Regulatory Agenda:

December 20, 2010 (Volume 75, Number 243)

Unified Agenda

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

DOCID:ua20de10_008-1

Page 79764-79767

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Part VIII

Department of Health and Human Services

Semiannual Regulatory Agenda

Page 79764

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order

(EO) 12866 require the semi-annual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public review.

FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary,

Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The information provided in the Agenda presents a forecast of the rulemaking activities that the Department of

Health and Human Services (HHS) expects to undertake in the foreseeable future. Rulemakings are grouped according to pre-rulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the Spring 2009 Agenda was published.

Please note that the rulemaking abstracts included in this paper issue of the Federal Register relate strictly to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Register is the Department's submission to the

Fiscal Year 2011 Regulatory Plan, as required under Executive Order 12866.

The purpose of the Agenda is to encourage more effective public participation in the regulatory process, and HHS invites all interested members of the public to comment on the rulemaking actions included in this issuance of the Agenda. The complete

Regulatory Agenda of the Department is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda's database.

Dated: September 21, 2010.

Dawn L. Smalls,

Executive Secretary,

Department of Health and Human Services.

Office of the Secretary--Proposed Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

302

Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money

0991-AB03

Penalties and Assessments (Section 610 Review)........................................

Office of the Secretary--Final Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

303

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

0991-AB57

Information Technology for Economic and Clinical Health Act (Reg Plan Seq No. 41).....

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

Office of the Secretary--Completed Actions

Regulation

Sequence

Title

Identifier

Number

Number

304

Health Information Technology: Initial Set of Standards, Implementation

0991-AB58

Specifications, and Certification Criteria for Electronic Health Record Technology

(Rulemaking Resulting From a Section 610 Review)......................................

Substance Abuse and Mental Health Services Administration--Long-Term Actions

Regulation

Sequence

Title

Identifier

Number

Number

305

Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical

0930-AA10

Community-Based Facilities for Children and Youth..................................... 306

Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section

0930-AA14 610 Review)...........................................................................

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Centers for Disease Control and Prevention--Proposed Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

307

Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman

0920-AA23

Primate...............................................................................

Centers for Disease Control and Prevention--Final Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

308

Control of Communicable Diseases: Foreign and Possessions............................. 0920-AA12 309

Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610

0920-AA32

Review)...............................................................................

Centers for Disease Control and Prevention--Long-Term Actions

Regulation

Sequence

Title

Identifier

Number

Number

310

Quality Assurance Requirements for Respirators........................................ 0920-AA04

Food and Drug Administration--Prerule Stage

Regulation

Sequence

Title

Identifier

Number

Number

311

Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of

0910-AG06

Shell Eggs Held for Retail Distribution (Section 610 Review)..........................

Food and Drug Administration--Proposed Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

312

Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg

0910-AC52

Plan Seq No. 45)...................................................................... 313

Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 314

Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 315

Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 316

Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 317

Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 318

Import Tolerances for Residues of Unapproved New Animal Drugs in Food................. 0910-AF78 319

Laser Products; Amendment to Performance Standard..................................... 0910-AF87 320

Pet Food Labeling Requirements........................................................ 0910-AG09 321

Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10 322

Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products.......... 0910-AG12 323

Electronic Distribution of Content of Labeling for Human Prescription Drug and

0910-AG18

Biological Products................................................................... 324

Unique Device Identification (Reg Plan Seq No. 46).................................... 0910-AG31 325

Cigars Subject to the Family Smoking Prevention and Tobacco Control Act............... 0910-AG38 326

Cigarette Warning Label Statements (Reg Plan Seq No. 47).............................. 0910-AG41 327

General Hospital and Personal Use Devices: Designation of Special Controls for

0910-AG54

Infusion Pumps........................................................................ 328

Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No.

0910-AG56 48)................................................................................... 329

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

0910-AG57

Plan Seq No. 49)......................................................................

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

Page 79766

Food and Drug Administration--Final Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

330

Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97 331

Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 332

Content and Format of Labeling for Human Prescription Drugs and Biologics;

0910-AF11

Requirements for Pregnancy and Lactation Labeling..................................... 333

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

0910-AF27

Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No. 50)................................................................................... 334

Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 335

Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 336

Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 337

Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 338

Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 339

Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration--Long-Term Actions

Regulation

Sequence

Title

Identifier

Number

Number

340

Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding

0910-AB88

Operations for Dietary Supplements.................................................... 341

Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 342

Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 343

Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 344

Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 345

Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 346

Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 347

Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 348

Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 349

Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 350

Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 351

Over-the-Counter (OTC) Drug Review--Antidiarrheal Drug Products....................... 0910-AF63 352

Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 353

Over-the-Counter (OTC) Drug Review--Certain Category II Active Ingredients............ 0910-AF95 354

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;

0910-AG14

Policies, Requirements, and Administrative Procedures (Section 610 Review)............ 355

Produce Safety Regulation............................................................. 0910-AG35 356

Modernization of the Current Food Good Manufacturing Practices Regulation............. 0910-AG36

Food and Drug Administration--Completed Actions

Regulation

Sequence

Title

Identifier

Number

Number

357

Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Completion

0910-AG25 of a Section 610 Review).............................................................. 358

Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco

0910-AG33

To Protect Children and Adolescents................................................... 359

Over-the-Counter Human Drugs; Labeling Requirements (Completion of a Section 610

0910-AG34

Review)...............................................................................

Centers for Medicare & Medicaid Services--Proposed Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

360

Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610

0938-AG81

Review)...............................................................................

Page 79767

361

Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 0938-AP32

Review)............................................................................... 362

Influenza Vaccination Standard for Certain Medicare Participating Providers and

0938-AP92

Suppliers(CMS-3213-P)................................................................. 363

Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric

0938-AP97 and Rehabilitation Units Excluded From the Prospective Payment System and LTCH

Requirements (CMS-3177-P)............................................................. 364

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

0938-AQ24

Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates

(CMS-1518-P) (Reg Plan Seq No. 55).................................................... 365

Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical

0938-AQ26

Center Payment System for CY 2012 (CMS-1525-P) (Reg Plan Seq No. 57).................. 366

Changes to the ESRD Prospective Payment System for CY 2012 (CMS-1577-P)............... 0938-AQ27 367

Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS- 0938-AQ53 2346-P)...............................................................................

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

Centers for Medicare & Medicaid Services--Final Rule Stage

Regulation

Sequence

Title

Identifier

Number

Number

368

Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011

0938-AP79

(CMS-1503-C).......................................................................... 369

Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical

0938-AP82

Center Payment System for CY 2011 (CMS-1504-C)........................................

Centers for Medicare & Medicaid Services--Completed Actions

Regulation

Sequence

Title

Identifier

Number

Number

370

Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

0938-AP77 for Contract Year 2011 (CMS-4085-F)................................................... 371

Electronic Health Record (EHR) Incentive Program (CMS-0033-F)......................... 0938-AP78 372

Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital

0938-AP80

Prospective Payment System............................................................ 373

Hospital IPPS for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term 0938-AQ03

Care Hospital PPS and Rate Year 2010 Rates (CMS-1406-N)...............................

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Department of Health and Human Services (HHS)

Proposed Rule Stage

Office of the Secretary (OS)

  1. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE

    CIVIL MONEY PENALTIES AND ASSESSMENTS (SECTION 610 REVIEW)

    Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42

    USC 1396b; PL 99-660; PL 107-188

    Abstract: This proposed rule would revise part 1003, addressing the

    Office of Inspector General's authority to propose the imposition of civil money penalties and assessments by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; clarify the availability of exclusion for certain violations in addition to civil money penalties and assessments; date various references to managed care organization authorities; and clarify the application of section 1140 of the Social

    Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e mail communications.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    04/00/11

    NPRM Comment Period End

    06/00/11

    Regulatory Flexibility Analysis Required: No

    Agency Contact: Patrice S. Drew, Department of Health and Human

    Services, Office of the Secretary, Office of the Inspector General, 330

    Independence Avenue SW., Washington, DC 20201

    Phone: 202 619-1368

    Email: patrice.drew@hhs.gov

    RIN: 0991-AB03

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    Department of Health and Human Services (HHS)

    Final Rule Stage

    Office of the Secretary (OS)

  2. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES

    UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH

    ACT

    Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register.

    RIN: 0991-AB57

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    Department of Health and Human Services (HHS)

    Completed Actions

    Office of the Secretary (OS)

  3. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS,

    IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC

    HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610

    REVIEW)

    Legal Authority: 42 USC 300jj-14

    Abstract: The Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology, will issue an interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health

    Service Act. The certification criteria adopted in this initial set establish the technical capabilities and related standards that certified electronic health record (EHR) technology will need to include in support of the Medicare and Medicaid EHR Incentive Programs.

    Timetable:

    Action

    Date

    FR Cite

    Interim Final Rule

    01/13/10

    75 FR 2014

    Interim Final Rule Comment

    Period End

    03/15/10

    Interim Final Rule Effective 02/12/10

    Final Action

    07/28/10

    75 FR 44590

    Regulatory Flexibility Analysis Required: No

    Agency Contact: Steven Posnack, Policy Analyst, Department of Health and Human Services, Office of the Secretary, Office of the National

    Coordinator for Health Information Technology, 200 Independence Avenue

    SW., Washington, DC 20201

    Phone: 202 690-7151

    RIN: 0991-AB58

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    Department of Health and Human Services (HHS)

    Long-Term Actions

    Substance Abuse and Mental Health Services Administration (SAMHSA)

  4. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN

    CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

    Legal Authority: PL 106-310, 42 USC 290jj to 290jj-2

    Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Paolo Del Vecchio, Department of Health and Human

    Services, Substance Abuse and Mental Health Services Administration,

    Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857

    Phone: 301 443-2619

    RIN: 0930-AA10

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    Department of Health and Human Services (HHS)

    Long-Term Actions

    Substance Abuse and Mental Health Services Administration (SAMHSA)

  5. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE

    ADDICTION (SECTION 610 REVIEW)

    Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11

    Abstract: This rule will amend the Federal opioid treatment program regulations. It will modify the dispensing requirements for buprenorphine and buprenorphine combination products that are approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    06/19/09

    74 FR 29153

    NPRM Comment Period End

    08/18/09

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: No

    Agency Contact: Nicholas Reuter, Department of Health and Human

    Services, Substance Abuse and Mental Health Services Administration,

    Suite

    Page 79769

    2-1063, One Choke Cherry Road, Rockville, MD 20857

    Phone: 240 276-2716

    RIN: 0930-AA14

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    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Disease Control and Prevention (CDC)

  6. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS

    REGULATIONS; NONHUMAN PRIMATE

    Legal Authority: 42 USC 264

    Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health significance. CDC is proposing to amend its regulations related to the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of cynomolgus,

    African green, and rhesus monkeys to all NHPs. The agency also is proposing to reduce the frequency at which importers of the three species are required to renew their registrations, (from every 180 days to every two years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address NHPs imported as part of a circus or trained animal act, NHPs imported by zoological societies, the transfer of NHPs from approved laboratories, and non- live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    01/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Stacy Howard, Department of Health and Human Services,

    Centers for Disease Control and Prevention, MS E03, CLFT Building 16,

    Room 4324, Atlanta, GA 30329

    Phone: 404 498-1600

    Email: showard@cdc.gov

    RIN: 0920-AA23

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    Department of Health and Human Services (HHS)

    Final Rule Stage

    Centers for Disease Control and Prevention (CDC)

  7. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS

    Legal Authority: 42 USC 243; 42 USC 264 and 265; 42 USC 267 and 268; 42

    USC 270 and 271

    Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42

    CFR Part 71) will update and improve CDC's response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system's ability to slow the introduction, transmission, and spread of communicable disease. The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    11/30/05

    70 FR 71892

    NPRM Comment Period End

    01/20/06

    Final Action

    12/00/10

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Stacy Howard, Department of Health and Human Services,

    Centers for Disease Control and Prevention, MS E03, CLFT Building 16,

    Room 4324, Atlanta, GA 30329

    Phone: 404 498-1600

    Email: showard@cdc.gov

    RIN: 0920-AA12

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    Department of Health and Human Services (HHS)

    Final Rule Stage

    Centers for Disease Control and Prevention (CDC)

  8. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE

    VIRUS (SECTION 610 REVIEW)

    Legal Authority: PL 107-188

    Abstract: The Public Health Security and Bioterrorism Preparedness and

    Response Act of 2002 authorizes the HHS Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR 73. Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on: (1) The effect on human health as a result of exposure to the agent or toxin, (2) the degree of contagiousness of the agent or toxin, (3) the methods by which the agent or toxin is transferred to humans, (4) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent and illness resulting from infection by the agent or toxin, and

    (5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate.

    Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list. After

    Page 79770

    consulting with subject matter experts from CDC, the National

    Institutes of Health (NIH), the Food Drug Administration (FDA), the

    United States Department of Agriculture (USDA) /Animal and Plant Health

    Inspection Service (APHIS), USDA/Agricultural Research Service (ARS),

    USDA/CVB (Center for Veterinary Biologics), and the Department of

    Defense (DOD)/United States Army Medical Research Institute for

    Infectious Diseases (USAMRIID) and review of relevant published studies, we believe the Chapare virus should be added to the list of

    HHS select agents and toxins based on our conclusion that the Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    08/19/09

    74 FR 159

    NPRM Comment Period End

    10/19/09

    Final Action

    11/00/11

    Regulatory Flexibility Analysis Required: No

    Agency Contact: Robbin Weyant, Department of Health and Human Services,

    Centers for Disease Control and Prevention, CLFT Building 20, Room 4202, 1600 Clifton Road NE., Atlanta, GA 30333

    Phone: 404 718-2000

    RIN: 0920-AA32

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    Department of Health and Human Services (HHS)

    Long-Term Actions

    Centers for Disease Control and Prevention (CDC)

  9. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS

    Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30

    USC 811; 30 USC 842(h); 30 USC 844

    Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices.

    Areas for potential modification in this module are: (1) Upgrade of quality assurance requirements; (2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; and (3) revised approval label requirements.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    12/10/08

    73 FR 75045

    NPRM Comment Period End

    02/09/09

    NPRM Comment Period Reopened 03/04/09

    74 FR 9381

    NPRM Comment Period Reopened End04/10/09

    NPRM Comment Period Reopening

    Extended

    05/21/09

    74 FR 23815

    NPRM Comment Period End

    10/09/09

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: William E. Newcomb, Physical Scientist, Department of

    Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236

    Phone: 412 386-5200

    RIN: 0920-AA04

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    Department of Health and Human Services (HHS)

    Prerule Stage

    Food and Drug Administration (FDA)

  10. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS;

    REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610

    REVIEW)

    Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271

    Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public

    Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50.

    FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement, provided the words ``keep refrigerated'' appear on the principal display panel or information panel. FDA is undertaking a review of 21 CFR sections 101.17(h), 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule;

    (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.

    Page 79771

    Timetable:

    Action

    Date

    FR Cite

    Begin Review

    12/15/09

    End Review

    12/00/10

    Regulatory Flexibility Analysis Required: Undetermined

    Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and

    Labeling Team, Department of Health and Human Services, Food and Drug

    Administration, Center for Food Safety and Applied Nutrition, (HFS- 820), 5100 Paint Branch Parkway, College Park, MD 20740

    Phone: 301 436-1802

    Fax: 301 436-2636

    Email: geraldine.june@fda.hhs.gov

    RIN: 0910-AG06

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-12

    Page 79771

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  11. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS

    AND BIOLOGICS

    Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register.

    RIN: 0910-AC52

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-13

    Page 79771

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  12. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE)

    PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antihistamine labeling claims for the common cold.

    Timetable:

    Action

    Date

    FR Cite

    Reopening of Administrative

    Record

    08/25/00

    65 FR 51780

    NPRM (Amendment) (Common Cold) 10/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF31

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-14

    Page 79771

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  13. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products.

    The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the internal analgesic products monograph.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment) (Required

    Warnings and Other Labeling) 12/26/06

    71 FR 77314

    NPRM Comment Period End

    05/25/07

    Final Action (Required Warnings and Other Labeling)

    04/29/09

    74 FR 19385

    Final Action (Correction)

    06/30/09

    74 FR 31177

    Final Action (Technical

    Amendment)

    11/25/09

    74 FR 61512

    NPRM (Acetaminophen)

    03/00/11

    NPRM (Amendment) (Pediatric)

    To Be

    Determined

    NPRM (Amendment) (Sodium

    Bicarbonate)

    To Be

    Determined

    NPRM (Overindulgence/ Hangover) To Be

    Determined

    Final Action (Internal

    Analgesics)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF36

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-15

    Page 79771-79772

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  14. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. The final action will address laxative drug products.

    Page 79772

    Timetable:

    Action

    Date

    FR Cite

    Final Action (Granular Psyllium)03/29/07

    72 FR 14669

    NPRM (Professional Labeling--

    Sodium Phosphate)

    12/00/10

    NPRM (Professional Labeling)

    To Be

    Determined

    Final Action (Laxative Drug

    Products)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF38

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-16

    Page 79772

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  15. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent

    Applications. The second action addresses other safety and effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen labeling and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients.

    Timetable:

    Action

    Date

    FR Cite

    ANPRM (Sunscreen and Insect

    Repellent)

    02/22/07

    72 FR 7941

    ANPRM Comment Period End

    05/23/07

    NPRM (UVA/UVB)

    08/27/07

    72 FR 49070

    NPRM Comment Period End

    12/26/07

    NPRM (Safety and Effectiveness) 12/00/10

    Final Action (UVA/UVB)

    12/00/10

    NPRM (Time and Extent

    Applications)

    04/00/11

    ANPRM (Safety)

    04/00/11

    NPRM (Sunscreen and Insect

    Repellent)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF43

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-17

    Page 79772

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  16. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG

    PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, food handlers, and first aid antiseptic drug products respectively.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Healthcare)

    06/17/94

    59 FR 31402

    NPRM (Consumer)

    03/00/11

    NPRM (Food Handlers)

    To Be

    Determined

    NPRM (Testing -- Healthcare

    Professional Products)

    To Be

    Determined

    Final Action (Healthcare)

    To Be

    Determined

    Final Action (Consumer)

    To Be

    Determined

    Final Action (Food Handlers)

    To Be

    Determined

    Final Action (First Aid

    Antiseptic)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF69

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-18

    Page 79772-79773

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  17. IMPORT TOLERANCES FOR RESIDUES OF UNAPPROVED NEW ANIMAL DRUGS IN

    FOOD

    Legal Authority: 21 USC 360b(a)(6); 21 USC 371

    Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residue of the new animal drug in the animal-derived food does not exceed that tolerance.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    03/00/11

    NPRM Comment Period End

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Page 79773

    Agency Contact: Thomas Moskal, Consumer Safety Officer, Department of

    Health and Human Services, Food and Drug Administration, Center for

    Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place,

    Rockville, MD 20855

    Phone: 240 276-9242

    Fax: 240 276-9241

    Email: thomas.moskal@fda.hhs.gov

    RIN: 0910-AF78

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-19

    Page 79773

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  18. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD

    Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393

    Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA's performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science. In addition, the proposal would include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue,

    Silver Spring, MD 20993

    Phone: 301 796-6248

    Fax: 301 847-8145

    Email: nancy.pirt@fda.hhs.gov

    RIN: 0910-AF87

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-20

    Page 79773

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  19. PET FOOD LABELING REQUIREMENTS

    Legal Authority: 21 USC 343; 21 USC 371; PL 110-85, sec 1002(a)(3)

    Abstract: The President signed into law the Food and Drug

    Administration Amendments Act of 2007 (FDAAA) on September 27, 2007

    (Pub. L. 110-85). Title X of the FDAAA includes several provisions pertaining to food safety, including the safety of pet food. Section 1002(a) of the new law directs FDA to issue new regulations to establish updated standards for the labeling of pet food that include nutritional and ingredient information. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the Association of American Feed

    Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    03/00/11

    NPRM Comment Period End

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: William Burkholder, Veterinary Medical Officer,

    Department of Health and Human Services, Food and Drug Administration,

    Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519

    Standish Place, Rockville, MD 20855

    Phone: 240 453-6865

    Email: william.burkholder@fda.hhs.gov

    RIN: 0910-AG09

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-21

    Page 79773

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  20. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED

    Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42

    USC 264; PL 110-85, sec 1002(a)(2)

    Abstract: The Food and Drug Administration (FDA) is proposing regulations for process controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed

    Safety System initiative. The proposed process controls will apply to animal feed ingredients and mixed animal feed, including pet food. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007. Section 1002(a) directs

    FDA to establish by regulation processing standards for pet food. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the

    Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    03/00/11

    NPRM Comment Period End

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Kim Young, Deputy Director, Division of Compliance,

    Department of Health and Human Services, Food and Drug Administration,

    Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519

    Standish Place, Rockville, MD 20855

    Phone: 240 276-9207

    Email: kim.young@fda.hhs.gov

    RIN: 0910-AG10

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-22

    Page 79773-79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  21. OVER-THE-COUNTER (OTC) DRUG REVIEW--PEDIATRIC DOSING FOR COUGH/COLD

    PRODUCTS

    Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903

    Page 79774

    New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AG12

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-23

    Page 79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  22. ELECTRONIC DISTRIBUTION OF CONTENT OF LABELING FOR HUMAN

    PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS

    Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42

    USC 262; 42 USC 264

    Abstract: This rule would require electronic package inserts for human drug and biological prescription products, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    04/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Connie T. Jung, Senior Advisor for Pharmacy Affairs,

    Department of Health and Human Services, Food and Drug Administration,

    Office of Policy, WO32, Room 4254, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-4830

    Email: connie.jung@fda.hhs.gov

    RIN: 0910-AG18

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-24

    Page 79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  23. UNIQUE DEVICE IDENTIFICATION

    Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register.

    RIN: 0910-AG31

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-25

    Page 79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  24. CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL

    ACT

    Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and

    Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco

    Control Act

    Abstract: The Family Smoking Prevention and Tobacco Control Act (the

    Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

    Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the Tobacco Control Act. This proposed rule would deem cigars to be subject to the Tobacco Control

    Act and include provisions to address public health concerns raised by cigars.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate

    Boulevard, Rockville, MD 20850

    Phone: 877 287-1373

    Fax: 240 276-3904

    Email: may.nelson@fda.hhs.gov

    RIN: 0910-AG38

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-26

    Page 79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  25. CIGARETTE WARNING LABEL STATEMENTS

    Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register.

    RIN: 0910-AG41

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-27

    Page 79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  26. GENERAL HOSPITAL AND PERSONAL USE DEVICES:

    DESIGNATION OF SPECIAL CONTROLS FOR INFUSION PUMPS

    Legal Authority: 21 USC 351 371; 21 USC 360 and 360c; 21 USC 360e and 360j; 21 USC 371

    Abstract: Since 2003, FDA has seen a dramatic increase in the number of device recalls, as well as an increase in the number of death and serious injury reports submitted regarding infusion pumps. An analysis of the reports reveals that a majority of the recalls and failures were caused by user error and/or device design flaw. As a result of these incidents, FDA is proposing to designate a special controls guidance document as the special controls for infusion pumps. The agency believes that establishing these special controls for infusion pumps is necessary to provide reasonable assurance of the safety and effectiveness of these devices.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    09/00/11

    NPRM Comment Period End

    12/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue,

    Silver Spring, MD 20993

    Phone: 301 796-6248

    Fax: 301 847-8145

    Email: nancy.pirt@fda.hhs.gov

    RIN: 0910-AG54

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-28

    Page 79774

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  27. FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD

    IN VENDING MACHINES

    Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register.

    RIN: 0910-AG56

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-29

    Page 79774-79775

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Food and Drug Administration (FDA)

  28. FOOD LABELING: NUTRITION LABELING OF STANDARD

    MENU ITEMS IN CHAIN RESTAURANTS

    Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register.

    RIN: 0910-AG57

    Page 79775

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-30

    Page 79775

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  29. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND

    BIOLOGICAL PRODUCTS

    Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21

    USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381

    Abstract: The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking

    (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products.

    FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    03/14/03

    68 FR 12406

    NPRM Comment Period Extended 06/18/03

    NPRM Comment Period End

    07/14/03

    NPRM Comment Period Extension

    End

    10/14/03

    Final Action

    08/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of

    Health and Human Services, Food and Drug Administration, Center for

    Drug Evaluation and Research, WO 51, Room 6362, 10903 New Hampshire

    Avenue, Silver Spring, MD 20993-0002

    Phone: 301 796-3469

    Fax: 301 847-8440

    Email: jane.baluss@fda.hhs.gov

    RIN: 0910-AA97

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    DOCID:ua20de10_008-31

    Page 79775

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  30. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING

    PRACTICE REQUIREMENTS

    Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353

    Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be permanently attached to the valve body.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    04/10/06

    71 FR 18039

    NPRM Comment Period End

    07/10/06

    Final Action

    10/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of

    Health and Human Services, Food and Drug Administration, Center for

    Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire

    Avenue, Silver Spring, MD 20993-0002

    Phone: 301 796-3522

    Fax: 301 847-8440

    Email: patrick.raulerson@fda.hhs.gov

    RIN: 0910-AC53

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-32

    Page 79775-79776

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  31. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND

    BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

    Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264

    Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different.

    Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women's health researchers, and women of childbearing age.

    Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product's risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    05/29/08

    73 FR 30831

    NPRM Comment Period End

    08/27/08

    Final Action

    10/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of

    Health and Human Services, Food and Drug Administration, Center for

    Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue,

    Silver Spring, MD 20993-0002

    Phone: 301 796-4288

    Page 79776

    Fax: 301 847-8440

    Email: rachel.bressler@fda.hhs.gov

    RIN: 0910-AF11

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    Page 79776

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  32. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY

    CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND

    QUALITY FACTORS

    Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register.

    RIN: 0910-AF27

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-34

    Page 79776

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  33. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR)

    PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment--Ephedrine

    Single Ingredient)

    07/13/05

    70 FR 40237

    NPRM Comment Period End

    11/10/05

    Final Action (Technical

    Amendment)

    11/30/07

    72 FR 67639

    Final Action (Amendment--Single

    Ingredient Labeling)

    01/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF32

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-35

    Page 79776

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  34. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION)

    PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses cough/cold drug products containing an oral bronchodilator

    (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment)

    07/13/05

    70 FR 40232

    NPRM Comment Period End

    11/10/05

    Final Action (Technical

    Amendment)

    03/19/07

    72 FR 12730

    Final Action

    10/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF33

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-36

    Page 79776

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  35. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings.

    Timetable:

    Action

    Date

    FR Cite

    Final Action (GRASE dosage forms)

    10/00/11

    NPRM (Amendment)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF35

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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    DOCID:ua20de10_008-37

    Page 79776-79777

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  36. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. The second action addresses skin protectant products used to treat fever blisters and cold sores.

    Timetable:

    Action

    Date

    FR Cite

    Final Action (Aluminum Acetate)

    (Technical Amendment)

    03/06/09

    74 FR 9759

    Final Action (Technical

    Amendments)

    02/01/08

    73 FR 6014

    Final Action (Diaper Rash)

    10/00/11

    Final Action (Fever Blisters/

    Cold Sores)

    10/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug

    Page 79777

    Administration, Center for Drug Evaluation and Research, WO 22, 10903

    New Hampshire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF42

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-38

    Page 79777

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  37. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS

    Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371

    Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy

    (BSE) in human food, including dietary supplements, and cosmetics.

    Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle.

    Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives.

    This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes

    BSE.

    Timetable:

    Action

    Date

    FR Cite

    Interim Final Rule

    07/14/04

    69 FR 42256

    Interim Final Rule Effective 07/14/04

    Interim Final Rule Comment

    Period End

    10/12/04

    Interim Final Rule (Amendments) 09/07/05

    70 FR 53063

    Interim Final Rule (Amendments)

    Effective

    10/07/05

    Interim Final Rule (Amendments)

    Comment Period End

    11/07/05

    Interim Final Rule (Amendments) 04/17/08

    73 FR 20785

    Interim Final Rule (Amendments)

    Comment Period End

    07/16/08

    Interim Final Rule (Amendments)

    Effective

    07/16/08

    Final Action

    04/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Amber McCoig, Consumer Safety Officer, Department of

    Health and Human Services, Food and Drug Administration, Center for

    Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch

    Parkway, College Park, MD 20740

    Phone: 301 436-2131

    Fax: 301 436-2644

    Email: amber.mccoig@fda.hhs.gov

    RIN: 0910-AF47

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-39

    Page 79777

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Food and Drug Administration (FDA)

  38. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE

    UNITED STATES

    Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264

    Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and

    Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    09/18/08

    73 FR 54106

    NPRM Comment Period End

    12/02/08

    Final Action

    03/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of

    Health and Human Services, Food and Drug Administration, Center for

    Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New

    Hampshire Avenue, Silver Spring, MD 20993

    Phone: 301 796-4706

    Email: daniel.sigelman@fda.hhs.gov

    RIN: 0910-AF61

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-40

    Page 79777-79778

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  39. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING,

    LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

    Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264

    Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72

    FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review

    Page 79778

    by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request.

    Timetable:

    Action

    Date

    FR Cite

    ANPRM

    02/06/97

    62 FR 5700

    ANPRM Comment Period End

    06/06/97

    NPRM

    03/13/03

    68 FR 12157

    NPRM Comment Period End

    08/11/03

    Final Rule

    06/25/07

    72 FR 34752

    Interim Final Rule

    06/25/07

    72 FR 34959

    Interim Final Rule Comment

    Period End

    10/24/07

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food

    Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway,

    College Park, MD 20740

    Phone: 301 436-2784

    Fax: 301 436-2657

    Email: linda.kahl@fda.hhs.gov

    RIN: 0910-AB88

    December 20, 2010 (Volume 75, Number 243)

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    DOCID:ua20de10_008-41

    Page 79778

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  40. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT)

    PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient phenylpropanolamine.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment) (Sinusitis

    Claim)

    08/02/04

    69 FR 46119

    NPRM Comment Period End

    11/01/04

    NPRM (Phenylephrine Bitartrate) 11/02/04

    69 FR 63482

    NPRM Comment Period End

    01/31/05

    NPRM (Phenyl- propanolamine) 12/22/05

    70 FR 75988

    NPRM Comment Period End

    03/22/06

    Final Action (Amendment)

    (Sinusitis Claim)

    10/31/05

    70 FR 58974

    Final Action (Phenylephrine

    Bitartrate)

    08/01/06

    71 FR 83358

    Final Action (Phenyl- propanolamine)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF34

    December 20, 2010 (Volume 75, Number 243)

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

    DOCID:ua20de10_008-42

    Page 79778

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  41. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR

    OTC HUMAN USE

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Convenience Sizes)

    12/12/06

    71 FR 74474

    NPRM Comment Period End

    04/11/07

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF37

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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    DOCID:ua20de10_008-43

    Page 79778

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  42. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes the monograph for emergency first aid eyewash drug products.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment) (Emergency

    First Aid Eyewashes)

    02/19/03

    68 FR 7917

    Final Action (Amendment)

    (Emergency First Aid Eyewashes) To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF39

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-44

    Page 79778-79779

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  43. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a

    Abstract: The OTC drug review establishes conditions under which

    Page 79779

    OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis.

    Timetable:

    Action

    Date

    FR Cite

    ANPRM (Plaque Gingivitis)

    05/29/03

    68 FR 32232

    ANPRM Comment Period End

    08/27/03

    NPRM (Plaque Gingivitis)

    To Be

    Determined

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF40

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-45

    Page 79779

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  44. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The proposed rule addresses vaginal contraceptive drug products.

    Timetable:

    Action

    Date

    FR Cite

    Final Action (Warnings)

    12/19/07

    72 FR 71769

    NPRM (Vaginal Contraceptive Drug

    Products)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF44

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-46

    Page 79779

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  45. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Phenyl- propanolamine) 12/22/05

    70 FR 75988

    NPRM Comment Period End

    03/22/06

    NPRM (Benzocaine)

    To Be

    Determined

    Final Action (Phenyl- propanolamine)

    To Be

    Determined

    Final Action (Benzocaine)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF45

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-47

    Page 79779

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  46. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND

    DRINK PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment)

    01/05/05

    70 FR 741

    NPRM Comment Period End

    04/05/05

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF51

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-48

    Page 79779-79780

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  47. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the labeling of products containing sodium

    Page 79780

    bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink.

    Timetable:

    Action

    Date

    FR Cite

    Final Action (Sodium Bicarbonate

    Labeling)

    To Be

    Determined

    Final Action (Overindulgence

    Labeling)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF52

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-49

    Page 79780

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  48. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses skin bleaching drug products containing hydroquinone.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    08/29/06

    71 FR 51146

    NPRM Comment Period End

    12/27/06

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF53

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-50

    Page 79780

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  49. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Amendment) (Hangover)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF56

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-51

    Page 79780

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  50. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTIDIARRHEAL DRUG PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address new labeling for antidiarrheal drug products.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (New Labeling)

    To Be

    Determined

    Final Action (New Labeling)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF63

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-52

    Page 79780-79781

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  51. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only

    OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the products used for urinary pain relief.

    Timetable:

    Action

    Date

    FR Cite

    NPRM (Urinary Analgesic)

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AF70

    Page 79781

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-53

    Page 79781

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  52. OVER-THE-COUNTER (OTC) DRUG REVIEW--CERTAIN CATEGORY II ACTIVE

    INGREDIENTS

    Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371

    Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    06/19/08

    73 FR 34895

    NPRM Comment Period End

    09/17/08

    Final Action

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Matthew R. Holman, Ph.D., Department of Health and

    Human Services, Food and Drug Administration, Center for Drug

    Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver

    Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: matthew.holman@fda.hhs.gov

    RIN: 0910-AF95

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-54

    Page 79781

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  53. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG

    AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE

    PROCEDURES (SECTION 610 REVIEW)

    Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381

    Abstract: Pursuant to section 610 of the Regulatory Flexibility Act,

    FDA is currently undertaking a review of regulations promulgated under the Prescription Drug Marketing Act (PDMA) including those contained in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64

    FR 67762 and 67763). The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50

    (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA solicited comments on the following: (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21

    CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763);

    (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules, and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763).

    FDA received one comment on this review; and FDA notes that portions of the PDMA have been stayed in connection with RxUSA Wholesale, Inc., v.

    HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006), aff'd, 2008 U.S. App. LEXIS 14661 (2d Cir. 2008)); and that the litigation itself has been administratively closed (with either party having the right to reopen) through June 30, 2011. FDA is certifying that it is not feasible for the agency to complete its review by December 4, 2010, and therefore is extending the completion date by one year.

    Timetable:

    Action

    Date

    FR Cite

    Begin Review of Current

    Regulation

    11/24/08

    End Review of Current Regulation12/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for

    Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire

    Avenue, Silver Spring, MD 20993-0002

    Phone: 301 796-3601

    Fax: 301 847-8440

    Email: pdma610(c)review@fda.hhs.gov

    RIN: 0910-AG14

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-55

    Page 79781-79782

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  54. PRODUCE SAFETY REGULATION

    Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264

    Abstract: The Food and Drug Administration (FDA) has determined that enforceable standards (as opposed to voluntary recommendations) for the production and packing of fresh produce are necessary to ensure best practices are commonly adopted. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce.

    The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh

    Fruits and Vegetables'' (GAPs Guide). The proposed rule also will reflect comments received on the agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance after the proposed rule is finalized to assist industry in

    Page 79782

    complying with the requirements of the new regulation.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Samir Assar, Department of Health and Human Services,

    Food and Drug Administration, Center for Food Safety and Applied

    Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College

    Park, MD 20740

    Phone: 301 436-1636

    Email: samir.assar@fda.hhs.gov

    RIN: 0910-AG35

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-56

    Page 79782

    Department of Health and Human Services (HHS)

    Long-Term Actions

    Food and Drug Administration (FDA)

  55. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES

    REGULATION

    Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264

    Abstract: The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practices (CGMP) regulations (21 CFR part 110) for manufacturing, packing, or holding human food. This proposed rule would require food facilities to address issues such as environmental pathogens, food allergens, mandatory employee training, and sanitation of food contact surfaces. The proposed rule also would require food facilities to develop and implement preventive control systems. FDA is taking this action to better address changes that have occurred in the food industry and protect public health.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    To Be

    Determined

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Paul South, Department of Health and Human Services,

    Food and Drug Administration, Center for Food Safety and Applied

    Nutrition (HFS-317), Office of Food Safety, 5100 Paint Branch Parkway,

    College Park, MD 20740

    Phone: 301 436-1640

    Email: paul.south@fda.hhs.gov

    RIN: 0910-AG36

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-57

    Page 79782

    Department of Health and Human Services (HHS)

    Completed Actions

    Food and Drug Administration (FDA)

  56. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL

    INHALATION (COMPLETION OF A SECTION 610 REVIEW)

    Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375

    Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether this regulation on aqueous-based drug products for oral inhalation should be continued without change, or whether it should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for 21 CFR 200.51; (2) the nature of complaints or comments received concerning 21 CFR 200.51; (3) the complexity of 21 CFR 200.51; (4) the extent to which the regulation overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by 21

    CFR 200.51. No comments were required. FDA's review of these regulations concluded that they should be continued without change.

    Timetable:

    Action

    Date

    FR Cite

    Begin Review

    05/01/09

    End Review

    05/31/10

    Regulatory Flexibility Analysis Required: No

    Agency Contact: Howard P. Muller, Office of Regulatory Policy,

    Department of Health and Human Services, Food and Drug Administration,

    Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New

    Hampshire Avenue, Silver Spring, MD 20993-0002

    Phone: 301 796-3601

    Fax: 301 847-8440

    Email: howard.mullerjr@fda.hhs.gov

    RIN: 0910-AG25

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-58

    Page 79782-79783

    Department of Health and Human Services (HHS)

    Completed Actions

    Food and Drug Administration (FDA)

  57. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND

    SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS

    Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and

    Cosmetic Act; PL 111-31, Family Smoking Prevention and Tobacco Control

    Act

    Abstract: This rule establishes regulations restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents, implementing section 102 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) require the Secretary to publish, within 270 days of enactment, a final rule regarding cigarettes and smokeless tobacco. This final rule must be identical, except for several changes identified in section 102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the

    Secretary of HHS in the August 28, 1996, issue of the Federal Register

    (61 FR 44396).

    This final rule prohibits the sale of cigarettes and smokeless tobacco to individuals under the age of 18 and requires manufacturers, distributors, and retailers to comply with certain conditions regarding access to, and promotion of, these products. Among other things, the final rule requires retailers to verify a purchaser's age by photographic identification. It also prohibits, with limited exception, free samples and prohibits the sale of these products through vending machines and self-service displays except in facilities where individuals under the age of 18 are not present or permitted at any time. The rule also limits the advertising and labeling to which children and adolescents are exposed. The rule accomplishes this by generally restricting advertising to which children and adolescents are exposed to a black-and-white, text-only format. The rule also prohibits the sale or

    Page 79783

    distribution of brand-identified promotional, non-tobacco items such as hats and tee shirts. Furthermore, the rule prohibits sponsorship of sporting and other events, teams, and entries in a brand name of a tobacco product, but permits such sponsorship in a corporate name.

    FDA also published in the same issue of the Federal Register an advance notice of proposed rulemaking requesting comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco.

    Timetable:

    Action

    Date

    FR Cite

    ANPRM

    03/19/10

    75 FR 13241

    Final Rule

    03/19/10

    75 FR 13225

    ANPRM Comment Period End

    05/18/10

    Final Rule Effective

    06/22/10

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of

    Health and Human Services, Food and Drug Administration, 9200 Corporate

    Boulevard, 100K, Rockville, MD 20850

    Phone: 877 287-1373

    Fax: 240 276-3904

    Email: annette.marthaler@fda.hhs.gov

    RIN: 0910-AG33

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-59

    Page 79783

    Department of Health and Human Services (HHS)

    Completed Actions

    Food and Drug Administration (FDA)

  58. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (COMPLETION OF

    A SECTION 610 REVIEW)

    Legal Authority: 5 USC 610

    Abstract: Section 201.66 (21 CFR section 201.66) established a standardized format for the labeling of OTC drug products that included: (1) Specific headings and subheadings presented in a standardized order, (2) standardized graphical features such as headings in bold type and the use of ``bullet points'' to introduce key information, and (3) minimum standards for type size and spacing. FDA issued the final rule to improve labeling after considering comments submitted to the agency following the publication of the proposed regulation in 1997. In 1999, FDA published the final rule and stated that a standardized labeling format would significantly improve readability by familiarizing consumers with the types of information in

    OTC drug product labeling and the location of that information. In addition, a standardized appearance and standardized content, including various ``user-friendly'' visual cues, would help consumers locate and read important health and safety information and allow quick and effective product comparisons, thereby helping consumers to select the most appropriate product.

    FDA undertook a review of section 201.66 under section 610 of the

    Regulatory Flexibility Act. The purpose of this review is to determine whether the regulation in section 201.66 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 201.66; (2) the nature of the complaints or comments received concerning the regulation in section 201.66; (3) the complexity of the regulations in section 201.66; (4) the extent to which the regulations in section 201.66 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling standard regulations in section 201.

    No comments were received. FDA's review of these regulations concluded that they should be continued without change.

    Timetable:

    Action

    Date

    FR Cite

    Begin Review of Current

    Regulation

    08/03/09

    End Review of Current Regulation05/27/10

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: M. Scott Furness, Department of Health and Human

    Services, Food and Drug Administration, Center for Drug Evaluation and

    Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993

    Phone: 301 796-2090

    Fax: 301 796-9899

    Email: micheal.furness@fda.hhs.gov

    RIN: 0910-AG34

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-60

    Page 79783-79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  59. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS- 3819-P) (SECTION 610 REVIEW)

    Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb

    Abstract: This proposed rule would revise the existing Conditions of

    Participation (CoPs) that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The CoPs were last revised in 1989. The new requirements will focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through federal programs while at the same time reducing procedural burdens on providers.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    03/10/97

    62 FR 11005

    NPRM Comment Period End

    06/09/97

    Second NPRM

    07/00/11

    Regulatory Flexibility Analysis Required: Undetermined

    Agency Contact: Danielle Shearer, Health Insurance Specialist,

    Department of Health and Human Services, Centers for Medicare &

    Medicaid Services, Clinical Standards & Quality, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244

    Page 79784

    Phone: 410 786-6617

    Email: danielle.shearer@cms.hhs.gov

    RIN: 0938-AG81

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-61

    Page 79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  60. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-F) (SECTION 610 REVIEW)

    Legal Authority: 42 USC 1302; 42 USC 1395hh

    Abstract: This rule establishes that in order to participate in the

    Medicare and Medicaid programs, long-term care facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility. The rule also contains quality of care requirements.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    10/22/10

    75 FR 65282

    NPRM Comment Period End

    12/21/10

    Final Action

    10/00/13

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Patricia Brooks, Health Insurance Specialist,

    Department of Health and Human Services, Centers for Medicare &

    Medicaid Services, Office of Clinical Standards and Quality, Mailstop

    S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244

    Phone: 410 786-4561

    Email: patricia.brooks@cms.hhs.gov

    RIN: 0938-AP32

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-62

    Page 79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  61. INFLUENZA VACCINATION STANDARD FOR CERTAIN MEDICARE PARTICIPATING

    PROVIDERS AND SUPPLIERS(CMS-3213-P)

    Legal Authority: Social Security Act sec 1881, 1861, 1920, 1102, 1871, 1965

    Abstract: This proposed rule would require certain Medicare providers and suppliers to offer all patients an annual influenza vaccination, unless medically inadvisable or if the patient declines vaccination.

    This proposed rule is intended to increase the number of patients receiving annual vaccination against seasonal influenza and to decrease the morbidity and mortality rate from influenza.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    01/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services,

    Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244

    Phone: 410 786-4683

    Email: lauren.oviatt@cms.hhs.gov

    RIN: 0938-AP92

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-63

    Page 79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  62. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HOSPITAL

    INPATIENT PSYCHIATRIC AND REHABILITATION UNITS EXCLUDED FROM THE

    PROSPECTIVE PAYMENT SYSTEM AND LTCH REQUIREMENTS (CMS-3177-P)

    Legal Authority: 42 USC 1385 X; 42 USC 1396 d; 42 USC 1395 hh

    Abstract: This proposed rule would transfer the existing process requirements for hospital inpatient psychiatric and rehabilitation units that are excluded from prospective payment systems to the hospital conditions of participation (CoPs) part of the Act. This would allow accrediting organizations to deem these units as part of their hospital accreditation process providing a timely and cost effective survey and certification process under the CoPs. In addition, this rule would propose long term care hospital requirements mandated by the

    Medicare, Medicaid and SCHIP Extension Act of 2007.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    05/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Capt. Katherine Berkhousen, Department of Health and

    Human Services, Centers for Medicare & Medicaid Services, 7500 Security

    Boulevard, Mailstop S3-02-01, Baltimore, MD 21244

    Phone: 410 786-1154

    Email: katherine.berkhousen@cms.hhs.gov

    RIN: 0938-AP97

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-64

    Page 79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  63. PROPOSED CHANGES TO THE HOSPITAL INPATIENT

    PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2012 RATES

    AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2012 RATES (CMS-1518-P)

    Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of the Federal Register.

    RIN: 0938-AQ24

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-65

    Page 79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  64. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE

    PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2012

    (CMS-1525-P)

    Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of the Federal Register.

    RIN: 0938-AQ26

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-66

    Page 79784

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  65. CHANGES TO THE ESRD PROSPECTIVE PAYMENT SYSTEM

    FOR CY 2012 (CMS-1577-P)

    Legal Authority: Sec 1881 of the Social Security Act

    Abstract: This proposed rule would update the bundled payment system for End Stage Renal Disease (ESRD) facilities as required by the

    Medicare Improvments for Patients and Providers Act (MIPPA). These changes would be applicable to services furnished on or after January 1 annually.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    06/00/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Janet Samen, Director, Division of Chronic Care

    Management, Department of Health and Human Services, Centers for

    Medicare & Medicaid Services, Mailstop C5-05-27, 7500 Security

    Boulevard, Baltimore, MD 21244

    Phone: 410 786-4533

    Email: janet.samen@cms.hhs.gov

    RIN: 0938-AQ27

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-67

    Page 79784-79785

    Department of Health and Human Services (HHS)

    Proposed Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  66. FEDERAL FUNDING FOR MEDICAID ELIGIBILITY

    DETERMINATION AND ENROLLMENT ACTIVITIES (CMS-2346-P)

    Legal Authority: PL 111-148, sec 1413

    Page 79785

    Abstract: The Affordable Care Act requires States' residents to apply, enroll, receive determinations, and participate in the State health subsidy programs known as ``the Exchange''. The ACA requires many changes to State eligibility and enrollment systems and each State is responsible for developing a secure, electronic interface allowing the exchange of data. Existing legacy eligibility systems are not able to implement the numerous requirements. This proposed rule is key to informing States about the higher rates that CMS will provide to help them update or build legacy eligibility systems that meet the ACA requirements.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    11/08/10

    75 FR 68583

    NPRM Comment Period End

    01/07/11

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Richard H. Friedman, Director, Division of State

    Systems, Department of Health and Human Services, Centers for Medicare

    & Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard,

    Baltimore, MD 21244

    Phone: 410 786-4451

    Email: richard.friedman@cms.hhs.gov

    RIN: 0938-AQ53

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-68

    Page 79785

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  67. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND

    PART B FOR CY 2011 (CMS-1503-C)

    Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871

    Abstract: This annual final rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B for CY 2011.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    07/13/10

    75 FR 40040

    NPRM Comment Period End

    09/24/10

    Final Action

    12/00/10

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Carol Bazell, Director, Division of Practitioner

    Services, Department of Health and Human Services, Centers for Medicare

    & Medicaid Services, Mail Stop C4-03-06, 7500 Security Boulevard,

    Baltimore, MD 21244

    Phone: 410 786-6960

    Email: carol.bazell@cms.hhs gov

    RIN: 0938-AP79

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-69

    Page 79785

    Department of Health and Human Services (HHS)

    Final Rule Stage

    Centers for Medicare & Medicaid Services (CMS)

  68. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND

    AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS-1504-C)

    Legal Authority: sec 1833 of the Social Security Act; BBA, BA, BIPA,

    MMA, PPACA

    Abstract: This final rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule changes the Ambulatory Surgical Center Payment System list of services and rates.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    08/03/10

    75 FR 46169

    NPRM Comment Period End

    08/31/10

    Final Action

    12/00/10

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Alberta Dwivedi, Health Insurance Specialist,

    Department of Health and Human Services, Centers for Medicare &

    Medicaid Services, Mail Stop C5-01-26, 7500 Security Boulevard,

    Baltimore, MD 21244

    Phone: 410 786-0763

    Email: alberta.dwivedi@cms.hhs.gov

    RIN: 0938-AP82

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-70

    Page 79785-79786

    Department of Health and Human Services (HHS)

    Completed Actions

    Centers for Medicare & Medicaid Services (CMS)

  69. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG

    BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS-4085-F)

    Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security

    Act)

    Abstract: This final rule makes revisions to the regulations governing the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) based on our continued experience in the administration of the Part C and D programs. The revisions strengthen various program participation and exit requirements; strengthen beneficiary protections; ensure that plan offerings to beneficiaries include meaningful differences; improve plan payment rules and processes; improve data collection for oversight and quality assessment; implement new policy such as a Part D formulary policy; and clarify program policy.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    10/22/09

    74 FR 54634

    NPRM Comment Period End

    12/07/09

    Final Action

    04/15/10

    75 FR 19678

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy and Quality, Department of Health and Human Services, Centers for

    Medicare & Medicaid Services, Mail Stop

    Page 79786

    C1-26-26, 7500 Security Boulevard, Baltimore, MD 21244

    Phone: 410 786-6041

    Email: alissa.deboy@cms.hhs.gov

    RIN: 0938-AP77

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-71

    Page 79786

    Department of Health and Human Services (HHS)

    Completed Actions

    Centers for Medicare & Medicaid Services (CMS)

  70. ELECTRONIC HEALTH RECORD (EHR) INCENTIVE PROGRAM (CMS-0033-F)

    Legal Authority: PL 111-5 (The American Recovery and Reinvestment Act of 2009, Title IV of Division B, Medicare and Medicaid Health

    Information Technology)

    Abstract: This rule would implement provisions of the American Recovery

    Act of 2009 (Recovery Act) that authorize incentive payments to eligible professionals (EPS) and eligible hospitals participating in the Medicare and Medicaid programs for adopting and becoming meaningful users of certified electronic health records (HER) technology. In accordance with the Recovery Act, the rule will establish maximum annual incentive amounts and include Medicare penalties for failing to meaningfully use EHRs beginning in 2015.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    01/13/10

    75 FR 1843

    NPRM Comment Period End

    03/15/10

    Final Action

    07/28/10

    75 FR 44413

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Elizabeth S. Holland, Health Insurance Specialist,

    Department of Health and Human Services, Centers for Medicare &

    Medicaid Services, Mailstop S2-26-17, 7500 Security Boulevard,

    Baltimore, MD 21244

    Phone: 410 786-1309

    Email: elizabeth.holland@cms.hhs.gov

    RIN: 0938-AP78

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-72

    Page 79786

    Department of Health and Human Services (HHS)

    Completed Actions

    Centers for Medicare & Medicaid Services (CMS)

  71. PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND THE LONG-

    TERM CARE HOSPITAL PROSPECTIVE PAYMENT SYSTEM

    Legal Authority: Sec 1886(d) of the Social Security Act

    Abstract: This rule updates the fiscal year (FY) 2011 hospital inpatient prospective payment systems (IPPS) and long-term care prospective payment system (LTCH PPS). This rule payments to hospitals for inpatient services that are contained in the Patient Protection and

    Affordable Care Act (the Affordable Care Act) as amended by the Health

    Care and Education Reconciliation Act of 2010 (HCERA) (collectively known as the Affordable Care Act). It would also specify statutorily required changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs, and for long-term care hospital costs.

    Timetable:

    Action

    Date

    FR Cite

    NPRM

    05/04/10

    75 FR 23851

    NPRM Comment Period End

    06/18/10

    Second NPRM

    06/02/10

    75 FR 30917

    Second NPRM Comment Period End 07/02/10

    Final Action

    08/16/10

    75 FR 50041

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Tiffany Swygert, Health Insurance Specialist,

    Department of Health and Human Services, Centers for Medicare &

    Medicaid Services, Mailstop C4-25-11, 7500 Security Boulevard,

    Baltimore, MD 21244

    Phone: 410 786-4642

    Email: tiffany.swygert@cms.hhs.gov

    RIN: 0938-AP80

    December 20, 2010 (Volume 75, Number 243)

    Unified Agenda

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

    DOCID:ua20de10_008-73

    Page 79786

    Department of Health and Human Services (HHS)

    Completed Actions

    Centers for Medicare & Medicaid Services (CMS)

  72. HOSPITAL IPPS FOR ACUTE CARE HOSPITALS AND

    FISCAL YEAR 2010 RATES AND TO THE LONG-TERM CARE HOSPITAL PPS AND RATE

    YEAR 2010 RATES (CMS-1406-N)

    Legal Authority: PL 111 148; PL 111-152

    Abstract: This notice contains the final wage indices, hospital reclassifications, payment rates, impacts, and other related tables effective for the fiscal year (FY) 2010 hospital inpatient prospective payment systems (IPPS) and rate year 2010 long-term care hospital

    (LTCH) prospective payment system (PPS) . The rates, tables, and impacts included in this notice reflect changes required or resulting from the implementation of several provisions of the Patient Protection and Affordable Care Act as amended by the Health Care and Education

    Reconciliation Act of 2010. These provisions require the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2010, and certain market basket updates for the IPPS and LTCH PPS effective April 1, 2010.

    Timetable:

    Action

    Date

    FR Cite

    Final Action

    06/02/10

    75 FR 31118

    Regulatory Flexibility Analysis Required: Yes

    Agency Contact: Tzvi Hefter, Department of Health and Human Services,

    Centers for Medicare & Medicaid Services, 7500 Security Boulevard,

    Baltimore, MD 21244

    Phone: 410 786-4487

    Email: tzvi.hefter@cms.hhs.gov

    RIN: 0938-AQ03

    FR Doc. 2010-30444 Filed 12-17-10; 8:45 am

    BILLING CODE 4150-24-S

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