[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Unknown Section]
[Pages 21781-21804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8934]


[[Page 21781]]

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Part VII





Department of Health and Human Services





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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
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                                                                                                     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)......................................
----------------------------------------------------------------------------------------------------------------


                   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)...........................................................................
----------------------------------------------------------------------------------------------------------------


                  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.....................................
----------------------------------------------------------------------------------------------------------------


[[Page 21783]]


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
127         Quality Assurance Requirements for Respirators........................................    0920-AA04
128         Control of Communicable Diseases: Foreign Quarantine..................................    0920-AA12
----------------------------------------------------------------------------------------------------------------


                          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)...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
130         Control of Communicable Diseases: Interstate Quarantine, Passenger Information........    0920-AA27
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


[[Page 21785]]


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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)...................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
181         Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs       0938-AP77
            for Contract Year 2011 (CMS-4085-F)...................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
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).......................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________
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