2010-08934 Pi

Monday,
April 26, 2010
Part VII
Department of
Health and Human
Services
Semiannual Regulatory Agenda
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62 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
DEPARTMENT OF HEALTH AND Services (HHS). We hope that this Regulatory Flexibility Act of 1980, relate
HUMAN SERVICES information will enable interested only to those prospective rulemakings
members of the public to more that are likely to have a significant
Office of the Secretary effectively participate in the economic impact on a substantial
Department’s regulatory activity. number of small entities.
21 CFR Ch. I
FOR FURTHER INFORMATION CONTACT: The purpose of the Agenda is to
42 CFR Chs. I-V Dawn L. Smalls, Executive Secretary, encourage more effective public
Department of Health and Human participation in the regulatory process.
45 CFR Subtitle A; Subtitle B, Chs. II, Services, Washington, DC 20201. HHS invites all interested members of
III, and XIII SUPPLEMENTARY INFORMATION: The the public to comment on the
information provided in the Agenda rulemaking actions included in this
Regulatory Agenda presents a forecast of the rulemaking issuance of the Agenda. The complete
AGENCY: Office of the Secretary, HHS. activities that HHS expects to undertake Agenda is accessible online at
in the foreseeable future. Rulemakings www.reginfo.gov in an interactive
ACTION: Semiannual regulatory agenda format that offers users enhanced
are grouped according to pre-
rulemaking actions, proposed rules, capabilities to obtain information from
SUMMARY: The following Agenda final rules, long-term actions, and the Agenda’s database.
presents the results of the statutorily rulemaking actions completed since the
required semi-annual inventory of most recent Agenda was published on Dated: March 10, 2010.
rulemaking actions currently under December 7, 2009. Please note that the Dawn L. Smalls,
development within the U.S. actions included in this issue of the Executive Secretary,
Department of Health and Human Federal Register, as required by the 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 Information Technology
for Economic and Clinical Health Act .......................................................................................................................... 0991–AB57
Office of the Secretary—Final Rule Stage

Regulation
Number Number
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) .......................... 0991–AB58
Substance Abuse and Mental Health Services Administration—Final Rule Stage

Regulation
Number Number
122 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review) ...................... 0930–AA14
Substance Abuse and Mental Health Services Administration—Long-Term Actions

Regulation
Number Number
123 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities
for Children and Youth ................................................................................................................................................ 0930–AA10
Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda 63
HHS
Centers for Disease Control and Prevention—Proposed Rule Stage

Regulation
Number Number
124 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Im-
portation Regulations ................................................................................................................................................... 0920–AA14
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
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
Number Number
129 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 Review) ....................... 0920–AA32
Centers for Disease Control and Prevention—Completed Actions

Regulation
Number Number
130 Control of Communicable Diseases: Interstate Quarantine, Passenger Information ................................................... 0920–AA27
Food and Drug Administration—Prerule Stage

Regulation
Number Number
131 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Dis-
tribution (Section 610 Review) ................................................................................................................................... 0910–AG06
132 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and
Administrative Procedures (Section 610 Review) ...................................................................................................... 0910–AG14
133 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 Review) ......................... 0910–AG25
134 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and
Adolescents ................................................................................................................................................................. 0910–AG33
135 Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review) ...................................................... 0910–AG34
Food and Drug Administration—Proposed Rule Stage

Regulation
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
HHS
Food and Drug Administration—Proposed Rule Stage (Continued)

Regulation
Number Number
143 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
Human Use; Proposed Amendment of Final Monograph ........................................................................................... 0910–AG12
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
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; Requirements for Pregnancy and
Lactation Labeling ........................................................................................................................................................ 0910–AF11
151 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements;
Records and Reports; and Quality Factors ................................................................................................................. 0910–AF27
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
Number Number
158 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Sup-
plements ...................................................................................................................................................................... 0910–AB88
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
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
HHS
Centers for Medicare & Medicaid Services—Proposed Rule Stage

Regulation
Number Number
174 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) .................... 0938–AG81
175 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 Review) .................... 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) .............................................. 0938–AP80
177 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Sys-
tem for CY 2011 (CMS-1504-P) .................................................................................................................................. 0938–AP82
178 Home Health Prospective Payment System Refinements and Rate Update for CY 2011 (CMS-1510-P) .................. 0938–AP88
179 Omnibus Influenza Immunization (CMS-3213-P) .......................................................................................................... 0938–AP92
180 Proposed Changes to the Hospital Conditions of Participation: Requirements for Hospital Psychiatric and Rehabili-
tation Units Excluded From the Prospective Payment System (CMS-3177-P) .......................................................... 0938–AP97
Centers for Medicare & Medicaid Services—Long-Term Actions

Regulation
Number Number
181 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs for Contract Year 2011
(CMS-4085-F) .............................................................................................................................................................. 0938–AP77
Centers for Medicare & Medicaid Services—Completed Actions

Regulation
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-FC) ............................. 0938–AP40
184 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Sys-
tem for CY 2010 (CMS-1414-FC) ................................................................................................................................ 0938–AP41
Department of Health and Human Services (HHS) Proposed Rule Stage

Office of the Secretary (OS)
120. MODIFICATIONS TO THE HIPAA Enforcement Rules as necessary to Regulatory Flexibility Analysis
PRIVACY, SECURITY, AND implement the privacy, security, and Required: Yes
ENFORCEMENT RULES UNDER THE certain enforcement provisions of
HEALTH INFORMATION subtitle D of the Health Information Agency Contact: Andra Wicks,
TECHNOLOGY FOR ECONOMIC AND Technology for Economic and Clinical Department of Health and Human
CLINICAL HEALTH ACT Health Act (Title XIII of the American Services, 200 Independence Avenue
Legal Authority: PL 111–5, secs 13400 Recovery and Reinvestment Act of SW., Washington, DC 20201
to 13410 2009). Phone: 202 205–2292
Fax: 202 205–4786
Abstract: The Department of Health Timetable:
and Human Services Office for Civil Email: andra.wicks@hhs.gov
Action Date FR Cite
Rights will issue rules to modify the RIN: 0991–AB57
HIPAA Privacy, Security, and NPRM 05/00/10
Department of Health and Human Services (HHS) Final Rule Stage

Office of the Secretary (OS)
121. HEALTH INFORMATION specifications, and certification criteria, Action Date FR Cite
TECHNOLOGY: INITIAL SET OF as required by section 3004(b)(1) of the
STANDARDS, IMPLEMENTATION Public Health Service Act. The Interim Final Rule 02/12/10
SPECIFICATIONS, AND Effective
certification criteria adopted in this
CERTIFICATION CRITERIA FOR Final Action 05/00/10
initial set establish the technical
ELECTRONIC HEALTH RECORD Final Action Effective 06/00/10
capabilities and related standards that
TECHNOLOGY (RULEMAKING certified electronic health record (EHR) Regulatory Flexibility Analysis
RESULTING FROM A SECTION 610 technology will need to include in Required: No
REVIEW) support of the Medicare and Medicaid Agency Contact: Steven Posnack,
Legal Authority: 42 USC 300jj–14 EHR Incentive Programs. Policy Analyst, Department of Health
Abstract: The Department of Health and Human Services, Office of the
Timetable:
and Human Services (HHS), Office of Secretary, Office of the National
the National Coordinator for Health Action Date FR Cite Coordinator for Health Information
Information Technology, will issue an Technology, 200 Independence Avenue
Interim Final Rule 01/13/10 75 FR 2014
interim final rule with a request for SW., Washington, DC 20201
Interim Final Rule 03/15/10 Phone: 202 690–7151
comments to adopt an initial set of Comment Period
standards, implementation End RIN: 0991–AB58

Substance Abuse and Mental Health Services Administration (SAMHSA)
122. OPIOID DRUGS IN buprenorphine and buprenorphine Regulatory Flexibility Analysis

MAINTENANCE OR DETOXIFICATION combination products that are approved Required: No
TREATMENT OF OPIATE ADDICTION by the Food and Drug Administration
(SECTION 610 REVIEW) (FDA) for opioid dependence and used Agency Contact: Nicholas Reuter,
in federally certified and registered Department of Health and Human
Legal Authority: 21 USC 823 (9); 42 Services, Substance Abuse and Mental
opioid treatment programs.
USC 257a; 42 USC 290aa(d); 42 USC Health Services Administration, Suite
290dd–2; 42 USC 300xx–23; 42 USC Timetable:
2–1063, One Choke Cherry Road,
300x–27(a); 42 USC 300y–11 Action Date FR Cite Rockville, MD 20857
Abstract: This rule will amend the NPRM 06/19/09 74 FR 29153 Phone: 240 276–2716
Federal opioid treatment program NPRM Comment 08/18/09
regulations. It will modify the Period End RIN: 0930–AA14
dispensing requirements for Final Action 09/00/10
Department of Health and Human Services (HHS) Long-Term Actions

Substance Abuse and Mental Health Services Administration (SAMHSA)
123. REQUIREMENTS GOVERNING rules and monitoring requirements Regulatory Flexibility Analysis
THE USE OF SECLUSION AND concerning behavior management Required: Yes
RESTRAINT IN CERTAIN practice that will ensure compliance;
NONMEDICAL COMMUNITY–BASED requires States to develop and Agency Contact: Paolo Del Vecchio,
FACILITIES FOR CHILDREN AND implement such licensing rules and Department of Health and Human
YOUTH implementation requirements within Services, Substance Abuse and Mental
Legal Authority: PL 106–310, 42 USC one year; and ensures that States Health Services Administration, Room
290jj to 290jj–2 require such facilities to have adequate 13–103, Parklawn Building, 5600
staff, and that the States provide Fishers Lane, Rockville, MD 20857
Abstract: The Secretary is required by training for professional staff. Phone: 301 443–2619
statute to publish regulations governing
States that license nonmedical, Timetable: RIN: 0930–AA10
community-based residential facilities
Action Date FR Cite
for children and youth. The regulation
requires States to develop licensing NPRM To Be Determined

Centers for Disease Control and Prevention (CDC)
124. CONTROL OF COMMUNICABLE Agency Contact: Stacy Howard, Timetable:

DISEASES: FOREIGN QUARANTINE Department of Health and Human Action Date FR Cite
REGULATIONS, PROPOSED REVISION Services, Centers for Disease Control
OF HHS/CDC ANIMAL IMPORTATION and Prevention, MS E03, CLFT NPRM 08/00/10
REGULATIONS Building 16, Room 4324, Atlanta, GA Regulatory Flexibility Analysis
Legal Authority: 42 USC 264 30329 Required: Yes
Phone: 404 498–1600
Abstract: By statute, the Secretary of Email: showard@cdc.gov Agency Contact: Stacy Howard,
Health and Human Services has broad Department of Health and Human
authority to prevent introduction, RIN: 0920–AA14
Services, Centers for Disease Control
transmission, and spread of and Prevention, MS E03, CLFT
communicable diseases from foreign 125. CONTROL OF COMMUNICABLE Building 16, Room 4324, Atlanta, GA
countries into the United States and DISEASES: FOREIGN QUARANTINE 30329
from one State or possession into REGULATIONS, NONHUMAN PRIMATE Phone: 404 498–1600
another. The Secretary has designated Email: showard@cdc.gov
Legal Authority: 42 USC 264
the authority to prevent the
introduction of diseases from foreign Abstract: By statute, the Secretary of RIN: 0920–AA23
countries to the Director, Centers for Health and Human Services has broad
Disease Control and Prevention (CDC). authority to prevent introduction,
CDC also enforces entry requirements transmission, and spread of 126. TOTAL INWARD LEAKAGE
for certain animals, etiologic agents, communicable diseases from foreign REQUIREMENTS FOR RESPIRATORS
and vectors deemed to be of public countries into the United States and Legal Authority: 29 USC 651 et seq;
health significance. Currently the from one State or possession into 29 USC 657(g); 30 USC 3; 30 USC 7;
regulations restrict the importation of another. The Secretary has delegated 30 USC 811; 30 USC 842(h) and 844
nonhuman primates, dogs, cats, small the authority to prevent the
turtles, etiologic agents, hosts, and introduction of diseases from foreign Abstract: The Centers for Disease
vectors, such as bats (42 CFR sections countries to the Director, CDC. CDC Control and Prevention (CDC) proposes
71.53, 71.51, 71.52, 71.54). In addition, also enforces entry requirements for to establish total inward leakage (TIL)
CDC has recently issued a series of certain animals, etiologic agents, and requirements under 42 CFR part 84 for
emergency orders restricting the vectors deemed to be of public health half-mask air-purifying particulate
importation of African rodents (42 CFR significance. CDC is proposing to respirators approved by the National
section 71.56) and civets (67 FR 3364- amend its regulations related to the Institute for Occupational Safety and
01). CDC is issuing this Notice of importation of live nonhuman primates Health (NIOSH) of CDC.
Proposed Rulemaking (NPRM) to revise (NHPs) by extending existing
requirements for the importation of Timetable:
the regulations for importation of
certain animals and vectors into the cynomolgus, African green, and rhesus Action Date FR Cite
United States (42 CFR parts 71, subpart monkeys to all NHPs. The agency also
NPRM 10/30/09 74 FR 66935
F). is proposing to reduce the frequency
NPRM Comment 12/29/09
at which importers of the three species Period End
Timetable:
are required to renew their registrations NPRM Comment 04/00/10
Action Date FR Cite (from every 180 days to every 2 years). Period Reopened
ANPRM 07/31/07 72 FR 41676 CDC proposes to incorporate existing
ANPRM Comment 10/01/07 guidelines into the regulations and add Regulatory Flexibility Analysis
Period End new provisions to address NHPs Required: Yes
Notice Extending 10/01/07 72 FR 55729 imported as part of a circus or trained Agency Contact: William E. Newcomb,
ANPRM Comment animal act, NHPs imported by Physical Scientist, Department of
Period zoological societies, the transfer of Health and Human Services, Centers for
ANPRM Extended 12/01/07 NHPs from approved laboratories, and
Comment Period Disease Control and Prevention, 626
non-live imported NHP products. CDC Cochran Mill Road, PO Box 18070,
End is also proposing that all NHPs be
NPRM 11/00/10 Pittsburgh, PA 15236
imported only through ports of entry Phone: 412 386–5200
Regulatory Flexibility Analysis where a CDC quarantine station is
Required: Yes located. RIN: 0920–AA33

127. QUALITY ASSURANCE Abstract: NIOSH plans to modify the assurance requirements; 2) ability to
REQUIREMENTS FOR RESPIRATORS Administrative/Quality Assurance use private sector quality auditors and
sections of 42 CFR part 84, Approval private sector testing laboratories in the
Legal Authority: 29 USC 651 et seq; of Respiratory Protective Devices. Areas approval program; and 3) revised
30 USC 3; 30 USC 5; 30 USC 7; 30 for potential modification in this approval label requirements.
USC 811; 30 USC 842(h); 30 USC 844 module are: 1) Upgrade of quality
HHS—CDC Final Rule Stage
Timetable: Abstract: By statute, the Secretary of which diseases may subject individuals
Action Date FR Cite Health and Human Services has broad to quarantine. The current disease list,
authority to prevent introduction, which was last updated in April 2005,
NPRM 12/10/08 73 FR 75045 transmission, and spread of includes cholera, diphtheria,
NPRM Comment 02/09/09 communicable diseases from foreign tuberculosis, plague, smallpox, yellow
Period End
countries into the United States and fever, viral hemorrhagic fevers, severe
NPRM Comment 03/04/09 74 FR 9381
Period Reopened from one State or possession into acute respiratory syndrome (SARS), and
NPRM Comment 04/10/09 another. Quarantine regulations are influenza caused by novel or
Period Reopened divided into two parts: Part 71 dealing reemergent influenza viruses that are
End with foreign arrivals and part 70 causing, or have the potential to cause
NPRM Comment 05/21/09 74 FR 23815 dealing with interstate matters. This a pandemic.
Period Reopening rule (42 CFR part 71) will update and
Extended improve CDC’s response to both global Timetable:
NPRM Comment 10/09/09 and domestic disease threats by Action Date FR Cite
Period End creating a multi-tiered illness detection
Final Action 12/00/10 and response process thus substantially NPRM 11/30/05 70 FR 71892
Regulatory Flexibility Analysis enhancing the public health system’s NPRM Comment 01/20/06
Required: Yes ability to slow the introduction, Period End
transmission, and spread of Final Action 11/00/10
Agency Contact: William E. Newcomb,
Physical Scientist, Department of communicable disease. The rule will
Regulatory Flexibility Analysis
Health and Human Services, Centers for also modify current Federal regulations
Required: Yes
Disease Control and Prevention, 626 governing the apprehension, quarantine
Cochran Mill Road, PO Box 18070, isolation, and conditional release of Agency Contact: Stacy Howard,
Pittsburgh, PA 15236 individuals suspected of carrying a Department of Health and Human
Phone: 412 386–5200 quarantinable disease, while respecting Services, Centers for Disease Control
RIN: 0920–AA04 individual autonomy. CDC maintains and Prevention, MS E03, CLFT
quarantine stations at 20 ports of entry Building 16, Room 4324, Atlanta, GA
staffed with medical and public health 30329
128. CONTROL OF COMMUNICABLE officers who respond to reports of Phone: 404 498–1600
DISEASES: FOREIGN QUARANTINE diseases from carriers. According to the Email: showard@cdc.gov
Legal Authority: 42 USC 243; 42 USC statutory scheme, the President
248 and 249 determines through Executive Order RIN: 0920–AA12

129. POSSESSION, USE, AND to treat and prevent and illness and toxins based on our conclusion
TRANSFER OF SELECT AGENTS AND resulting from infection by the agent or that the Chapare virus has been
TOXINS: CHAPARE VIRUS (SECTION toxin, and 5) any other criteria, phylogenetically identified as a Clade
610 REVIEW) including the needs of children and B arenavirus and is closely related to
Legal Authority: PL 107–188 other vulnerable populations that the other South American arenaviruses that
HHS Secretary considers appropriate. cause haemorrhagic fever, particularly
Abstract: The Public Health Security Based on these criteria, we are Sabia virus.
and Bioterrorism Preparedness and proposing to amend the list of HHS
Response Act of 2002 authorizes the select agents and toxins by adding Timetable:
HHS Secretary to regulate the Chapare virus to the list. After Action Date FR Cite
possession, use, and transfer of select consulting with subject matter experts NPRM 08/19/09 74 FR 159
agents and toxins that have the from CDC, the National Institutes of NPRM Comment 10/19/09
potential to pose a severe threat to Health (NIH), the Food Drug Period End
public health and safety. These Administration (FDA), the United Final Action To Be Determined
regulations are set forth at 42 CFR 73. States Department of Agriculture
Criteria used to determine whether a (USDA) /Animal and Plant Health Regulatory Flexibility Analysis
select agent or toxin should be Inspection Service (APHIS), Required: No
included under the provisions of these USDA/Agricultural Research Service
Agency Contact: Robbin Weyant,
regulations are based on: 1) The effect (ARS), USDA/CVB (Center for
Department of Health and Human
on human health as a result of Veterinary Biologics), and the
Services, Centers for Disease Control

exposure to the agent or toxin, 2) the Department of Defense (DOD)/United
and Prevention, CLFT Building 20,
degree of contagiousness of the agent States Army Medical Research Institute
Room 4202, 1600 Clifton Road NE.,
or toxin, 3) the methods by which the for Infectious Diseases (USAMRIID) and
Atlanta, GA 30333
agent or toxin is transferred to humans, review of relevant published studies,
Phone: 404 718–2000
4) the availability and effectiveness of we believe the Chapare virus should be
pharmacotherapies and immunizations added to the list of HHS select agents RIN: 0920–AA32
Department of Health and Human Services (HHS) Completed Actions

130. CONTROL OF COMMUNICABLE authority to investigate suspected cases persons, in regard to significant health
DISEASES: INTERSTATE and potential spread of communicable risks.
QUARANTINE, PASSENGER disease among interstate travelers is Timetable:
INFORMATION thus not limited to those known or
suspected of having a quarantinable Action Date FR Cite
Legal Authority: 25 USC 198.231; 25
disease, but rather all communicable NPRM 11/30/05 70 FR 71892
USC 1661; 42 USC 243; 42 USC 248;
42 USC 249; 42 USC 264; 42 USC 266 diseases that may necessitate a public NPRM Comment 01/30/06
health response. Period End
to 268; 42 USC 270 to 272; 42 USC
Merged With 02/12/10
2001 Among the fundamental components of 0920–AA22
Abstract: By statute, the Secretary of the public health response to the report Regulatory Flexibility Analysis
Health and Human Services has broad of a person with a communicable Required: Yes
authority to prevent introduction, disease is the identification and
transmission, and spread of evaluation of individuals who may Agency Contact: Stacy Howard,
communicable diseases from one State have been exposed. This provision, Department of Health and Human
or possession into another. Quarantine which was proposed section 70.4, Services, Centers for Disease Control
regulations are divided into two parts: would require any airline operating in and Prevention, MS E03, CLFT
Part 71 dealing with foreign arrivals interstate traffic to solicit and Building 16, Room 4324, Atlanta, GA
and part 70 dealing with interstate electronically submit certain passenger 30329
matters. The CDC Director has been information to CDC for use in contact Phone: 404 498–1600
delegated the responsibility for carrying tracing when necessary to protect the Email: showard@cdc.gov
out these regulations. The Director’s vital interests of an individual, or other RIN: 0920–AA27
Department of Health and Human Services (HHS) Prerule Stage

Food and Drug Administration (FDA)
131. FOOD LABELING: SAFE sections 101.17(h), 115.50 and and Applied Nutrition, (HFS–820),
HANDLING STATEMENTS, LABELING 16.5(a)(4) should be continued without 5100 Paint Branch Parkway, College
OF SHELL EGGS; REFRIGERATION change, or whether they should be Park, MD 20740
OF SHELL EGGS HELD FOR RETAIL amended or rescinded, consistent with Phone: 301 436–1802
DISTRIBUTION (SECTION 610 the stated objectives of applicable Fax: 301 436–2636
REVIEW) statutes, to minimize any significant Email: geraldine.june@fda.hhs.gov
Legal Authority: 15 USC 1453 to 1455; economic impact on a substantial RIN: 0910–AG06
21 USC 321; 21 USC 331; 21 USC 342 number of small entities. FDA will
and 343; 21 USC 348; 21 USC 371; 42 consider, and is soliciting comments
on, the following: (1) The continued 132. PRESCRIPTION DRUG
USC 243; 42 USC 264; 42 USC 271
need for the rule; (2) the nature of MARKETING ACT OF 1987;
Abstract: Section 101.17(h) (21 CFR complaints or comments received PRESCRIPTION DRUG AMENDMENTS
101.17(h)) describes requirements for concerning the rule from the public; (3) OF 1992; POLICIES, REQUIREMENTS,
the labeling of the cartons of shell eggs the complexity of the rule; (4) the AND ADMINISTRATIVE PROCEDURES
that have not been treated to destroy extent to which the rule overlaps, (SECTION 610 REVIEW)
Salmonella microorganisms. Section duplicates, or conflicts with other
115. 50 (21 CFR 115.50) describes Legal Authority: 21 USC 331; 21 USC
Federal rules, and, to the extent 333; 21 USC 351; 21 USC 352; 21 USC
requirements for refrigeration of shell feasible, with State and local
eggs held for retail distribution. Section 353; 21 USC 360; 21 USC 371; 21 USC
governmental rules; and (5) the length 374; 21 USC 381
16.5(a)(4) (21 CFR 16.5(a)(4)) provides of time since the rule has been
that part 16 does not apply to a hearing evaluated or the degree to which Abstract: FDA is undertaking a review
on an order for relabeling, diversion, technology, economic conditions, or of 21 CFR part 203 and 21 CFR sections
or destruction of shell eggs under other factors have changed in the area 205.3 and 205.50 (as amended in 64
section 361 of the Public Health Service affected by the rule. FR 67762 and 67763) under section 610
Act (42 U.S.C. 264) and sections of the Regulatory Flexibility Act. The
101.17(h) and 115.50. FDA amended 21 Timetable: purpose of this review is to determine
CFR 101.17(h) on August 20, 2007 (72 Action Date FR Cite whether the regulations in 21 CFR part
FR 46375) to permit the safe handling Begin Review 12/15/09
203 and 21 CFR sections 205.3 and
statement to appear on the inside lid End Review 12/00/10
205.50 (as amended in 64 FR 67762
of egg cartons to provide the industry and 67763) should be continued
greater flexibility in the placement of Regulatory Flexibility Analysis without change, or whether they should
the statement. FDA is undertaking a Required: Undetermined be amended or rescinded, consistent

review of 21 CFR sections 101.17(h), Agency Contact: Geraldine A. June, with the stated objectives of applicable
115.50, and 16.5(a)(4) under section Supervisor, Product Evaluation and statutes, to minimize adverse impacts
610 of the Regulatory Flexibility Act. Labeling Team, Department of Health on a substantial number of small
The purpose of this review is to and Human Services, Food and Drug entities. FDA will consider, and is
determine whether the regulations in Administration, Center for Food Safety soliciting comments on, the following:
HHS—FDA Prerule Stage
(1) The continued need for the whether it should be amended or 1996, issue of the Federal Register (61
regulations in 21 CFR part 203 and 21 rescinded, consistent with the stated FR 44396).
CFR sections 205.3 and 205.50 (as objectives of applicable statues, to
amended in 64 FR 67762 and 67763); minimize adverse impacts on a This final rule prohibits the sale of
(2) the nature of complaints or substantial number of small entities. cigarettes and smokeless tobacco to
comments received from the public FDA will consider, and is soliciting individuals under the age of 18 and
concerning the regulations in 21 CFR comments on the following: (1) The requires manufacturers, distributors,
part 203 and 21 CFR sections 205.3 and continued need for 21 CFR 200.51; (2) and retailers to comply with certain
205.50 (as amended in 64 FR 67762 the nature of complaints or comments conditions regarding access to, and
and 67763); (3) the complexity of the received concerning 21 CFR 200.51; (3) promotion of, these products. Among
regulations in 21 CFR part 203 and 21 the complexity of 21 CFR 200.51; (4) other things, the final rule requires
CFR sections 205.3 and 205.50 (as the extent to which the regulation retailers to verify a purchaser’s age by
amended in 64 FR 67762 and 67763); overlaps, duplicates, or conflicts with photographic identification. It also
(4) the extent to which the regulations other Federal, State, or governmental prohibits, with limited exception, free
in 21 CFR part 203 and 21 CFR sections rules; and (5) the degree to which samples and prohibits the sale of these
205.3 and 205.50 (as amended in 64 technology, economic conditions, or products through vending machines
FR 67762 and 67763) overlap, other factors have changed in the area and self-service displays except in
duplicate, or conflict with other Federal affected by 21 CFR 200.51. facilities where individuals under the
rules, and to the extent feasible, with age of 18 are not present or permitted
Timetable: at any time. The rule also limits the
State and local governmental rules; and
(5) the degree to which technology, Action Date FR Cite advertising and labeling to which
economic conditions, or other factors Begin Review 05/01/09 children and adolescents are exposed.
have changed in the area affected by End Review 05/00/10 The rule accomplishes this by generally
the regulations in 21 CFR part 203 and restricting advertising to which
Regulatory Flexibility Analysis children and adolescents are exposed
21 CFR sections 205.3 and 205.50 (as Required: No
amended in 64 FR 67762 and 67763). to a black-and-white, text-only format.
Agency Contact: Howard P. Muller, The rule also prohibits the sale or
Timetable: Office of Regulatory Policy, Department distribution of brand-identified
Action Date FR Cite of Health and Human Services, Food promotional, non-tobacco items such as
Begin Review of 11/24/08
and Drug Administration, Center for hats and tee shirts. Furthermore, the
Current Regulation Drug Evaluation and Research, WO 51, rule prohibits sponsorship of sporting
End Review of Current 06/00/10 Room 6234, 10903 New Hampshire and other events, teams, and entries in
Regulation Avenue, Silver Spring, MD 20993–0002 a brand name of a tobacco product, but
Phone: 301 796–3601 permits such sponsorship in a
Regulatory Flexibility Analysis Fax: 301 847–8440 corporate name.
Required: Yes Email: howard.mullerjr@fda.hhs.gov
Agency Contact: Howard Muller, FDA will also publish in the same issue
RIN: 0910–AG25
Office of Regulatory Policy, Department of the Federal Register an advance
of Health and Human Services, Food notice of proposed rulemaking
and Drug Administration, Center for 134. REGULATIONS RESTRICTING requesting comments, data, research, or
Drug Evaluation and Research, WO 51, THE SALE AND DISTRIBUTION OF other information on the regulation of
Room 6234, 10903 New Hampshire CIGARETTES AND SMOKELESS outdoor advertising of cigarettes and
Avenue, Silver Spring, MD 20993–0002 TOBACCO TO PROTECT CHILDREN smokeless tobacco.
Phone: 301 796–3601 AND ADOLESCENTS
Fax: 301 847–8440 Timetable:
Legal Authority: 21 USC 301 et seq,
Email: pdma610(c)review@fda.hhs.gov The Federal Food, Drug, and Cosmetic Action Date FR Cite
RIN: 0910–AG14 Act; PL 111–31, Family Smoking ANPRM 03/19/10 75 FR 13241
Prevention and Tobacco Control Act Final Rule 03/19/10 75 FR 13225
133. STERILITY REQUIREMENT FOR Abstract: This rule establishes ANPRM Comment 05/18/10
regulations restricting the sale and Period End
AQUEOUS–BASED DRUG PRODUCTS
distribution of cigarettes and smokeless Final Rule Effective 06/22/10
FOR ORAL INHALATION (SECTION
610 REVIEW) tobacco to children and adolescents,
implementing section 102 of the Family
Legal Authority: 21 USC 321; 21 USC Required: Yes
Smoking Prevention and Tobacco
331; 21 USC 351 to 353; 21 USC 355; Control Act (FSPTCA). FSPTCA
21 USC 358; 21 USC 360e; 21 USC 371; Agency Contact: Annette L. Marthaler,
sections 102 and 6(c)(1) require the Regulatory Counsel, Department of
21 USC 374; 21 USC 375 Secretary to publish, within 270 days Health and Human Services, Food and
Abstract: FDA is undertaking a review of enactment, a final rule regarding
Drug Administration, 9200 Corporate

of 21 CFR 200.51, under section 610 cigarettes and smokeless tobacco. This Boulevard, 100K, Rockville, MD 20850
of the Regulatory Flexibility Act. The final rule must be identical, except for Phone: 877 287–1373
purpose of this review is to determine several changes identified in section Fax: 240 276–3904
whether this regulation on aqueous- 102(a)(2) of FSPTCA, to part 897 of the Email: annette.marthaler@fda.hhs.gov
based drug products for oral inhalation regulations promulgated by the
should be continued without change, or Secretary of HHS in the August 28, RIN: 0910–AG33
HHS—FDA Prerule Stage
135. OVER–THE–COUNTER HUMAN consumers to select the most 12866, which calls for agencies to
DRUGS; LABELING REQUIREMENTS appropriate product. periodically review existing regulations
(SECTION 610 REVIEW) FDA is initiating a review under to determine whether any should be
Legal Authority: 5 USC 610 section 610 of the Regulatory Flexibility modified or eliminated so as to make
Act for the regulation in part 201.66. the agency’s regulatory program more
Abstract: Part 201.66 (21 CFR section effective in achieving its goals, less
201.66) established a standardized The purpose of this review is to
determine whether the regulation in burdensome, or in greater alignment
format for the labeling of OTC drug with the President’s priorities and the
products that included: (1) Specific part 201.66 should be continued
without change, or whether it should principles set forth in the Executive
headings and subheadings presented in order.
a standardized order, (2) standardized be further amended or rescinded,
graphical features such as Helvetica consistent with the stated objectives of
Timetable:
type style and the use of ‘‘bullet applicable statutes, to minimize adverse
impacts on a substantial number of Action Date FR Cite
points’’ to introduce key information,
and (3) minimum standards for type small entities. FDA will consider, and Begin Review of 08/03/09
size and spacing. FDA issued the final is soliciting comments on the Current Regulation
rule to improve labeling after following: (1) The continued need for End Review of Current 05/00/10
considering comments submitted to the the regulation in part 201.66; (2) the Regulation
agency following the publication of the nature of the complaints or comments
received concerning the regulation in Regulatory Flexibility Analysis
proposed regulation in 1997. In 1999,
part 201.66; (3) the complexity of the Required: Yes
FDA published the final rule and stated
that a standardized labeling format regulations in part 201.66; (4) the
Agency Contact: Walter J. Ellenberg,
would significantly improve readability extent to which the regulations in part
201.66 overlap, duplicate, or conflict Regulatory Project Management Officer,
by familiarizing consumers with the Department of Health and Human
types of information in OTC drug with other Federal, State, or
governmental rules; and (5) the degree Services, Food and Drug
product labeling and the location of Administration, Center for Drug
that information. In addition, a to which technology, economic
conditions, or other factors have Evaluation and Research, WO–22,
standardized appearance and Room 5488, 10903 New Hampshire
standardized content, including various changed for the products still subject
to the labeling standard regulations in Avenue, Silver Spring, MD 20993
‘‘user-friendly’’ visual cues, would help Phone: 301 796–2090
consumers locate and read important part 201.
Fax: 301 796–9899
health and safety information and allow The section 610 review will be carried Email: walter.ellenberg@fda.hhs.gov
quick and effective product out along with a regulatory review
comparisons, thereby helping under section 5 of Executive Order RIN: 0910–AG34

136. ELECTRONIC SUBMISSION OF Regulatory Flexibility Analysis recognized as safe and effective and not
DATA FROM STUDIES EVALUATING Required: Yes misbranded. After a final monograph
HUMAN DRUGS AND BIOLOGICS Agency Contact: Martha Nguyen, (i.e., final rule) is issued, only OTC
Legal Authority: 21 USC 355; 21 USC Regulatory Counsel, Department of drugs meeting the conditions of the
371; 42 USC 262 Health and Human Services, Food and monograph, or having an approved new
Drug Administration, Center for Drug drug application, may be legally
Abstract: The Food and Drug marketed. This action addresses
Evaluation and Research, WO 51, Room
Administration is proposing to amend antihistamine labeling claims for the
6352, 10903 New Hampshire Avenue,
the regulations governing the format in common cold.
Silver Spring, MD 20993–0002
which clinical study data and
Phone: 301 796–3471 Timetable:
bioequivalence data are required to be
Fax: 301 847–8440
submitted for new drug applications Action Date FR Cite
Email: martha.nguyen@fda.hhs.gov
(NDAs), biological license applications
Reopening of 08/25/00 65 FR 51780
(BLAs), and abbreviated new drug RIN: 0910–AC52
Administrative
applications (ANDAs). The proposal Record
would revise our regulations to require 137. OVER–THE–COUNTER (OTC) NPRM (Amendment) 03/00/11
that data submitted for NDAs, BLAs, DRUG REVIEW—COUGH/COLD (Common Cold)
and ANDAs, and their supplements and (ANTIHISTAMINE) PRODUCTS
amendments, be provided in an Regulatory Flexibility Analysis
electronic format that FDA can process, Legal Authority: 21 USC 321p; 21 USC Required: Yes
review, and archive. 331; 21 USC 351 to 353; 21 USC 355; Agency Contact: Walter J. Ellenberg,
21 USC 360; 21 USC 371 Regulatory Project Management Officer,
Timetable:
Abstract: The OTC drug review Department of Health and Human
Action Date FR Cite
establishes conditions under which Services, Food and Drug
NPRM 10/00/10 OTC drugs are considered generally Administration, Center for Drug
HHS—FDA Proposed Rule Stage
Evaluation and Research, WO–22, Action Date FR Cite Department of Health and Human
Room 5488, 10903 New Hampshire Services, Food and Drug
Avenue, Silver Spring, MD 20993 NPRM (Amendment) To Be Determined Administration, Center for Drug
Phone: 301 796–2090 (Sodium Evaluation and Research, WO–22,
Bicarbonate)
Fax: 301 796–9899 Room 5488, 10903 New Hampshire
Final Action (Internal To Be Determined
Email: walter.ellenberg@fda.hhs.gov Avenue, Silver Spring, MD 20993
Analgesics)
Phone: 301 796–2090
RIN: 0910–AF31 Regulatory Flexibility Analysis Fax: 301 796–9899
Required: Yes Email: walter.ellenberg@fda.hhs.gov
138. OVER–THE–COUNTER (OTC) Agency Contact: Walter J. Ellenberg, RIN: 0910–AF38
DRUG REVIEW—INTERNAL Regulatory Project Management Officer,
ANALGESIC PRODUCTS Department of Health and Human
Services, Food and Drug 140. OVER–THE–COUNTER (OTC)
Legal Authority: 21 USC 321p; 21 USC DRUG REVIEW—SUNSCREEN
331; 21 USC 351 to 353; 21 USC 355; Administration, Center for Drug
Evaluation and Research, WO–22, PRODUCTS
21 USC 360; 21 USC 371; 21 USC 374;
Room 5488, 10903 New Hampshire Legal Authority: 21 USC 321p; 21 USC
21 USC 379e
Avenue, Silver Spring, MD 20993 331; 21 USC 351 to 353; 21 USC 355;
Abstract: The OTC drug review Phone: 301 796–2090 21 USC 360; 21 USC 371
establishes conditions under which Fax: 301 796–9899 Abstract: The OTC drug review
OTC drugs are considered generally Email: walter.ellenberg@fda.hhs.gov establishes conditions under which
recognized as safe and effective and not OTC drugs are considered generally
RIN: 0910–AF36
misbranded. After a final monograph recognized as safe and effective and not
(i.e., final rule) is issued, only OTC misbranded. After a final monograph
drugs meeting the conditions of the 139. OVER–THE–COUNTER (OTC) (i.e., final rule) is issued, only OTC
monograph, or having an approved new DRUG REVIEW—LAXATIVE DRUG drugs meeting the conditions of the
drug application, may be legally PRODUCTS monograph, or having an approved new
marketed. The first action addresses Legal Authority: 21 USC 321p; 21 USC drug application, may be legally
products labeled to relieve upset 331; 21 USC 351 to 353; 21 USC 355; marketed. The first action addresses
stomach associated with 21 USC 360 to 360a; 21 USC 371 to active ingredients reviewed under Time
overindulgence in food and drink and 371a and Extent Applications. The second
to relieve symptoms associated with a action addresses other effectiveness
hangover. The second action addresses Abstract: The OTC drug review
establishes conditions under which issues for OTC sunscreen drug
acetaminophen safety. The third action products. The third action finalizes
addresses products marketed for OTC drugs are considered generally
recognized as safe and effective and not sunscreen formulation, labeling, and
children under 2 years old and weight- testing requirements for both ultraviolet
and age-based dosing for children’s misbranded. After a final monograph
(i.e., final rule) is issued, only OTC B and ultraviolet A radiation
products. The fourth action addresses protection. The last action addresses
combination products containing the drugs meeting the conditions of the
monograph, or having an approved new combination products containing
analgesic acetaminophen or aspirin and sunscreen and insect repellent
sodium bicarbonate used as an antacid drug application, may be legally
marketed. The first NPRM listed will ingredients.
ingredient. The last document finalizes
the Internal Analgesic Products address the professional labeling for Timetable:
monograph. sodium phosphate drug products. The Action Date FR Cite
second NPRM listed will address all
Timetable: other professional labeling ANPRM (Sunscreen 02/22/07 72 FR 7941
and Insect
Action Date FR Cite requirements for laxative drug
Repellent)
products. The final action will address
NPRM (Amendment) 12/26/06 71 FR 77314 ANPRM Comment 05/23/07
(Required Warnings laxative drug products. Period End
and Other Labeling) Timetable: NPRM (UVA/UVB) 08/27/07 72 FR 49070
NPRM Comment 05/25/07 NPRM Comment 12/26/07
Action Date FR Cite
Period End Period End
NPRM (Over- To Be Determined Final Action (Granular 03/29/07 72 FR 14669 NPRM (Time and 07/00/10
indulgence/ Psyllium) Extent Applications)
Hangover) NPRM (Professional 10/00/10 NPRM (Effectiveness) 10/00/10
Final Action (Required 04/29/09 74 FR 19385 Labeling—Sodium Final Action 10/00/10
Warnings and Other Phosphate) (UVA/UVB)
Labeling) NPRM (Professional To Be Determined NPRM (Sunscreen To Be Determined
Final Action 06/30/09 74 FR 31177 Labeling) and Insect
(Correction) Final Action (Laxative To Be Determined Repellent)

Final Action (Technical 11/25/09 74 FR 61512 Drug Products) Regulatory Flexibility Analysis
Amendment)
Regulatory Flexibility Analysis Required: Yes
NPRM 03/00/11
Required: Yes Agency Contact: Walter J. Ellenberg,
(Acetaminophen)
NPRM (Amendment) To Be Determined Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer,
(Pediatric) Regulatory Project Management Officer, Department of Health and Human
Services, Food and Drug Email: walter.ellenberg@fda.hhs.gov 143. PEDIATRIC DOSING FOR
Administration, Center for Drug COUGH, COLD, ALLERGY,
Evaluation and Research, WO–22, RIN: 0910–AF69 BRONCHODILATOR, AND
Room 5488, 10903 New Hampshire ANTIASTHMATIC DRUG PRODUCTS
Avenue, Silver Spring, MD 20993 FOR OVER–THE–COUNTER HUMAN
142. PROCESS CONTROLS FOR
Phone: 301 796–2090 USE; PROPOSED AMENDMENT OF
Fax: 301 796–9899 ANIMAL FEED INGREDIENTS AND
FINAL MONOGRAPH
Email: walter.ellenberg@fda.hhs.gov MIXED ANIMAL FEED
Legal Authority: 21 USC 331; 21 USC
RIN: 0910–AF43 Legal Authority: 21 USC 342; 21 USC 351 to 353; 21 USC 355; 21 USC 360;
350e; 21 USC 371; 21 USC 374; 42 USC 21 USC 371
141. OVER–THE–COUNTER (OTC) 264; PL 110–85, sec 1002(a)(2)
Abstract: The OTC drug review
DRUG REVIEW—TOPICAL Abstract: The Food and Drug establishes conditions under which
ANTIMICROBIAL DRUG PRODUCTS Administration (FDA) is proposing OTC drugs are considered generally
Legal Authority: 21 USC 321p; 21 USC regulations for process controls for recognized as safe and effective and not
331; 21 USC 351 to 353; 21 USC 355; animal feed ingredients and mixed misbranded. After a monograph is
21 USC 360; 21 USC 371 animal feed to provide greater issued, only OTC drugs meeting the
Abstract: The OTC drug review assurance that marketed animal feed conditions of the monograph, or having
establishes conditions under which ingredients and mixed feeds intended an approved new drug application, may
OTC drugs are considered generally for all animals, including pets, are safe. be legally marketed. This action will
recognized as safe and effective and not This action is being taken as part of propose changes to the final monograph
misbranded. After a final monograph the FDA’s Animal Feed Safety System to address safety and efficacy issues
(i.e., final rule) is issued, only OTC initiative. The proposed process associated with pediatric cough and
drugs meeting the conditions of the controls will apply to animal feed cold products.
monograph, or having an approved new ingredients and mixed animal feed, Timetable:
drug application, may be legally including pet food. This action is also
marketed. The first action addresses being taken to carry out the Action Date FR Cite
food handler products. The second requirements of the Food and Drug NPRM 12/00/10
action addresses testing requirements Administration Amendments Act of
for healthcare professional products. Regulatory Flexibility Analysis
2007. Section 1002(a) directs FDA to
The third action addresses the safety Required: Yes
establish by regulation processing
and effectiveness of consumer products.
standards for pet food. This same Agency Contact: Walter J. Ellenberg,
The final actions listed will address the
provision of the law also directs that, Regulatory Project Management Officer,
healthcare, consumer, and first aid
in developing these new regulations, Department of Health and Human
antiseptic drug products respectively.
FDA obtain input from its stakeholders, Services, Food and Drug
Timetable: including the Association of American Administration, Center for Drug
Action Date FR Cite Feed Control Officials, veterinary Evaluation and Research, WO–22,
medical associations, animal health Room 5488, 10903 New Hampshire
NPRM (Healthcare) 06/17/94 59 FR 31402
organizations, and pet food Avenue, Silver Spring, MD 20993
NPRM (Food To Be Determined
Handlers) manufacturers. Phone: 301 796–2090
NPRM (Testing — To Be Determined
Fax: 301 796–9899
Healthcare Timetable: Email: walter.ellenberg@fda.hhs.gov
Professional Action Date FR Cite RIN: 0910–AG12
Products)
NPRM (Consumer) 03/00/11 NPRM 03/00/11
Final Action To Be Determined NPRM Comment 06/00/11 144. UNIQUE DEVICE IDENTIFICATION
(Healthcare) Period End
Final Action To Be Determined Legal Authority: Not Yet Determined
(Consumer) Regulatory Flexibility Analysis
Abstract: The Food and Drug
Final Action (First Aid To Be Determined Required: Yes
Antiseptic) Administration Amendments Act of
Agency Contact: Kim Young, Deputy 2007, amended the Federal Food, Drug,
Regulatory Flexibility Analysis and Cosmetic Act by adding section
Required: Yes Director, Division of Compliance,
Department of Health and Human 519(f) (21 USC 360i(f)). This section
Agency Contact: Walter J. Ellenberg, Services, Food and Drug requires FDA to promulgate regulations
Regulatory Project Management Officer, Administration, Center for Veterinary establishing a unique identification
Department of Health and Human Medicine, Room 106 (MPN–4, system for medical devices requiring
Services, Food and Drug the label of medical devices to bear a
HFV–230), 7519 Standish Place,

Administration, Center for Drug unique identifier, unless FDA specifies
Rockville, MD 20855
Evaluation and Research, WO–22, an alternative placement or provides for
Room 5488, 10903 New Hampshire Phone: 240 276–9207 exceptions. The unique identifier must
Avenue, Silver Spring, MD 20993 Email: kim.young@fda.hhs.gov adequately identify the device through
Phone: 301 796–2090 RIN: 0910–AG10 distribution and use, and may include
Fax: 301 796–9899 information on the lot or serial number.
Timetable: possible pathways of contamination Regulatory Flexibility Analysis

Action Date FR Cite and provide examples of risk reduction Required: Yes
practices recognizing that operators
NPRM 12/00/10 must tailor their preventive controls to Agency Contact: Paul South,
Regulatory Flexibility Analysis particular hazards and conditions Department of Health and Human
Required: Yes affecting their operations. The Services, Food and Drug
requirements of the proposed rule Administration, Center for Food Safety
Agency Contact: John J. Crowley, and Applied Nutrition (HFS–317),
Senior Advisor for Patient Safety, would be scale appropriate and
commensurate with the relative risks Office of Food Safety, 5100 Paint
Department of Health and Human Branch Parkway, College Park, MD
and complexity of individual
Services, Food and Drug 20740
operations. FDA intends to issue
Administration, Center for Devices and Phone: 301 436–1640
guidance after the proposed rule is
Radiological Health, WO 66, Room
finalized to assist industry in Email: paul.south@fda.hhs.gov
2315, 10903 New Hampshire Avenue,
complying with the requirements of the
Silver Spring, MD 20993 RIN: 0910–AG36
new regulation.
Phone: 301 980–1936
Email: jay.crowley@fda.hhs.gov Timetable:
RIN: 0910–AG31 Action Date FR Cite 147. ∑ CIGARS SUBJECT TO THE
FAMILY SMOKING PREVENTION AND
NPRM 12/00/10 TOBACCO CONTROL ACT
145. PRODUCE SAFETY REGULATION Regulatory Flexibility Analysis
Required: Yes Legal Authority: 21 USC 301 et seq,
Legal Authority: 21 USC 342; 21 USC
The Federal Food, Drug, and Cosmetic
371; 42 USC 264 Agency Contact: Samir Assar, Act; PL 111–31, The Family Smoking
Abstract: The Food and Drug Department of Health and Human Prevention and Tobacco Control Act
Administration (FDA) has determined Services, Food and Drug
that enforceable standards (as opposed Administration, Center for Food Safety Abstract: The Family Smoking
to voluntary recommendations) for the and Applied Nutrition, Office of Food Prevention and Tobacco Control Act
production and packing of fresh Safety, 5100 Paint Branch Parkway, (the Tobacco Control Act) provides
produce are necessary to ensure best College Park, MD 20740 FDA authority to regulate cigarettes,
practices are commonly adopted. FDA Phone: 301 436–1636 cigarette tobacco, roll-your-own
is proposing to promulgate regulations Email: samir.assar@fda.hhs.gov tobacco, and smokeless tobacco.
setting enforceable standards for fresh RIN: 0910–AG35 Section 901 of the Federal Food, Drug,
produce safety at the farm and packing and Cosmetic Act, as amended by the
house. The purpose of the proposed Tobacco Control Act, permits FDA to
146. MODERNIZATION OF THE issue regulations deeming other tobacco
rule is to reduce the risk of illness
CURRENT FOOD GOOD products to be subject to the Tobacco
associated with contaminated fresh
MANUFACTURING PRACTICES Control Act. This proposed rule would
produce. The proposed rule will be REGULATION
based on prevention-oriented public deem cigars to be subject to the
health principles and incorporate what Legal Authority: 21 USC 342; 21 USC Tobacco Control Act and include
we have learned in the past decade 371; 42 USC 264 provisions to address public health
since the agency issued general good Abstract: The Food and Drug concerns raised by cigars.
agricultural practice guidelines entitled Administration (FDA) is proposing to
‘‘Guide to Minimize Microbial Food amend its current good manufacturing Timetable:
Safety Hazards for Fresh Fruits and practices (CGMP) regulations (21 CFR Action Date FR Cite
Vegetables’’ (GAPs Guide). The part 110) for manufacturing, packing, or
proposed rule also will reflect holding human food. This proposed NPRM 06/00/10
comments received on the agency’s rule would require food facilities to Regulatory Flexibility Analysis
1998 update of its GAPs guide and its address issues such as environmental Required: Yes
July 2009 draft commodity specific pathogens, food allergens, mandatory
guidances for tomatoes, leafy greens, employee training, and sanitation of Agency Contact: May Nelson,
and melons. Although the proposed food contact surfaces. The proposed Regulatory Counsel, Department of
rule will be based on recommendations rule also would require food facilities Health and Human Services, Food and
that are included in the GAPs guide, to develop and implement preventive Drug Administration, Center for Food
FDA does not intend to make the entire control systems. FDA is taking this Safety and Applied Nutrition, 5100
guidance mandatory. FDA’s proposed action to better address changes that Paint Branch Parkway, College Park,
rule would, however, set out clear have occurred in the food industry and MD 20740
standards for implementation of protect public health. Phone: 877 287–1373
modern preventive controls. The Timetable: Fax: 301 436–2637
proposed rule also would emphasize Email: may.nelson@fda.hhs.gov

the importance of environmental Action Date FR Cite
assessments to identify hazards and NPRM 03/00/11 RIN: 0910–AG38

148. POSTMARKETING SAFETY 149. MEDICAL GAS CONTAINERS 150. CONTENT AND FORMAT OF
REPORTING REQUIREMENTS FOR AND CLOSURES; CURRENT GOOD LABELING FOR HUMAN
HUMAN DRUG AND BIOLOGICAL MANUFACTURING PRACTICE PRESCRIPTION DRUGS AND
PRODUCTS REQUIREMENTS BIOLOGICS; REQUIREMENTS FOR
PREGNANCY AND LACTATION
Legal Authority: 42 USC 216; 42 USC Legal Authority: 21 USC 321; 21 USC LABELING
241; 42 USC 242a; 42 USC 262 and 351 to 21 USC 353 Legal Authority: 21 USC 321; 21 USC
263; 42 USC 263a to 263n; 42 USC 264;
Abstract: The Food and Drug 331; 21 USC 351 to 353; 21 USC 355;
42 USC 300aa; 21 USC 321; 21 USC
Administration is amending its current 21 USC 358; 21 USC 360; 21 USC 360b;
331; 21 USC 351 to 353; 21 USC 355;
good manufacturing practice 21 USC 360gg to 360ss; 21 USC 371;
21 USC 360; 21 USC 360b to 360j; 21 21 USC 374; 21 USC 379e; 42 USC 216;
USC 361a; 21 USC 371; 21 USC 374; regulations and other regulations to
clarify and strengthen requirements for 42 USC 241; 42 USC 262; 42 USC 264
21 USC 375; 21 USC 379e; 21 USC 381
the label, color, dedication, and design Abstract: To amend the regulations
Abstract: The final rule would amend of medical gas containers and closures. governing the format and content of
the postmarketing expedited and Despite existing regulatory labeling for human prescription drugs
periodic safety reporting regulations for requirements and industry standards and biological products (21 CFR parts
human drugs and biological products for medical gases, there have been 201.56, 201.57, and 201.80). Under
to revise certain definitions and repeated incidents in which cryogenic FDA’s current regulations, labeling
reporting formats as recommended by containers of harmful industrial gases concerning the use of prescription
the International Conference on have been connected to medical oxygen drugs in pregnancy uses letter
Harmonisation and to define new categories (A, B, C, D, X) to characterize
supply systems in hospitals and
terms; to add to or revise current the risk to the fetus of using the drug
nursing homes and subsequently
reporting requirements; to revise certain in pregnancy. One of the deficiencies
administered to patients. These of the category system is that drugs
reporting time frames; and to propose incidents have resulted in death and
other revisions to these regulations to may be assigned to the same category
serious injury. There have also been when the severity, incidence, and types
enhance the quality of safety reports several incidents involving high-
received by FDA. These revisions were of risk are quite different.
pressure medical gas cylinders that Dissatisfaction with the category system
proposed as part of a single rulemaking
have resulted in death and injuries to has been expressed by health care
(68 FR 12406) to clarify and revise both
patients. These amendments, together providers, medical organizations,
premarketing and postmarketing safety
with existing regulations, are intended experts in the study of birth defects,
reporting requirements for human drug
to ensure that the types of incidents women’s health researchers, and
and biological products. FDA plans to
that have occurred in the past, as well women of childbearing age.
finalize the premarket and postmarket
safety reporting requirements in as other types of foreseeable and Stakeholders consulted through a
separate final rules. potentially deadly medical gas public hearing, several focus groups,
accidents, do not occur in the future. and several advisory committees have
Timetable: recommended that FDA replace the
Timetable: category system with a concise
Action Date FR Cite narrative summarizing a product’s risks
Action Date FR Cite
NPRM 03/14/03 68 FR 12406 to pregnant women and to women of
NPRM 04/10/06 71 FR 18039 childbearing age. Therefore, the revised
Period Extended NPRM Comment 07/10/06 format and the information provided in
Period End the labeling would make it easier for
Period End Final Action 03/00/11 health care providers to understand the
NPRM Comment 10/14/03 risks and benefits of drug use during
Regulatory Flexibility Analysis pregnancy and lactation.
Period Extension
End Required: Yes
Timetable:
Final Action 11/00/10 Agency Contact: Patrick Raulerson, Action Date FR Cite
Regulatory Flexibility Analysis Regulatory Counsel, Department of
Health and Human Services, Food and NPRM 05/29/08 73 FR 30831
Required: Yes NPRM Comment 08/27/08
Drug Administration, Center for Drug
Period End
Agency Contact: Jane E. Baluss, Evaluation and Research, WO 51, Room Final Action 03/00/11
Regulatory Counsel, Department of 6368, 10903 New Hampshire Avenue,
Health and Human Services, Food and Silver Spring, MD 20993–0002 Regulatory Flexibility Analysis
Drug Administration, Center for Drug Phone: 301 796–3522 Required: Yes
Evaluation and Research, WO 51, Room Fax: 301 847–8440 Agency Contact: Rachel S. Bressler,
6362, 10903 New Hampshire Avenue, Regulatory Counsel, Department of
Email: patrick.raulerson@fda.hhs.gov
Silver Spring, MD 20993–0002 Health and Human Services, Food and
Phone: 301 796–3469 RIN: 0910–AC53 Drug Administration, Center for Drug
Fax: 301 847–8440 Evaluation Research, WO 51, Room
Email: jane.baluss@fda.hhs.gov 6224, 10903 New Hampshire Avenue,
Silver Spring, MD 20993–0002
RIN: 0910–AA97 Phone: 301 796–4288
HHS—FDA Final Rule Stage
Fax: 301 847–8440 152. OVER–THE–COUNTER (OTC) marketed. This action addresses
Email: rachel.bressler@fda.hhs.gov DRUG REVIEW—COUGH/COLD cough/cold drug products containing an
(BRONCHODILATOR) PRODUCTS oral bronchodilator (ephedrine and its
RIN: 0910–AF11 Legal Authority: 21 USC 321p; 21 USC salts) in combination with any
331; 21 USC 351 to 353; 21 USC 355; expectorant or any oral nasal
21 USC 360; 21 USC 371 decongestant.
151. INFANT FORMULA: CURRENT
GOOD MANUFACTURING Abstract: The OTC drug review Timetable:
PRACTICES; QUALITY CONTROL establishes conditions under which Action Date FR Cite
PROCEDURES; NOTIFICATION OTC drugs are considered generally
NPRM (Amendment) 07/13/05 70 FR 40232
REQUIREMENTS; RECORDS AND recognized as safe and effective and not
REPORTS; AND QUALITY FACTORS misbranded. After a final monograph Period End
(i.e., final rule) is issued, only OTC Final Action (Technical 03/19/07 72 FR 12730
Legal Authority: 21 USC 321; 21 USC drugs meeting the conditions of the Amendment)
350a; 21 USC 371; . . . monograph, or having an approved new Final Action 03/00/11
drug application, may be legally
Abstract: The Food and Drug marketed. This action addresses Regulatory Flexibility Analysis
Administration (FDA) is revising its labeling for single ingredient Required: Yes
infant formula regulations in 21 CFR bronchodilator products. Agency Contact: Walter J. Ellenberg,
parts 106 and 107 to establish Regulatory Project Management Officer,
Timetable:
requirements for current good Department of Health and Human
manufacturing practices (CGMP), Action Date FR Cite Services, Food and Drug
including audits; to establish NPRM (Amendment— 07/13/05 70 FR 40237 Administration, Center for Drug
requirements for quality factors; and to Ephedrine Single Evaluation and Research, WO–22,
amend FDA’s quality control Ingredient) Room 5488, 10903 New Hampshire
procedures, notification, and record NPRM Comment 11/10/05 Avenue, Silver Spring, MD 20993
and reporting requirements for infant Period End Phone: 301 796–2090
formula. FDA is taking this action to Final Action (Technical 11/30/07 72 FR 67639 Fax: 301 796–9899
Amendment) Email: walter.ellenberg@fda.hhs.gov
improve the protection of infants who
Final Action 09/00/10
consume infant formula products. (Amendment— RIN: 0910–AF33
Single Ingredient
Timetable:
Labeling)
Action Date FR Cite 154. OVER–THE–COUNTER (OTC)
Regulatory Flexibility Analysis DRUG REVIEW—EXTERNAL
NPRM 07/09/96 61 FR 36154 Required: Yes ANALGESIC PRODUCTS
NPRM Comment 12/06/96 Agency Contact: Walter J. Ellenberg, Legal Authority: 21 USC 321p; 21 USC
Period End Regulatory Project Management Officer, 331; 21 USC 351 to 353; 21 USC 355;
NPRM Comment 04/28/03 68 FR 22341 Department of Health and Human 21 USC 360; 21 USC 371
Period Reopened Services, Food and Drug
NPRM Comment 06/27/03 68 FR 38247 Administration, Center for Drug Abstract: The OTC drug review
Period Extended Evaluation and Research, WO–22, establishes conditions under which
NPRM Comment 08/26/03 Room 5488, 10903 New Hampshire OTC drugs are considered generally
Period End Avenue, Silver Spring, MD 20993 recognized as safe and effective and not
NPRM Comment 08/01/06 71 FR 43392 Phone: 301 796–2090 misbranded. After a final monograph
Period Reopened Fax: 301 796–9899 (i.e., final rule) is issued, only OTC
NPRM Comment 09/15/06 Email: walter.ellenberg@fda.hhs.gov drugs meeting the conditions of the
Period End monograph, or having an approved new
RIN: 0910–AF32 drug application, may be legally
Final Action 10/00/10
marketed. The final action addresses
Regulatory Flexibility Analysis 153. OVER–THE–COUNTER (OTC) the 2003 proposed rule on patches,
Required: Yes DRUG REVIEW—COUGH/COLD plasters, and poultices. The proposed
(COMBINATION) PRODUCTS rule will address issues not addressed
Agency Contact: Benson Silverman, in previous rulemakings.
Department of Health and Human Legal Authority: 21 USC 321p; 21 USC
Services, Food and Drug 331; 21 USC 351 to 353; 21 USC 355; Timetable:
Administration, Center for Food Safety 21 USC 360; 21 USC 371 Action Date FR Cite
and Applied Nutrition (HFS–850), 5100 Abstract: The OTC drug review Final Action (GRASE 12/00/10
Paint Branch Parkway, College Park, establishes conditions under which dosage forms)
MD 20740 OTC drugs are considered generally
NPRM (Amendment) To Be Determined

Phone: 301 436–1459 recognized as safe and effective and not
misbranded. After a final monograph Regulatory Flexibility Analysis
Email: benson.silverman@fda.hhs.gov Required: Yes
(i.e., final rule) is issued, only OTC
RIN: 0910–AF27 drugs meeting the conditions of the Agency Contact: Walter J. Ellenberg,
monograph, or having an approved new Regulatory Project Management Officer,
drug application, may be legally Department of Health and Human
Services, Food and Drug 156. USE OF MATERIALS DERIVED Action Date FR Cite
Administration, Center for Drug FROM CATTLE IN HUMAN FOOD AND
Evaluation and Research, WO–22, COSMETICS Interim Final Rule 07/16/08
(Amendments)
Room 5488, 10903 New Hampshire
Legal Authority: 21 USC 342; 21 USC Comment Period
Avenue, Silver Spring, MD 20993 End
Phone: 301 796–2090 361; 21 USC 371
Interim Final Rule 07/16/08
Fax: 301 796–9899 Abstract: On July 14, 2004, FDA issued (Amendments)
Email: walter.ellenberg@fda.hhs.gov an interim final rule (IFR), effective Effective
immediately, to prohibit the use of Final Action 10/00/10
RIN: 0910–AF35
certain cattle material and to address Regulatory Flexibility Analysis
the potential risk of bovine spongiform Required: Yes
155. OVER–THE–COUNTER (OTC) encephalopathy (BSE) in human food, Agency Contact: Amber McCoig,
DRUG REVIEW—SKIN PROTECTANT including dietary supplements, and Consumer Safety Officer, Department of
PRODUCTS cosmetics. Prohibited cattle materials Health and Human Services, Food and
under the IFR include specified risk Drug Administration, Center for Food
Legal Authority: 21 USC 321p; 21 USC materials, small intestine of all cattle,
331; 21 USC 351 to 353; 21 USC 355; Safety and Applied Nutrition,
material from nonambulatory disabled (HFS–316), 5100 Paint Branch Parkway,
21 USC 360; 21 USC 371 cattle, material from cattle not College Park, MD 20740
Abstract: The OTC drug review inspected and passed for human Phone: 301 436–2131
establishes conditions under which consumption, and mechanically Fax: 301 436–2644
OTC drugs are considered generally separated (MS) beef. Specified risk Email: amber.mccoig@fda.hhs.gov
recognized as safe and effective and not materials are the brain, skull, eyes,
trigeminal ganglia, spinal cord, RIN: 0910–AF47
misbranded. After a final monograph
(i.e., final rule) is issued, only OTC vertebral column (excluding the
drugs meeting the conditions of the vertebrae of the tail, the transverse 157. LABEL REQUIREMENT FOR
monograph, or having an approved new processes of the thoracic and lumbar FOOD THAT HAS BEEN REFUSED
drug application, may be legally vertebrae, and the wings of the sacrum), ADMISSION INTO THE UNITED
marketed. The first action addresses and dorsal root ganglia of cattle 30 STATES
skin protectant products used to treat months and older; and the tonsils and
distal ileum of the small intestine of Legal Authority: 15 USC 1453 to 1455;
fever blisters and cold sores. The 21 USC 321; 21 USC 342 and 343; 21
second action identifies safe and all cattle. Prohibited cattle materials do
not include tallow that contains no USC 371; 21 USC 374; 21 USC 381;
effective skin protectant active 42 USC 216; 42 USC 264
ingredients to treat and prevent diaper more than 0.15 percent hexane-
rash. insoluble impurities and tallow Abstract: The final rule will require
derivatives. This action minimizes owners or consignees to label imported
Timetable: human exposure to materials that food that is refused entry into the
scientific studies have demonstrated are United States. The label will read,
Action Date FR Cite
highly likely to contain the BSE agent ‘‘UNITED STATES: REFUSED ENTRY.’’
Final Action 03/06/09 74 FR 9759 in cattle infected with the disease. The proposal describes the label’s
(Aluminum Acetate) Scientists believe that the human characteristics (such as its size) and
(Technical disease variant Creutzfeldt-Jakob processes for verifying that the label
Amendment) disease (vCJD) is likely caused by the has been affixed properly. We are
Final Action (Diaper 03/00/11 consumption of products contaminated taking this action to prevent the
Rash) with the agent that causes BSE. introduction of unsafe food into the
Final Action (Technical 02/01/08 73 FR 6014 United States, to facilitate the
Amendments) Timetable: examination of imported food, and to
Final Action (Fever 03/00/11
Action Date FR Cite implement section 308 of the Public
Blisters/Cold Sores)
Health Security and Bioterrorism
Interim Final Rule 07/14/04 69 FR 42256 Preparedness and Response Act of 2002
Regulatory Flexibility Analysis Interim Final Rule 07/14/04
Required: Yes (the Bioterrorism Act) (Pub. L. 107-
Effective
188).
Agency Contact: Walter J. Ellenberg, Interim Final Rule 10/12/04
Comment Period Timetable:
Regulatory Project Management Officer, End
Department of Health and Human Action Date FR Cite
Interim Final Rule 09/07/05 70 FR 53063
Services, Food and Drug (Amendments) NPRM 09/18/08 73 FR 54106
Administration, Center for Drug Interim Final Rule 10/07/05 NPRM Comment 12/02/08
Evaluation and Research, WO–22, (Amendments) Period End
Room 5488, 10903 New Hampshire Effective Final Action 03/00/11

Avenue, Silver Spring, MD 20993 Interim Final Rule 11/07/05 Regulatory Flexibility Analysis
Phone: 301 796–2090 (Amendments) Required: Yes
Fax: 301 796–9899 Comment Period
Email: walter.ellenberg@fda.hhs.gov End Agency Contact: John D. Reilly,
Interim Final Rule 04/17/08 73 FR 20785 Regulatory Counsel, Department of
RIN: 0910–AF42 (Amendments) Health and Human Services, Food and
Drug Administration, Center for Food Branch Parkway, College Park, MD Fax: 301 436–2637
Safety and Applied Nutrition, CPK 1, 20740 Email: john.reilly@fda.hhs.gov
Room 1C–015, (HFS–024), 5100 Paint Phone: 301 436–1530 RIN: 0910–AF61

158. CURRENT GOOD Administration, Center for Food Safety Department of Health and Human
MANUFACTURING PRACTICE IN and Applied Nutrition (HFS–024), 5100 Services, Food and Drug
MANUFACTURING, PACKING, Paint Branch Parkway, College Park, Administration, Center for Drug
LABELING, OR HOLDING MD 20740 Evaluation and Research, WO–22,
OPERATIONS FOR DIETARY Phone: 301 436–2784 Room 5488, 10903 New Hampshire
SUPPLEMENTS Fax: 301 436–2657 Avenue, Silver Spring, MD 20993
Legal Authority: 21 USC 321; 21 USC Email: linda.kahl@fda.hhs.gov Phone: 301 796–2090
342 and 343; 21 USC 348; 21 USC 371; RIN: 0910–AB88 Fax: 301 796–9899
21 USC 374; 21 USC 381; 21 USC 393; Email: walter.ellenberg@fda.hhs.gov
42 USC 264 RIN: 0910–AF34
159. OVER–THE–COUNTER (OTC)
Abstract: The Food and Drug DRUG REVIEW—COUGH/COLD
Administration published a final rule (NASAL DECONGESTANT) 160. OVER–THE–COUNTER (OTC)
in the Federal Register of June 25, 2007 PRODUCTS DRUG REVIEW—LABELING OF DRUG
(72 FR 34752), on current good PRODUCTS FOR OTC HUMAN USE
Legal Authority: 21 USC 321p; 21 USC
manufacturing practice (CGMP)
331; 21 USC 351 to 353; 21 USC 355; Legal Authority: 21 USC 321p; 21 USC
regulations for dietary supplements.
21 USC 360; 21 USC 371 331; 21 USC 351 to 353; 21 USC 355;
FDA also published an Interim Final
Rule in the same Federal Register (72 Abstract: The OTC drug review 21 USC 358; 21 USC 360; 21 USC 371;
FR 34959) that provided a procedure establishes conditions under which 21 UCS 374; 21 USC 379e
for requesting an exemption from the OTC drugs are considered generally Abstract: The OTC drug review
final rule requirement that the recognized as safe and effective and not establishes conditions under which
manufacturer conduct at least one misbranded. After a final monograph OTC drugs are considered generally
appropriate test or examination to (i.e., final rule) is issued, only OTC recognized as safe and effective and not
verify the identity of any component drugs meeting the conditions of the misbranded. After a final monograph
that is a dietary ingredient. This IFR monograph, or having an approved new (i.e., final rule) is issued, only OTC
allows for submission to, and review drug application, may be legally drugs meeting the conditions of the
by, FDA of an alternative to the marketed. This action addresses the monograph, or having an approved new
required 100 percent identity testing of ingredient phenylpropanolamine. drug application, may be legally
components that are dietary Timetable: marketed. This action addresses
ingredients, provided certain conditions labeling for convenience (small) size
Action Date FR Cite
are met. This IFR also establishes a OTC drug packages.
requirement for retention of records NPRM (Amendment) 08/02/04 69 FR 46119
relating to the FDA’s response to an (Sinusitis Claim) Timetable:
exemption request. NPRM Comment 11/01/04 Action Date FR Cite
Period End
Timetable: NPRM (Phenylephrine 11/02/04 69 FR 63482 NPRM (Convenience 12/12/06 71 FR 74474
Bitartrate) Sizes)
Action Date FR Cite
NPRM Comment 01/31/05 NPRM Comment 04/11/07
ANPRM 02/06/97 62 FR 5700 Period End Period End
ANPRM Comment 06/06/97 NPRM (Phenyl- 12/22/05 70 FR 75988 Final Action To Be Determined
Period End propanolamine) Regulatory Flexibility Analysis
NPRM 03/13/03 68 FR 12157 NPRM Comment 03/22/06 Required: Yes
NPRM Comment 08/11/03 Period End
Period End Final Action 10/31/05 70 FR 58974 Agency Contact: Walter J. Ellenberg,
Final Rule 06/25/07 72 FR 34752 (Amendment) Regulatory Project Management Officer,
Interim Final Rule 06/25/07 72 FR 34959 (Sinusitis Claim) Department of Health and Human
Interim Final Rule 10/24/07 Final Action 08/01/06 71 FR 83358 Services, Food and Drug
Comment Period (Phenylephrine Administration, Center for Drug
End Bitartrate) Evaluation and Research, WO–22,
Final Action To Be Determined Final Action (Phenyl- To Be Determined Room 5488, 10903 New Hampshire
Regulatory Flexibility Analysis propanolamine) Avenue, Silver Spring, MD 20993
Required: Yes Regulatory Flexibility Analysis Phone: 301 796–2090
Agency Contact: Linda Kahl, Senior Required: Yes Fax: 301 796–9899
Policy Analyst, Department of Health Agency Contact: Walter J. Ellenberg, Email: walter.ellenberg@fda.hhs.gov
and Human Services, Food and Drug Regulatory Project Management Officer, RIN: 0910–AF37
HHS—FDA Long-Term Actions
161. OVER–THE–COUNTER (OTC) used to reduce or prevent dental plaque Room 5488, 10903 New Hampshire
DRUG REVIEW—OPHTHALMIC and gingivitis. Avenue, Silver Spring, MD 20993
PRODUCTS Timetable: Phone: 301 796–2090
Legal Authority: 21 USC 321p; 21 USC Fax: 301 796–9899
Action Date FR Cite
331; 21 USC 351 to 353; 21 USC 355; Email: walter.ellenberg@fda.hhs.gov
21 USC 360; 21 USC 371 ANPRM (Plaque 05/29/03 68 FR 32232
Gingivitis) RIN: 0910–AF44
Abstract: The OTC drug review ANPRM Comment 08/27/03
establishes conditions under which Period End
OTC drugs are considered generally NPRM (Plaque To Be Determined 164. OVER–THE–COUNTER (OTC)
recognized as safe and effective and not Gingivitis) DRUG REVIEW—WEIGHT CONTROL
misbranded. After a final monograph Final Action To Be Determined PRODUCTS
Regulatory Flexibility Analysis Legal Authority: 21 USC 321p; 21 USC
drugs meeting the conditions of the
Required: Yes 331; 21 USC 351 to 353; 21 USC 355;
monograph, or having an approved new
drug application, may be legally Agency Contact: Walter J. Ellenberg, 21 USC 360; 21 USC 371
marketed. This action finalizes the Regulatory Project Management Officer,
Department of Health and Human Abstract: The OTC drug review
monograph for emergency first aid
Services, Food and Drug establishes conditions under which
eyewash drug products.
Administration, Center for Drug OTC drugs are considered generally
Timetable: Evaluation and Research, WO–22, recognized as safe and effective and not
Action Date FR Cite Room 5488, 10903 New Hampshire misbranded. After a final monograph
Avenue, Silver Spring, MD 20993 (i.e., final rule) is issued, only OTC
NPRM (Amendment) 02/19/03 68 FR 7917
Phone: 301 796–2090 drugs meeting the conditions of the
(Emergency First
Aid Eyewashes) Fax: 301 796–9899 monograph, or having an approved new
Final Action To Be Determined Email: walter.ellenberg@fda.hhs.gov drug application, may be legally
(Amendment) marketed. The NPRM addresses the use
RIN: 0910–AF40
(Emergency First of benzocaine for weight control. The
Aid Eyewashes) first final action finalizes the 2005
Regulatory Flexibility Analysis 163. OVER–THE–COUNTER (OTC) proposed rule for weight control
Required: Yes DRUG REVIEW—VAGINAL products containing
CONTRACEPTIVE PRODUCTS phenylpropanolamine. The second final
Agency Contact: Walter J. Ellenberg, action will finalize the proposed rule
Regulatory Project Management Officer, Legal Authority: 21 USC 321p; 21 USC
331; 21 USC 351 to 353; 21 USC 355; for weight control products containing
Department of Health and Human benzocaine.
Services, Food and Drug 21 USC 358; 21 USC 360; 21 USC 371;
Administration, Center for Drug 21 USC 374; 21 USC 379e
Timetable:
Evaluation and Research, WO–22, Abstract: The OTC drug review
Room 5488, 10903 New Hampshire Action Date FR Cite
establishes conditions under which
Avenue, Silver Spring, MD 20993 OTC drugs are considered generally NPRM (Phenyl- 12/22/05 70 FR 75988
Phone: 301 796–2090 recognized as safe and effective and not propanolamine)
Fax: 301 796–9899 misbranded. After a final monograph NPRM Comment 03/22/06
Email: walter.ellenberg@fda.hhs.gov (i.e., final rule) is issued, only OTC Period End
RIN: 0910–AF39 drugs meeting the conditions of the NPRM (Benzocaine) To Be Determined
monograph, or having an approved new Final Action (Phenyl- To Be Determined
drug application, may be legally propanolamine)
162. OVER–THE–COUNTER (OTC) marketed. The proposed rule addresses Final Action To Be Determined
DRUG REVIEW—ORAL HEALTH CARE vaginal contraceptive drug products. (Benzocaine)
PRODUCTS
Timetable: Regulatory Flexibility Analysis
Action Date FR Cite Required: Yes
331; 21 USC 351 to 353; 21 USC 355;
21 USC 360 to 360a; 21 USC 371 to Final Action 12/19/07 72 FR 71769 Agency Contact: Walter J. Ellenberg,
371a (Warnings)
Regulatory Project Management Officer,
NPRM (Vaginal To Be Determined
Abstract: The OTC drug review Contraceptive Drug
establishes conditions under which Products) Services, Food and Drug
OTC drugs are considered generally Administration, Center for Drug
recognized as safe and effective and not Regulatory Flexibility Analysis Evaluation and Research, WO–22,
misbranded. After a final monograph Required: Yes Room 5488, 10903 New Hampshire
(i.e., final rule) is issued, only OTC Agency Contact: Walter J. Ellenberg, Avenue, Silver Spring, MD 20993
drugs meeting the conditions of the Regulatory Project Management Officer, Phone: 301 796–2090
monograph, or having an approved new Department of Health and Human Fax: 301 796–9899
drug application, may be legally Services, Food and Drug Email: walter.ellenberg@fda.hhs.gov
marketed. The NPRM and final action Administration, Center for Drug
will address oral health care products Evaluation and Research, WO–22, RIN: 0910–AF45
165. OVER–THE–COUNTER (OTC) associated with overindulgence in food Phone: 301 796–2090
DRUG REVIEW—OVERINDULGENCE and drink. Fax: 301 796–9899
IN FOOD AND DRINK PRODUCTS Timetable: Email: walter.ellenberg@fda.hhs.gov
Legal Authority: 21 USC 321p; 21 USC Action Date FR Cite
RIN: 0910–AF53
331; 21 USC 351 to 353; 21 USC 355;
21 USC 360; 21 USC 371 Final Action (Sodium To Be Determined
Bicarbonate 168. OVER–THE–COUNTER (OTC)
Abstract: The OTC drug review Labeling) DRUG REVIEW—STIMULANT DRUG
establishes conditions under which Final Action To Be Determined PRODUCTS
OTC drugs are considered generally (Overindulgence
recognized as safe and effective and not Legal Authority: 21 USC 321p; 21 USC
Labeling)
misbranded. After a final monograph 331; 21 USC 351 to 353; 21 USC 355;
Regulatory Flexibility Analysis 21 USC 360; 21 USC 371
Required: Yes
drugs meeting the conditions of the Abstract: The OTC drug review
monograph, or having an approved new Agency Contact: Walter J. Ellenberg, establishes conditions under which
drug application, may be legally Regulatory Project Management Officer, OTC drugs are considered generally
marketed. This action addresses Department of Health and Human recognized as safe and effective and not
products containing bismuth Services, Food and Drug misbranded. After a final monograph
subsalicylate for relief of symptoms of Administration, Center for Drug (i.e., final rule) is issued, only OTC
upset stomach due to overindulgence Evaluation and Research, WO–22, drugs meeting the conditions of the
resulting from food and drink. Room 5488, 10903 New Hampshire monograph, or having an approved new
Avenue, Silver Spring, MD 20993 drug application, may be legally
Timetable:
Phone: 301 796–2090 marketed. This action addresses the use
Action Date FR Cite Fax: 301 796–9899 of stimulant active ingredients to
NPRM (Amendment) 01/05/05 70 FR 741 Email: walter.ellenberg@fda.hhs.gov relieve symptoms associated with a
NPRM Comment 04/05/05 RIN: 0910–AF52 hangover.
Period End Timetable:
Final Action To Be Determined
167. OVER–THE–COUNTER (OTC) Action Date FR Cite
Regulatory Flexibility Analysis DRUG REVIEW—SKIN BLEACHING
Required: Yes NPRM (Amendment) To Be Determined
PRODUCTS (Hangover)
Agency Contact: Walter J. Ellenberg, Legal Authority: 21 USC 321p; 21 USC
Regulatory Project Management Officer, Regulatory Flexibility Analysis
331; 21 USC 351 to 353; 21 USC 355; Required: Yes
Department of Health and Human 21 USC 360; 21 USC 371
Services, Food and Drug Agency Contact: Walter J. Ellenberg,
Administration, Center for Drug Abstract: The OTC drug review Regulatory Project Management Officer,
Evaluation and Research, WO–22, establishes conditions under which Department of Health and Human
Room 5488, 10903 New Hampshire OTC drugs are considered generally Services, Food and Drug
Avenue, Silver Spring, MD 20993 recognized as safe and effective and not Administration, Center for Drug
Phone: 301 796–2090 misbranded. After a final monograph Evaluation and Research, WO–22,
Fax: 301 796–9899 (i.e., final rule) is issued, only OTC Room 5488, 10903 New Hampshire
Email: walter.ellenberg@fda.hhs.gov drugs meeting the conditions of the Avenue, Silver Spring, MD 20993
monograph, or having an approved new Phone: 301 796–2090
RIN: 0910–AF51 drug application, may be legally Fax: 301 796–9899
marketed. This action addresses skin Email: walter.ellenberg@fda.hhs.gov
166. OVER–THE–COUNTER (OTC) bleaching drug products containing
hydroquinone. RIN: 0910–AF56
DRUG REVIEW—ANTACID PRODUCTS
Legal Authority: 21 USC 321p; 21 USC Timetable:
331; 21 USC 351 to 353; 21 USC 355; 169. OVER–THE–COUNTER
Action Date FR Cite ANTIDIARRHEAL DRUG PRODUCTS
21 USC 360; 21 USC 371
NPRM 08/29/06 71 FR 51146 Legal Authority: 21 USC 321p; 21 USC
Abstract: The OTC drug review NPRM Comment 12/27/06
establishes conditions under which 331; 21 USC 351 to 353; 21 USC 355;
Period End
OTC drugs are considered generally 21 USC 360; 21 USC 371
Final Action To Be Determined
recognized as safe and effective and not Abstract: The OTC drug review
misbranded. After a final monograph Regulatory Flexibility Analysis establishes conditions under which
(i.e., final rule) is issued, only OTC Required: Yes OTC drugs are considered generally
drugs meeting the conditions of the Agency Contact: Walter J. Ellenberg, recognized as safe and effective and not
monograph, or having an approved new Regulatory Project Management Officer, misbranded. After a final monograph
drug application, may be legally Department of Health and Human (i.e., final rule) is issued, only OTC
marketed. One action addresses the Services, Food and Drug drugs meeting the conditions of the
labeling of products containing sodium Administration, Center for Drug monograph, or having an approved new
bicarbonate as an active ingredient. The Evaluation and Research, WO–22, drug application, may be legally
other action addresses the use of Room 5488, 10903 New Hampshire marketed. These actions address new
antacids to relieve upset stomach Avenue, Silver Spring, MD 20993 labeling for antidiarrheal drug products.
Timetable: drugs meeting the conditions of the Abstract: The Food and Drug
Action Date FR Cite monograph, or having an approved new Administration (FDA) is proposing that
drug application, may be legally certain ingredients in over-the-counter
NPRM (New Labeling) To Be Determined marketed. This action addresses the (OTC) drug products are not generally
Final Action (New To Be Determined products used for urinary pain relief. recognized as safe and effective or are
Labeling) misbranded. FDA issued proposed rule
Timetable:
Regulatory Flexibility Analysis because we did not receive any data
Required: Yes Action Date FR Cite and information on these ingredients in
Agency Contact: Walter J. Ellenberg, NPRM (Urinary To Be Determined response to our request on December
Regulatory Project Management Officer, Analgesic) 31, 2003 (68 FR 75585). This rule will
Department of Health and Human finalize the 2008 proposed rule.
Services, Food and Drug Required: Yes Timetable:
Administration, Center for Drug
Evaluation and Research, WO–22, Agency Contact: Walter J. Ellenberg, Action Date FR Cite
Room 5488, 10903 New Hampshire Regulatory Project Management Officer,
NPRM 06/19/08 73 FR 34895
Avenue, Silver Spring, MD 20993 Department of Health and Human
Phone: 301 796–2090 Services, Food and Drug Period End
Fax: 301 796–9899 Administration, Center for Drug Final Action To Be Determined
Email: walter.ellenberg@fda.hhs.gov Evaluation and Research, WO–22,
RIN: 0910–AF63 Room 5488, 10903 New Hampshire Regulatory Flexibility Analysis
Avenue, Silver Spring, MD 20993 Required: Yes
Phone: 301 796–2090
170. OVER–THE–COUNTER (OTC) Fax: 301 796–9899 Agency Contact: Walter J. Ellenberg,
DRUG REVIEW—URINARY Email: walter.ellenberg@fda.hhs.gov Regulatory Project Management Officer,
ANALGESIC DRUG PRODUCTS Department of Health and Human
RIN: 0910–AF70 Services, Food and Drug
331; 21 USC 351 to 353; 21 USC 355; Administration, Center for Drug
21 USC 360; 21 USC 371 171. STATUS OF CERTAIN Evaluation and Research, WO–22,
ADDITIONAL OVER–THE–COUNTER Room 5488, 10903 New Hampshire
Abstract: The OTC drug review Avenue, Silver Spring, MD 20993
DRUG CATEGORY II ACTIVE
establishes conditions under which Phone: 301 796–2090
INGREDIENTS
OTC drugs are considered generally Fax: 301 796–9899
recognized as safe and effective and not Legal Authority: 21 USC 321p; 21 USC Email: walter.ellenberg@fda.hhs.gov
misbranded. After a final monograph 331; 21 USC 351 to 353; 21 USC 355;
(i.e., final rule) is issued, only OTC 21 USC 360; 21 USC 371 RIN: 0910–AF95

172. POSITRON EMISSION Agency Contact: Reena Raman, OTC drugs are considered generally
TOMOGRAPHY DRUGS; CURRENT Regulatory Counsel, Department of recognized as safe and effective and not
GOOD MANUFACTURING PRACTICES Health and Human Services, Food and misbranded. After a final monograph
Legal Authority: PL 105–115, sec 121 Drug Administration, Center for Drug (i.e., final rule) is issued, only OTC
Evaluation and Research, 10903 New drugs meeting the conditions of the
Abstract: Section 121 of the Food and Hampshire Ave., WO 51, Room 6238, monograph, or having an approved new
Drug Administration Modernization Act Silver Spring, MD 20993–0002 drug application, may be legally
of 1997 (Pub. L. 105-115) directs FDA Phone: 301 796–7577 marketed. This action will address acne
to establish requirements for current Fax: 301 847–8440 drug products containing benzoyl
good manufacturing practices (CGMPs) Email: reena.raman@fda.hhs.gov peroxide.
for positron emission tomography (PET)
drugs, a type of radiopharmaceutical. RIN: 0910–AC55 Timetable:
The final rule adopts CGMPs that
Action Date FR Cite
reflect the unique characteristics of PET 173. OVER–THE–COUNTER (OTC)
drugs. DRUG REVIEW—ACNE DRUG
Final Action 03/04/10 75 FR 9767
Timetable: PRODUCTS CONTAINING BENZOYL Regulatory Flexibility Analysis
Action Date FR Cite PEROXIDE Required: Yes
NPRM 09/20/05 70 FR 55038 Legal Authority: 21 USC 321p; 21 USC

Agency Contact: Walter J. Ellenberg,
NPRM Comment 12/19/05 331; 21 USC 351 to 353; 21 USC 355;
Regulatory Project Management Officer,
Period End 21 USC 360 to 360a; 21 USC 371 to
Final Action 12/10/09 74 FR 65409 371a
Services, Food and Drug
Regulatory Flexibility Analysis Abstract: The OTC drug review Administration, Center for Drug
Required: Yes establishes conditions under which Evaluation and Research, WO–22,
HHS—FDA Completed Actions
Room 5488, 10903 New Hampshire Phone: 301 796–2090 Email: walter.ellenberg@fda.hhs.gov
Avenue, Silver Spring, MD 20993 Fax: 301 796–9899 RIN: 0910–AG00

Centers for Medicare & Medicaid Services (CMS)
174. HOME HEALTH AGENCY (HHA) Abstract: This proposed rule would Agency Contact: Tiffany Swygert,
CONDITIONS OF PARTICIPATION establish that in order to participate in Health Insurance Specialist,
(COPS) (CMS–3819–P) (SECTION 610 the Medicare and Medicaid programs, Department of Health and Human
REVIEW) long-term care (LTC) facilities must Services, Centers for Medicare &
Legal Authority: 42 USC 1302; 42 USC have an agreement with hospice Medicaid Services, Mailstop C4–25–11,
1395x; 42 USC 1395cc(a); 42 USC agencies when hospice care is provided 7500 Security Boulevard, Baltimore,
1395hh; 42 USC 1395bb in a long-term care facility. We are MD 21244
proposing new requirements to ensure Phone: 410 786–4642
Abstract: This proposed rule would that quality hospice care is provided Email: tiffany.swygert@cms.hhs.gov
revise the existing Conditions of to eligible residents.
Participation (CoPs), last set in 1999, RIN: 0938–AP80
that Home Health Agencies (HHAs) Timetable:
must meet to participate in the Action Date FR Cite 177. CHANGES TO THE HOSPITAL
Medicare program. The requirements OUTPATIENT PROSPECTIVE
NPRM 03/00/11
focus on the actual care delivered to PAYMENT SYSTEM AND
patients by HHAs, reflect an Regulatory Flexibility Analysis AMBULATORY SURGICAL CENTER
interdisciplinary view of patient care, Required: Yes PAYMENT SYSTEM FOR CY 2011
allow HHAs greater flexibility in (CMS–1504–P)
Agency Contact: Trish Brooks, Health
meeting quality standards, and
Insurance Specialist, Department of Legal Authority: sec 1833 of the Social
eliminate unnecessary procedural
Health and Human Services, Centers for Security Act
requirements. These changes are an
Medicare & Medicaid Services, Office
integral part of our efforts to achieve Abstract: This annual proposed rule
of Clinical Standards and Quality,
broad-based improvements and would revise the Medicare hospital
Mailstop S3–02–01, 7500 Security
measurements of the quality of care outpatient prospective payment system
Boulevard, Baltimore, MD 21244
furnished through Federal programs to implement applicable statutory
Phone: 410 786–4561
while at the same time reducing requirements and changes arising from
Email: trish.brooks@cms.hhs.gov
procedural burdens on providers. our continuing experience with this
Timetable: RIN: 0938–AP32 system. In addition, the proposed rule
describes proposed changes to the
Action Date FR Cite
176. PROPOSED CHANGES TO THE amounts and factors used to determine
NPRM 03/10/97 62 FR 11005 HOSPITAL INPATIENT PROSPECTIVE the payment rates for Medicare hospital
NPRM Comment 06/09/97 PAYMENT SYSTEMS FOR ACUTE outpatient services paid under the
Period End prospective payment system. The rule
CARE HOSPITALS AND FY 2011
Second NPRM 09/00/10 also proposes changes to the
RATES AND TO THE LONG–TERM
Regulatory Flexibility Analysis CARE HOSPITAL PPS AND RY 2011 Ambulatory Surgical Center Payment
Required: Undetermined RATES (CMS–1498–P) System list of services and rates. These
changes would be applicable to services
Agency Contact: Danielle Shearer, Legal Authority: Sec 1886(d) of the furnished on or after January 1st.
Health Insurance Specialist, Social Security Act
Department of Health and Human Timetable:
Services, Centers for Medicare & Abstract: This annual proposed rule
would revise the Medicare hospital Action Date FR Cite
Medicaid Services, Clinical Standards &
Quality, Mailstop S3–02–01, 7500 inpatient and long-term care NPRM 06/00/10
Security Boulevard, Baltimore, MD prospective payment systems for
operating and capital-related costs to Regulatory Flexibility Analysis
21244 Required: Yes
Phone: 410 786–6617 implement changes arising from our
Email: danielle.shearer@cms.hhs.gov continuing experience with these Agency Contact: Alberta Dwivedi,
systems. These changes would be Health Insurance Specialist,
RIN: 0938–AG81 applicable to services furnished on or Department of Health and Human
after October 1st. Services, Centers for Medicare &
175. REQUIREMENTS FOR Timetable: Medicaid Services, Mail Stop

LONG–TERM CARE FACILITIES: C5–01–26, 7500 Security Boulevard,
Action Date FR Cite Baltimore, MD 21244
HOSPICE SERVICES (CMS–3140–P)
(SECTION 610 REVIEW) NPRM 04/00/10 Phone: 410 786–0763
Email: alberta.dwivedi@cms.hhs.gov
Legal Authority: 42 USC 1302; 42 USC Regulatory Flexibility Analysis
1395hh Required: Yes RIN: 0938–AP82
HHS—CMS Proposed Rule Stage
178. HOME HEALTH PROSPECTIVE 179. ∑ OMNIBUS INFLUENZA 180. ∑ PROPOSED CHANGES TO THE
PAYMENT SYSTEM REFINEMENTS IMMUNIZATION (CMS–3213–P) HOSPITAL CONDITIONS OF
AND RATE UPDATE FOR CY 2011 Legal Authority: Social Security Act PARTICIPATION: REQUIREMENTS
(CMS–1510–P) sec 1881, 1861, 1920, 1102, 1871, 1965 FOR HOSPITAL PSYCHIATRIC AND
REHABILITATION UNITS EXCLUDED
Legal Authority: Social Security Act, Abstract: This proposed rule would FROM THE PROSPECTIVE PAYMENT
secs 1102 and 1871; 42 USC 1302 and require certain providers to offer all SYSTEM (CMS–3177–P)
42 USC 1395(hh); Social Security Act, patients or residents an influenza
sec 1895 immunization annually. The providers Legal Authority: 42 USC 1385 X; 42
required to do so are hospitals, USC 1396 d; 42 USC 1395 hh
Abstract: This annual proposed rule
would update the 60-day national intermediate care facilities, critical Abstract: This proposed rule would
episode rate (based on the applicable access hospitals, rural health clinics, transfer the existing process
Home Health Market Basket Update Federally qualified health centers, requirements for hospital psychiatric
and case-mix adjustment) and would ESRD facilities, psychiatric residential and rehabilitation units that are
also update the national per-visit rates treatment facilities, and inpatient excluded from prospective payment
(used to calculate low utilization rehabilitation facilities. This proposed systems to the hospital conditions of
payment adjustments (LUPAs) and rule is based on the most recent participation (CoPs) part of the Act.
outlier payments) amounts under the recommendations from the CDC’s This would allow accrediting
Medicare Prospective Payment System Advisory 3 Committee on organizations to deem these units as
for home health agencies. These Immunization Practices. The goal of part of their hospital accreditation
changes would be applicable to services this proposed rule is to improve process providing a timely and cost
furnished on or after January 1st. influenza immunization rates for all effective survey and certification
patients and residents and to address process under the CoPs.
Timetable: the disparities in immunization rates
Action Date FR Cite
Timetable:
Timetable:
Action Date FR Cite
NPRM 07/00/10 Action Date FR Cite
NPRM 01/00/11
Regulatory Flexibility Analysis NPRM 09/00/10
Required: Yes Regulatory Flexibility Analysis Regulatory Flexibility Analysis
Required: Yes Required: Yes
Agency Contact: Randy Throndeset,
Technical Advisor, Department of Agency Contact: Lauren Oviatt, Health Agency Contact: Scott Cooper, Health
Health and Human Services, Centers for Insurance Specialist, Department of Insurnce Specialist, Department of
Medicare & Medicaid Services, Centers Health and Human Services, Centers for Health and Human Services, Centers for
for Medicare Management, Mailstop Medicare & Medicaid Services, Mail Medicare & Medicaid Services, Mail
C5–07–28, 7500 Security Boulevard, Stop S3–02–01, 7500 Security stop S3–02–01, 7500 Security
Baltimore, MD 21244 Boulevard, Baltimore, MD 21244 Boulevard, Baltimore, MD 21244
Phone: 410 786–0131 Phone: 410 786–4683 Phone: 410 786–9465
Email: randy.throndeset@cms.hhs.gov Email: lauren.oviatt@cms.hhs.gov Email: scott.cooper@cms.hhs.gov
RIN: 0938–AP88 RIN: 0938–AP92 RIN: 0938–AP97

181. REVISIONS TO THE MEDICARE requirements; strengthen beneficiary Regulatory Flexibility Analysis
ADVANTAGE AND MEDICARE protections; ensure that plan offerings Required: Yes
PRESCRIPTION DRUG BENEFIT to beneficiaries include meaningful
PROGRAMS FOR CONTRACT YEAR differences; improve plan payment Agency Contact: Alissa Deboy,
2011 (CMS–4085–F) rules and processes; improve data Director, Division of Drug Plan Policy
Legal Authority: MMA 2003; MIPPA collection for oversight and quality and Quality, Department of Health and
(title XVIII of the Social Security Act) assessment; implement new policy Human Services, Centers for Medicare
such as a Part D formulary policy; and & Medicaid Services, Mail Stop
Abstract: This final rule makes clarify program policy. C1–26–26, 7500 Security Boulevard,
revisions to the regulations governing Baltimore, MD 21244
the Medicare Advantage (MA) program Timetable: Phone: 410 786–6041
(Part C) and prescription drug benefit
Action Date FR Cite Email: alissa.deboy@cms.hhs.gov
program (Part D) based on our

continued experience in the NPRM 10/22/09 74 FR 54634 RIN: 0938–AP77
administration of the Part C and D NPRM Comment 12/07/09
programs. The revisions strengthen Period End
various program participation and exit Final Action 10/00/12

182. ELECTRONIC CLAIMS Abstract: This annual rule revises related provisions of the Medicare
ATTACHMENTS STANDARDS payment polices under the physician Improvements for Patients and
(CMS–0050–IFC) fee schedule, as well as other policy Providers Act of 2008 (MIPPA). In
Legal Authority: 42 USC changes to payment under Part B. addition, the rule describes changes to
1320d–2(a)(2)(B) Timetable: the amounts and factors used to
Abstract: This rule sets forth electronic determine the payment rates for
Action Date FR Cite
standards for health care claims Medicare hospital outpatient services
NPRM 07/13/09 74 FR 33520 paid under the prospective payment
attachments. The standards are required
NPRM Comment 08/31/09 system. The rule also changes the
by the Health Insurance Portability and Period End
Accountability Act of 1996. They will Ambulatory Surgical Center Payment
Final Action 11/25/09 74 FR 61738
be used to transmit clinical or System list of services and rates. These
administrative data for claims Regulatory Flexibility Analysis changes are applicable to services
adjudication purposes. Required: Yes furnished on or after January 1st.
Timetable: Agency Contact: Diane Milstead,
Health Insurance Specialist, Timetable:
Action Date FR Cite Department of Health and Human Action Date FR Cite
NPRM 09/23/05 70 FR 55989 Services, Centers for Medicare &
NPRM Comment 11/22/05 Medicaid Services, Centers for NPRM 07/20/09 74 FR 35231
Period End Medicaid Mangement, Mailstop NPRM Comment 08/31/09
Withdrawn 01/25/10 C4–03–06, 7500 Security Boulevard, Period End
Baltimore, MD 21244 Final Action 11/20/09 74 FR 60315
Required: Yes Phone: 410 786–3355 Regulatory Flexibility Analysis
Email: diane.milstead@cms.hhs.gov
Agency Contact: Elizabeth Holland, Required: Yes
Health Insurance Specialist, RIN: 0938–AP40
Department of Health and Human Agency Contact: Alberta Dwivedi,
Services, Centers for Medicare & Health Insurance Specialist,
184. CHANGES TO THE HOSPITAL Department of Health and Human
Medicaid Services, Office of E–Health OUTPATIENT PROSPECTIVE
Standards and Services, Mailstop Services, Centers for Medicare &
PAYMENT SYSTEM AND
S2–26–17, 7500 Security Boulevard, Medicaid Services, Centers for
AMBULATORY SURGICAL CENTER
Baltimore, MD 21244 Medicare Management, Mailstop
PAYMENT SYSTEM FOR CY 2010
Phone: 410 786–1309 C5–01–26, 7500 Security Boulevard,
(CMS–1414–FC)
Email: elizabeth.holland@cms.hhs.gov, Baltimore, MD 21244
Legal Authority: BBA; BBA; BIPA; Phone: 410 786–0763
RIN: 0938–AK62
MMA; MMSEA; MIPPA; DRA; TRHCA Email: alberta.dwivedi@cms.hhs.gov
Abstract: This annual rule revises the
183. REVISIONS TO PAYMENT Medicare hospital outpatient RIN: 0938–AP41
POLICIES UNDER THE PHYSICIAN prospective payment system to [FR Doc. 2010–8934 Filed 04–23–10; 8:45
FEE SCHEDULE FOR CY 2010 implement applicable statutory am]
(CMS–1413–FC) requirements and changes arising from BILLING CODE 4150–24–S
Legal Authority: Social Security Act, our continuing experience with this
sec 1102; Social Security Act, sec 1871 system and to implement certain

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Monday,

April 26, 2010

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary—Proposed Rule Stage

Office of the Secretary—Final Rule Stage

Substance Abuse and Mental Health Services Administration—Final Rule Stage

Substance Abuse and Mental Health Services Administration—Long-Term Actions

for Children and Youth ................................................................................................................................................ 0930–AA10

Centers for Disease Control and Prevention—Proposed Rule Stage

Centers for Disease Control and Prevention—Final Rule Stage

127 Quality Assurance Requirements for Respirators ......................................................................................................... 0920–AA04

Centers for Disease Control and Prevention—Long-Term Actions

Centers for Disease Control and Prevention—Completed Actions

Food and Drug Administration—Prerule Stage

Food and Drug Administration—Proposed Rule Stage

137 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products .......................................................... 0910–AF31

Food and Drug Administration—Proposed Rule Stage (Continued)

Food and Drug Administration—Final Rule Stage

Food and Drug Administration—Long-Term Actions

Food and Drug Administration—Completed Actions

Centers for Medicare & Medicaid Services—Proposed Rule Stage

Centers for Medicare & Medicaid Services—Long-Term Actions

Centers for Medicare & Medicaid Services—Completed Actions

182 Electronic Claims Attachments Standards (CMS-0050-IFC) ........................................................................................ 0938–AK62

Department of Health and Human Services (HHS) Proposed Rule Stage

Department of Health and Human Services (HHS) Final Rule Stage

Department of Health and Human Services (HHS) Final Rule Stage

122. OPIOID DRUGS IN buprenorphine and buprenorphine Regulatory Flexibility Analysis

Department of Health and Human Services (HHS) Long-Term Actions

Department of Health and Human Services (HHS) Proposed Rule Stage

124. CONTROL OF COMMUNICABLE Agency Contact: Stacy Howard, Timetable:

Department of Health and Human Services (HHS) Final Rule Stage

HHS—CDC Final Rule Stage

Department of Health and Human Services (HHS) Long-Term Actions

Services, Centers for Disease Control

Department of Health and Human Services (HHS) Completed Actions

Department of Health and Human Services (HHS) Prerule Stage

the statement. FDA is undertaking a Required: Undetermined be amended or rescinded, consistent

HHS—FDA Prerule Stage

Drug Administration, 9200 Corporate

HHS—FDA Prerule Stage

Department of Health and Human Services (HHS) Proposed Rule Stage

HHS—FDA Proposed Rule Stage

(Correction) Final Action (Laxative To Be Determined Repellent)

HHS—FDA Proposed Rule Stage

HFV–230), 7519 Standish Place,

HHS—FDA Proposed Rule Stage

Timetable: possible pathways of contamination Regulatory Flexibility Analysis

proposed rule also would emphasize Email: may.nelson@fda.hhs.gov

Department of Health and Human Services (HHS) Final Rule Stage

HHS—FDA Final Rule Stage

NPRM (Amendment) To Be Determined

HHS—FDA Final Rule Stage

Room 5488, 10903 New Hampshire Effective Final Action 03/00/11

HHS—FDA Final Rule Stage

Department of Health and Human Services (HHS) Long-Term Actions

HHS—FDA Long-Term Actions

HHS—FDA Long-Term Actions

HHS—FDA Long-Term Actions

Department of Health and Human Services (HHS) Completed Actions

NPRM 09/20/05 70 FR 55038 Legal Authority: 21 USC 321p; 21 USC

HHS—FDA Completed Actions