[The Regulatory Plan and Unified Agenda of
Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Publishing Office, www.gpo.gov]
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Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
[[Page 79764]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
_______________________________________________________________________
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
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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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[[Page 79765]]
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
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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)......................................................................
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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
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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
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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
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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
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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)...............................................................................
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
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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)...............................................................................
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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)
_______________________________________________________________________
302. 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: [email protected]
RIN: 0991-AB03
[[Page 79768]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
303. 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
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
304. 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
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
305. 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
_______________________________________________________________________
306. 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
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
307. 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: [email protected]
RIN: 0920-AA23
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
308. 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: [email protected]
RIN: 0920-AA12
_______________________________________________________________________
309. 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
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
310. 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
_______________________________________________________________________
Department of Health and Human Services (HHS) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
311. 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: [email protected]
RIN: 0910-AG06
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
312. 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
_______________________________________________________________________
313. 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: [email protected]
RIN: 0910-AF31
_______________________________________________________________________
314. 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: [email protected]
RIN: 0910-AF36
_______________________________________________________________________
315. 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: [email protected]
RIN: 0910-AF38
_______________________________________________________________________
316. 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: [email protected]
RIN: 0910-AF43
_______________________________________________________________________
317. 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: [email protected]
RIN: 0910-AF69
_______________________________________________________________________
318. 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: [email protected]
RIN: 0910-AF78
_______________________________________________________________________
319. 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: [email protected]
RIN: 0910-AF87
_______________________________________________________________________
320. 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: [email protected]
RIN: 0910-AG09
_______________________________________________________________________
321. 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: [email protected]
RIN: 0910-AG10
_______________________________________________________________________
322. 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: [email protected]
RIN: 0910-AG12
_______________________________________________________________________
323. 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: [email protected]
RIN: 0910-AG18
_______________________________________________________________________
324. UNIQUE DEVICE IDENTIFICATION
Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of
the Federal Register.
RIN: 0910-AG31
_______________________________________________________________________
325. 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: [email protected]
RIN: 0910-AG38
_______________________________________________________________________
326. 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
_______________________________________________________________________
327. 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: [email protected]
RIN: 0910-AG54
_______________________________________________________________________
328. 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
_______________________________________________________________________
329. 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]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
330. 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: [email protected]
RIN: 0910-AA97
_______________________________________________________________________
331. 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: [email protected]
RIN: 0910-AC53
_______________________________________________________________________
332. 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: [email protected]
RIN: 0910-AF11
_______________________________________________________________________
333. 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
_______________________________________________________________________
334. 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: [email protected]
RIN: 0910-AF32
_______________________________________________________________________
335. 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: [email protected]
RIN: 0910-AF33
_______________________________________________________________________
336. 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: [email protected]
RIN: 0910-AF35
_______________________________________________________________________
337. 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: [email protected]
RIN: 0910-AF42
_______________________________________________________________________
338. 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: [email protected]
RIN: 0910-AF47
_______________________________________________________________________
339. 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: [email protected]
RIN: 0910-AF61
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
340. 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: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
341. 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: [email protected]
RIN: 0910-AF34
_______________________________________________________________________
342. 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: [email protected]
RIN: 0910-AF37
_______________________________________________________________________
343. 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: [email protected]
RIN: 0910-AF39
_______________________________________________________________________
344. 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: [email protected]
RIN: 0910-AF40
_______________________________________________________________________
345. 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: [email protected]
RIN: 0910-AF44
_______________________________________________________________________
346. 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: [email protected]
RIN: 0910-AF45
_______________________________________________________________________
347. 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: [email protected]
RIN: 0910-AF51
_______________________________________________________________________
348. 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: [email protected]
RIN: 0910-AF52
_______________________________________________________________________
349. 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: [email protected]
RIN: 0910-AF53
_______________________________________________________________________
350. 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: [email protected]
RIN: 0910-AF56
_______________________________________________________________________
351. 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: [email protected]
RIN: 0910-AF63
_______________________________________________________________________
352. 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: [email protected]
RIN: 0910-AF70
[[Page 79781]]
_______________________________________________________________________
353. 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: [email protected]
RIN: 0910-AF95
_______________________________________________________________________
354. 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)[email protected]
RIN: 0910-AG14
_______________________________________________________________________
355. 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: [email protected]
RIN: 0910-AG35
_______________________________________________________________________
356. 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: [email protected]
RIN: 0910-AG36
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
357. 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: [email protected]
RIN: 0910-AG25
_______________________________________________________________________
358. 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: [email protected]
RIN: 0910-AG33
_______________________________________________________________________
359. 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: [email protected]
RIN: 0910-AG34
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
360. 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: [email protected]
RIN: 0938-AG81
_______________________________________________________________________
361. 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: [email protected]
RIN: 0938-AP32
_______________________________________________________________________
362. 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: [email protected]
RIN: 0938-AP92
_______________________________________________________________________
363. 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: [email protected]
RIN: 0938-AP97
_______________________________________________________________________
364. 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
_______________________________________________________________________
365. 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
_______________________________________________________________________
366. 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: [email protected]
RIN: 0938-AQ27
_______________________________________________________________________
367. 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: [email protected]
RIN: 0938-AQ53
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
368. 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: [email protected] gov
RIN: 0938-AP79
_______________________________________________________________________
369. 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: [email protected]
RIN: 0938-AP82
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
370. 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: [email protected]
RIN: 0938-AP77
_______________________________________________________________________
371. 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: [email protected]
RIN: 0938-AP78
_______________________________________________________________________
372. 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: [email protected]
RIN: 0938-AP80
_______________________________________________________________________
373. 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: [email protected]
RIN: 0938-AQ03
[FR Doc. 2010-30444 Filed 12-17-10; 8:45 am]
BILLING CODE 4150-24-S