Act of 2016's amendments to VAWA's lease bifurcation
provisions, and VAWA 2022, to fully implement changes to VAWA and
clarify which requirements and changes HUD grantees are expected to
comply with, and when those requirements and changes go into effect.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Proposed Rule....................... 10/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: No.
Federalism Affected: No.
Energy Affected: No.
International Impacts: No.
HUD--OFFICE OF THE SECRETARY (HUDSEC)
Proposed Rule Stage
115. Violence Against Women Act Reauthorization Act of 2022: Compliance
in HUD Housing Programs (FR-6319) [2501-AE05]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 1437a,c,d,f; 42 U.S.C. 1437n; 42 U.S.C.
3535(d); sec. 327, Pub. L. 109-115,119; Stat 2936; 42 U.S.C. 14043e et;
sec. 601, Pub. L. 11304, 127 Stat 101; Pub. L. 117-103
CFR Citation: 24 CFR 5, 92, 93, 200, 247, 574, 576 578; 24 CFR 880,
882, 883, 884, 886, 891; 24 CFR 905, 960, 966, 982, 983.
Legal Deadline: None.
Abstract: This proposed rule would amend HUD's regulations to fully
implement the requirements of the Violence Against Women Act (VAWA) as
reauthorized on March 15, 2022, under the Violence Against Women Act
Reauthorization Act of 2022 (VAWA 2022). VAWA 2022 in part requires
that HUD issue regulations to define standards of compliance for
covered housing programs, address prohibitions on retaliation, and
update certain definitions. HUD will also consider other revisions to
update its VAWA regulations.
Statement of Need: The rule is needed to conform HUD regulations
with statutory standards and amendments, and to ensure consistency in
application and enforcement of VAWA protections and requirements across
HUD's covered housing programs. This proposed rule would consider HUD's
VAWA 2013 rule published on November 16, 2016, and improve upon its
framework and impose less regulatory burden.
Summary of Legal Basis: These regulatory revisions would implement
the requirements of the Violence Against Women Act (VAWA) as
reauthorized on March 15, 2022, under the Violence Against Women Act
Reauthorization Act of 2022 (VAWA 2022).
Alternatives: HUD has no alternative to implementing the provisions
of VAWA 2022. VAWA 2022 requires stakeholder consultation and
rulemaking to establish VAWA compliance review processes, and to
incorporate this process into existing compliance review processes,
where possible. Therefore, HUD does not have the discretion to choose
an alternative to rulemaking for compliance review processes. HUD has
also determined that rulemaking is needed to implement new and revised
statutory protections and requirements. Furthermore, prior VAWA
reauthorizations were implemented through rulemaking.
Anticipated Cost 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 pursued in FY 2022. HUD expects
that the neither the total economic costs nor the total efficiency
gains will exceed $100 million. Unlike HUD's VAWA 2013 final rule that
was published in 2016 (VAWA 2013 rule), which had costs that were
primarily paperwork costs, this rulemaking has fewer paperwork costs.
The benefits of HUD's rulemaking include codifying in regulation the
protections that VAWA 2022 provides to applicants and tenants of
covered housing programs; strengthening the rights of survivors
[[Page 11069]]
accessing and living in covered housing programs, including existing
emergency transfer rights and new rights against retaliation and
prohibition and the right to report crime from one's home; and
improving and streamlining HUD's VAWA compliance monitoring and review
processes. HUD grantees are already familiar with HUD's VAWA
regulations as instituted by the 2016 final rule; this proposed rule
will largely build on that regulatory framework and related forms and
documents. HUD is also planning to publish a notice in the Federal
Register in the Fall of 2022 that will provide initial guidance on VAWA
2022, its impact on VAWA-covered HUD programs, and HUD's planned
implementation actions. HUD believes that grantees' prior experience
with HUD's implementation of other VAWA reauthorization legislation and
HUD's advanced notice will reduce costs by helping grantees to
understand the new protections and requirements ahead of rulemaking.
Risks: Previous and unfinished implementations of prior VAWA
reauthorizations have resulted in challenges for grantees. HUD must
seek to complete implementation of VAWA 2013, the Justice for All
Reauthorization Act of 2016's amendments to VAWA's lease bifurcation
provisions, and VAWA 2022, to fully implement changes to VAWA and
clarify which requirements and changes HUD grantees are expected to
comply with, and when those requirements and changes go into effect.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Agency Contact: Karlo Ng, Director on Gender-based Violence
Prevention and Equity, Department of Housing and Urban Development,
Office of the Secretary, 451 Seventh Street SW, Washington, DC 20410,
Phone: 202 288-1850.
RIN: 2501-AE05
HUD--OFFICE OF COMMUNITY PLANNING AND DEVELOPMENT (CPD)
Proposed Rule Stage
116. Floodplain Management and Protection of Wetlands (FR-6272) [2506-
AC54]
Priority: Other Significant.
Legal Authority: 42 U.S.C. 3535(d); E.O. 11990; E.O. 11988; E.O.
13690
CFR Citation: 24 CFR 50; 24 CFR 55; 24 CFR 58; 24 CFR 200.
Legal Deadline: None.
Abstract: This proposed rule would revise HUD's regulations
governing floodplain management and the protection of wetlands to
implement the Federal Flood Risk Management Standard (FFRMS), in
accordance with Executive Order 13690 (Establishing a Federal Flood
Risk Management Standard and a Process for Further Soliciting and
Considering Stakeholder Input), improve the resilience of HUD-assisted
or financed projects to the effects of climate change and natural
disasters, and provide for greater flexibility in the use of HUD
assistance in floodways under certain circumstances. This rule would
also revise HUD's floodplain and wetland regulations to streamline
them, improve overall clarity, and modernize standards.
Statement of Need: The rule is part of HUD's commitment under HUD's
2021 Climate Action Plan. HUD committed to completing rulemaking to
update 24 CFR part 55 of its regulations and implement FFRMS as a key
component of its plan to increase climate resilience and climate
justice across the Department, noting that low-income families and
communities of color are disproportionately impacted by climate change.
Additionally, HUD notes that affordable housing is increasingly at risk
from both extreme weather events and sea-level rise, and that coastal
communities are especially at risk.
HUD's existing regulations currently rely on Flood Insurance Rate
Maps, which are critical resources when assessing flood risk, but are
not intended to reflect changes in future flood risk influenced by a
changing climate. This rule would ensure that HUD projects are designed
with a more complete picture of a proposed project site's flood risk
over time. Building to the standards discussed in this proposed rule
would increase resiliency, reduce the risk of flood loss, minimize the
impact of floods on human safety, health, and welfare, and promote
sound, sustainable, long-term planning informed by a more accurate
evaluation of risk that takes into account possible sea level rise and
increased development associated with population growth.
Summary of Legal Basis: These regulatory revisions would implement
the Federal Flood Risk Management Standard (FFRMS), in accordance with
Executive Order (E.O.) 13690 (Establishing a Federal Flood Risk
Management Standard and a Process for Further Soliciting and
Considering Stakeholder Input) (2015).
Alternatives: An alternative to promulgating this rule would be to
maintain HUD's existing regulations governing floodplain management and
the protection of wetlands. However, doing so would ignore the threats
that increasing flood risks pose to life and taxpayer-funded property.
Additionally, HUD would not be in compliance with Executive Order 13960
and implementing guidance if HUD did not revise its regulations. Other
alternatives include higher additional elevation standards for HUD
projects without using a CISA approach. HUD prefers the CISA approach
because it provides a forward-looking assessment of flood risk based on
likely or potential climate change scenarios, regional climate factors,
and an advanced scientific understanding of these effects.
Anticipated Cost 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 pursued in FY 2022. HUD expects
that the neither the total economic costs nor the total efficiency
gains will exceed $100 million. Elevating HUD-assisted structures
located in and around the FFRMS floodplain will lessen damage caused by
flooding and avoid relocation costs to tenants associated with
temporary moves when HUD-assisted structures sustain flood damage and
are temporarily uninhabitable. These benefits, which are realized
throughout the life of HUD-assisted structures, are offset by the one-
time increase in construction costs, borne only at the time of
construction.
Risks: This rule could increase construction costs for HUD projects
where it leads to additional elevation requirements, thereby increasing
the cost of constructing affordable housing. However, these costs are
offset by the decreased damage caused by flooding a project will endure
throughout its lifetime, and the avoidance of relocation costs when
HUD-assisted structures sustain flood damage.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kristin L. Fontenot, Director, Office of
Environment and
[[Page 11070]]
Energy, Department of Housing and Urban Development, Office of
Community Planning and Development, 451 Seventh Street SW, Washington,
DC 20410, Phone: 202 402-7077.
RIN: 2506-AC54
BILLING CODE 4210-67-P
UNITED STATES DEPARTMENT OF THE INTERIOR
Fall 2022 Regulatory Plan
Introduction
The U.S. Department of the Interior (Department) is the principal
steward of our Nation's public lands and resources, including many of
our cultural treasures. The Department serves as trustee to Native
Americans, Alaska Natives, and Federally Recognized Tribes and is
responsible for our ongoing relationships with the Island Territories
under U.S. jurisdiction and the freely associated States. Among the
Department's many responsibilities is managing more than 500 million
surface acres of Federal land, which constitutes approximately 20
percent of the Nation's land area, as well as approximately 700 million
subsurface acres of Federal mineral estate, and more than 2.5 billion
acres of submerged lands on the Outer Continental Shelf (OCS).
In addition, the Department protects and recovers endangered
species; protects natural, historic, and cultural resources; provides
scientific and other information about those resources; and manages
water projects that are an essential lifeline and economic engine for
many communities.
Hundreds of millions of people visit Department-managed lands each
year to take advantage of a wide range of recreational pursuits--
including camping, hiking, hunting, fishing and various other forms of
outdoor recreation--and to learn about our Nation's history. Each of
these activities supports local communities and their economies. The
Department also provides access to Federal lands and offshore areas for
the development of energy, minerals, and other natural resources that
generate billions of dollars in revenue.
In short, the Department plays a central role in how the United
States stewards its public lands, ensures environmental protections,
pursues environmental justice, honors the nation-to-nation relationship
with Tribes and the special relationships with other Indigenous people
and the insular areas.
Regulatory and Deregulatory Priorities
To help advance the Secretary of the Interior's (Secretary)
commitment to honoring the Nation's trust responsibilities and to
conserve and manage the Nation's natural resources and cultural
heritage, the Department's regulatory and deregulatory priorities in
the coming year will focus on:
Tackling the Climate Crisis, Strengthening Climate
Resiliency, and Facilitating the Transition to Renewable Energy;
Upholding Trust Responsibilities to Federally-Recognized
American Indian and Alaska Native Tribes, Restoring Tribal Lands, and
Protecting Natural and Cultural Resources, Advancing Equity and
Supporting Underserved Communities; and
Investing in Healthy Lands, Waters and Local Economies and
Strengthening Conservation of the Nation's Lands, Waters and Wildlife.
Tackling the Climate Crisis, Strengthening Climate Resiliency, and
Facilitating the Transition to Renewable Energy
The Biden-Harris administration remains committed to combatting
climate change and reducing greenhouse gas emissions while improving
public health, protecting the environment, and ensuring access to clean
air and water. Under this administration, the Department has been a key
leader in tackling the climate crises. Pursuant to Executive Order
(E.O.) 13990 ``Protecting Public Health and the Environment and
Restoring Science to Tackle the Climate Crisis,'' (signed on Jan. 20,
2021) and E.O. 14008, ``Tackling the Climate Crisis at Home and
Abroad,'' (signed January 27, 2021), the Department has advanced
multiple policy and regulatory efforts to reduce climate pollution;
improve and increase adaptation and resilience to the impacts of
drought, wildfire, and extreme weather; address current and historic
environmental injustice; protect public health; and conserve
Department-managed lands and waters.
The historic Infrastructure Investment and Jobs Act of 2021 (BIL)
and the Inflation Reduction Act (IRA), which President Biden signed
respectively on November 15, 2021, and August 16, 2022, will enable
transformational outcomes on these clean energy and resilience
priorities while driving the creation of good-paying union jobs. In
referring to the BIL Secretary Haaland said, ``The infrastructure law
invests in areas where we, working closely together, have a chance to
make a better future for the people we serve in the areas of wildfire,
drought, legacy pollution clean-up, and restoration of the outdoors
that we all love.''
In accordance with E.O.s 13990 and 14008, as well as E.O. 14052,
``Implementation of the Infrastructure Investment and Jobs Act,''
(signed on Nov. 15, 2021), several bureaus within the Department are
pursuing regulatory actions to implement these administration
priorities, including steps to increase renewable energy production by
improving siting and permitting processes on public lands and in
offshore waters.
The Department is committed to fully facilitating the development
of renewable energy on public lands and waters, as well as supporting
tribal and territorial efforts to develop renewable energy, including
deploying 30 gigawatts (GW) of offshore wind by 2030 and 25GW of
onshore renewable energy by 2025. The Department will meet these
ambitious goals while also ensuring appropriate protection of public
lands, waters, and biodiversity and creating good jobs. As Secretary
Haaland has stated, ``The Department of the Interior continues to make
significant progress in our efforts to spur a clean energy revolution,
strengthen and decarbonize the nation's economy, and help communities
transition to a clean energy future.''
As part of these ongoing efforts, the Bureau of Ocean Energy
Management's (BOEM) most important regulatory initiative is focused on
expanding offshore wind energy's role in strengthening U.S. energy
security and independence, creating jobs, providing benefits to local
communities, and further developing the U.S. economy. The BOEM's
renewable energy program has matured over the past 10 years, a time in
which BOEM has conducted numerous auctions and issued and managed
multiple commercial leases. Based on this experience, BOEM has
identified multiple opportunities to update its regulations to better
facilitate the development of renewable energy resources and to promote
U.S. energy independence. In FY 2023, BOEM will propose a rule, the
``Renewable Energy Modernization Rule'' (1010-AE04). This rule would
substantially update existing renewable energy regulations to more
efficiently facilitate responsible development of renewable energy
resources on the Outer Continental Shelf (OCS) and strengthen U.S.
energy independence. The rule also aims to significantly reduce costs
to developers for expanding renewable energy development in an
environmentally sound manner.
[[Page 11071]]
Similarly, the Bureau of Land Management (BLM) plans to update its
regulations for onshore rights-of-way, leasing, and operations related
to all activities associated with renewable energy and transmission
lines with a proposed rule, ``Rights-of-way, Leasing and Operations for
Renewable Energy and Transmission Lines'' (1004-AE78). This rule aims
to improve permitting activities and processes to facilitate increased
renewable energy production on public lands.
To advance the deployment of clean energy infrastructure while also
meeting obligations to conserve habitats and wildlife, the Department
will improve permitting frameworks for bird conservation. On September
30, 2022 (87 FR 59598), the U.S. Fish and Wildlife Service (FWS)
proposed the ``Eagle Permits; Incidental Take'' rule (108-BE70) to
revise the regulations authorizing eagle incidental take and eagle nest
take permits to increase the efficiency and effectiveness of
permitting, facilitate and improve compliance, and increase the
conservation benefit for eagles. The FWS will also propose a rule, the
``Migratory Bird Permits; Authorizing the Incidental Take of Migratory
Birds'' (1018-BF71), to clarify the MBTA's prohibitions on taking and
killing migratory birds and consider establishing a straight-forward
process to secure authorizations for otherwise prohibited take of
migratory birds.
The BIL enables the Department to establish important regulations
governing carbon transportation and storage on the OCS. The orderly
implementation of negative emissions technologies, such as carbon
capture, utilization, and storage, is necessary to reduce hard-to-abate
emissions from the industrial sector, which emits nearly 25 percent of
all carbon dioxide released into the atmosphere in the United States.
In implementing the BIL the Bureau of Safety and Environmental
Enforcement (BSEE) and BOEM are drafting a joint proposed rule that
would address the transportation and geologic sequestration aspects of
carbon capture utilization and storage development on the OCS,
including leasing, geological, and geophysical exploration for
appropriate storage reservoirs; environmental plans and mitigations;
facility and infrastructure design and installation; injection
operations; long-term site stewardship (i.e., monitoring and response);
financial assurance; and safety.
The Department is also committed to modernizing its oversight of
oil and gas leasing and development to help address the climate and
biodiversity crises and to advance environmental justice. In November
2021, the Department released its report on federal oil and gas leasing
and permitting practices, following a review of onshore and offshore
oil and gas programs called for in E.O. 14008. The report identified
significant reforms needed to ensure the programs provide a fair return
to taxpayers, discourage speculation, hold operators responsible for
remediation, and more fully include communities and Tribal, state, and
local governments in decision-making. As Secretary Haaland stated about
the report, ``Our nation faces a profound climate crisis that is
impacting every American. The Interior Department has an obligation to
responsibly manage our public lands and waters--providing a fair return
to the taxpayer and mitigating worsening climate impacts--while staying
steadfast in the pursuit of environmental justice.''
In the coming year, the Department will pursue regulations to
implement important reforms, including the report's recommendations and
reforms included in the IRA regarding oil and gas resources on public
lands. For example, BLM will propose rules to ensure the responsible
development of oil and gas on public lands, including ``Waste
Prevention, Production Subject to Royalties, and Resource Conservation
43 CFR parts 3160 and 3170'' (1004-AE79), known as the Waste Prevention
Rule, and ``Revision of Existing Regulations Pertaining to Oil and Gas
Leases and Leasing Process 43 CFR parts 3100 and 3400'' (1004-AE80),
known as the Oil and Gas Leasing Rule. The Waste Prevention Rule would
prevent waste of federal resources with an additional benefit of
reducing methane emissions in the oil and gas sector. The Oil and Gas
Leasing Rule would incorporate many urgent fiscal and programmatic
reforms included in the report and IRA, such as updating BLM's process
for leasing to ensure the protection and proper stewardship of the
public lands, including potential climate and other impacts associated
with oil and gas leasing activities.
Upholding Trust Responsibilities to Federally Recognized American
Indian and Alaska Native Tribes Restoring Tribal Lands, and Protecting
Natural and Cultural Resources
Among the Department's most important responsibilities is its
commitment to honor the nation-to-nation relationship between the
Federal Government and Tribes. Secretary Haaland is strongly committed
to strengthening how the Department carries out its trust
responsibilities and to increasing economic development opportunities
for Tribes and other historically underserved communities.
To advance the Department's trust responsibilities, the Bureau of
Indian Affairs (BIA) has identified opportunities, following
consultation and in close collaboration with Tribal governments, to
promote Tribal economic growth and development. For example, BIA is
working to remove barriers to the development of renewable energy and
other resources in Indian country.
In consultation with Tribes, BIA engaged in efforts to update and
improve its regulations governing how it manages land held in trust or
in restricted status for Tribes and individual Indians. These efforts
included improving the consultation process, identifying best
practices, and strengthening relationships with Tribal governments. The
BIA also launched a broader review to determine whether any regulatory
reforms are needed to facilitate restoration of Tribal lands and
safeguard natural and cultural resources. As a result of these
consultations and this review, BIA is preparing a proposed rule,
``Agricultural Leasing of Indian Land,'' which would revise the
regulations governing leases of Indian land for agricultural purposes
found at 25 CFR part 162 (1076-AF66). This proposed rule would
streamline how leases are obtained and increase the agricultural usage
of Indian land.
The Department is also committed to improving regulations meant to
protect sacred and cultural resources. To this end, the Assistant
Secretary for Indian Affairs and the Assistant Secretary for Fish and
Wildlife and Parks are working with the National Park Service (NPS) to
consult with Tribes on updates to regulations implementing the Native
American Graves and Repatriation Act (NAGPRA), 43 CFR part 10 (1024-
AE19). This proposed rule, the ``Native American Graves Protection and
Repatriation Act Systematic Process for Disposition and Repatriation of
Native American Human Remains, Funerary Objects, Sacred Objects, and
Objects of Cultural Patrimony,'' which published on October 18, 2022
(87 FR 63202), would provide a systematic process for the disposition
and repatriation of Native American human remains, funerary objects,
sacred objects, and objects of cultural patrimony. The updates are
intended to simplify and improve the regulatory process for
repatriation, rectify provisions in the current regulations that
inhibit and effectively prevent respectful repatriation, and remove the
burden on Indian Tribes and Native Hawaiian
[[Page 11072]]
organizations to initiate the process and add a requirement for museums
and Federal agencies to complete the process.
On November 15, 2021, Secretary Haaland signed joint SO 3403,
``Joint Secretarial Order on Fulfilling the Trust Responsibility to
Indian Tribes in the Stewardship of Federal Lands and Waters,'' with
the Secretary of Agriculture to ensure that the Department of the
Interior, the Department of Agriculture, and their component Bureaus
and Offices are managing Federal lands and waters in a manner that
seeks to protect the treaty, religious, subsistence, and cultural
interests of federally recognized Indian Tribes, including the Native
Hawaiian community; that such management is consistent with the nation-
to-nation relationship between the United States and federally
recognized Indian Tribes; and, that such management fulfills the United
States' unique trust obligation to federally recognized Indian Tribes
and their citizens.
Advancing Equity and Supporting Underserved Communities
The Biden-Harris administration and Secretary Haaland recognize and
support the goals of advancing equity and addressing the needs of
underserved communities. In January 2021, the President signed E.O.
13985, ``Advancing Racial Equity and Support for Underserved
Communities Through the Federal Government.'' This E.O. directs all
Federal agencies to pursue a comprehensive approach to advancing equity
for all, including people of color and others who have been
historically underserved, marginalized, and adversely affected by
persistent poverty and inequality. On February 17, 2022, Secretary
Haaland issued SO 3406, ``Establishment of a Diversity, Equity,
Inclusion and Accessibility Council.'' This council is working to
identify policies and/or revisions to existing policies or practices
that are needed, and make recommendations on how diversity, equity,
inclusion and accessibility may be prioritized in policymaking and
budget processes and decisions in accordance with the E.O.s related to
equity. In response to E.O. 13985 and the SO 3406, the Department
issued its Equity Action Plan on April 14, 2022. The Equity Action Plan
is a key part of the Department's efforts to implement E.O. 13985,
which calls on Federal agencies to advance equity by identifying and
addressing barriers to equal opportunity that underserved communities
may face as a result of Government policies and programs. Highlighting
the importance of this initiative, Secretary Haaland said, ``We must
continue to proactively ensure that historically underrepresented
communities benefit from our efforts to address the climate crisis and
make our nation's public lands and waters accessible and welcoming to
everyone.''
In FY 2023, the Department will undertake a number of regulatory
actions that will assist people who reside in underserved communities.
In support of SO 3406 and the Equity Action Plan, the Department
published a final rule on April 8, 2022 (87 FR 20761), ``Acquisition
Regulations; Buy Indian Act; Procedures for Contracting'' (RIN 1090-
AB21). This final rule better implements the Buy Indian Act, which
provides the Department with authority to set aside procurement
contracts for Indian-owned and controlled businesses. These revisions
will eliminate barriers that inhibit Indian Economic Enterprises (IEEs)
from competing on certain construction contracts, expand IEEs' ability
to subcontract construction work consistent with other socio-economic
set-aside programs, and give greater preference to IEEs when a
deviation from the Buy Indian Act is necessary, among other updates.
The BLM (1004-AE60), FWS (1018-BD78), and NPS (1024-AE75) are
proposing right-of-way (ROW) rules that would streamline and improve
efficiencies in the permitting process for electric transmission,
distribution facilities, and broadband facilities. These rules should
result in increased services, such as broadband connectivity, with
resulting benefits to underserved communities and visitors to
Departmental lands and promote good governance. These proposed rules
are expected to publish in FY 2023 as well as implement several
provisions of the BIL.
Investing in Healthy Lands, Waters and Local Economies and
Strengthening Conservation of the Nation's Lands, Waters and Wildlife
The Department's regulatory agenda will continue to advance the
goals of investing in healthy lands, waters, and local economies across
the country. These regulatory efforts, which are consistent with the
Biden-Harris administration's America the Beautiful initiative as well
as the BIL and IRA which provide the Department with historic
resilience and restoration investments, include expanding opportunities
for outdoor recreation, such as hunting and fishing, for all Americans;
enhancing conservation stewardship; and improving the management of
species and their habitat.
Per section 2 of E.O. 13990 and the ``Fact Sheet: List of Agency
Actions for Review,'' the Departments of Commerce and the Interior
(Departments) initiated a review of the August 27, 2019, final rule,
``Endangered and Threatened Wildlife and Plants; Regulations for
Listing Endangered and Threatened Species and Designating Critical
Habitat,'' (1018-BF95) (84 FR 45020) that revised the regulations for
adding and removing species from the Lists of Endangered and Threatened
Wildlife and Plants and the procedures for designating critical
habitat. On July 5, 2022, the 2019 rule was vacated and remanded by the
U.S. District Court for the Northern District of California. In
response to the court order, the Departments will propose a new
rulemaking for FY 2023.
Also, per section 2 of E.O. 13990 and the ``Fact Sheet: List of
Agency Actions for Review,'' the Departments initiated a review of the
August 27, 2019, final rule, ``Endangered and Threatened Wildlife and
Plants; Regulations for Interagency Cooperation,'' (1018-BC87) (84 FR
44976) that revised portions of the regulations that implement section
7 of the ESA, as amended. On July 5, 2022, the 2019 rule was vacated
and remanded by the U.S. District Court for the Northern District of
California. In response to the court order, the Departments will
propose a new rulemaking for FY 2023.
Under section 4(d) of the Endangered Species Act (ESA), FWS plans
to promulgate several species-specific rules to protect threatened
species. Of particular note, the FWS issued a proposed rule on November
17, 2022, (87 FR 68975) that would revise the rule for the African
elephant (Loxodonta africana) promulgated under section 4(d) of the
ESA. The proposed rule intends to increase domestic protection for
African elephants in light of the recent rise in global trade of live
African elephants from range countries by establishing ESA permit
requirements and enhancement standards for trade in live African
elephants. This rulemaking action would also clarify the existing
enhancement requirement during our evaluation of the application for a
permit to import African elephant sport-hunted trophies and incorporate
a Party's designation under the Convention on International Trade in
Endangered Species of Wild Fauna and Flora (CITES) National Legislation
Project into the decision-making process for the import of live African
elephants, African elephant sport-hunted trophies,
[[Page 11073]]
and African elephant parts and products other than ivory.
The NPS is also pursuing several regulatory actions under the
Department's direction and in accordance with these goals. These
regulatory actions would authorize recreational activities, such as
off-road vehicle use, personal watercraft and bicycling, within
appropriate, designated areas of certain National Park System units.
These regulations would promote appropriate visitor use while
supporting long-term preservation of park resources and quality visitor
experiences.
The Biden-Harris administration and Secretary Haaland are strongly
committed to strengthening conservation and improving conservation
partnerships. Through this regulatory plan, the Department affirms the
importance of the Endangered Species Act (ESA) in providing a broad and
flexible framework to facilitate conservation with a variety of
stakeholders. The Department, through FWS, is committed to working with
diverse Federal, Tribal, State, and industry partners not only to
protect and recover America's imperiled wildlife, but to ensure the ESA
is helping meet 21st century challenges.
In Fiscal Year (FY) 2022, FWS reviewed several ESA rules that were
finalized prior to January 20, 2021, to continue improving
implementation of the ESA so that it is clearly and consistently
applied, helps recover listed species, and provides the maximum degree
of certainty possible to all parties. As a result of that review, FWS
finalized two critically important ESA rules. The FWS and the National
Marine Fisheries Service (NMFS) finalized the rule, ``Regulations for
Listing Endangered and Threatened Species and Designating Critical
Habitat,'' which published on June 24, 2022 (87 FR 37757), removing the
regulatory definition of ``habitat.'' The FWS also finalized the rule,
``Endangered and Threatened Wildlife and Plants; Regulations for
Designating Critical Habitat,'' which published on July 21, 2022 (87 FR
43433). This rule sets forth the process for excluding areas of
critical habitat under section 4(b)(2) of the ESA, which mandates
consideration of the impacts of designating critical habitat and
permits exclusions of particular areas following a discretionary
exclusion analysis.
FWS published a final rule on September 16, 2022 (87 FR 57838),
``2022-2023 Station-Specific Hunting and Sport Fishing Regulations,''
(1018-BF66) and opened, for the first time, two National Wildlife
Refuges (NWRs) that are currently closed to hunting and sport fishing.
In addition, FWS opened or expanded hunting or sport fishing at 16
other NWRs and added pertinent station-specific regulations for other
NWRs that pertain to migratory game bird hunting, upland game hunting,
big game hunting, or sport fishing for the 2022-2023 season. The FWS
also changed existing station-specific regulations to reduce regulatory
burden on the public and increase access for hunters and anglers on FWS
lands and waters.
Bureaus and Offices Within the Department of the Interior
The following is an overview of some of the major regulatory and
deregulatory priorities of the Department's Bureaus and Offices.
Bureau of Indian Affairs
The BIA enhances the quality of life, promotes economic
opportunity, and protects and improves the trust assets of
approximately 1.9 million American Indians, Indian Tribes, and Alaska
Natives. The BIA maintains a government-to-government relationship with
the 574 Federally Recognized Indian Tribes. The BIA also administers
and manages 55 million acres of surface land and 57 million acres of
subsurface minerals held in trust by the United States for American
Indians and Indian Tribes.
Regulatory and Deregulatory Actions
Elections of Officers of the Osage Minerals Council (1076-AF58)
BIA finalized revisions to its regulations governing elections of
the Osage Nation (86 FR 54364, October 1, 2021). These revisions update
and limit the Secretary's role to the task of compiling a list of
voters for Osage Minerals Council elections. These changes reaffirm the
inherent sovereign rights of the Osage Nation to determine its
membership and form of government.
In the coming year, BIA will prioritize the following rulemakings:
Procedures for Federal Acknowledgment of Indian Tribes (1076-AF67)
This rule will update the regulations in response to recent Federal
court decisions to address whether previously denied petitioners for
Federal acknowledgment may petition again.
Appeals From Administrative Actions (1076-AF64)
This rule would clarify the processes for appeals of actions taken
by officials in the Office of the Assistant Secretary--Indian Affairs,
BIA, Bureau of Indian Education, and Office of the Special Trustee for
American Indians (collectively, Indian Affairs). The rule would advance
the purposes of E.O. 14058 to effectively reduce administrative
burdens, simplify both public-facing and internal processes to improve
efficiency, and empower the Federal workforce to solve problems. The
rule would streamline the process for appeals of Tribal government
representative decisions, to ensure the continued government-to-
government relations with the appropriate Tribal leadership is not
unduly interrupted.
Mining of the Osage Mineral Estate for Oil and Gas (1076-AF59)
The regulations in 25 CFR part 226 would be revised to allow BIA to
strengthen management of the Osage Mineral Estate by updating bonding,
royalty payment and reporting, production valuation and measurement,
site security, and operational requirements to address the changes in
technology and industry standards that have occurred in the 48 years
since the regulations were last revised and ensure consistency with
Departmental regulations governing oil and gas development throughout
the rest of Indian country.
Land Acquisitions (1076-AF71)
This rule would advance the purposes of E.O. 13985 and address the
Department's jurisdiction to acquire land in trust for certain Tribes,
streamline acquisitions on existing reservations, clarify Tribal
jurisdiction, and promote Tribal conservation of lands.
Class III Tribal State Gaming Compact Process (1076-AF68)
This rule would provide States and Tribes with a better
understanding of how the Department reviews their compacts by codifying
longstanding Departmental policy and interpretations of existing case
law.
Self-Governance PROGRESS Act Regulations (1076-AF62)
This rule would implement the requirements of the Practical Reforms
& Other Goals to Reinforce the Effectiveness of Self Governance & Self
Determination for Indian Tribes Act (PROGRESS Act) requiring updates to
BIA's regulations governing Tribal self-governance. The PROGRESS Act
amends subchapter I of the Indian Self-Determination and Education
Assistance Act (ISDEAA), 25 U.S.C. 5301 et seq., which addresses Indian
self-determination, and subchapter IV of
[[Page 11074]]
the ISDEAA which addresses the Department's Tribal Self-Governance
Program. The PROGRESS Act calls for a negotiated rulemaking committee
to be established under 5 U.S.C. 565, with membership consisting only
of representatives of Federal and Tribal governments, with the Office
of Self-Governance serving as the lead agency for the Department. The
PROGRESS Act also authorizes the Secretary to adapt negotiated
rulemaking procedures to the unique context of self-governance and the
government-to-government relationship between the United States and
Indian Tribes.
Agricultural Leasing of Indian Land (1076-AF66)
This rule would update provisions addressing leasing of trust or
restricted land (Indian land) for agricultural purposes to reflect
updates that have been made to business and residential leasing
provisions and address outdated provisions.
Bureau of Land Management
The BLM manages more than 245 million acres of public land, known
as the National System of Public Lands, primarily located in 12 Western
States, including Alaska. The BLM also administers 700 million acres of
sub-surface mineral estate throughout the Nation. The agency's mission
is to sustain the health, diversity, and productivity of America's
public lands for the use and enjoyment of present and future
generations.
Regulatory and Deregulatory Actions
In the coming year, the BLM will prioritize the following
rulemaking actions:
Livestock Grazing (1004-AE82)
This proposed rule would revise BLM's grazing regulations to
improve resource management and increase efficiency by streamlining and
clarifying grazing processes and improving coordination among Federal,
State, and local government entities. The proposed rule would revise
the regulations at 43 CFR parts 4100, 1600, and 1500. These revisions
and additions would help provide the public and land managers with
accurate and reliable information regarding grazing administration on
public lands.
Update of the Communications Uses Program, Right-of-Way Cost Recovery
Fee Schedules and Section 512 of FLPMA for Rights-of-Way (1004-AE60)
The BLM will propose amendments to its existing ROW regulations to
streamline and improve efficiencies in the communications uses program,
update the cost recovery fee schedules for ROW work activities, and
include provisions governing the development and approval of operating
plans and agreements for ROWs for electric transmission and
distribution facilities. Communications uses, such as broadband, are a
subset of ROW activities authorized under the Federal Land Policy and
Management Act of 1976 (FLPMA), as amended. Cost recovery fees apply to
most ROW activities authorized under either FLPMA or the Mineral
Leasing Act of 1920, as amended. This proposed rule would also
implement vegetation management requirements included in the
Consolidated Appropriations Act, 2018 (codified at 43 U.S.C. 1772) to
address fire risk from and to powerline ROWs on public lands and
national forests. The regulatory amendments would also codify statutory
requirements regarding review and approval of utilities maintenance
plans, liability limitations, and definitions of hazard trees and
emergency conditions.
Bonding (1004-AE68)
This proposed rule would update the bonding procedures for ROWs on
BLM-managed public land to make them clearer and easier to understand,
which would facilitate efficient bond calculations.
Rights-of-Way, Leasing and Operations for Renewable Energy and
Transmission Lines 43 CFR Parts 2800, 2880, 3200 (1004-AE78)
This proposed rule, which published on November 7, 2022 (87 FR
67306) would revise BLM's regulations for ROWs, leasing, and operations
related to all activities associated with renewable energy and
transmission lines. The Energy Act of 2020 and E.O. 14008 prioritize
the Department's need to improve permitting activities and processes to
facilitate increased renewable energy production on public lands.
Waste Prevention, Production Subject to Royalties, and Resource
Conservation 43 CFR Parts 3160 and 3170 (1004-AE79)
This proposed rule which published on November 30, 2022, (87 FR
73588) would update BLM's regulations governing the waste of natural
gas through venting, flaring, and leaks on onshore Federal and Indian
oil and gas leases. The proposed rule would address the priorities
associated with E.O. 14008. In addition, in accordance with E.O. 13990,
this proposed rule would reduce methane emissions in the oil and gas
sector and mitigate impacts of climate change.
Revision of Existing Regulations Pertaining to Oil and Gas Leases and
Leasing Process 43 CFR Parts 3100 and 3400 (1004-AE80)
This proposed rule would revise BLM's oil and gas regulations to
update the fees, rents, royalties, and bonding requirements related to
oil and gas leasing, development, and production. The proposed rule
would also update BLM's process for leasing to ensure the protection
and proper stewardship of the public lands, including potential climate
and other impacts associated with oil and gas activities. This rule
would implement provisions of the IRA regarding oil and gas resources
on public lands.
Revision of Existing Regulations Retaining to Leasing and Operations of
Geothermal 43 CFR Part 3200 (1004-AE84)
This proposed rule would update and codify BLM's Geothermal
Resource Orders into regulation, including common geothermal standard
practices, and inspection requirements and procedures.
Protection, Management, and Control of Wild Horses and Burros 43 CFR
Part 4700 (1004-AE83)
This proposed rule would address wild horse and burro management
challenges by adding regulatory tools that better reflect BLM's current
statutory authorities. For example, the existing regulations do not
address certain management authorities that Congress has provided since
1986 to control wild horse and burro populations, such as the BLM's
authority to sell excess wild horses and burros. Updating the
regulations would also facilitate management strategies and priorities
that were not utilized when the regulations were originally
promulgated, such as the application of fertility control vaccines,
managing for nonreproducing herds, and feeding and caring for unsold
and unadopted animals at off-range corrals and pastures. The proposed
rule would also clarify ambiguities and management limitations in the
existing regulations.
Revisions to the Oil and Gas Site Security, Oil Measurement, and Gas
Measurement Regulations (1004-AE87)
This rule would update BLM's existing rules governing site security
and measurement of oil and gas from onshore Federal and Indian oil and
gas leases. Since BLM adopted the existing rules in November 2016, the
agency has
[[Page 11075]]
encountered significant challenges in implementing them. This
regulatory action would rectify gaps and inconsistencies in the current
regulations and improve measurement accuracy, verifiability, and
accountability on Federal and Indian minerals.
Wildfire Prevention (1004-AE88)
This rule would revise BLM's fire-trespass and cost recovery
regulations. The changes would help prevent wildfires by creating a
more effective deterrent to human-caused wildfires and unauthorized
burning of public lands and make it easier for the agency to recover
damages from wildfires.
Closure and Restriction Orders (1004-AE89)
This proposed rule would help BLM to better protect persons,
property, and public lands and resources by allowing the agency to
close or restrict the use of public lands in a timelier manner. The
rule would also make BLM's regulations more consistent with other
Federal land management agencies' closure and restriction authorities.
Sustained Yield and Land Health (1004-AE92)
The BLM is drafting a rule to clarify and support the principles of
multiple use and sustained yield in the management of the public lands
pursuant to FLPMA and other relevant authorities. This proposed rule
rests within 43 CFR 6000 and would provide an overarching framework
governing multiple resource areas to ensure land health and sustained
yield. This rule would affirm the important role of restoration and
conservation actions in building and maintaining sustainable land
management practices to ensure healthy and productive ecosystems for
current and future generations.
Bureau of Ocean Energy Management
The mission of BOEM is to manage development of U.S. OCS energy and
mineral resources in an environmentally and economically responsible
way. In accordance with its statutory mandate under Outer Continental
Shelf Lands Act (OCSLA), BOEM is committed to implementing its dual
mission of promoting the expeditious and orderly development of the
Nation's energy resources while simultaneously protecting the marine,
human, and coastal environment of the OCS State submerged lands and the
coastal communities. Consistent with the policy outlined by the
administration in E.O. 14008, BOEM is reevaluating its programs related
to the offshore development of energy and mineral resources. The BOEM
is working with the Department to review options for expanding
renewable energy production while evaluating alternatives to better
protect the lands, waters, and biodiversity of species located within
the U.S. exclusive economic zone.
Regulatory and Deregulatory Actions
In the coming year, BOEM will prioritize the following rulemaking
actions:
Renewable Energy Modernization Rule (1010-AE04)
The BOEM will propose a rule that would update existing renewable
energy regulations to help facilitate the timely and responsible
development of renewable energy resources on the OCS and promote U.S.
energy independence. This proposed rule contains reforms identified by
BOEM and recommended by industry, including proposals for incremental
funding of decommissioning accounts; more flexible geophysical and
geotechnical survey submission requirements; streamlined approval of
meteorological buoys; revised project verification procedures; and
greater clarity regarding safety requirements. This rule advances the
administration's energy policies in a safe and environmentally sound
manner that provides a fair return to the American taxpayer while also.
Bureau of Ocean Energy Management, and Bureau of Safety and
Environmental Enforcement Renewable Energy Split Final Rule (1082-AA03)
The Department updated the Departmental Manual, which transferred
the safety, environmental enforcement, and compliance functions
relevant to renewable energy activities on the OCS from BOEM to BSEE.
BSEE and BOEM will amend their respective regulations to reflect the
split of functions between the two Bureaus.
Risk Management and Financial Assurance for OCS Lease and Grant
Obligations (1010-AE14)
The BOEM has reconsidered the financial assurance policies
expressed in the joint proposed rule (85 FR 65904) issued with BSEE
(1082-AA02) and has determined that it would be appropriate to issue a
new proposed rule that will better protect the American taxpayers from
shouldering liability for the decommissioning of offshore oil and gas
facilities. The proposed rule would ensure that facilities no longer
needed for oil or gas exploration, or development are shut down in a
safe and environmentally responsible manner. The proposed rule would
modify the evaluation criteria for determining whether oil, gas and
sulfur lessees, right-of-use and easement grant holders, and pipeline
ROW grant holders may be required to provide bonds or other financial
assurance, above the regulatorily prescribed amounts for base bonds, to
ensure compliance with their OCS obligations.
Carbon Sequestration (1082-AA04)
In accordance with the BIL, BOEM and BSEE are jointly proposing to
establish regulations governing carbon transportation and storage on
the OCS. Carbon capture, utilization, transport and storage (CCUTS)
technologies are necessary to reduce hard-to-abate emissions from the
industrial sector, which emits nearly 25 percent of all carbon dioxide
released into the atmosphere in the United States. The CCUTS is likely
needed to achieve mid-century climate goals and has the potential to
drive regional economic development, technological innovation, and
high-wage employment.
Protection of Marine Archaeological Resources (1010-AE11)
The BOEM is tasked to consider the effects of its undertakings on
significant cultural resources. Title 36 section 800.4(b)(1)
(Protection of Historic Properties) of the Code of Federal Regulations
requires that ``the agency official shall make a reasonable and good
faith effort to carry out appropriate identification efforts, which may
include background research, consultation, oral history interviews,
sample field investigation, and field survey.'' The BOEM would propose
a rule that would revise when lessees and operators would need to
conduct archaeological surveys. It would clarify when operators would
submit an archaeological report with their applications and clarify the
source and extent of the data utilized.
Bureau of Safety and Environmental Enforcement
The BSEE's mission is to promote safety, protect the environment,
and conserve resources offshore through vigorous regulatory oversight
and enforcement. The BSEE is the lead Federal agency charged with
improving safety and ensuring environmental protection related to
conventional and renewable energy activities on the U.S. OCS.
Regulatory and Deregulatory Actions
In the coming year, BSEE will prioritize the following rulemaking
actions:
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Oil-Spill Response Requirements for Facilities Located Seaward of the
Coast Line Proposed Rule (1014-AA44)
The oil spill response requirements regulations found in 30 CFR
part 254 were last updated over 20 years ago (62 FR 13996, Mar. 25,
1997). This proposed rule would update existing regulations to
incorporate the latest advancements in spill response and preparedness
policies and technologies, as well as lessons learned and
recommendations from reports related to the Deepwater Horizon explosion
and subsequent oil spill.
Revisions to Subpart J--Pipelines and Pipeline Rights-of-Way Proposed
Rule (1014-AA45)
This proposed rule would revise specific provisions of the current
pipelines and pipeline ROW regulations under 30 CFR 250 subpart J to
update those regulations to align with current technology and state-of-
the-art safety equipment and procedures, primarily through the
incorporation of industry standards.
Outer Continental Shelf Lands Act; Operating in High-Pressure and/or
High-Temperature (HPHT) Environments (1014-AA49)
Currently, BSEE has no regulations specific to high pressure and/or
high temperature (HPHT) projects, requiring it to issue multiple
guidance documents clarifying the specific HPHT information prospective
operators should submit to BSEE to support the Bureau's programmatic
reviews and approvals of such projects. This final rule will formally
codify BSEE's existing process for reviewing and approving projects in
HPHT environments.
Oil and Gas and Sulfur Operations in the Outer Continental Shelf-
Blowout Preventer Systems and Well Control Revisions (RIN
This rulemaking would revise BSEE regulations published in the 2019
final rule ``Oil and Gas and Sulfur Operations in the Outer Continental
Shelf Blowout Preventer Systems and Well Control Revisions,'' 84 FR
21908 (May 15, 2019), for drilling, workover, completion, and
decommissioning operations.
Revisions to Decommissioning Requirements on the OCS (1014-AA53)
This proposed rule would address issues relating to: (1) idle iron
by adding a definition of this term to clarify that it applies to idle
wells and structures on active leases; (2) abandonment in place of
subsea infrastructure by adding regulations addressing when BSEE may
approve decommissioning-in-place instead of removal of certain subsea
equipment; and (3) other operational considerations.
Risk Management, Financial Assurance and Loss Prevention--
Decommissioning Activities and Obligations (1082-AA02)
On October 12, 2020, BOEM and BSEE published the joint proposed
rule in the Federal Register (85 FR 65904). The BSEE will continue to
pursue this rulemaking as a BSEE-only final rule to revise policies and
procedures concerning compliance with decommissioning obligations for
OCS oil and gas. The final rule will clarify and streamline specific
regulatory requirements associated with the operational and procedural
aspects of applicable decommissioning responsibilities of OCS lessees
and grant holders. The BOEM will continue to evaluate and develop a
comprehensive set of regulations to manage the risks and financial
obligations associated with industry activities on the OCS and pursue
these actions in a separate rulemaking under RIN 1010-AE14.
Bureau of Ocean Energy Management, and Bureau of Safety and
Environmental Enforcement Renewable Energy Split Final Rule (1082-AA03)
The BOEM currently has authority over all renewable energy
activities on the OCS under regulations at 30 CFR part 585. The BOEM
and BSEE are in the process of amending various chapters in the
Departmental Manual to transfer the safety, environmental enforcement,
and compliance functions relevant to renewable energy activities from
BOEM to BSEE. Consistent with that effort, BSEE and BOEM will amend
their respective regulations to reflect the split of functions between
the two Bureaus.
Office of the Chief Information Officer
The Office of the Chief Information Officer (OCIO) provides
leadership to the Department and its Bureaus in all areas of
information management and technology (IT). To successfully serve the
Department's multiple missions, the OCIO applies modern IT tools,
approaches, systems, and products. Effective and innovative use of
technology and information resources enables transparency and
accessibility of information and services to the public.
In 2022, OCIO finalized the following rules:
Insider Threat Program System of Records (1090-AB15)
This final rule, which published on February 15, 2022 (87 FR 8427),
revised the Department's Privacy Act regulations at 43 CFR 2.254 to
claim Privacy Act exemptions for certain records in the DOI-50, Insider
Threat Program, system of records from one or more provisions of the
Privacy Act pursuant to 5 U.S.C. 552a(j) and (k), because of criminal,
civil, and administrative law enforcement requirements.
Social Security Number Fraud Prevention Act of 2017 Implementation
(1090-AB24)
This direct final rule, which published on July 14, 2022 (87 FR
42097), amends 43 CFR part 2 to add subpart M to implement the Social
Security Number Fraud Prevention Act of 2017, which directs Federal
agencies to issue regulations that prohibit the inclusion of an
individual's Social Security number (SSN) on any document sent through
the mail unless the Secretary deems it necessary. The regulations also
include requirements for protecting documents with SSNs sent through
postal mail.
For the coming year, OCIO will prioritize the following rules:
Network Security System of Records (1090-AB14)
This rule would revise the Department's Privacy Act regulations at
43 CFR 2.254 to claim Privacy Act exemptions for certain records in the
DOI-49, Network Security, system of records from one or more provisions
of the Privacy Act pursuant to 5 U.S.C. 552a(j) and (k), because of
criminal, civil, and administrative law enforcement requirements.
Personnel Security Files System of Records (1090-AB16)
This rule would revise the Department's Privacy Act regulations at
43 CFR 2.254 to claim Privacy Act exemptions for certain records in the
DOI-45, Personnel Security Files, system of records from one or more
provisions of the Privacy Act pursuant to 5 U.S.C. 552a(k), because of
criminal, civil, and administ