[April 26, 2010 (Volume 75, Number 79)]
[Unified Agenda]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID: f:ua100407.wais]
[Page 21782-21804]
Department of Health and Human Services
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Part VII
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Semiannual Regulatory Agenda
[[Page 21782]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
42 CFR Chs. I-V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
Regulatory Agenda
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual regulatory agenda
_______________________________________________________________________
SUMMARY: The following Agenda presents the results of the statutorily
required semi-annual inventory of rulemaking actions currently under
development within the U.S. Department of Health and Human Services
(HHS). We hope that this information will enable interested members of
the public to more effectively participate in the Department's
regulatory activity.
FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary,
Department of Health and Human Services, Washington, DC 20201.
SUPPLEMENTARY INFORMATION: The information provided in the Agenda
presents a forecast of the rulemaking activities that HHS expects to
undertake in the foreseeable future. Rulemakings are grouped according
to pre-rulemaking actions, proposed rules, final rules, long-term
actions, and rulemaking actions completed since the most recent Agenda
was published on December 7, 2009. Please note that the actions
included in this issue of the Federal Register, as required by the
Regulatory Flexibility Act of 1980, relate only to those prospective
rulemakings that are likely to have a significant economic impact on a
substantial number of small entities.
The purpose of the Agenda is to encourage more effective public
participation in the regulatory process. HHS invites all interested
members of the public to comment on the rulemaking actions included
in this issuance of the Agenda. The complete Agenda is accessible
online at www.reginfo.gov in an interactive format that offers
users enhanced capabilities to obtain information from the Agenda's
database.
Dated: March 10, 2010.
Dawn L. Smalls,
Executive Secretary,
Department of Health and Human Services.
Office of the Secretary--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
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120 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health 0991-AB57
Information Technology for Economic and Clinical Health Act...........................
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Final Rule Stage
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
121 Health Information Technology: Initial Set of Standards, Implementation 0991-AB58
Specifications, and Certification Criteria for Electronic Health Record Technology
(Rulemaking Resulting From a Section 610 Review)......................................
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Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
122 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 0930-AA14
610 Review)...........................................................................
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Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
123 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10
Community-Based Facilities for Children and Youth.....................................
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[[Page 21783]]
Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
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124 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of 0920-AA14
HHS/CDC Animal Importation Regulations................................................
125 Control of Communicable Diseases: Foreign Quarantine Regulations, Nonhuman Primate.... 0920-AA23
126 Total Inward Leakage Requirements for Respirators..................................... 0920-AA33
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Centers for Disease Control and Prevention--Final Rule Stage
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
127 Quality Assurance Requirements for Respirators........................................ 0920-AA04
128 Control of Communicable Diseases: Foreign Quarantine.................................. 0920-AA12
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Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
129 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 0920-AA32
Review)...............................................................................
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Centers for Disease Control and Prevention--Completed Actions
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Regulation
Sequence Title Identifier
Number Number
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130 Control of Communicable Diseases: Interstate Quarantine, Passenger Information........ 0920-AA27
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Food and Drug Administration--Prerule Stage
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Regulation
Sequence Title Identifier
Number Number
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131 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06
Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
132 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14
Policies, Requirements, and Administrative Procedures (Section 610 Review)............
133 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 0910-AG25
Review)...............................................................................
134 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco 0910-AG33
To Protect Children and Adolescents...................................................
135 Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review).............. 0910-AG34
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Food and Drug Administration--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
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136 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52
137 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31
138 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36
139 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38
140 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43
141 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69
142 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10
[[Page 21784]]
143 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug 0910-AG12
Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........
144 Unique Device Identification.......................................................... 0910-AG31
145 Produce Safety Regulation............................................................. 0910-AG35
146 Modernization of the Current Food Good Manufacturing Practices Regulation............. 0910-AG36
147 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act............... 0910-AG38
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Food and Drug Administration--Final Rule Stage
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Regulation
Sequence Title Identifier
Number Number
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148 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97
149 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53
150 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11
Requirements for Pregnancy and Lactation Labeling.....................................
151 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27
Notification Requirements; Records and Reports; and Quality Factors...................
152 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32
153 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33
154 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35
155 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42
156 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47
157 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61
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Food and Drug Administration--Long-Term Actions
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Regulation
Sequence Title Identifier
Number Number
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158 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88
Operations for Dietary Supplements....................................................
159 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34
160 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37
161 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39
162 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40
163 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44
164 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45
165 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51
166 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52
167 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53
168 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56
169 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63
170 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70
171 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95
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Food and Drug Administration--Completed Actions
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Regulation
Sequence Title Identifier
Number Number
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172 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55
173 Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00
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[[Page 21785]]
Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
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174 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81
Review)...............................................................................
175 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32
Review)...............................................................................
176 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care 0938-AP80
Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates
(CMS-1498-P)..........................................................................
177 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP82
Center Payment System for CY 2011 (CMS-1504-P)........................................
178 Home Health Prospective Payment System Refinements and Rate Update for CY 2011 (CMS- 0938-AP88
1510-P)...............................................................................
179 Omnibus Influenza Immunization (CMS-3213-P)........................................... 0938-AP92
180 Proposed Changes to the Hospital Conditions of Participation: Requirements for 0938-AP97
Hospital Psychiatric and Rehabilitation Units Excluded From the Prospective Payment
System (CMS-3177-P)...................................................................
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Centers for Medicare & Medicaid Services--Long-Term Actions
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Regulation
Sequence Title Identifier
Number Number
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181 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs 0938-AP77
for Contract Year 2011 (CMS-4085-F)...................................................
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Centers for Medicare & Medicaid Services--Completed Actions
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Regulation
Sequence Title Identifier
Number Number
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182 Electronic Claims Attachments Standards (CMS-0050-IFC)................................ 0938-AK62
183 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413- 0938-AP40
FC)...................................................................................
184 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP41
Center Payment System for CY 2010 (CMS-1414-FC).......................................
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_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
120. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES
UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH
ACT
Legal Authority: PL 111-5, secs 13400 to 13410
Abstract: The Department of Health and Human Services Office for Civil
Rights will issue rules to modify the HIPAA Privacy, Security, and
Enforcement Rules as necessary to implement the privacy, security, and
certain enforcement provisions of subtitle D of the Health Information
Technology for Economic and Clinical Health Act (Title XIII of the
American Recovery and Reinvestment Act of 2009).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Andra Wicks, Department of Health and Human Services,
200 Independence Avenue SW., Washington, DC 20201
Phone: 202 205-2292
Fax: 202 205-4786
Email: andra.wicks@hhs.gov
RIN: 0991-AB57
[[Page 21786]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
121. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS,
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC
HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610
REVIEW)
Legal Authority: 42 USC 300jj-14
Abstract: The Department of Health and Human Services (HHS), Office of
the National Coordinator for Health Information Technology, will issue
an interim final rule with a request for comments to adopt an initial
set of standards, implementation specifications, and certification
criteria, as required by section 3004(b)(1) of the Public Health
Service Act. The certification criteria adopted in this initial set
establish the technical capabilities and related standards that
certified electronic health record (EHR) technology will need to
include in support of the Medicare and Medicaid EHR Incentive Programs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 01/13/10 75 FR 2014
Interim Final Rule Comment
Period End 03/15/10
Interim Final Rule Effective 02/12/10
Final Action 05/00/10
Final Action Effective 06/00/10
Regulatory Flexibility Analysis Required: No
Agency Contact: Steven Posnack, Policy Analyst, Department of Health
and Human Services, Office of the Secretary, Office of the National
Coordinator for Health Information Technology, 200 Independence Avenue
SW., Washington, DC 20201
Phone: 202 690-7151
RIN: 0991-AB58
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
122. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE
ADDICTION (SECTION 610 REVIEW)
Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC
290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11
Abstract: This rule will amend the Federal opioid treatment program
regulations. It will modify the dispensing requirements for
buprenorphine and buprenorphine combination products that are approved
by the Food and Drug Administration (FDA) for opioid dependence and
used in federally certified and registered opioid treatment programs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/19/09 74 FR 29153
NPRM Comment Period End 08/18/09
Final Action 09/00/10
Regulatory Flexibility Analysis Required: No
Agency Contact: Nicholas Reuter, Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration,
Suite 2-1063, One Choke Cherry Road, 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)
_______________________________________________________________________
123. 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
[[Page 21787]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
124. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS,
PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS
Legal Authority: 42 USC 264
Abstract: By statute, the Secretary of Health and Human Services has
broad authority to prevent introduction, transmission, and spread of
communicable diseases from foreign countries into the United States and
from one State or possession into another. The Secretary has designated
the authority to prevent the introduction of diseases from foreign
countries to the Director, Centers for Disease Control and Prevention
(CDC). CDC also enforces entry requirements for certain animals,
etiologic agents, and vectors deemed to be of public health
significance. Currently the regulations restrict the importation of
nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts,
and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54).
In addition, CDC has recently issued a series of emergency orders
restricting the importation of African rodents (42 CFR section 71.56)
and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed
Rulemaking (NPRM) to revise the regulations for importation of certain
animals and vectors into the United States (42 CFR parts 71, subpart
F).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 07/31/07 72 FR 41676
ANPRM Comment Period End 10/01/07
Notice Extending ANPRM Comment
Period 10/01/07 72 FR 55729
ANPRM Extended Comment Period
End 12/01/07
NPRM 11/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, MS E03, CLFT Building 16,
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov
RIN: 0920-AA14
_______________________________________________________________________
125. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS,
NONHUMAN PRIMATE
Legal Authority: 42 USC 264
Abstract: By statute, the Secretary of Health and Human Services has
broad authority to prevent introduction, transmission, and spread of
communicable diseases from foreign countries into the United States and
from one State or possession into another. The Secretary has delegated
the authority to prevent the introduction of diseases from foreign
countries to the Director, CDC. CDC also enforces entry requirements
for certain animals, etiologic agents, and vectors deemed to be of
public health significance. CDC is proposing to amend its regulations
related to the importation of live nonhuman primates (NHPs) by
extending existing requirements for the importation of cynomolgus,
African green, and rhesus monkeys to all NHPs. The agency also is
proposing to reduce the frequency at which importers of the three
species are required to renew their registrations (from every 180 days
to every 2 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 08/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, MS E03, CLFT Building 16,
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov
RIN: 0920-AA23
_______________________________________________________________________
126. TOTAL INWARD LEAKAGE REQUIREMENTS FOR RESPIRATORS
Legal Authority: 29 USC 651 et seq; 29 USC 657(g); 30 USC 3; 30 USC 7;
30 USC 811; 30 USC 842(h) and 844
Abstract: The Centers for Disease Control and Prevention (CDC) proposes
to establish total inward leakage (TIL) requirements under 42 CFR part
84 for half-mask air-purifying particulate respirators approved by the
National Institute for Occupational Safety and Health (NIOSH) of CDC.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/30/09 74 FR 66935
NPRM Comment Period End 12/29/09
NPRM Comment Period Reopened 04/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: William E. Newcomb, Physical Scientist, Department of
Health and Human Services, Centers for Disease Control and Prevention,
626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236
Phone: 412 386-5200
RIN: 0920-AA33
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
127. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS
Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30
USC 811; 30 USC 842(h); 30 USC 844
Abstract: NIOSH plans to modify the Administrative/Quality Assurance
sections of 42 CFR part 84, Approval of Respiratory Protective Devices.
Areas for potential modification in this module are: 1) Upgrade of
quality assurance requirements; 2) ability to use private sector
quality auditors and private sector testing laboratories in the
approval program; and 3) revised approval label requirements.
[[Page 21788]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/10/08 73 FR 75045
NPRM Comment Period End 02/09/09
NPRM Comment Period Reopened 03/04/09 74 FR 9381
NPRM Comment Period Reopened End04/10/09
NPRM Comment Period Reopening
Extended 05/21/09 74 FR 23815
NPRM Comment Period End 10/09/09
Final Action 12/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: William E. Newcomb, Physical Scientist, Department of
Health and Human Services, Centers for Disease Control and Prevention,
626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236
Phone: 412 386-5200
RIN: 0920-AA04
_______________________________________________________________________
128. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE
Legal Authority: 42 USC 243; 42 USC 248 and 249
Abstract: By statute, the Secretary of Health and Human Services has
broad authority to prevent introduction, transmission, and spread of
communicable diseases from foreign countries into the United States and
from one State or possession into another. Quarantine regulations are
divided into two parts: Part 71 dealing with foreign arrivals and part
70 dealing with interstate matters. This rule (42 CFR part 71) will
update and improve CDC's response to both global and domestic disease
threats by creating a multi-tiered illness detection and response
process thus substantially enhancing the public health system's ability
to slow the introduction, transmission, and spread of communicable
disease. The rule will also modify current Federal regulations
governing the apprehension, quarantine isolation, and conditional
release of individuals suspected of carrying a quarantinable disease,
while respecting individual autonomy. CDC maintains quarantine stations
at 20 ports of entry staffed with medical and public health officers
who respond to reports of diseases from carriers. According to the
statutory scheme, the President determines through Executive Order
which diseases may subject individuals to quarantine. The current
disease list, which was last updated in April 2005, includes cholera,
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral
hemorrhagic fevers, severe acute respiratory syndrome (SARS), and
influenza caused by novel or reemergent influenza viruses that are
causing, or have the potential to cause a pandemic.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/30/05 70 FR 71892
NPRM Comment Period End 01/20/06
Final Action 11/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, MS E03, CLFT Building 16,
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov
RIN: 0920-AA12
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
129. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE
VIRUS (SECTION 610 REVIEW)
Legal Authority: PL 107-188
Abstract: The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 authorizes the HHS Secretary to regulate the
possession, use, and transfer of select agents and toxins that have the
potential to pose a severe threat to public health and safety. These
regulations are set forth at 42 CFR 73. Criteria used to determine
whether a select agent or toxin should be included under the provisions
of these regulations are based on: 1) The effect on human health as a
result of exposure to the agent or toxin, 2) the degree of
contagiousness of the agent or toxin, 3) the methods by which the agent
or toxin is transferred to humans, 4) the availability and
effectiveness of pharmacotherapies and immunizations to treat and
prevent and illness resulting from infection by the agent or toxin, and
5) any other criteria, including the needs of children and other
vulnerable populations that the HHS Secretary considers appropriate.
Based on these criteria, we are proposing to amend the list of HHS
select agents and toxins by adding Chapare virus to the list. After
consulting with subject matter experts from CDC, the National
Institutes of Health (NIH), the Food Drug Administration (FDA), the
United States Department of Agriculture (USDA) /Animal and Plant Health
Inspection Service (APHIS), USDA/Agricultural Research Service (ARS),
USDA/CVB (Center for Veterinary Biologics), and the Department of
Defense (DOD)/United States Army Medical Research Institute for
Infectious Diseases (USAMRIID) and review of relevant published
studies, we believe the Chapare virus should be added to the list of
HHS select agents and toxins based on our conclusion that the Chapare
virus has been phylogenetically identified as a Clade B arenavirus and
is closely related to other South American arenaviruses that cause
haemorrhagic fever, particularly Sabia virus.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/19/09 74 FR 159
NPRM Comment Period End 10/19/09
Final Action To Be Determined
Regulatory Flexibility Analysis Required: No
Agency Contact: Robbin Weyant, Department of Health and Human Services,
Centers for Disease Control and Prevention, CLFT Building 20, Room
4202, 1600 Clifton Road NE., Atlanta, GA 30333
Phone: 404 718-2000
RIN: 0920-AA32
[[Page 21789]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
130. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER
INFORMATION
Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248;
42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC
2001
Abstract: By statute, the Secretary of Health and Human Services has
broad authority to prevent introduction, transmission, and spread of
communicable diseases from one State or possession into another.
Quarantine regulations are divided into two parts: Part 71 dealing with
foreign arrivals and part 70 dealing with interstate matters. The CDC
Director has been delegated the responsibility for carrying out these
regulations. The Director's authority to investigate suspected cases
and potential spread of communicable disease among interstate travelers
is thus not limited to those known or suspected of having a
quarantinable disease, but rather all communicable diseases that may
necessitate a public health response.
Among the fundamental components of the public health response to the
report of a person with a communicable disease is the identification
and evaluation of individuals who may have been exposed. This
provision, which was proposed section 70.4, would require any airline
operating in interstate traffic to solicit and electronically submit
certain passenger information to CDC for use in contact tracing when
necessary to protect the vital interests of an individual, or other
persons, in regard to significant health risks.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/30/05 70 FR 71892
NPRM Comment Period End 01/30/06
Merged With 0920-AA22 02/12/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Stacy Howard, Department of Health and Human Services,
Centers for Disease Control and Prevention, MS E03, CLFT Building 16,
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov
RIN: 0920-AA27
_______________________________________________________________________
Department of Health and Human Services (HHS) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
131. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS;
REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610
REVIEW)
Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC
342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271
Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements
for the labeling of the cartons of shell eggs that have not been
treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR
115.50) describes requirements for refrigeration of shell eggs held for
retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides
that part 16 does not apply to a hearing on an order for relabeling,
diversion, or destruction of shell eggs under section 361 of the Public
Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50.
FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit
the safe handling statement to appear on the inside lid of egg cartons
to provide the industry greater flexibility in the placement of the
statement. FDA is undertaking a review of 21 CFR sections 101.17(h),
115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility
Act. The purpose of this review is to determine whether the regulations
in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued
without change, or whether they should be amended or rescinded,
consistent with the stated objectives of applicable statutes, to
minimize any significant economic impact on a substantial number of
small entities. FDA will consider, and is soliciting comments on, the
following: (1) The continued need for the rule; (2) the nature of
complaints or comments received concerning the rule from the public;
(3) the complexity of the rule; (4) the extent to which the rule
overlaps, duplicates, or conflicts with other Federal rules, and, to
the extent feasible, with State and local governmental rules; and (5)
the length of time since the rule has been evaluated or the degree to
which technology, economic conditions, or other factors have changed in
the area affected by the rule.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review 12/15/09
End Review 12/00/10
Regulatory Flexibility Analysis Required: Undetermined
Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and
Labeling Team, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, (HFS-
820), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1802
Fax: 301 436-2636
Email: geraldine.june@fda.hhs.gov
RIN: 0910-AG06
_______________________________________________________________________
132. 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:
[[Page 21790]]
(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 Regulation06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Howard Muller, Office of Regulatory Policy, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: pdma610(c)review@fda.hhs.gov
RIN: 0910-AG14
_______________________________________________________________________
133. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL
INHALATION (SECTION 610 REVIEW)
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375
Abstract: FDA is undertaking a review of 21 CFR 200.51, under section
610 of the Regulatory Flexibility Act. The purpose of this review is to
determine whether this regulation on aqueous-based drug products for
oral inhalation should be continued without change, or whether it
should be amended or rescinded, consistent with the stated objectives
of applicable statues, to minimize adverse impacts on a substantial
number of small entities. FDA will consider, and is soliciting comments
on the following: (1) The continued need for 21 CFR 200.51; (2) the
nature of complaints or comments received concerning 21 CFR 200.51; (3)
the complexity of 21 CFR 200.51; (4) the extent to which the regulation
overlaps, duplicates, or conflicts with other Federal, State, or
governmental rules; and (5) the degree to which technology, economic
conditions, or other factors have changed in the area affected by 21
CFR 200.51.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review 05/01/09
End Review 05/00/10
Regulatory Flexibility Analysis Required: No
Agency Contact: Howard P. Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: howard.mullerjr@fda.hhs.gov
RIN: 0910-AG25
_______________________________________________________________________
134. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND
SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS
Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and
Cosmetic Act; PL 111-31, Family Smoking Prevention and Tobacco Control
Act
Abstract: This rule establishes regulations restricting the sale and
distribution of cigarettes and smokeless tobacco to children and
adolescents, implementing section 102 of the Family Smoking Prevention
and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1)
require the Secretary to publish, within 270 days of enactment, a final
rule regarding cigarettes and smokeless tobacco. This final rule must
be identical, except for several changes identified in section
102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the
Secretary of HHS in the August 28, 1996, issue of the Federal Register
(61 FR 44396).
This final rule prohibits the sale of cigarettes and smokeless tobacco
to individuals under the age of 18 and requires manufacturers,
distributors, and retailers to comply with certain conditions regarding
access to, and promotion of, these products. Among other things, the
final rule requires retailers to verify a purchaser's age by
photographic identification. It also prohibits, with limited exception,
free samples and prohibits the sale of these products through vending
machines and self-service displays except in facilities where
individuals under the age of 18 are not present or permitted at any
time. The rule also limits the advertising and labeling to which
children and adolescents are exposed. The rule accomplishes this by
generally restricting advertising to which children and adolescents are
exposed to a black-and-white, text-only format. The rule also prohibits
the sale or distribution of brand-identified promotional, non-tobacco
items such as hats and tee shirts. Furthermore, the rule prohibits
sponsorship of sporting and other events, teams, and entries in a brand
name of a tobacco product, but permits such sponsorship in a corporate
name.
FDA will also publish in the same issue of the Federal Register an
advance notice of proposed rulemaking requesting comments, data,
research, or other information on the regulation of outdoor advertising
of cigarettes and smokeless tobacco.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 03/19/10 75 FR 13241
Final Rule 03/19/10 75 FR 13225
ANPRM Comment Period End 05/18/10
Final Rule Effective 06/22/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 9200 Corporate
Boulevard, 100K, Rockville, MD 20850
Phone: 877 287-1373
Fax: 240 276-3904
Email: annette.marthaler@fda.hhs.gov
RIN: 0910-AG33
[[Page 21791]]
_______________________________________________________________________
135. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (SECTION 610
REVIEW)
Legal Authority: 5 USC 610
Abstract: Part 201.66 (21 CFR section 201.66) established a
standardized format for the labeling of OTC drug products that
included: (1) Specific headings and subheadings presented in a
standardized order, (2) standardized graphical features such as
Helvetica type style and the use of ``bullet points'' to introduce key
information, and (3) minimum standards for type size and spacing. FDA
issued the final rule to improve labeling after considering comments
submitted to the agency following the publication of the proposed
regulation in 1997. In 1999, FDA published the final rule and stated
that a standardized labeling format would significantly improve
readability by familiarizing consumers with the types of information in
OTC drug product labeling and the location of that information. In
addition, a standardized appearance and standardized content, including
various ``user-friendly'' visual cues, would help consumers locate and
read important health and safety information and allow quick and
effective product comparisons, thereby helping consumers to select the
most appropriate product.
FDA is initiating a review under section 610 of the Regulatory
Flexibility Act for the regulation in part 201.66. The purpose of this
review is to determine whether the regulation in part 201.66 should be
continued without change, or whether it should be further amended or
rescinded, consistent with the stated objectives of applicable
statutes, to minimize adverse impacts on a substantial number of small
entities. FDA will consider, and is soliciting comments on the
following: (1) The continued need for the regulation in part 201.66;
(2) the nature of the complaints or comments received concerning the
regulation in part 201.66; (3) the complexity of the regulations in
part 201.66; (4) the extent to which the regulations in part 201.66
overlap, duplicate, or conflict with other Federal, State, or
governmental rules; and (5) the degree to which technology, economic
conditions, or other factors have changed for the products still
subject to the labeling standard regulations in part 201.
The section 610 review will be carried out along with a regulatory
review under section 5 of Executive Order 12866, which calls for
agencies to periodically review existing regulations to determine
whether any should be modified or eliminated so as to make the agency's
regulatory program more effective in achieving its goals, less
burdensome, or in greater alignment with the President's priorities and
the principles set forth in the Executive order.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review of Current
Regulation 08/03/09
End Review of Current Regulation05/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AG34
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
136. 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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/10
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, WO 51, Room 6352, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone: 301 796-3471
Fax: 301 847-8440
Email: martha.nguyen@fda.hhs.gov
RIN: 0910-AC52
_______________________________________________________________________
137. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE)
PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses antihistamine labeling claims for the common cold.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Reopening of Administrative
Record 08/25/00 65 FR 51780
NPRM (Amendment) (Common Cold) 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug
[[Page 21792]]
Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF31
_______________________________________________________________________
138. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses products labeled to relieve upset stomach associated
with overindulgence in food and drink and to relieve symptoms
associated with a hangover. The second action addresses acetaminophen
safety. The third action addresses products marketed for children under
2 years old and weight- and age-based dosing for children's products.
The fourth action addresses combination products containing the
analgesic acetaminophen or aspirin and sodium bicarbonate used as an
antacid ingredient. The last document finalizes the Internal Analgesic
Products monograph.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Required
Warnings and Other Labeling) 12/26/06 71 FR 77314
NPRM Comment Period End 05/25/07
NPRM (Over- indulgence/
Hangover) To Be Determined
Final Action (Required Warnings
and Other Labeling) 04/29/09 74 FR 19385
Final Action (Correction) 06/30/09 74 FR 31177
Final Action (Technical
Amendment) 11/25/09 74 FR 61512
NPRM (Acetaminophen) 03/00/11
NPRM (Amendment) (Pediatric) To Be Determined
NPRM (Amendment) (Sodium
Bicarbonate) To Be Determined
Final Action (Internal
Analgesics) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF36
_______________________________________________________________________
139. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360 to 360a; 21 USC 371 to 371a
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first NPRM
listed will address the professional labeling for sodium phosphate drug
products. The second NPRM listed will address all other professional
labeling requirements for laxative drug products. The final action will
address laxative drug products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Granular Psyllium)03/29/07 72 FR 14669
NPRM (Professional Labeling--
Sodium Phosphate) 10/00/10
NPRM (Professional Labeling) To Be Determined
Final Action (Laxative Drug
Products) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF38
_______________________________________________________________________
140. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses active ingredients reviewed under Time and Extent
Applications. The second action addresses other effectiveness issues
for OTC sunscreen drug products. The third action finalizes sunscreen
formulation, labeling, and testing requirements for both ultraviolet B
and ultraviolet A radiation protection. The last action addresses
combination products containing sunscreen and insect repellent
ingredients.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM (Sunscreen and Insect
Repellent) 02/22/07 72 FR 7941
ANPRM Comment Period End 05/23/07
NPRM (UVA/UVB) 08/27/07 72 FR 49070
NPRM Comment Period End 12/26/07
NPRM (Time and Extent
Applications) 07/00/10
NPRM (Effectiveness) 10/00/10
Final Action (UVA/UVB) 10/00/10
NPRM (Sunscreen and Insect
Repellent) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human
[[Page 21793]]
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring,
MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF43
_______________________________________________________________________
141. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG
PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses food handler products. The second action addresses
testing requirements for healthcare professional products. The third
action addresses the safety and effectiveness of consumer products. The
final actions listed will address the healthcare, consumer, 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 -- Healthcare
Professional Products) To Be Determined
NPRM (Consumer) 03/00/11
Final Action (Healthcare) To Be Determined
Final Action (Consumer) To Be Determined
Final Action (First Aid
Antiseptic) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF69
_______________________________________________________________________
142. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED
Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42
USC 264; PL 110-85, sec 1002(a)(2)
Abstract: The Food and Drug Administration (FDA) is proposing
regulations for process controls for animal feed ingredients and mixed
animal feed to provide greater assurance that marketed animal feed
ingredients and mixed feeds intended for all animals, including pets,
are safe. This action is being taken as part of the FDA's Animal Feed
Safety System initiative. The proposed process controls will apply to
animal feed ingredients and mixed animal feed, including pet food. This
action is also being taken to carry out the requirements of the Food
and Drug Administration Amendments Act of 2007. Section 1002(a) directs
FDA to establish by regulation processing standards for pet food. This
same provision of the law also directs that, in developing these new
regulations, FDA obtain input from its stakeholders, including the
Association of American Feed Control Officials, veterinary medical
associations, animal health organizations, and pet food manufacturers.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/00/11
NPRM Comment Period End 06/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Kim Young, Deputy Director, Division of Compliance,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519
Standish Place, Rockville, MD 20855
Phone: 240 276-9207
Email: kim.young@fda.hhs.gov
RIN: 0910-AG10
_______________________________________________________________________
143. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND
ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED
AMENDMENT OF FINAL MONOGRAPH
Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360;
21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a monograph is issued, only OTC drugs meeting the
conditions of the monograph, or having an approved new drug
application, may be legally marketed. This action will propose changes
to the final monograph to address safety and efficacy issues associated
with pediatric cough and cold products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AG12
_______________________________________________________________________
144. UNIQUE DEVICE IDENTIFICATION
Legal Authority: Not Yet Determined
Abstract: The Food and Drug Administration Amendments Act of 2007,
amended the Federal Food, Drug, and Cosmetic Act by adding section
519(f) (21 USC 360i(f)). This section requires FDA to promulgate
regulations establishing a unique identification system for medical
devices requiring the label of medical devices to bear a unique
identifier, unless FDA specifies an alternative placement or provides
for exceptions. The unique identifier must adequately identify the
device through distribution and use, and may include information on the
lot or serial number.
[[Page 21794]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: John J. Crowley, Senior Advisor for Patient Safety,
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New
Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 980-1936
Email: jay.crowley@fda.hhs.gov
RIN: 0910-AG31
_______________________________________________________________________
145. PRODUCE SAFETY REGULATION
Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264
Abstract: The Food and Drug Administration (FDA) has determined that
enforceable standards (as opposed to voluntary recommendations) for the
production and packing of fresh produce are necessary to ensure best
practices are commonly adopted. FDA is proposing to promulgate
regulations setting enforceable standards for fresh produce safety at
the farm and packing house. The purpose of the proposed rule is to
reduce the risk of illness associated with contaminated fresh produce.
The proposed rule will be based on prevention-oriented public health
principles and incorporate what we have learned in the past decade
since the agency issued general good agricultural practice guidelines
entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables'' (GAPs Guide). The proposed rule also will
reflect comments received on the agency's 1998 update of its GAPs guide
and its July 2009 draft commodity specific guidances for tomatoes,
leafy greens, and melons. Although the proposed rule will be based on
recommendations that are included in the GAPs guide, FDA does not
intend to make the entire guidance mandatory. FDA's proposed rule
would, however, set out clear standards for implementation of modern
preventive controls. The proposed rule also would emphasize the
importance of environmental assessments to identify hazards and
possible pathways of contamination and provide examples of risk
reduction practices recognizing that operators must tailor their
preventive controls to particular hazards and conditions affecting
their operations. The requirements of the proposed rule would be scale
appropriate and commensurate with the relative risks and complexity of
individual operations. FDA intends to issue guidance after the proposed
rule is finalized to assist industry in complying with the requirements
of the new regulation.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Samir Assar, Department of Health and Human Services,
Food and Drug Administration, Center for Food Safety and Applied
Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College
Park, MD 20740
Phone: 301 436-1636
Email: samir.assar@fda.hhs.gov
RIN: 0910-AG35
_______________________________________________________________________
146. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES
REGULATION
Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its current good manufacturing practices (CGMP) regulations (21 CFR
part 110) for manufacturing, packing, or holding human food. This
proposed rule would require food facilities to address issues such as
environmental pathogens, food allergens, mandatory employee training,
and sanitation of food contact surfaces. The proposed rule also would
require food facilities to develop and implement preventive control
systems. FDA is taking this action to better address changes that have
occurred in the food industry and protect public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Paul South, Department of Health and Human Services,
Food and Drug Administration, Center for Food Safety and Applied
Nutrition (HFS-317), Office of Food Safety, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone: 301 436-1640
Email: paul.south@fda.hhs.gov
RIN: 0910-AG36
_______________________________________________________________________
147. CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION
AND TOBACCO CONTROL ACT
Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and
Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco
Control Act
Abstract: The Family Smoking Prevention and Tobacco Control Act (the
Tobacco Control Act) provides FDA authority to regulate cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by
the Tobacco Control Act, permits FDA to issue regulations deeming other
tobacco products to be subject to the Tobacco Control Act. This
proposed rule would deem cigars to be subject to the Tobacco Control
Act and include provisions to address public health concerns raised by
cigars.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: May Nelson, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Food
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park,
MD 20740
Phone: 877 287-1373
Fax: 240 276-3904
Email: may.nelson@fda.hhs.gov
RIN: 0910-AG38
[[Page 21795]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
148. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND
BIOLOGICAL PRODUCTS
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and
263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC
331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21
USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381
Abstract: The final rule would amend the postmarketing expedited and
periodic safety reporting regulations for human drugs and biological
products to revise certain definitions and reporting formats as
recommended by the International Conference on Harmonisation and to
define new terms; to add to or revise current reporting requirements;
to revise certain reporting time frames; and to propose other revisions
to these regulations to enhance the quality of safety reports received
by FDA. These revisions were proposed as part of a single rulemaking
(68 FR 12406) to clarify and revise both premarketing and postmarketing
safety reporting requirements for human drug and biological products.
FDA plans to finalize the premarket and postmarket safety reporting
requirements in separate final rules.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/14/03 68 FR 12406
NPRM Comment Period Extended 06/18/03
NPRM Comment Period End 07/14/03
NPRM Comment Period Extension
End 10/14/03
Final Action 11/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6362, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3469
Fax: 301 847-8440
Email: jane.baluss@fda.hhs.gov
RIN: 0910-AA97
_______________________________________________________________________
149. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING
PRACTICE REQUIREMENTS
Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353
Abstract: The Food and Drug Administration is amending its current good
manufacturing practice regulations and other regulations to clarify and
strengthen requirements for the label, color, dedication, and design of
medical gas containers and closures. Despite existing regulatory
requirements and industry standards for medical gases, there have been
repeated incidents in which cryogenic containers of harmful industrial
gases have been connected to medical oxygen supply systems in hospitals
and nursing homes and subsequently administered to patients. These
incidents have resulted in death and serious injury. There have also
been several incidents involving high-pressure medical gas cylinders
that have resulted in death and injuries to patients. These amendments,
together with existing regulations, are intended to ensure that the
types of incidents that have occurred in the past, as well as other
types of foreseeable and potentially deadly medical gas accidents, do
not occur in the future.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/10/06 71 FR 18039
NPRM Comment Period End 07/10/06
Final Action 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3522
Fax: 301 847-8440
Email: patrick.raulerson@fda.hhs.gov
RIN: 0910-AC53
_______________________________________________________________________
150. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371;
21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
Abstract: To amend the regulations governing the format and content of
labeling for human prescription drugs and biological products (21 CFR
parts 201.56, 201.57, and 201.80). Under FDA's current regulations,
labeling concerning the use of prescription drugs in pregnancy uses
letter categories (A, B, C, D, X) to characterize the risk to the fetus
of using the drug in pregnancy. One of the deficiencies of the category
system is that drugs may be assigned to the same category when the
severity, incidence, and types of risk are quite different.
Dissatisfaction with the category system has been expressed by health
care providers, medical organizations, experts in the study of birth
defects, women's health researchers, and women of childbearing age.
Stakeholders consulted through a public hearing, several focus groups,
and several advisory committees have recommended that FDA replace the
category system with a concise narrative summarizing a product's risks
to pregnant women and to women of childbearing age. Therefore, the
revised format and the information provided in the labeling would make
it easier for health care providers to understand the risks and
benefits of drug use during pregnancy and lactation.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/29/08 73 FR 30831
NPRM Comment Period End 08/27/08
Final Action 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone: 301 796-4288
[[Page 21796]]
Fax: 301 847-8440
Email: rachel.bressler@fda.hhs.gov
RIN: 0910-AF11
_______________________________________________________________________
151. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND
QUALITY FACTORS
Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . .
Abstract: The Food and Drug Administration (FDA) is revising its infant
formula regulations in 21 CFR parts 106 and 107 to establish
requirements for current good manufacturing practices (CGMP), including
audits; to establish requirements for quality factors; and to amend
FDA's quality control procedures, notification, and record and
reporting requirements for infant formula. FDA is taking this action to
improve the protection of infants who consume infant formula products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/09/96 61 FR 36154
NPRM Comment Period End 12/06/96
NPRM Comment Period Reopened 04/28/03 68 FR 22341
NPRM Comment Period Extended 06/27/03 68 FR 38247
NPRM Comment Period End 08/26/03
NPRM Comment Period Reopened 08/01/06 71 FR 43392
NPRM Comment Period End 09/15/06
Final Action 10/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Benson Silverman, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park,
MD 20740
Phone: 301 436-1459
Email: benson.silverman@fda.hhs.gov
RIN: 0910-AF27
_______________________________________________________________________
152. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR)
PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses labeling for single ingredient bronchodilator products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment--Ephedrine
Single Ingredient) 07/13/05 70 FR 40237
NPRM Comment Period End 11/10/05
Final Action (Technical
Amendment) 11/30/07 72 FR 67639
Final Action (Amendment--Single
Ingredient Labeling) 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF32
_______________________________________________________________________
153. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION)
PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses cough/cold drug products containing an oral bronchodilator
(ephedrine and its salts) in combination with any expectorant or any
oral nasal decongestant.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) 07/13/05 70 FR 40232
NPRM Comment Period End 11/10/05
Final Action (Technical
Amendment) 03/19/07 72 FR 12730
Final Action 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF33
_______________________________________________________________________
154. 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) 12/00/10
NPRM (Amendment) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human
[[Page 21797]]
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring,
MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF35
_______________________________________________________________________
155. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The first
action addresses skin protectant products used to treat fever blisters
and cold sores. The second action identifies safe and effective skin
protectant active ingredients to treat and prevent diaper rash.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Aluminum Acetate)
(Technical Amendment) 03/06/09 74 FR 9759
Final Action (Diaper Rash) 03/00/11
Final Action (Technical
Amendments) 02/01/08 73 FR 6014
Final Action (Fever Blisters/
Cold Sores) 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF42
_______________________________________________________________________
156. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS
Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371
Abstract: On July 14, 2004, FDA issued an interim final rule (IFR),
effective immediately, to prohibit the use of certain cattle material
and to address the potential risk of bovine spongiform encephalopathy
(BSE) in human food, including dietary supplements, and cosmetics.
Prohibited cattle materials under the IFR include specified risk
materials, small intestine of all cattle, material from nonambulatory
disabled cattle, material from cattle not inspected and passed for
human consumption, and mechanically separated (MS) beef. Specified risk
materials are the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse
processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older; and the
tonsils and distal ileum of the small intestine of all cattle.
Prohibited cattle materials do not include tallow that contains no more
than 0.15 percent hexane-insoluble impurities and tallow derivatives.
This action minimizes human exposure to materials that scientific
studies have demonstrated are highly likely to contain the BSE agent in
cattle infected with the disease. Scientists believe that the human
disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by
the consumption of products contaminated with the agent that causes
BSE.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 07/14/04 69 FR 42256
Interim Final Rule Effective 07/14/04
Interim Final Rule Comment
Period End 10/12/04
Interim Final Rule (Amendments) 09/07/05 70 FR 53063
Interim Final Rule (Amendments)
Effective 10/07/05
Interim Final Rule (Amendments)
Comment Period End 11/07/05
Interim Final Rule (Amendments) 04/17/08 73 FR 20785
Interim Final Rule (Amendments)
Comment Period End 07/16/08
Interim Final Rule (Amendments)
Effective 07/16/08
Final Action 10/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Amber McCoig, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2644
Email: amber.mccoig@fda.hhs.gov
RIN: 0910-AF47
_______________________________________________________________________
157. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE
UNITED STATES
Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343;
21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264
Abstract: The final rule will require owners or consignees to label
imported food that is refused entry into the United States. The label
will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the
label's characteristics (such as its size) and processes for verifying
that the label has been affixed properly. We are taking this action to
prevent the introduction of unsafe food into the United States, to
facilitate the examination of imported food, and to implement section
308 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/18/08 73 FR 54106
NPRM Comment Period End 12/02/08
Final Action 03/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: John D. Reilly, Regulatory Counsel, Department of
Health and Human Services, Food and
[[Page 21798]]
Drug Administration, Center for Food Safety and Applied Nutrition, CPK
1, Room 1C-015, (HFS-024), 5100 Paint Branch Parkway, College Park, MD
20740
Phone: 301 436-1530
Fax: 301 436-2637
Email: john.reilly@fda.hhs.gov
RIN: 0910-AF61
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
158. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING,
LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Legal Authority: 21 USC 321; 21 USC 342 and 343; 21 USC 348; 21 USC
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264
Abstract: The Food and Drug Administration published a final rule in
the Federal Register of June 25, 2007 (72 FR 34752), on current good
manufacturing practice (CGMP) regulations for dietary supplements. FDA
also published an Interim Final Rule in the same Federal Register (72
FR 34959) that provided a procedure for requesting an exemption from
the final rule requirement that the manufacturer conduct at least one
appropriate test or examination to verify the identity of any component
that is a dietary ingredient. This IFR allows for submission to, and
review by, FDA of an alternative to the required 100 percent identity
testing of components that are dietary ingredients, provided certain
conditions are met. This IFR also establishes a requirement for
retention of records relating to the FDA's response to an exemption
request.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 02/06/97 62 FR 5700
ANPRM Comment Period End 06/06/97
NPRM 03/13/03 68 FR 12157
NPRM Comment Period End 08/11/03
Final Rule 06/25/07 72 FR 34752
Interim Final Rule 06/25/07 72 FR 34959
Interim Final Rule Comment
Period End 10/24/07
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health
and Human Services, Food and Drug Administration, Center for Food
Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone: 301 436-2784
Fax: 301 436-2657
Email: linda.kahl@fda.hhs.gov
RIN: 0910-AB88
_______________________________________________________________________
159. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT)
PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses the ingredient phenylpropanolamine.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Sinusitis
Claim) 08/02/04 69 FR 46119
NPRM Comment Period End 11/01/04
NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482
NPRM Comment Period End 01/31/05
NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988
NPRM Comment Period End 03/22/06
Final Action (Amendment)
(Sinusitis Claim) 10/31/05 70 FR 58974
Final Action (Phenylephrine
Bitartrate) 08/01/06 71 FR 83358
Final Action (Phenyl-
propanolamine) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF34
_______________________________________________________________________
160. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR
OTC HUMAN USE
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses labeling for convenience (small) size OTC drug packages.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Convenience Sizes) 12/12/06 71 FR 74474
NPRM Comment Period End 04/11/07
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF37
[[Page 21799]]
_______________________________________________________________________
161. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
finalizes the monograph for emergency first aid eyewash drug products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Emergency
First Aid Eyewashes) 02/19/03 68 FR 7917
Final Action (Amendment)
(Emergency First Aid Eyewashes) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF39
_______________________________________________________________________
162. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360 to 360a; 21 USC 371 to 371a
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The NPRM and
final action will address oral health care products used to reduce or
prevent dental plaque and gingivitis.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM (Plaque Gingivitis) 05/29/03 68 FR 32232
ANPRM Comment Period End 08/27/03
NPRM (Plaque Gingivitis) To Be Determined
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF40
_______________________________________________________________________
163. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The proposed
rule addresses vaginal contraceptive drug products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Warnings) 12/19/07 72 FR 71769
NPRM (Vaginal Contraceptive Drug
Products) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF44
_______________________________________________________________________
164. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The NPRM
addresses the use of benzocaine for weight control. The first final
action finalizes the 2005 proposed rule for weight control products
containing phenylpropanolamine. The second final action will finalize
the proposed rule for weight control products containing benzocaine.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988
NPRM Comment Period End 03/22/06
NPRM (Benzocaine) To Be Determined
Final Action (Phenyl-
propanolamine) To Be Determined
Final Action (Benzocaine) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF45
[[Page 21800]]
_______________________________________________________________________
165. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND
DRINK PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses products containing bismuth subsalicylate for relief of
symptoms of upset stomach due to overindulgence resulting from food and
drink.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) 01/05/05 70 FR 741
NPRM Comment Period End 04/05/05
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF51
_______________________________________________________________________
166. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. One action
addresses the labeling of products containing sodium bicarbonate as an
active ingredient. The other action addresses the use of antacids to
relieve upset stomach associated with overindulgence in food and drink.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Sodium Bicarbonate
Labeling) To Be Determined
Final Action (Overindulgence
Labeling) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF52
_______________________________________________________________________
167. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses skin bleaching drug products containing hydroquinone.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/29/06 71 FR 51146
NPRM Comment Period End 12/27/06
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF53
_______________________________________________________________________
168. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses the use of stimulant active ingredients to relieve symptoms
associated with a hangover.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Hangover) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF56
_______________________________________________________________________
169. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. These actions
address new labeling for antidiarrheal drug products.
[[Page 21801]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (New Labeling) To Be Determined
Final Action (New Labeling) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF63
_______________________________________________________________________
170. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses the products used for urinary pain relief.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Urinary Analgesic) To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF70
_______________________________________________________________________
171. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II
ACTIVE INGREDIENTS
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371
Abstract: The Food and Drug Administration (FDA) is proposing that
certain ingredients in over-the-counter (OTC) drug products are not
generally recognized as safe and effective or are misbranded. FDA
issued this proposed rule because we did not receive any data and
information on these ingredients in response to our request on December
31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/19/08 73 FR 34895
NPRM Comment Period End 09/17/08
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22, Room
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF95
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
172. 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
adopts CGMPs that reflect the unique characteristics of PET drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/20/05 70 FR 55038
NPRM Comment Period End 12/19/05
Final Action 12/10/09 74 FR 65409
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Reena Raman, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., WO 51, Room 6238,
Silver Spring, MD 20993-0002
Phone: 301 796-7577
Fax: 301 847-8440
Email: reena.raman@fda.hhs.gov
RIN: 0910-AC55
_______________________________________________________________________
173. 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 03/04/10 75 FR 9767
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Walter J. Ellenberg, Regulatory Project Management
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO-22,
[[Page 21802]]
Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AG00
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
174. 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), last set in 1999, 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 09/00/10
Regulatory Flexibility Analysis Required: Undetermined
Agency Contact: Danielle Shearer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards & Quality, Mailstop S3-02-01,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617
Email: danielle.shearer@cms.hhs.gov
RIN: 0938-AG81
_______________________________________________________________________
175. 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 that in order to
participate in the Medicare and Medicaid programs, long-term care (LTC)
facilities must have an agreement with hospice agencies when hospice
care is provided in a long-term care facility. We are proposing new
requirements to ensure that quality hospice care is provided to
eligible residents.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/00/11
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
_______________________________________________________________________
176. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT
SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES AND TO THE LONG-TERM
CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P)
Legal Authority: Sec 1886(d) of the Social Security Act
Abstract: This annual proposed rule would revise the Medicare hospital
inpatient and long-term care prospective payment systems for operating
and capital-related costs to implement changes arising from our
continuing experience with these systems. These changes would be
applicable to services furnished on or after October 1st.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Tiffany Swygert, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop C4-25-11, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-4642
Email: tiffany.swygert@cms.hhs.gov
RIN: 0938-AP80
_______________________________________________________________________
177. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS-1504-P)
Legal Authority: sec 1833 of the Social Security Act
Abstract: This annual proposed 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. 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
1st.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Alberta Dwivedi, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C5-01-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-0763
Email: alberta.dwivedi@cms.hhs.gov
RIN: 0938-AP82
[[Page 21803]]
_______________________________________________________________________
178. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE
FOR CY 2011 (CMS-1510-P)
Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302
and 42 USC 1395(hh); Social Security Act, sec 1895
Abstract: This annual proposed rule would update the 60-day national
episode rate (based on the applicable Home Health Market Basket Update
and case-mix adjustment) and would also update the national per-visit
rates (used to calculate low utilization payment adjustments (LUPAs)
and outlier payments) amounts under the Medicare Prospective Payment
System for home health agencies. These changes would be applicable to
services furnished on or after January 1st.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Randy Throndeset, Technical Advisor, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Centers for Medicare Management, Mailstop C5-07-28, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-0131
Email: randy.throndeset@cms.hhs.gov
RIN: 0938-AP88
_______________________________________________________________________
179. OMNIBUS INFLUENZA IMMUNIZATION (CMS-3213-P)
Legal Authority: Social Security Act sec 1881, 1861, 1920, 1102, 1871,
1965
Abstract: This proposed rule would require certain providers to offer
all patients or residents an influenza immunization annually. The
providers required to do so are hospitals, intermediate care
facilities, critical access hospitals, rural health clinics, Federally
qualified health centers, ESRD facilities, psychiatric residential
treatment facilities, and inpatient rehabilitation facilities. This
proposed rule is based on the most recent recommendations from the
CDC's Advisory 3 Committee on Immunization Practices. The goal of this
proposed rule is to improve influenza immunization rates for all
patients and residents and to address the disparities in immunization
rates
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/10
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4683
Email: lauren.oviatt@cms.hhs.gov
RIN: 0938-AP92
_______________________________________________________________________
180. PROPOSED CHANGES TO THE HOSPITAL CONDITIONS OF
PARTICIPATION: REQUIREMENTS FOR HOSPITAL PSYCHIATRIC AND REHABILITATION
UNITS EXCLUDED FROM THE PROSPECTIVE PAYMENT SYSTEM (CMS-3177-P)
Legal Authority: 42 USC 1385 X; 42 USC 1396 d; 42 USC 1395 hh
Abstract: This proposed rule would transfer the existing process
requirements for hospital psychiatric and rehabilitation units that are
excluded from prospective payment systems to the hospital conditions of
participation (CoPs) part of the Act. This would allow accrediting
organizations to deem these units as part of their hospital
accreditation process providing a timely and cost effective survey and
certification process under the CoPs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/00/11
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Scott Cooper, Health Insurnce Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Mail stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9465
Email: scott.cooper@cms.hhs.gov
RIN: 0938-AP97
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
181. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG
BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS-4085-F)
Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security
Act)
Abstract: This final rule makes revisions to the regulations governing
the Medicare Advantage (MA) program (Part C) and prescription drug
benefit program (Part D) based on our continued experience in the
administration of the Part C and D programs. The revisions strengthen
various program participation and exit requirements; strengthen
beneficiary protections; ensure that plan offerings to beneficiaries
include meaningful differences; improve plan payment rules and
processes; improve data collection for oversight and quality
assessment; implement new policy such as a Part D formulary policy; and
clarify program policy.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/22/09 74 FR 54634
NPRM Comment Period End 12/07/09
Final Action 10/00/12
Regulatory Flexibility Analysis Required: Yes
Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy
and Quality, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Mail Stop C1-26-26, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-6041
Email: alissa.deboy@cms.hhs.gov
RIN: 0938-AP77
[[Page 21804]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
182. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-IFC)
Legal Authority: 42 USC 1320d-2(a)(2)(B)
Abstract: This rule sets forth electronic standards for health care
claims attachments. The standards are required by the Health Insurance
Portability and Accountability Act of 1996. They will be used to
transmit clinical or administrative data for claims adjudication
purposes.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/23/05 70 FR 55989
NPRM Comment Period End 11/22/05
Withdrawn 01/25/10
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
_______________________________________________________________________
183. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR
CY 2010 (CMS-1413-FC)
Legal Authority: Social Security Act, sec 1102; Social Security Act,
sec 1871
Abstract: This annual rule revises payment polices under the physician
fee schedule, as well as other policy changes to payment under Part B.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/13/09 74 FR 33520
NPRM Comment Period End 08/31/09
Final Action 11/25/09 74 FR 61738
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
Boulevard, Baltimore, MD 21244
Phone: 410 786-3355
Email: diane.milstead@cms.hhs.gov
RIN: 0938-AP40
_______________________________________________________________________
184. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-FC)
Legal Authority: BBA; BBA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA
Abstract: This annual rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system and to implement certain related provisions of the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA). In
addition, the rule describes changes to the amounts and factors used to
determine the payment rates for Medicare hospital outpatient services
paid under the prospective payment system. The rule also changes the
Ambulatory Surgical Center Payment System list of services and rates.
These changes are applicable to services furnished on or after January
1st.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/20/09 74 FR 35231
NPRM Comment Period End 08/31/09
Final Action 11/20/09 74 FR 60315
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 Boulevard, Baltimore, MD 21244
Phone: 410 786-0763
Email: alberta.dwivedi@cms.hhs.gov
RIN: 0938-AP41
[FR Doc. 2010-8934 Filed 04-23-10; 8:45 am]
BILLING CODE 4150-24-S