[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]
[Unknown Section]
[Pages 64423-64446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28598]
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Part VI
Department of Health and Human Services
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Semiannual Regulatory Agenda
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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 requires 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
issue of the Federal Register relate only 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 2010
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: October 9, 2009.
Dawn L. Smalls,
Executive Secretary,
Department of Health and Human Services.
Office of the Secretary--Final Rule Stage
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
306 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) (Reg Plan Seq No. 43)................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.
Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
307 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section 0930-AA14
610 Review)...........................................................................
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Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
308 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10
Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
309 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation 0920-AA14
Regulations...........................................................................
310 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of 0920-AA23
HHS/CDC Nonhuman Primate Regulations..................................................
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[[Page 64425]]
Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
311 Control of Communicable Diseases Foreign Quarantine................................... 0920-AA12
312 Control of Communicable Diseases: Interstate Quarantine, Passenger Information........ 0920-AA27
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
313 Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review)......... 0920-AA32
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
314 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06
Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
315 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14
Policies, Requirements, and Administrative Procedures (Section 610 Review)............
316 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 0910-AG25
Review)...............................................................................
317 Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review).............. 0910-AG34
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Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
318 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg 0910-AC52
Plan Seq No. 44)......................................................................
319 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31
320 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38
321 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43
322 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44
323 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45
324 Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68
325 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10
326 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug 0910-AG12
Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........
327 Produce Safety Regulation (Reg Plan Seq No. 46)....................................... 0910-AG35
328 Modernization of the Current Food Good Manufacturing Practices Regulation (Reg Plan 0910-AG36
Seq No. 47)...........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.
Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
329 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97
330 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53
331 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55
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.
48)...................................................................................
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
[[Page 64426]]
336 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34
337 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35
338 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36
339 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37
340 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42
341 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47
342 Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00
343 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco 0910-AG33
to Protect Children and Adolescents (Reg Plan Seq No. 50).............................
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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
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
344 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88
Operations for Dietary Supplements....................................................
345 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39
346 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40
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 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61
352 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63
353 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69
354 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70
355 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95
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Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
356 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14
357 Substances Prohibited From Use in Animal Food or Feed to Prevent the Transmission of 0910-AF46
Bovine Spongiform Encephalopathy......................................................
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
358 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs 0938-AP77
for Contract Year 2011 (CMS-4085-F)...................................................
359 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care 0938-AP80
Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates
(CMS-1498-P) (Reg Plan Seq No. 53)....................................................
360 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP82
Center Payment System for CY 2011 (CMS-1504-P) (Reg Plan Seq No. 54)..................
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References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.
[[Page 64427]]
Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
361 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413- 0938-AP40
FC)...................................................................................
362 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP41
Center Payment System for CY 2010 (CMS-1414-FC).......................................
363 Children's Health Insurance Program (CHIP); Allotment Methodology and States' Fiscal 0938-AP53
Year 2009 CHIP Allotments (CMS-2291-F)................................................
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Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
364 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81
Review)...............................................................................
365 Electronic Claims Attachments Standards (CMS-0050-IFC)................................ 0938-AK62
366 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 0938-AO53
Review)...............................................................................
367 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32
Review)...............................................................................
368 State Flexibility for Medicaid Benefit Packages (CMS-2232-F4)......................... 0938-AP72
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Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
369 Medicaid Graduate Medical Education (CMS-2279-F)...................................... 0938-AO95
370 Genetic Information Nondiscrimination Act of 2008 (CMS-4137-IFC)...................... 0938-AP37
371 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 0938-AP39
2010 (CMS-1406-F).....................................................................
372 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AP46
Update for FY 2010 (CMS-1410-F).......................................................
373 Home Health Prospective Payment System and Rate Update for CY 2010 (CMS-1560-F)....... 0938-AP55
374 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2010 (CMS- 0938-AP56
1538-F)...............................................................................
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_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
306. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF
STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR
ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION
610 REVIEW)
Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of
the Federal Register.
RIN: 0991-AB58
[[Page 64428]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
307. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE
ADDITION (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 06/00/10
Regulatory Flexibility Analysis Required: No
Agency Contact: Nicholas Reuter, Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration,
One Choke Cherry Rd, Suite 2-1063, Rockville, MD 20857
Phone: 240 276-2716
RIN: 0930-AA14
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
308. 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
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
309. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL
IMPORTATION REGULATIONS
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 designated
the authority to prevent the introduction of diseases from foreign
countries to the Director, Centers for Disease Control and Prevention
(CDC). CDC also enforces entry requirements for certain animals,
etiologic agents and vectors deemed to be of public health
significance. Currently the regulations restrict the importation of
nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts
and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54).
In addition, CDC has recently issued a series of emergency orders,
restricting the importation of African rodents (42 CFR section 71.56)
and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed
Rulemaking (NPRM) to revise the regulations for importation of certain
animals and vectors into the United States (42 CFR parts 71, Subpart
F).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 07/31/07 72 FR 41676
ANPRM Comment Period End 10/01/07
Notice Extending ANPRM Comment
Period 10/01/07 72 FR 55729
ANPRM Extended Comment Period
End 12/01/07
NPRM 06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, CLFT Building 16, Room
4324, MS E03, Atlanta, GA 30329
Phone: 404 498-1600
Email: [email protected]
RIN: 0920-AA14
_______________________________________________________________________
310. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS,
PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS
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
[[Page 64429]]
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 03/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, CLFT Building 16, Room
4324, MS E03, 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)
_______________________________________________________________________
311. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE
Legal Authority: 42 USC 243; 42 USC 248 and 249
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. Quarantine regulations are
divided into two parts: Part 71 dealing with foreign arrivals and part
70 dealing with 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 rule will also modify current Federal regulations
governing the apprehension, quarantine isolation and conditional
release of individuals suspected of carrying a quarantinable disease
while respecting individual autonomy. CDC maintains quarantine stations
at 20 ports of entry staffed with medical and public health officers
who respond to reports of diseases from carriers. According to the
statutory scheme, the President determines through Executive Order
which diseases may subject individuals to quarantine. The current
disease list, which was last updated in April 2005, includes cholera,
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral
hemorrhagic fevers, severe acute respiratory syndrome (SARS), and
influenza caused by novel or reemergent influenza viruses that are
causing, or have the potential to cause a pandemic.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/30/05 70 FR 71892
NPRM Comment Period End 01/20/06
Final Action 03/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, CLFT Building 16, Room
4324, MS E03, Atlanta, GA 30329
Phone: 404 498-1600
Email: [email protected]
RIN: 0920-AA12
_______________________________________________________________________
312. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER
INFORMATION
Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248;
42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC
2001
Abstract: By statute, the Secretary of Health and Human Services has
broad authority to prevent introduction, transmission, and spread of
communicable diseases from one State or possession into another.
Quarantine regulations are divided into two parts: Part 71 dealing with
foreign arrivals and part 70 dealing with interstate matters. The CDC
Director has been delegated the responsibility for carrying out these
regulations. The Director's authority to investigate suspected cases
and potential spread of communicable disease among interstate travelers
is thus not limited to those known or suspected of having a
quarantinable disease, but rather all communicable diseases that may
necessitate a public health response.
Among the fundamental components of the public health response to the
report of a person with a communicable disease is the identification
and evaluation of individuals who may have been exposed. This
provision, which was proposed section 70.4, would require any airline
operating in interstate traffic to solicit and electronically submit
certain passenger information to CDC for use in contact tracing when
necessary to protect the vital interests of an individual, or other
persons, in regard to significant health risks.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/30/05 70 FR 71892
NPRM Comment Period End 01/30/06
Final Action 03/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, CLFT Building 16, Room
4324, MS E03, Atlanta, GA 30329
Phone: 404 498-1600
Email: [email protected]
RIN: 0920-AA27
[[Page 64430]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
313. POSSESSION, USE AND TRANSFER OF SELECT AGENTS AND TOXINS (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
reuslt 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 andy 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
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 To Be Determined
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) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
314. 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. 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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review 12/00/09
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
_______________________________________________________________________
315. 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: FDA is undertaking a review of 21 CFR part 203 and 21 CFR
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under
section 610 of the Regulatory Flexibility Act. The purpose of this
review is to determine
[[Page 64431]]
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 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 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).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review of Current
Regulation 11/24/08
End Review of Current Regulation12/00/09
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, 10903 New Hampshire Ave., Bldg. 51, Room
6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847 8440
Email: pdma610(c)[email protected]
RIN: 0910-AG14
_______________________________________________________________________
316. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG
PRODUCTS FOR ORAL INHALATION (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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review 05/01/09
End Review 05/00/10
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, 10903 New Hampshire Avenue,
Building 51, Room 6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]
RIN: 0910-AG25
_______________________________________________________________________
317. OVER-THE-COUNTER HUMAN DRUGS; LABELING
REQUIREMENTS (SECTION 610 REVIEW)
Legal Authority: 5 USC 610
Abstract: Part 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
Helvetica type style 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 is initiating a review under section 610 of the Regulatory
Flexibility Act for the regulation in part 201.66. The purpose of this
review is to determine whether the regulation in part 201.66 should be
continued without change, or whether they 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 part 201.66;
(2) the nature of the complaints or comments received concerning the
regulation in part 201.66; (3) the complexity of the regulations in
part 201.66; (4) the extent to which the regulation in part 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 part 201.
The section 610 review will be carried out along with a regulatory
review under section 5 of Executive Order 12866, which calls for
agencies to periodically review existing regulations to determine
whether any should be modified or eliminated so as to make the agency's
regulatory program more effective in achieving its goals, less
[[Page 64432]]
burdensome, or in greater alignment with the President's priorities and
the principles set forth in the Executive order.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review of Current
Regulation 08/03/09
End Review of Current Regulation02/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire 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
Food and Drug Administration (FDA)
_______________________________________________________________________
318. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS
AND BIOLOGICS
Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of
the Federal Register.
RIN: 0910-AC52
_______________________________________________________________________
319. 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) 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF31
_______________________________________________________________________
320. 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 final
action will address laxative drug products. 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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Granular Psyllium)03/29/07 72 FR 14669
NPRM (Professional Labeling--
Sodium Phosphate) 06/00/10
Final Action (Laxative Drug
Products) To Be Determined
NPRM (Professional Labeling) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF38
_______________________________________________________________________
321. 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 combination products containing sunscreen and insect
repellent ingredients. The second action addresses active ingredients
reviewed under Time and Extent Applications. The third action addresses
other effectiveness issues for OTC sunscreen drug products. The fourth
action is the final action that addresses sunscreen formulation,
labeling, and testing requirements for both ultraviolet B and
ultraviolet A radiation protection.
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 (Effectiveness) 05/00/10
[[Page 64433]]
Final Action (UVA/UVB) 05/00/10
NPRM (Sunscreen and Insect
Repellent) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF43
_______________________________________________________________________
322. 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) 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF44
_______________________________________________________________________
323. 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 (Phenylpropanol -amine) 12/22/05 70 FR 75988
NPRM (Benzocaine) 05/00/10
Final Action (Phenylpropanol -
amine) 05/00/10
Final Action (Benzocaine) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF45
_______________________________________________________________________
324. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT 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 ingredient ipecac syrup.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (IPECAC) 06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF68
_______________________________________________________________________
325. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED
Legal Authority: 21 USC 342; 21 USC 371; 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 10/00/10
[[Page 64434]]
NPRM Comment Period End 01/00/11
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
_______________________________________________________________________
326. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND
ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED
AMENDMENT OF FINAL MONOGRAPH
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 06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AG12
_______________________________________________________________________
327. PRODUCE SAFETY REGULATION
Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of
the Federal Register.
RIN: 0910-AG35
_______________________________________________________________________
328. MODERNIZATION OF THE CURRENT FOOD GOOD
MANUFACTURING PRACTICES REGULATION
Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of
the Federal Register.
RIN: 0910-AG36
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
329. 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 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Meredith S. Francis, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51,
Room 6238, Silver Spring, MD 20993-0002
Phone: 301 796-3476
Fax: 301-847-8440
RIN: 0910-AA97
_______________________________________________________________________
330. 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
[[Page 64435]]
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/10/06 71 FR 18039
NPRM Comment Period End 07/10/06
Final Action 06/00/10
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, 10903 New Hampshire Avenue, Bldg. 51,
Room 6368, Silver Spring, MD 20993-0002
Phone: 301 796-3522
Fax: 301 847-8440
Email: [email protected]
RIN: 0910-AC53
_______________________________________________________________________
331. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING
PRACTICES
Legal Authority: PL 105-115, sec 121
Abstract: Section 121 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for
current good manufacturing practices (CGMPs) for positron emission
tomography (PET) drugs, a type of radiopharmaceutical. The final rule
would adopt CGMPs that reflect the unique characteristics of PET drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/20/05 70 FR 55038
NPRM Comment Period End 12/19/05
Final Action 12/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, Office of Regulatory Policy,
10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993-
0002
Phone: 301 796-3478
Fax: 301 847-8440
Email: [email protected]
RIN: 0910-AC55
_______________________________________________________________________
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. 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. 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 04/00/10
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, 10903 New Hampshire Avenue, Bldg. 51, Room
6224, Silver Spring, MD 20993-0002
Phone: 301 796-4288
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. 48 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
Final Action (Technical
Amendment) 11/30/07 72 FR 67639
Final Action (Amendment--
Ephedrine Single Ingredient) 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
[[Page 64436]]
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
finalizes cough/cold combination products containing oral
bronchodilators and expectorants.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) 07/13/05 70 FR 40232
Final Action (Technical
Amendment) 03/19/07 72 FR 12730
Final Action 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire 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--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 (Phenylephrine Bitartrate) 11/02/04 69 FR 63482
NPRM (Phenylpropanol -amine) 12/22/05 70 FR 75988
Final Action (Amendment)
(Sinusitis Claim) 10/31/05 70 FR 58974
Final Action (Phenylephrine
Bitartrate) 08/01/06 71 FR 83358
Final Action (Phenylpropanol -
amine) 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF34
_______________________________________________________________________
337. 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) 09/00/10
NPRM (Amendment) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF35
_______________________________________________________________________
338. 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 products
marketed for children under 2 years old and weight- and age-based
dosing for children's products. The third action addresses combination
products containing the analgesic acetaminophen or aspirin and sodium
bicarbonate used as an antacid ingredient. The fourth action addresses
other miscellaneous issues relating to internal analgesics. 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
NPRM (Amendment) (Overindulgence
/Hangover) To Be Determined
Final Action (Required Warnings
and Other Labeling) 04/29/09 74 FR 19385
[[Page 64437]]
Final Action (Correction) 06/30/09 74 FR 31177
Final Action (Technical
Amendment) 12/00/09
NPRM (Amendment) (Miscellaneous
Issues) 09/00/10
NPRM (Amendment) (Pediatric) To Be Determined
NPRM (Amendment) (Combinations
With Sodium Bicarbonate) To Be Determined
Final Action (Internal
Analgesics) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF36
_______________________________________________________________________
339. 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
Final Action 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF37
_______________________________________________________________________
340. 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 addresses skin protectant products used to treat fever blisters
and cold sores. The second action identifies safe and effective skin
protectant active ingredients to treat and prevent diaper rash.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Technical
Amendments) 02/01/08 73 FR 6014
Final Action (Fever Blisters/
Cold Sores) 06/00/10
Final Action (Aluminum Acetate)
(Technical Amendment) 03/06/09 74 FR 9759
Final Action (Diaper Rash) 06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF42
_______________________________________________________________________
341. 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.
On September 7, 2005, FDA amended the IFR to permit the use of small
intestine in human food and cosmetics if it is effectively removed from
the distal ileum. The amendment also clarified that milk and milk
products, hides, and tallow derivatives are not prohibited for use in
human food and cosmetics.
On April 17, 2008, FDA amended the IFR so that FDA may designate a
country as not subject to certain BSE-related restrictions relating to
prohibited cattle materials applicable to human food and cosmetics.
Comments submitted in response to the July 14, 2004 IFR that were not
addressed in the September 7, 2005 and April 17, 2008 amendments will
be addressed in the final rule. The final
[[Page 64438]]
rule also will respond to comments submitted following the September 7,
2005 and April 17, 2008 amendments.
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 10/00/10
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
_______________________________________________________________________
342. OVER-THE-COUNTER (OTC) DRUG REVIEW--ACNE DRUG PRODUCTS CONTAINING
BENZOYL PEROXIDE
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. This action
will address acne drug products containing benzoyl peroxide.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action 12/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AG00
_______________________________________________________________________
343. REGULATIONS RESTRICTING THE SALE AND
DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND
ADOLESCENTS
Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of
the Federal Register.
RIN: 0910-AG33
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
344. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING,
LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Legal Authority: 21 USC 321; 21 USC 342 and 343; 21 USC 348; 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 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 Action 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
_______________________________________________________________________
345. 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
[[Page 64439]]
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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF39
_______________________________________________________________________
346. 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 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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF40
_______________________________________________________________________
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
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire 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 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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire 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
[[Page 64440]]
NPRM Comment Period End 12/27/06
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF56
_______________________________________________________________________
351. 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 To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: John D. Reilly, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, CPK 1, Room 1C-015, (HFS-024), 5100
Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1530
Fax: 301-436-2637
Email: [email protected]
RIN: 0910-AF61
_______________________________________________________________________
352. OVER-THE-COUNTER 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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF63
_______________________________________________________________________
353. 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 health care products. The second action addresses food
handler products. The third action addresses testing requirements. The
fourth action addresses consumer products. The final actions listed
will address the healthcare, consumer, and first aid antiseptic drug
products respectively.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Healthcare) 06/17/94 59 FR 31402
NPRM (Food Handlers) To Be Determined
NPRM (Testing) To Be Determined
NPRM (Consumer) 12/00/10
Final Action (Healthcare) To Be Determined
Final Action (Consumer) To Be Determined
Final Action (First Aid
Antiseptic) To Be Determined
[[Page 64441]]
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF69
_______________________________________________________________________
354. 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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF70
_______________________________________________________________________
355. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG 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 is
issuing 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 proposed rule is part of FDA's ongoing
review of OTC drug products.
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: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]
RIN: 0910-AF95
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
356. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC
393; 42 USC 243; 42 USC 264; 42 USC 271; . . .
Abstract: Publication of this final rule was an action item in the Food
Protection Plan announced by the Department of Health and Human
Services (HHS) in November 2007.
In July 1999, the Food and Drug Administration (FDA) and the Food
Safety Inspection Service (FSIS) committed to developing an action plan
to address the presence of Salmonella Enteritidis (SE) in shell eggs
and egg products using a farm-to-table approach. FDA and FSIS held a
public meeting on August 26, 1999, to obtain stakeholder input on the
draft goals, as well as to further develop the objectives and action
items for the action plan. The Egg Safety Action Plan was announced on
December 11, 1999. The goal of the Action Plan is to reduce egg-related
SE illnesses. The Egg Safety Action Plan consists of eight objectives
covering all stages of the farm-to-table continuum as well as support
functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento,
CA), and July 31, 2000 (Washington, DC), joint public meetings were
held by FDA and FSIS to solicit and discuss information related to the
implementation of the objectives in the Egg Safety Action Plan.
On September 22, 2004, FDA published a proposed rule that would require
egg safety measures to prevent the contamination of shell eggs with SE
during egg production. The proposal also solicited comment on whether
recordkeeping requirements should include a written SE prevention plan
and records for compliance with the SE prevention measures, and whether
safe egg handling and preparation practices should be mandated for
retail establishments that specifically serve a highly susceptible
population (e.g., nursing homes, hospitals, day care centers). The
proposed egg production SE prevention measures included: (1) Provisions
for procurement of chicks and pullets; (2) a biosecurity program; (3) a
rodent and pest control program; (4) cleaning and disinfection of
poultry houses that have had an environmental or egg test positive for
SE; (5) egg testing when an environmental test is positive; and (6)
refrigerated storage of eggs held at the farm. Additionally, to verify
that the measures have been effective, the rule proposes that producers
test the poultry house environment for SE. If the environmental test is
positive, eggs from that environment must be tested for SE, and if the
egg test is positive, the eggs must be diverted to egg products
processing or a treatment
[[Page 64442]]
process that achieves at least a five-log destruction of SE.
The proposed rule was a step in a broader farm-to-table egg safety
effort that includes FDA's requirements for safe handling statements on
egg cartons, and refrigerated storage of shell eggs at retail, and egg
safety education for consumers and retail establishments. The rule had
a 90-day comment period, which ended December 21, 2004. To discuss the
proposed rule and solicit comments from interested stakeholders, FDA
held three public meetings: October 28, 2004, in College Park, MD;
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los
Angeles, CA. The comment period was reopened until July 25, 2005, to
solicit further comment and information on industry practices and
programs that prevent SE-monitored chicks from becoming infected by SE
during the period of pullet rearing until placement into laying hen
houses.
On July 9, 2009, FDA published the final rule that requires shell egg
producers to implement measures to prevent SE from contaminating eggs
on the farm and from further growth during storage and transportation,
and requires these producers to maintain records concerning their
compliance with the rule and to register with FDA. FDA took this action
because SE is among the leading bacterial causes of foodborne illness
in the United States, and shell eggs are a primary source of human SE
infections. The final rule will reduce SE-associated illnesses and
deaths by reducing the risk that shell eggs are contaminated with SE.
Egg producers with 50,000 or more laying hens have 12 months to comply
with the final rule, as do persons who must comply with only the
refrigeration requirements. Producers with fewer than 50,000 but at
least 3,000 laying hens have 36 months to comply. Producers with fewer
than 3,000 laying hens and those who sell all of their eggs directly to
consumers are exempt from the rule.
FDA is developing guidance documents and will hold public meetings this
year to help ensure covered persons understand how to comply with the
final rule.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/22/04 69 FR 56824
NPRM Comment Period End 12/21/04
NPRM Reopened Comment Period End06/09/05 70 FR 24490
NPRM Extension of Reopened
Comment Period End 07/25/05 70 FR 33404
Final Action 07/09/09 74 FR 33030
Regulatory Flexibility Analysis Required: Yes
Agency Contact: John F. Sheehan, Director, Department of Health and
Human Services, Food and Drug Administration, Division of Plant and
Dairy Food Safety (HFS-315), Room 3B-012, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone: 301 436-2367
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AC14
_______________________________________________________________________
357. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT
THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC
371
Abstract: On October 6, 2005, the Food and Drug Administration (FDA)
proposed to amend its regulations to prohibit the use of certain cattle
origin materials in the food or feed of all animals to further
strengthen existing safeguards designed to help prevent the spread of
bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of
a BSE-positive dairy cow in December 2003 has caused FDA to review its
policies for prevention of BSE, which resulted in this rulemaking. On
April 28, 2008, FDA published a final rule prohibiting the use of
certain cattle origin materials in the food and feed of all animals. On
October 23, 2008 FDA corrected the final rule on BSE that appeared in
the Federal Register of April 25, 2008 (73 FR 22719-22758). The final
rule was inadvertently published with incorrect dollar amounts in two
separate areas: the summary of economic impacts and the paperwork
burden table.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 07/14/04 69 FR 42288
ANPRM Comment Period End 08/13/04
NPRM 10/06/05 70 FR 58569
NPRM Comment Period End 12/20/05
Final Rule 04/25/08 73 FR 22720
Final Rule-Correction 10/23/08 73 FR 63072
Final Rule Effective 04/27/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Burt Pritchett, Biologist, Department of Health and
Human Services, Food and Drug Administration, Center for Veterinary
Medicine, Room 2654 (MPN-4, HFV-222), 7519 Standish Place, Rockville,
MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: [email protected]
RIN: 0910-AF46
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
358. 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 proposed rule sets forth programmatic and operational
changes to the Medicare Advantage and Prescription Drug Benefit
programs (for example, strengthens beneficiary protections and sponsor
entrance and exit rules, provides plan offerings with meaningful
differences, improves payment rules and data collection for oversight
and quality assessment).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/22/09 74 FR 54634
[[Page 64443]]
NPRM Comment Period End 12/07/09
Final Action 10/00/12
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 C1-26-26, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-6041
Email: [email protected]
RIN: 0938-AP77
_______________________________________________________________________
359. PROPOSED CHANGES TO THE HOSPITAL INPATIENT
PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES
AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P)
Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of
the Federal Register.
RIN: 0938-AP80
_______________________________________________________________________
360. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE
PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011
(CMS-1504-P)
Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of
the Federal Register.
RIN: 0938-AP82
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
361. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR
CY 2010 (CMS-1413-FC)
Legal Authority: Social Security Act, sec 1102; Social Security Act,
sec 1871
Abstract: This rule revises payment polices under the physician fee
schedule, as well as other policy changes to payment under Part B.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/13/09 74 FR 33520
NPRM Comment Period End 08/31/09
Final Action 12/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Diane Milstead, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Centers for Medicaid Mangement, Mailstop C4-03-06, 7500 Security Blvd,
Baltimore, MD 21244
Phone: 410 786-3355
Email: [email protected]
RIN: 0938-AP40
_______________________________________________________________________
362. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-FC)
Legal Authority: BBA; BBA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA
Abstract: This rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system and to implement certain related provisions of the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA). In
addition, the rule describes changes to the amounts and factors used to
determine the payment rates for Medicare hospital outpatient services
paid under the prospective payment system. The rule also changes the
Ambulatory Surgical Center Payment System list of services and rates.
These changes applicable to services furnished on or after January 1
annually.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/20/09 74 FR 35231
NPRM Comment Period End 08/31/09
Final Action 12/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Alberta Dwivedi, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Centers for Medicare Management, Mailstop C5-01-26,
7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-0763
Email: [email protected]
RIN: 0938-AP41
_______________________________________________________________________
363. CHILDREN'S HEALTH INSURANCE PROGRAM (CHIP); ALLOTMENT METHODOLOGY
AND STATES' FISCAL YEAR 2009 CHIP ALLOTMENTS (CMS-2291-F)
Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) and
2104(f) of the Social Security Act; CHIPRA of 2009 (PL 111-3)
Abstract: This proposed rule describes the implementation of certain
funding provisions under existing Medicaid laws, the Children's Health
Insurance Program (CHIP) and recent legislation, and other related CHIP
legislation. It proposes methodologies and procedures for determining
States' fiscal year (FY) 2009 through FY 2013 allotments and payments
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/16/09 74 FR 47517
NPRM Comment Period End 11/16/09
Final Action 02/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Richard Strauss, Technical Director, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicaid State Operations, Mailstop S3-13-15, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-1850
Email: [email protected]
RIN: 0938-AP53
[[Page 64444]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
364. 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 requirements 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 To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Agency Contact: Mercedes Benitez-McCray, 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
Phone: 410 786-5716
Email: [email protected]
RIN: 0938-AG81
_______________________________________________________________________
365. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-IFC)
Legal Authority: 42 USC 1320d-2(a)(2)(B)
Abstract: This rule sets forth electronic standards for health care
claims attachments. The standards are required by the Health Insurance
Portability and Accountability Act of 1996. They will be used to
transmit clinical or administrative data for claims adjudication
purposes.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/23/05 70 FR 55989
NPRM Comment Period End 11/22/05
Next Action Undetermined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Elizabeth Holland, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of E-Health Standards and Services, Mailstop
S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1309
Email: [email protected],
RIN: 0938-AK62
_______________________________________________________________________
366. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-
2249-F) (SECTION 610 REVIEW)
Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086
Abstract: This rule amends the Medicaid regulations to define and
describe the home- and community-based State plan services implementing
the new section 1915(i) of the Social Security Act as added by section
6086 of the Deficit Reduction Act of 2005.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/04/08 73 FR 18676
NPRM Comment Period End 06/03/08
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Suzanne Bosstick, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-1301
Email: [email protected]
RIN: 0938-AO53
_______________________________________________________________________
367. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS-
3140-P) (SECTION 610 REVIEW)
Legal Authority: 42 USC 1302; 42 USC 1395hh
Abstract: This proposed rule would establish requirements that long-
term care (LTC) facilities must have an agreement with hospice agencies
when hospice care is provided in a long-term care facility to
participate in the Medicare and Medicaid programs. We are proposing
these new requirements to ensure that quality hospice care is provided
to eligible residents.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Trish 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
_______________________________________________________________________
368. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS-2232-F4)
Legal Authority: PL 109-171, sec 6044
Abstract: This rule replaces the final rule published on December 3,
2008 (73 FR 73694) to implement provisions of the Deficit Reduction Act
(DRA) of 2005. It also provides States increased flexibility under an
approved State plan to define the scope of covered medical assistance
by offering coverage of benchmark or benchmark-equivalent benefit
packages to certain Medicaid-eligible individuals. In addition, this
final rule responds to public comments on the February 22, 2008
proposed rule as well as public comments on the December 3, 2009
``final rule'' which was temporarily delayed twice, once by an interim
final rule with comment period published on February 2, 2009, and the
second time by a final rule published on April 3, 2009, further
delaying the effective date and reopening the comment period.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Chris Gerhardt, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Mailstop S2-01-16,
[[Page 64445]]
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0693
Email: [email protected]
RIN: 0938-AP72
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
369. MEDICAID GRADUATE MEDICAL EDUCATION (CMS-2279-F)
Legal Authority: title XIX; Social Security Act
Abstract: As part of the President's 2008 Budget, this rule establishes
that States may not include GME as a reimbursable cost or program under
their approved Medicaid State Plan. The rule enhances fiscal integrity
and improves accountability with respect to payment for medical
services in the Medicaid program.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/23/07 72 FR 28930
NPRM Comment Period End 06/22/07
Withdrawn 10/08/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Kristin Fan, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Centers for Medicaid State
Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD
21224
Phone: 410 786-4581
Fax: 410 786-1008
Email: [email protected]
RIN: 0938-AO95
_______________________________________________________________________
370. GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (CMS-4137-IFC)
Legal Authority: Genetic information Nondiscrimination Act of 2008 (PL
110-223), enacted May 21, 2008.
Abstract: This rule implements statutory changes to the PHSA affecting
the group and individual health insurance markets, non-federal
governmental plans, and Medicare supplemental insurance (Medigap) made
by the Genetic Information Nondiscrimination Act of 2008 (Pub. L. 110-
223).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 10/10/08 73 FR 60208
ANPRM Comment Period End 12/09/08
Interim Final Rule 10/07/09 74 FR 51663
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Adam M Shaw, Senior Technical Adviser, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Mail Stop C1-22-06, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1091
Email: [email protected]
RIN: 0938-AP37
_______________________________________________________________________
371. CHANGES TO THE HOSPITAL INPATIENT AND LONG-TERM CARE PROSPECTIVE
PAYMENT SYSTEM FOR FY 2010 (CMS-1406-F)
Legal Authority: Sec 1886(d) of the Social Security Act
Abstract: This rule revises the Medicare hospital inpatient and Long
Term Care prospective payment systems (IPPS) for operating and capital-
related costs to implement changes arising from our continuing
experience with these systems.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/22/09 74 FR 24080
NPRM Comment Period End 06/30/09
Final Rule 08/27/09 74 FR 43753
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Tiffany Swygert, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Div of Acute Care, Hosp and Ambulatory Policy Group,
Mailstop C4-25-11, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4642
Email: [email protected]
RIN: 0938-AP39
_______________________________________________________________________
372. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED
NURSING FACILITIES--UPDATE FOR FY 2010 (CMS-1410-F)
Legal Authority: Social Security Act, sec 1888(e)
Abstract: This rule updates the payment rates used under the SNF PPS
beginning October 1, 2009.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/12/09 74 FR 22208
NPRM Comment Period End 06/30/09
Final Action 08/11/09 74 FR 40287
Regulatory Flexibility Analysis Required: Yes
Agency Contact: William Ullman, Technical Advisor, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Centers
for Medicare Management, Mailstop C5-06-27, 7500 Security Boulvard,
Baltimore, MD 21244
Phone: 410 786-5667
Fax: 410 786-0765
Email: [email protected]
RIN: 0938-AP46
_______________________________________________________________________
373. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM AND RATE UPDATE FOR CY 2010
(CMS-1560-F)
Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302
and 42 USC 1395(hh); Social Security Act, sec 1895; 42 USC 1395(fff)
Abstract: This rule updates the 60-day national episode rate and the
national per visit rate amounts under the Medicare Prospective Payment
System for home health agencies, effective January 1, 2010.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/06/09 74 FR 39435
NPRM Comment Period End 08/28/09
Final Action 11/10/09 74 FR 58077
Final Action Effective 01/01/10
[[Page 64446]]
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Randy Throndset, Technical Advisor, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare Management, Mailstop C5-07-28, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-0131
Fax: 410 786-0765
Email: [email protected]
RIN: 0938-AP55
_______________________________________________________________________
374. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES
FOR FY 2010 (CMS-1538-F)
Legal Authority: Social Security Act, sec 1886(j); PL 106-554; PL 106-
113
Abstract: This rule updates rates for the prospective payment system
for inpatient rehabilitation facilities for FY 2010.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/06/09 74 FR 21052
Final Action 08/13/09 74 FR 40947
NPRM Comment Period End 06/29/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Julie Stankivic, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Mailstop,
C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5725
Email: julie.stankivic @ cms.hhs.gov
RIN: 0938-AP56
[FR Doc. E9-28598 Filed 12-04-09; 8:45 am]
BILLING CODE 4150-24-S