[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Unknown Section]
[Pages 21919-21941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10274]
[[Page 21919]]
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Part VI
Department of Health and Human Services
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Semiannual Regulatory Agenda
[[Page 21920]]
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, Chs. II, III, and XIII
Unified Agenda of Federal Regulatory and Deregulatory Actions
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual regulations agenda.
_______________________________________________________________________
SUMMARY: The Department's semiannual Agenda of Regulatory and
Deregulatory Actions forecasts the rulemaking activities that we expect
to undertake over the foreseeable future. We focus primarily on those
areas of work anticipated to result in publication of Notices of
Proposed Rulemaking or of Final Rules within the next 12 months.
(Please note that the abstracts included below relate only to those
prospective rulemakings that are likely to have a significant economic
impact on a substantial number of small entities; the Regulatory
Flexibility Act of 1980 requires dissemination of this information in
the paper edition of the Federal Register. The complete HHS Agenda is
accessible online at www.reginfo.gov.)
FOR FURTHER INFORMATION CONTACT: by e-mail, John.Gallivan@hhs.gov; by
fax, (202) 205-2135; by telephone, (202) 205-9165.
SUPPLEMENTARY INFORMATION:
The Regulatory Flexibility Act of 1980 and Executive Order
12866 require semi-annual publication of an inventory outlining all
current and projected rulemakings. The purpose of this exercise is
to inform the public about regulatory actions under development
across the Department, and to provide an opportunity for all
concerned with the impact of these actions to participate in their
development at an early stage.
The regulatory actions capsulized in this Agenda do not
necessarily reflect the policy perspectives of the Obama
Administration. The statutorily dictated timing of the Agenda
caused the Department to initiate preparation of the requisite
information before the Department's policy officials had the
opportunity to conduct a full review. This Agenda thus reflects
ongoing efforts by HHS to comply with existing statutory
obligations, or to effect improvements at the program-
implementation level based on experience in administering existing
programs. By contrast, the timing of the October 2009 Agenda will,
obviously, provide the Department with an opportunity to set out a
regulatory agenda that does reflect current policy directions of
the Obama Administration.
Public commentary is invited. Comments may be directed to the
agency officials cited at the conclusion of each entry. If early
attention at the Secretary's level appears needed, comments should
be sent to: Ashley Files Flory, Acting Executive Secretary to the
Department, Suite 603H, 200 Independence Avenue SW., Washington, DC
20201.
Dated: April 3, 2009.
Ashley Files Flory,
Acting Executive Secretary to the Department.
Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
147 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section 0930-AA14
610 Review)...........................................................................
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
148 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
----------------------------------------------------------------------------------------------------------------
149 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation 0920-AA14
Regulations...........................................................................
150 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of 0920-AA23
HHS/CDC Nonhuman Primate Regulations..................................................
----------------------------------------------------------------------------------------------------------------
[[Page 21921]]
Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
151 Control of Communicable Diseases Foreign Quarantine................................... 0920-AA12
152 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
----------------------------------------------------------------------------------------------------------------
153 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
----------------------------------------------------------------------------------------------------------------
154 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06
Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
155 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14
Policies, Requirements, and Administrative Procedures (Section 610 Review)............
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
156 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52
157 Over-The-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31
158 Over-The-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38
159 Over-The-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43
160 Over-The-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45
161 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug 0910-AG12
Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph........
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
162 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14
163 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53
164 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55
165 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11
Requirements for Pregnancy and Lactation Labeling.....................................
166 Over-The-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32
167 Over-The-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33
168 Over-The-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35
169 Over-The-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36
170 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42
171 Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of 0910-AF46
Bovine Spongiform Encephalopathy......................................................
172 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47
173 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61
174 Over-The-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00
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[[Page 21922]]
Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
175 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97
176 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88
Operations for Dietary Supplements....................................................
177 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34
178 Over-The-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37
179 Over-The-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39
180 Over-The-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40
181 Over-The-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44
182 Over-The-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51
183 Over-The-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52
184 Over-The-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53
185 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56
186 Over-The-Counter Antidiarrheal Drug Products.......................................... 0910-AF63
187 Over-The-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68
188 Over-The-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69
189 Over-The-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70
190 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95
191 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
192 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23
193 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12
194 Obstetrical and Gynecological Devices; Designation of Special Controls for Male 0910-AF21
Condoms Made of Natural Rubber Latex..................................................
195 Food Labeling; Serving Sizes and Nutrition Labeling (Completion of a Section 610 0910-AF99
Review)...............................................................................
----------------------------------------------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
196 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 0938-AP39
2010 (CMS-1406-P).....................................................................
197 Revisions to Payment Policies Under the Physician Fee Schedule For CY 2010 (CMS-1413- 0938-AP40
P)....................................................................................
198 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP41
Center Payment System for CY 2010 (CMS-1414-P)........................................
199 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AP46
Update for FY 2010 (CMS-1410-P).......................................................
----------------------------------------------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
200 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81
Review)...............................................................................
201 Electronic Claims Attachments Standards (CMS-0050-IFC)................................ 0938-AK62
202 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 0938-AO53
Review)...............................................................................
203 Medicaid Graduate Medical Education (CMS-2279-F)...................................... 0938-AO95
204 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32
Review)...............................................................................
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[[Page 21923]]
Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
205 Updates to Electronic Transactions (Version 5010) (CMS-0009-F) (Completion of a 0938-AM50
Section 610 Review)...................................................................
206 Revisions to HIPAA Code Sets (CMS-0013-F) (Completion of a Section 610 Review)........ 0938-AN25
207 Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, 0938-AO84
Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Completion of a Section 610 Review)....
208 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP17
Center Payment System for CY 2009 (CMS-1404-F)........................................
209 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (CMS-1403- 0938-AP18
FC)...................................................................................
210 Home Health Prospective Payment System Refinements and Rate Update for CY 2009 (CMS- 0938-AP20
1555-N)...............................................................................
211 Changes to Long-Term Care Prospective Payment System Based on Specific Provisions in 0938-AP33
the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-F)..................
----------------------------------------------------------------------------------------------------------------
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
147. 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 proposed rule, when finalized will modify the regulatory
dispensing restrictions under 42 CFR part 8 for the drug substance
buprenorphine. This medication is used to treat kersin and other opioid
addiction.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/09
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)
_______________________________________________________________________
148. 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)
_______________________________________________________________________
149. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL
IMPORTATION REGULATIONS
Legal Authority: Not Yet Determined
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
[[Page 21924]]
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 Unite States (42 CFR parts 71, Subpart F).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 07/31/07 72 FR 41676
Notice Extending ANPRM Comment
Period 10/01/07 72 FR 55729
NPRM 12/00/09
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
RIN: 0920-AA14
_______________________________________________________________________
150. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS,
PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS
Legal Authority: 42 U.S.C. 264
Abstract: By statute, the Secretary of Health and Human Services has
broad authority to prevent introduction, transmission, and spread of
communicable diseases from foreign countries into the United States and
from one State or possession into another. The Secretary has delegated
the authority to prevent the introduction of diseases from foreign
countries to the Director, CDC. CDC also enforces entry requirements
for certain animals, etiologic agents, and vectors deemed to be of
public health significance. CDC is proposing to amend its regulations
related to the importation of live nonhuman primates (NHPs) by
extending existing requirements for the importation of cynomolgus,
African green, and rhesus monkeys to all NHPs. The agency also is
proposing to reduce the frequency at which importers of the three
species are required to renew their registrations, (from every 180 days
to every two years). CDC proposes to incorporate existing guidelines
into the regulations and add new provisions to address NHPs imported as
part of a circus or trained animal act, NHPs imported by zoological
societies, the transfer of NHPs from approved laboratories, and non-
live imported NHP products. CDC is also proposing that all NHPs be
imported only through ports of entry where a CDC quarantine station is
located.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/09
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
RIN: 0920-AA23
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
151. 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
Final Action 09/00/09
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
RIN: 0920-AA12
_______________________________________________________________________
152. 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
[[Page 21925]]
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
Final Action 12/00/09
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
RIN: 0920-AA27
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
153. <> 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 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)
_______________________________________________________________________
154. 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) provides that part 16 does not
apply to a hearing on an order for relabeling, diversion, or
destruction if 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,
[[Page 21926]]
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: geraldine.june@fda.hhs.gov
RIN: 0910-AG06
_______________________________________________________________________
155. 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 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 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,
Bldg. 51, Room 6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: howard.mullerjr@fda.hhs.gov
RIN: 0910-AG14
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
156. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS
AND BIOLOGICS
Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262
Abstract: The Food and Drug Administration is proposing to amend the
regulations governing the format in which clinical study data and
bioequivalence data are required to be submitted for new drug
applications (NDAs), biological license applications (BLAs), and
abbreviated new drug applications (ANDAs). The proposal would revise
our regulations to require that data submitted for NDAs, BLAs, and
ANDAs, and their supplements and amendments, be provided in an
electronic format that FDA can process, review, and archive. The
proposal would also require that FDA periodically issue guidance on the
use of standardized data structure, terminology, and code sets (e.g.,
the Study Data Tabulation Model (SDTM) developed by the Clinical Data
Interchange Standards Consortium) to allow for more efficient and
comprehensive data review.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Martha Nguyen, 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
6224, Silver Spring, MD 20993-0002
Phone: 301 796-3471
Fax: 301 847-8440
[[Page 21927]]
Email: martha.nguyen@fda.hhs.gov
RIN: 0910-AC52
_______________________________________________________________________
157. 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 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
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) 04/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF31
_______________________________________________________________________
158. 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
Final Action (Laxative Drug
Products) To Be Determined
NPRM (Professional Labeling--
Sodium Phosphate) 09/00/09
NPRM (Professional Labeling) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF38
_______________________________________________________________________
159. 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 to 360a; 21 USC 371 to 371a
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses active ingredients reviewed under Time and Extent
Applications. The second action is the final action that addresses
sunscreen formulation, labeling, and testing requirements for both
ultraviolet B and ultraviolet A radiation protection. The third action
addresses combination products containing sunscreen and insect
repellent ingredients.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM (Sunscreen and Insect
Repellent) 02/22/07 72 FR 7941
ANPRM Comment Period End 05/23/07
NPRM (UVA/UVB) 08/27/07 72 FR 49070
NPRM Comment Period End 12/26/07
NPRM (Time and Extent) 09/00/09
Final Action (UVA/UVB) 09/00/09
NPRM (Sunscreen and Insect
Repellent) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF43
_______________________________________________________________________
160. 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. One action
addresses the ingredient phenylpropanolamine, and the other actions
address the ingredient benzocaine.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Phenylpropanol amine) 12/22/05 70 FR 75988
NPRM (Benzocaine) 09/00/09
Final Action (Phenylpropanol
amine) 05/00/10
Final Action (Benzocaine) To Be Determined
[[Page 21928]]
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF45
_______________________________________________________________________
161. 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
to 360(a); 21 USC 371 to 371(a)
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 09/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AG12
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
162. 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 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.
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
[[Page 21929]]
NPRM Extension of Reopened
Comment Period End 07/25/05 70 FR 33404
Final Action 07/00/09
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: john.sheehan@fda.hhs.gov
RIN: 0910-AC14
_______________________________________________________________________
163. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING
PRACTICE REQUIREMENTS
Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353
Abstract: The Food and Drug Administration is amending its current good
manufacturing practice regulations and other regulations to clarify and
strengthen requirements for the label, color, dedication, and design of
medical gas containers and closures. Despite existing regulatory
requirements and industry standards for medical gases, there have been
repeated incidents in which cryogenic containers of harmful industrial
gases have been connected to medical oxygen supply systems in hospitals
and nursing homes, and subsequently administered to patients. These
incidents have resulted in death and serious injury. There have also
been several incidents involving high-pressure medical gas cylinders
that have resulted in death and injuries to patients. These amendments,
together with existing regulations, are intended to ensure that the
types of incidents that have occurred in the past, as well as other
types of foreseeable and potentially deadly medical gas mixups, 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 09/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Quynh H. Nguyen, 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 6370, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: quynh.h.nguyen@fda.hhs.gov
RIN: 0910-AC53
_______________________________________________________________________
164. 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 08/00/09
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: michael.bernstein@fda.hhs.gov
RIN: 0910-AC55
_______________________________________________________________________
165. 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).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/29/08 73 FR 30831
NPRM Comment Period End 08/27/08
Final Action 03/00/10
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 Ave., Bldg. 51, Room
6224, Silver Spring, MD 20993-0002
Phone: 301 796-4288
Fax: 301-847-8440
Email: rachel.bressler@fda.hhs.gov
RIN: 0910-AF11
_______________________________________________________________________
166. 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 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
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 63679
Final Action (Amendment--
Ephedrine Single Ingredient) 09/00/09
Regulatory Flexibility Analysis Required: Yes
[[Page 21930]]
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF32
_______________________________________________________________________
167. 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 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 technical
amendment revises a paragraph designation in the CFR. The other 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 09/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF33
_______________________________________________________________________
168. 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) 12/00/09
NPRM (Amendment) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF35
_______________________________________________________________________
169. 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 fifth
document finalizes the document regarding the required warnings and
other labeling. 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) 05/00/10
NPRM (Amendment) (Pediatric) To Be Determined
NPRM (Amendment) (Combinations
With Sodium Bicarbonate) 05/00/10
NPRM (Amendment) (Miscellaneous
Issues) 05/00/10
Final Action (Required Warnings
and Other Labeling) 05/00/09
Final Action (Internal
Analgesics) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF36
_______________________________________________________________________
170. 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
[[Page 21931]]
skin protectant products used to treat fever blisters and cold sores.
The second action addresses astringent active ingredients. The third
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) To Be Determined
Final Action (Aluminum Acetate)
(Technical Amendment) 03/06/09 74 FR 9759
Final Action (Diaper Rash) 12/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF42
_______________________________________________________________________
171. 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 help strengthen
existing safeguards to 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. FDA is correcting
the final rule on BSE that appeared in the Federal Register of April
25, 2008 (73 FR 22719-22758). The final rule 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, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: burt.pritchett@fda.hhs.gov
RIN: 0910-AF46
_______________________________________________________________________
172. 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 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 09/00/09
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,
[[Page 21932]]
(HFS-316), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2644
Email: amber.mccoig@fda.hhs.gov
RIN: 0910-AF47
_______________________________________________________________________
173. 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: Kevin O. Kwon, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Food
Safety and Applied Nutrition, (HFS-024), Room 1B-032, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-2780
Fax: 301 436-2637
Email: kevin.kwon@fda.hhs.gov
RIN: 0910-AF61
_______________________________________________________________________
174. 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 10/00/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AG00
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
175. 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: These regulations are one component of the Secretary's
initiative to reduce medical errors. The final rule would amend the
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.
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 To Be Determined
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
_______________________________________________________________________
176. 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. The
final rule (the CGMP rule) was published to establish the minimum CGMPs
necessary to ensure that, if firms engage in activities related to
manufacturing, packaging, labeling, or
[[Page 21933]]
holding dietary supplements, they do so in a manner that will ensure
the quality of the dietary supplements--i.e., to ensure that the
dietary supplement consistently meets the established specifications
for identity, purity, strength, and composition, and limits on
contaminants, and has been manufactured, packaged, labeled, and held
under conditions to prevent adulteration under section 402(a)(1),
(a)(2), (a)(3), and (a)(4) of the act.
FDA also published an interim final rule (IFR) in the June 25, 2007
Federal Register (72 FR 34959) that sets forth a procedure for
requesting an exemption from the requirement in the final rule
described above 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: linda.kahl@fda.hhs.gov
RIN: 0910-AB88
_______________________________________________________________________
177. 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 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
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) 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF34
_______________________________________________________________________
178. 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, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF37
_______________________________________________________________________
179. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses emergency first aid eyewash products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Emergency
First Aid Eyewashes) 02/19/03 68 FR 7917
NPRM (Amendment) (Emergency
First Aid Eyewashes) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and
[[Page 21934]]
Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF39
_______________________________________________________________________
180. 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. This 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, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF40
_______________________________________________________________________
181. 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 to 360a; 21 USC 360gg to 360ss; 21 USC 371
to 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262;
42 USC 264
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) 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF44
_______________________________________________________________________
182. 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 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF51
_______________________________________________________________________
183. 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) 05/00/10
Final Action (Overindulgence
Labeling) 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF52
_______________________________________________________________________
184. 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;
[[Page 21935]]
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
addresses skin bleaching drug products containing hydroquinone.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/29/06 71 FR 51146
NPRM Comment Period End 12/27/06
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF53
_______________________________________________________________________
185. 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 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
addresses the use of stimulant active ingredients to relieve symptoms
associated with a hangover.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Hangover) 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF56
_______________________________________________________________________
186. 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 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. These actions
address new labeling for antidiarrheal drug products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Proposed 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, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF63
_______________________________________________________________________
187. 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, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF68
_______________________________________________________________________
188. 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 to 360a; 21 USC 371 to 371a
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses food handler products. The second action addresses
testing requirements. 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) To Be Determined
Final Action (Healthcare) To Be Determined
Final Action (Consumer) To Be Determined
[[Page 21936]]
Final Action (First Aid
Antiseptic) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF69
_______________________________________________________________________
189. 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 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
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, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF70
_______________________________________________________________________
190. 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 to 360a; 21 USC 371 to 371a
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, Center for Drug Evaluation and Research, Department of Health
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF95
_______________________________________________________________________
191. 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 04/00/10
NPRM Comment Period End 07/00/10
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, MPN4, Room 106, HFV-230, 7519 Standish
Place, Rockville, MD 20855
Phone: 240 276-9207
Email: kim.young@fda.hhs.gov
RIN: 0910-AG10
[[Page 21937]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
192. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355
to 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 21
USC 379
Abstract: The Food and Drug Administration (FDA) published a proposed
regulation on October 29, 2003 (68 FR 61640), that would amend its
regulations on submission of bioequivalence (BE) data to require an
abbreviated new drug application (ANDA) applicant to submit data from
all BE studies the applicant conducts on a drug product formulation
submitted for approval. In the past, ANDA applicants have submitted BE
studies demonstrating that a generic product meets BE criteria for FDA
to approve the ANDA but have not typically submitted additional BE
studies conducted on the same drug product formulation. If finalized,
this rule would require ANDA applicants to submit information, in
either a complete or summary report, from all additional passing and
nonpassing BE studies conducted on the same drug product formulation
submitted for approval.
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 01/16/09 74 FR 2849
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Jennifer L. Stevens
Phone: 301 796-3601
Fax: 301 847-8440
Email: jennifer.stevens@fda.hhs.gov
RIN: 0910-AC23
_______________________________________________________________________
193. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION
Legal Authority: 21 USC 379e(b)
Abstract: The Agency published a final rule on January 5, 2009, to
require the label declaration of all foods and cosmetics containing the
color additives cochineal extract and carmine in order to protect
consumers with allergies to these additives. This final rule was issued
in response to adverse event reports received by FDA and to a citizen
petition submitted to FDA.
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 01/05/09 74 FR 207
Final Rule--Objection Period End02/04/09
Final Rule-Confirmation of
Effective Date 03/11/09 74 FR 10483
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Mical E. Honigfort
Phone: 301 436-1278
Fax: 301 436-2972
Email: mical.honigfort@fda.hhs.gov
RIN: 0910-AF12
_______________________________________________________________________
194. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL
CONTROLS FOR MALE CONDOMS MADE OF NATURAL RUBBER LATEX
Legal Authority: 21 USC 360c
Abstract: The classification regulation for condoms would be amended to
specify a labeling guidance document as a special control for condoms
made from natural rubber latex. The new special control guidance
document would identify issues presented by these devices, and would
provide detailed recommendations for labeling to address these issues.
FDA believes that addressing the issues identified in the guidance,
either by following the recommendations in the guidance or by some
other means that provide equivalent assurances of safety and
effectiveness, together with the general controls, will provide a
reasonable assurance of the safety and effectiveness of these devices.
These labeling recommendations are also consistent with the labeling
requirements of 21 CFR part 801. The rule will demonstrate how the
Agency is addressing the congressional directive of Public Law 106-554
that FDA review condom labeling to assure that the information
regarding the overall effectiveness or lack of effectiveness of condoms
in preventing sexually transmitted diseases is medically accurate.
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 11/10/08 73 FR 66522
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Myrna Hanna
Phone: 240 276-2347
Fax: 240 276-2352
Email: myrna.hanna@fda.hhs.gov
RIN: 0910-AF21
_______________________________________________________________________
195. FOOD LABELING; SERVING SIZES AND NUTRITION LABELING (COMPLETION OF
A 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
Abstract: Section 101.9 (21 CFR 101.9) describes the nutrition labeling
requirements for foods. Section 101.12 (21 CFR 101.12) specifies the
reference amount customarily consumed per eating occasion for each food
category. The reference amount customarily consumed of a food is the
basis for the serving size that is declared in the food's nutrition
labeling. Under section 101.9, the serving size must be expressed in a
common household measure that is appropriate to the food. The most
recent change to sections 101.9 and 101.12 was in 1999, when FDA
amended these regulations to reduce the reference amount customarily
consumed for baking powder, baking soda, and pectin, and to include 1/8
teaspoon as an allowable unit of household measure for nutrition
labeling purposes. FDA has completed a review of sections 101.9 and
101.12 under section 610 of the Regulatory Flexibility Act. The purpose
of this review was to determine whether the regulations in sections
101.9 and 101.12 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 solicited comments on the
following: (1) The continued need for the regulations in sections 101.9
and 101.12; (2) the nature of complaints or comments received
concerning the regulations in sections 101.9 and 101.12; (3) the
complexity of the regulations; (4) the extent to which the regulations
in sections 101.9 and 101.12 overlap, duplicate, or conflict with other
Federal rules, and to the extent feasible, with State or governmental
rules; and (5) the degree to which technology, economic conditions, or
other factors have changed in the area affected by the regulations in
sections 101.9 and 101.12. FDA received no comments and concluded that
there is a continuing
[[Page 21938]]
need for the nutrition labeling and serving size regulations in
sections 101.9 and 101.12 and that these regulations should be retained
without change.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review 12/12/08
End Review 02/10/09
Regulatory Flexibility Analysis Required: No
Agency Contact: Mary Brandt, Statistician, Department of Health and
Human Services, Food and Drug Administration, Center for Food Safey and
Applied Nutrition, 5100 Paint Branch Parkway, ONLDS (HFS-820), College
Park, MD 20740
Phone: 301 436-1788
Fax: 301 436-1191
Email: mary.brandt@fda.hhs.gov
RIN: 0910-AF99
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
196. CHANGES TO THE HOSPITAL INPATIENT AND LONG-TERM CARE PROSPECTIVE
PAYMENT SYSTEM FOR FY 2010 (CMS-1406-P)
Legal Authority: Sec 1886(d) of the Social Security Act
Abstract: This major rule proposes to revise 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 04/00/09
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: tiffany.swygert@cms.hhs.gov
RIN: 0938-AP39
_______________________________________________________________________
197. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR
CY 2010 (CMS-1413-P)
Legal Authority: Social Security Act, sec 1102; Social Security Act,
sec 1871
Abstract: This major proposed rule would revise payment polices under
the physician fee schedule, as well as other policy changes to payment
under Part B.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/09
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: diane.milstead@cms.hhs.gov
RIN: 0938-AP40
_______________________________________________________________________
198. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-P)
Legal Authority: BBA; PPRA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA
Abstract: This major rule would revise the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system and to implement certain related provisions of the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In
addition, the proposed rule describes proposed 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 proposes changes to the Ambulatory Surgical Center Payment System
list of services and rates. These changes would be applicable to
services furnished on or after January 1 annually.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/09
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: alberta.dwivedi@cms.hhs.gov
RIN: 0938-AP41
_______________________________________________________________________
199. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED
NURSING FACILITIES--UPDATE FOR FY 2010 (CMS-1410-P)
Legal Authority: Social Security Act, sec 1888(e)
Abstract: This major rule proposes updates to the payment rates used
under the SNF PPS beginning October 1, 2009.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/09
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: bill.ullman@cms.hhs.gov
RIN: 0938-AP46
[[Page 21939]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
200. 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: Danielle Shearer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716
Email: danielle.shearer@cms.hhs.gov
RIN: 0938-AG81
_______________________________________________________________________
201. 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
Interim Final Rule To Be Determined
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: elizabeth.holland@cms.hhs.gov,
RIN: 0938-AK62
_______________________________________________________________________
202. 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 major 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: suzanne.bosstick@cms.hhs.gov
RIN: 0938-AO53
_______________________________________________________________________
203. MEDICAID GRADUATE MEDICAL EDUCATION (CMS-2279-F)
Legal Authority: title XIX; Social Security Act
Abstract: As part of the President's 2008 Budget, this major 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
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Dianne Heffron, 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: 410 786-3247
Fax: 410 786-1008
Email: dianne.heffron@cms.hhs.gov
RIN: 0938-AO95
_______________________________________________________________________
204. 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: trish.brooks@cms.hhs.gov
RIN: 0938-AP32
[[Page 21940]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
205. UPDATES TO ELECTRONIC TRANSACTIONS (VERSION 5010) (CMS-0009-F)
(COMPLETION OF A SECTION 610 REVIEW)
Legal Authority: sec 1171 to 1179 of the Social Security Act; Deficit
Reduction Act of 2005, PL 109-171, sec 6035
Abstract: This rule adopts new versions of the X12 suite of HIPAA
transactions and allows the industry to use the most up-to-date
versions of the HIPAA transactions for claims and remittance advice.
The rule will also adopt an updated pharmacy transactions standard for
retail pharmacy claims.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/22/08 73 FR 49741
NPRM Comment Period End 10/21/08
Final Action 01/16/09 74 FR 3296
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Gladys C. Wheeler, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of E-Health Standards and Services, Mailstop
S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: gladys.wheeler@cms.hhs.gov
RIN: 0938-AM50
_______________________________________________________________________
206. REVISIONS TO HIPAA CODE SETS (CMS-0013-F) (COMPLETION OF A SECTION
610 REVIEW)
Legal Authority: PL 104-191
Abstract: This rule revises some of the adopted transaction and code
set standards detailed in regulations published by HHS on August 17,
2000, and February 20, 2003.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/22/08 73 FR 49795
NPRM Comment Period End 10/21/08
Final Action 01/16/09 74 FR 3328
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Denise Buenning, Health Insurance Specialist, Office of
E-Health Standards and Services, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6711
Email: denise.buenning@cms.hhs.gov
RIN: 0938-AN25
_______________________________________________________________________
207. SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT,
PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-F) (COMPLETION
OF A SECTION 610 REVIEW)
Legal Authority: sec 4312(a) of BBA of 1997
Abstract: This rule implements section 4312(a) of the Balanced Budget
Act of 1997, which requires a Medicare supplier of durable medical
equipment (DME) to furnish CMS with a surety bond.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/01/07 72 FR 42001
NPRM Comment Period End 10/01/07
Final Action 01/02/09 74 FR 166
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Frank Whelan, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Office of Financial Management, Mailstop C3-02-16, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-1302
Email: frank.whelan@cms.hhs.gov
RIN: 0938-AO84
_______________________________________________________________________
208. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 (CMS-1404-F)
Legal Authority: BBA; PPRA; BIPA; MMA; 42 USC 1302 et al
Abstract: This rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from continuing experience with this
system and to implement certain related provisions of the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In
addition, the rule describes proposed 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 to the Ambulatory Surgical Center Payment System list of
services and rates. These changes would be applicable to services
furnished on or after January 1 annually.
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 11/18/08 73 FR 68501
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Alberta Dwivedi
Phone: 410 786-0763
Email: alberta.dwivedi@cms.hhs.gov
RIN: 0938-AP17
_______________________________________________________________________
209. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR
CY 2009 (CMS-1403-FC)
Legal Authority: Social Security Act, sec 1102; Social Security Act,
sec 1871
Abstract: This major rule makes changes affecting Medicare Part B
payment to physicians and other Part B suppliers.
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 11/19/08 73 FR 69725
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Diane Milstead
Phone: 410 786-3355
Email: diane.milstead@cms.hhs.gov
RIN: 0938-AP18
_______________________________________________________________________
210. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE
FOR CY 2009 (CMS-1555-N)
Legal Authority: Social Security Act, secs 1102 and 1871; (42 USC 1302
and 1395(hh)); Social Security Act, sec 1895 (42 USC 1395fff)
Abstract: Section 1895 of the Act requires that the Home Health PPS be
adjusted in a prospective manner specified by the Secretary by the home
health increase percentage applicable to the year involved.
[[Page 21941]]
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Notice 11/03/08 73 FR 65351
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Randy Throndset
Phone: 410 786-0131
Fax: 410 786-0765
Email: randy.throndset@cms.hhs.gov
RIN: 0938-AP20
_______________________________________________________________________
211. CHANGES TO LONG-TERM CARE PROSPECTIVE PAYMENT SYSTEM BASED ON
SPECIFIC PROVISIONS IN THE MEDICARE, MEDICAID, AND SCHIP EXTENSION ACT
OF 2007 (CMS-1493-F)
Legal Authority: Provisions of sec 114 of PL 110-173 (MMSE Act of
2007); sec 1886(d) of the Social Security Act as amended by sec 114 of
PL 110-173 (MMSE Act of 2007)
Abstract: This rule implements provisions of the Medicare, Medicaid,
and SCHIP Extension Act of 2007 relating to long-term care hospitals.
In addition to amending section 1861 of the Act with a new definition
of LTCHs, this rule includes provisions that are effective on the date
of enactment (December 29, 2007). Specifically, the statute imposes a
3-year delay in implementation of certain payment policies that set
percentage thresholds for LTCH patients admitted from certain referring
hospitals and raises the percentage threshold for those LTCHs
unaffected by the 3-year delay. The legislation imposes the same 3-year
delay on the implementation of a particular payment adjustment for
short-stay patients and also for the possible application of a one-time
adjustment to the standard Federal rate. The statute also required a
change in the Federal rate for RY 2008, (effective April 1, 2008).
Additionally, the statute created a 3-year moratorium on the
establishment of new LTCHs and LTCH satellites and on bed expansion in
existing LTCHs, subject to significant exceptions.
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 01/29/09
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Tzvi Hefter
Phone: 410 786-4487
Email: tzvi.hefter@cms.hhs.gov
RIN: 0938-AP33
[FR Doc. E9-10274 Filed 05-08-09; 8:45 am]
BILLING CODE 4150-24-S
