[The Regulatory Plan and Unified Agenda of
                Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Publishing Office, www.gpo.gov]


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Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 79764]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
(EO) 12866 require the semi-annual issuance of an inventory of 
rulemaking actions under development throughout the Department with a 
view to offering summarized information about forthcoming regulatory 
actions for public review.

FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary, 
Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The information provided in the Agenda 
presents a forecast of the rulemaking activities that the Department of 
Health and Human Services (HHS) expects to undertake in the foreseeable 
future. Rulemakings are grouped according to pre-rulemaking actions, 
proposed rules, final rules, long-term actions, and rulemaking actions 
completed since the Spring 2009 Agenda was published.

    Please note that the rulemaking abstracts included in this 
paper issue of the Federal Register relate strictly to those 
prospective rulemakings that are likely to have a significant 
economic impact on a substantial number of small entities, as 
required by the Regulatory Flexibility Act of 1980. Also available 
in this issue of the Register is the Department's submission to the 
Fiscal Year 2011 Regulatory Plan, as required under Executive Order 
12866.

    The purpose of the Agenda is to encourage more effective public 
participation in the regulatory process, and HHS invites all 
interested members of the public to comment on the rulemaking 
actions included in this issuance of the Agenda. The complete 
Regulatory Agenda of the Department is accessible online at 
www.reginfo.gov in an interactive format that offers users enhanced 
capabilities to obtain information from the Agenda's database.

Dated:  September 21, 2010.

 Dawn L. Smalls,

Executive Secretary,
Department of Health and Human Services.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
302         Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money             0991-AB03
            Penalties and Assessments (Section 610 Review)........................................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
303         Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health      0991-AB57
            Information Technology for Economic and Clinical Health Act (Reg Plan Seq No. 41).....
----------------------------------------------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
304         Health Information Technology: Initial Set of Standards, Implementation                   0991-AB58
            Specifications, and Certification Criteria for Electronic Health Record Technology
            (Rulemaking Resulting From a Section 610 Review)......................................
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
305         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
306         Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section      0930-AA14
            610 Review)...........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 79765]]


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
307         Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman           0920-AA23
            Primate...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
308         Control of Communicable Diseases: Foreign and Possessions.............................    0920-AA12
309         Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610     0920-AA32
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
310         Quality Assurance Requirements for Respirators........................................    0920-AA04
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
311         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
312         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg      0910-AC52
            Plan Seq No. 45)......................................................................
313         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
314         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
315         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
316         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
317         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
318         Import Tolerances for Residues of Unapproved New Animal Drugs in Food.................    0910-AF78
319         Laser Products; Amendment to Performance Standard.....................................    0910-AF87
320         Pet Food Labeling Requirements........................................................    0910-AG09
321         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
322         Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products..........    0910-AG12
323         Electronic Distribution of Content of Labeling for Human Prescription Drug and            0910-AG18
            Biological Products...................................................................
324         Unique Device Identification (Reg Plan Seq No. 46)....................................    0910-AG31
325         Cigars Subject to the Family Smoking Prevention and Tobacco Control Act...............    0910-AG38
326         Cigarette Warning Label Statements (Reg Plan Seq No. 47)..............................    0910-AG41
327         General Hospital and Personal Use Devices: Designation of Special Controls for            0910-AG54
            Infusion Pumps........................................................................
328         Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No.     0910-AG56
            48)...................................................................................
329         Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants (Reg        0910-AG57
            Plan Seq No. 49)......................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.


[[Page 79766]]


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
330         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
331         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
332         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
333         Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No.
            50)...................................................................................
334         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
335         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
336         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
337         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
338         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
339         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
----------------------------------------------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
340         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
341         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
342         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
343         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
344         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
345         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
346         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
347         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
348         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
349         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
350         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
351         Over-the-Counter (OTC) Drug Review--Antidiarrheal Drug Products.......................    0910-AF63
352         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
353         Over-the-Counter (OTC) Drug Review--Certain Category II Active Ingredients............    0910-AF95
354         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
355         Produce Safety Regulation.............................................................    0910-AG35
356         Modernization of the Current Food Good Manufacturing Practices Regulation.............    0910-AG36
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
357         Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Completion     0910-AG25
            of a Section 610 Review)..............................................................
358         Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco     0910-AG33
            To Protect Children and Adolescents...................................................
359         Over-the-Counter Human Drugs; Labeling Requirements (Completion of a Section 610          0910-AG34
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
360         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................

[[Page 79767]]

 
361         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610    0938-AP32
            Review)...............................................................................
362         Influenza Vaccination Standard for Certain Medicare Participating Providers and           0938-AP92
            Suppliers(CMS-3213-P).................................................................
363         Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric     0938-AP97
            and Rehabilitation Units Excluded From the Prospective Payment System and LTCH
            Requirements (CMS-3177-P).............................................................
364         Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care     0938-AQ24
            Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates
            (CMS-1518-P) (Reg Plan Seq No. 55)....................................................
365         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AQ26
            Center Payment System for CY 2012 (CMS-1525-P) (Reg Plan Seq No. 57)..................
366         Changes to the ESRD Prospective Payment System for CY 2012 (CMS-1577-P)...............    0938-AQ27
367         Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-    0938-AQ53
            2346-P)...............................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
368         Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011     0938-AP79
            (CMS-1503-C)..........................................................................
369         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP82
            Center Payment System for CY 2011 (CMS-1504-C)........................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
370         Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs       0938-AP77
            for Contract Year 2011 (CMS-4085-F)...................................................
371         Electronic Health Record (EHR) Incentive Program (CMS-0033-F).........................    0938-AP78
372         Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital      0938-AP80
            Prospective Payment System............................................................
373         Hospital IPPS for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term    0938-AQ03
            Care Hospital PPS and Rate Year 2010 Rates (CMS-1406-N)...............................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________

302. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE 
CIVIL MONEY PENALTIES AND ASSESSMENTS (SECTION 610 REVIEW)

Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 
USC 1396b; PL 99-660; PL 107-188

Abstract: This proposed rule would revise part 1003, addressing the 
Office of Inspector General's authority to propose the imposition of 
civil money penalties and assessments by reorganizing and simplifying 
existing regulatory text and eliminating obsolete references contained 
in the current regulations. Among the proposed revisions, this rule 
would establish separate subparts within part 1003 for various 
categories of violations; clarify the availability of exclusion for 
certain violations in addition to civil money penalties and 
assessments; date various references to managed care organization 
authorities; and clarify the application of section 1140 of the Social 
Security Act with respect to the misuse of certain Departmental 
symbols, emblems, or names through Internet and e mail communications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: No

Agency Contact: Patrice S. Drew, Department of Health and Human 
Services, Office of the Secretary, Office of the Inspector General, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-1368
Email: [email protected]

RIN: 0991-AB03

[[Page 79768]]

_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________

303. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES 
UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH 
ACT

 Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of 
the Federal Register.

RIN: 0991-AB57
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________

304. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, 
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC 
HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 
REVIEW)

Legal Authority: 42 USC 300jj-14

Abstract: The Department of Health and Human Services (HHS), Office of 
the National Coordinator for Health Information Technology, will issue 
an interim final rule with a request for comments to adopt an initial 
set of standards, implementation specifications, and certification 
criteria, as required by section 3004(b)(1) of the Public Health 
Service Act. The certification criteria adopted in this initial set 
establish the technical capabilities and related standards that 
certified electronic health record (EHR) technology will need to 
include in support of the Medicare and Medicaid EHR Incentive Programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/13/10                     75 FR 2014
Interim Final Rule Comment 
Period End                      03/15/10
Interim Final Rule Effective    02/12/10
Final Action                    07/28/10                    75 FR 44590

Regulatory Flexibility Analysis Required: No

Agency Contact: Steven Posnack, Policy Analyst, Department of Health 
and Human Services, Office of the Secretary, Office of the National 
Coordinator for Health Information Technology, 200 Independence Avenue 
SW., Washington, DC 20201
Phone: 202 690-7151

RIN: 0991-AB58
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________

305. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN 
CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

Legal Authority: PL 106-310, 42 USC 290jj to 290jj-2

Abstract: The Secretary is required by statute to publish regulations 
governing States that license nonmedical, community-based residential 
facilities for children and youth. The regulation requires States to 
develop licensing rules and monitoring requirements concerning behavior 
management practice that will ensure compliance; requires States to 
develop and implement such licensing rules and implementation 
requirements within one year; and ensures that States require such 
facilities to have adequate staff, and that the States provide training 
for professional staff.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Paolo Del Vecchio, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2619

RIN: 0930-AA10
_______________________________________________________________________

306. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE 
ADDICTION (SECTION 610 REVIEW)

Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 
290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11

Abstract: This rule will amend the Federal opioid treatment program 
regulations. It will modify the dispensing requirements for 
buprenorphine and buprenorphine combination products that are approved 
by the Food and Drug Administration (FDA) for opioid dependence and 
used in federally certified and registered opioid treatment programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/09                    74 FR 29153
NPRM Comment Period End         08/18/09
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Agency Contact: Nicholas Reuter, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
Suite

[[Page 79769]]

2-1063, One Choke Cherry Road, Rockville, MD 20857
Phone: 240 276-2716

RIN: 0930-AA14
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

307. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS 
REGULATIONS; NONHUMAN PRIMATE

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. The Secretary has delegated 
the authority to prevent the introduction of diseases from foreign 
countries to the Director, CDC. CDC also enforces entry requirements 
for certain animals, etiologic agents, and vectors deemed to be of 
public health significance. CDC is proposing to amend its regulations 
related to the importation of live nonhuman primates (NHPs) by 
extending existing requirements for the importation of cynomolgus, 
African green, and rhesus monkeys to all NHPs. The agency also is 
proposing to reduce the frequency at which importers of the three 
species are required to renew their registrations, (from every 180 days 
to every two years). CDC proposes to incorporate existing guidelines 
into the regulations and add new provisions to address NHPs imported as 
part of a circus or trained animal act, NHPs imported by zoological 
societies, the transfer of NHPs from approved laboratories, and non-
live imported NHP products. CDC is also proposing that all NHPs be 
imported only through ports of entry where a CDC quarantine station is 
located.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS E03, CLFT Building 16, 
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: [email protected]

RIN: 0920-AA23
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

308. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS

Legal Authority: 42 USC 243; 42 USC 264 and 265; 42 USC 267 and 268; 42 
USC 270 and 271

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. Communicable disease 
regulations are divided into two parts: Part 71 pertaining to foreign 
arrivals and part 70 pertaining to interstate matters. This rule (42 
CFR Part 71) will update and improve CDC's response to both global and 
domestic disease threats by creating a multi-tiered illness detection 
and response process thus substantially enhancing the public health 
system's ability to slow the introduction, transmission, and spread of 
communicable disease. The final rule focuses primarily on requirements 
relating to the reporting of deaths and illnesses onboard aircrafts and 
ships, and the collection of specific traveler contact information for 
the purpose of CDC contacting travelers in the event of an exposure to 
a communicable disease.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/20/06
Final Action                    12/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS E03, CLFT Building 16, 
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: [email protected]

RIN: 0920-AA12
_______________________________________________________________________

309. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE 
VIRUS (SECTION 610 REVIEW)

Legal Authority: PL 107-188

Abstract: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 authorizes the HHS Secretary to regulate the 
possession, use, and transfer of select agents and toxins that have the 
potential to pose a severe threat to public health and safety. These 
regulations are set forth at 42 CFR 73. Criteria used to determine 
whether a select agent or toxin should be included under the provisions 
of these regulations are based on: (1) The effect on human health as a 
result of exposure to the agent or toxin, (2) the degree of 
contagiousness of the agent or toxin, (3) the methods by which the 
agent or toxin is transferred to humans, (4) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent and illness resulting from infection by the agent or toxin, and 
(5) any other criteria, including the needs of children and other 
vulnerable populations that the HHS Secretary considers appropriate. 
Based on these criteria, we are proposing to amend the list of HHS 
select agents and toxins by adding Chapare virus to the list. After

[[Page 79770]]

consulting with subject matter experts from CDC, the National 
Institutes of Health (NIH), the Food Drug Administration (FDA), the 
United States Department of Agriculture (USDA) /Animal and Plant Health 
Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), 
USDA/CVB (Center for Veterinary Biologics), and the Department of 
Defense (DOD)/United States Army Medical Research Institute for 
Infectious Diseases (USAMRIID) and review of relevant published 
studies, we believe the Chapare virus should be added to the list of 
HHS select agents and toxins based on our conclusion that the Chapare 
virus has been phylogenetically identified as a Clade B arenavirus and 
is closely related to other South American arenaviruses that cause 
haemorrhagic fever, particularly Sabia virus.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/19/09                      74 FR 159
NPRM Comment Period End         10/19/09
Final Action                    11/00/11

Regulatory Flexibility Analysis Required: No

Agency Contact: Robbin Weyant, Department of Health and Human Services, 
Centers for Disease Control and Prevention, CLFT Building 20, Room 
4202, 1600 Clifton Road NE., Atlanta, GA 30333
Phone: 404 718-2000

RIN: 0920-AA32
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

310. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842(h); 30 USC 844

Abstract: NIOSH plans to modify the Administrative/Quality Assurance 
sections of 42 CFR part 84, Approval of Respiratory Protective Devices. 
Areas for potential modification in this module are: (1) Upgrade of 
quality assurance requirements; (2) ability to use private sector 
quality auditors and private sector testing laboratories in the 
approval program; and (3) revised approval label requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/08                    73 FR 75045
NPRM Comment Period End         02/09/09
NPRM Comment Period Reopened    03/04/09                     74 FR 9381
NPRM Comment Period Reopened End04/10/09
NPRM Comment Period Reopening 
Extended                        05/21/09                    74 FR 23815
NPRM Comment Period End         10/09/09
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William E. Newcomb, Physical Scientist, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA04
_______________________________________________________________________
Department of Health and Human Services (HHS)             Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

311. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; 
REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 
REVIEW)

Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 
342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271

Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements 
for the labeling of the cartons of shell eggs that have not been 
treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 
115.50) describes requirements for refrigeration of shell eggs held for 
retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides 
that part 16 does not apply to a hearing on an order for relabeling, 
diversion, or destruction of shell eggs under section 361 of the Public 
Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. 
FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit 
the safe handling statement to appear on the inside lid of egg cartons 
to provide the industry greater flexibility in the placement of the 
statement, provided the words ``keep refrigerated'' appear on the 
principal display panel or information panel. FDA is undertaking a 
review of 21 CFR sections 101.17(h), 115.50, and 16.5(a)(4) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in sections 101.17(h), 
115.50 and 16.5(a)(4) should be continued without change, or whether 
they should be amended or rescinded, consistent with the stated 
objectives of applicable statutes, to minimize any significant economic 
impact on a substantial number of small entities. FDA will consider, 
and is soliciting comments on, the following: (1) The continued need 
for the rule; (2) the nature of complaints or comments received 
concerning the rule from the public; (3) the complexity of the rule; 
(4) the extent to which the rule overlaps, duplicates, or conflicts 
with other Federal rules, and, to the extent feasible, with State and 
local governmental rules; and (5) the length of time since the rule has 
been evaluated or the degree to which technology, economic conditions, 
or other factors have changed in the area affected by the rule.

[[Page 79771]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/15/09
End Review                      12/00/10

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and 
Labeling Team, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, (HFS-
820), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1802
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AG06
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

312. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS 
AND BIOLOGICS

 Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of 
the Federal Register.

RIN: 0910-AC52
_______________________________________________________________________

313. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses antihistamine labeling claims for the common cold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Reopening of Administrative 
Record                          08/25/00                    65 FR 51780
NPRM (Amendment) (Common Cold)  10/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF31
_______________________________________________________________________

314. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action addresses products labeled to relieve upset stomach associated 
with overindulgence in food and drink and to relieve symptoms 
associated with a hangover. The second action addresses acetaminophen 
safety. The third action addresses products marketed for children under 
2 years old and weight- and age-based dosing for children's products. 
The fourth action addresses combination products containing the 
analgesic acetaminophen or aspirin and sodium bicarbonate used as an 
antacid ingredient. The last document finalizes the internal analgesic 
products monograph.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    12/26/06                    71 FR 77314
NPRM Comment Period End         05/25/07
Final Action (Required Warnings 
and Other Labeling)             04/29/09                    74 FR 19385
Final Action (Correction)       06/30/09                    74 FR 31177
Final Action (Technical 
Amendment)                      11/25/09                    74 FR 61512
NPRM (Acetaminophen)            03/00/11
NPRM (Amendment) (Pediatric)     To Be                       Determined
NPRM (Amendment) (Sodium 
Bicarbonate)                     To Be                       Determined
NPRM (Overindulgence/ Hangover)  To Be                       Determined
Final Action (Internal 
Analgesics)                      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF36
_______________________________________________________________________

315. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360 to 360a; 21 USC 371 to 371a

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first NPRM 
listed will address the professional labeling for sodium phosphate drug 
products. The second NPRM listed will address all other professional 
labeling requirements for laxative drug products. The final action will 
address laxative drug products.

[[Page 79772]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
NPRM (Professional Labeling--
Sodium Phosphate)               12/00/10
NPRM (Professional Labeling)     To Be                       Determined
Final Action (Laxative Drug 
Products)                        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF38
_______________________________________________________________________

316. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action addresses active ingredients reviewed under Time and Extent 
Applications. The second action addresses other safety and 
effectiveness issues for OTC sunscreen drug products. The third action 
finalizes sunscreen labeling and testing requirements for both 
ultraviolet B and ultraviolet A radiation protection. The fourth action 
addresses the safety of sunscreen products. The last action addresses 
combination products containing sunscreen and insect repellent 
ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
NPRM (UVA/UVB)                  08/27/07                    72 FR 49070
NPRM Comment Period End         12/26/07
NPRM (Safety and Effectiveness) 12/00/10
Final Action (UVA/UVB)          12/00/10
NPRM (Time and Extent 
Applications)                   04/00/11
ANPRM (Safety)                  04/00/11
NPRM (Sunscreen and Insect 
Repellent)                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF43
_______________________________________________________________________

317. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action addresses food handler products. The second action addresses 
testing requirements for healthcare professional products. The third 
action addresses the safety and effectiveness of consumer products. The 
final actions listed will address the healthcare, consumer, food 
handlers, and first aid antiseptic drug products respectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Healthcare)               06/17/94                    59 FR 31402
NPRM (Consumer)                 03/00/11
NPRM (Food Handlers)             To Be                       Determined
NPRM (Testing -- Healthcare 
Professional Products)           To Be                       Determined
Final Action (Healthcare)        To Be                       Determined
Final Action (Consumer)          To Be                       Determined
Final Action (Food Handlers)     To Be                       Determined
Final Action (First Aid 
Antiseptic)                      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF69
_______________________________________________________________________

318. IMPORT TOLERANCES FOR RESIDUES OF UNAPPROVED NEW ANIMAL DRUGS IN 
FOOD

Legal Authority: 21 USC 360b(a)(6); 21 USC 371

Abstract: The Food and Drug Administration (FDA) plans to publish a 
proposed rule related to the implementation of the import tolerances 
provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA 
authorizes FDA to establish tolerances for unapproved new animal drugs 
where edible portions of animals imported into the United States may 
contain residues of such drugs (import tolerances). It is unlawful to 
import animal-derived food that bears or contains residues of a new 
animal drug that is not approved in the United States, unless FDA has 
established an import tolerance for that new animal drug and the 
residue of the new animal drug in the animal-derived food does not 
exceed that tolerance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: Yes

[[Page 79773]]

Agency Contact: Thomas Moskal, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place, 
Rockville, MD 20855
Phone: 240 276-9242
Fax: 240 276-9241
Email: [email protected]

RIN: 0910-AF78
_______________________________________________________________________

319. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD

Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393

Abstract: FDA is proposing to amend the performance standard for laser 
products to achieve closer harmonization between the current standard 
and the International Electrotechnical Commission (IEC) standard for 
laser products and medical laser products. The proposed amendment is 
intended to update FDA's performance standard to reflect advancements 
in technology. The proposal would adopt portions of an IEC standard to 
achieve greater harmonization and reflect current science. In addition, 
the proposal would include an alternative mechanism for providing 
certification and identification, address novelty laser products, and 
clarify the military exemption for laser products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993
Phone: 301 796-6248
Fax: 301 847-8145
Email: [email protected]

RIN: 0910-AF87
_______________________________________________________________________

320. PET FOOD LABELING REQUIREMENTS

Legal Authority: 21 USC 343; 21 USC 371; PL 110-85, sec 1002(a)(3)

Abstract: The President signed into law the Food and Drug 
Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 
(Pub. L. 110-85). Title X of the FDAAA includes several provisions 
pertaining to food safety, including the safety of pet food. Section 
1002(a) of the new law directs FDA to issue new regulations to 
establish updated standards for the labeling of pet food that include 
nutritional and ingredient information. This same provision of the law 
also directs that, in developing these new regulations, FDA obtain 
input from its stakeholders, including the Association of American Feed 
Control Officials, veterinary medical associations, animal health 
organizations, and pet food manufacturers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William Burkholder, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 
Standish Place, Rockville, MD 20855
Phone: 240 453-6865
Email: [email protected]

RIN: 0910-AG09
_______________________________________________________________________

321. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED

Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 
USC 264; PL 110-85, sec 1002(a)(2)

Abstract: The Food and Drug Administration (FDA) is proposing 
regulations for process controls for animal feed ingredients and mixed 
animal feed to provide greater assurance that marketed animal feed 
ingredients and mixed feeds intended for all animals, including pets, 
are safe. This action is being taken as part of the FDA's Animal Feed 
Safety System initiative. The proposed process controls will apply to 
animal feed ingredients and mixed animal feed, including pet food. This 
action is also being taken to carry out the requirements of the Food 
and Drug Administration Amendments Act of 2007. Section 1002(a) directs 
FDA to establish by regulation processing standards for pet food. This 
same provision of the law also directs that, in developing these new 
regulations, FDA obtain input from its stakeholders, including the 
Association of American Feed Control Officials, veterinary medical 
associations, animal health organizations, and pet food manufacturers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kim Young, Deputy Director, Division of Compliance, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 
Standish Place, Rockville, MD 20855
Phone: 240 276-9207
Email: [email protected]

RIN: 0910-AG10
_______________________________________________________________________

322. OVER-THE-COUNTER (OTC) DRUG REVIEW--PEDIATRIC DOSING FOR COUGH/COLD 
PRODUCTS

Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 
21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a monograph is issued, only OTC drugs meeting the 
conditions of the monograph, or having an approved new drug 
application, may be legally marketed. This action will propose changes 
to the final monograph to address safety and efficacy issues associated 
with pediatric cough and cold products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903

[[Page 79774]]

New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG12
_______________________________________________________________________

323. ELECTRONIC DISTRIBUTION OF CONTENT OF LABELING FOR HUMAN 
PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 
360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

Abstract: This rule would require electronic package inserts for human 
drug and biological prescription products, in lieu of paper, which is 
currently used. These inserts contain prescribing information intended 
for healthcare practitioners. This would ensure that the information 
accompanying the product is the most up-to-date information regarding 
important safety and efficacy issues about these products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Connie T. Jung, Senior Advisor for Pharmacy Affairs, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Policy, WO32, Room 4254, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-4830
Email: [email protected]

RIN: 0910-AG18
_______________________________________________________________________

324. UNIQUE DEVICE IDENTIFICATION

 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of 
the Federal Register.

RIN: 0910-AG31
_______________________________________________________________________

325. CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL 
ACT

Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and 
Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco 
Control Act

Abstract: The Family Smoking Prevention and Tobacco Control Act (the 
Tobacco Control Act) provides FDA authority to regulate cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. 
Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by 
the Tobacco Control Act, permits FDA to issue regulations deeming other 
tobacco products to be subject to the Tobacco Control Act. This 
proposed rule would deem cigars to be subject to the Tobacco Control 
Act and include provisions to address public health concerns raised by 
cigars.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: May Nelson, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, 9200 Corporate 
Boulevard, Rockville, MD 20850
Phone: 877 287-1373
Fax: 240 276-3904
Email: [email protected]

RIN: 0910-AG38
_______________________________________________________________________

326. CIGARETTE WARNING LABEL STATEMENTS

 Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of 
the Federal Register.

RIN: 0910-AG41
_______________________________________________________________________

327.  GENERAL HOSPITAL AND PERSONAL USE DEVICES: 
DESIGNATION OF SPECIAL CONTROLS FOR INFUSION PUMPS

Legal Authority: 21 USC 351 371; 21 USC 360 and 360c; 21 USC 360e and 
360j; 21 USC 371

Abstract: Since 2003, FDA has seen a dramatic increase in the number of 
device recalls, as well as an increase in the number of death and 
serious injury reports submitted regarding infusion pumps. An analysis 
of the reports reveals that a majority of the recalls and failures were 
caused by user error and/or device design flaw. As a result of these 
incidents, FDA is proposing to designate a special controls guidance 
document as the special controls for infusion pumps. The agency 
believes that establishing these special controls for infusion pumps is 
necessary to provide reasonable assurance of the safety and 
effectiveness of these devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/11
NPRM Comment Period End         12/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993
Phone: 301 796-6248
Fax: 301 847-8145
Email: [email protected]

RIN: 0910-AG54
_______________________________________________________________________

328.  FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD 
IN VENDING MACHINES

 Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of 
the Federal Register.

RIN: 0910-AG56
_______________________________________________________________________

329.  FOOD LABELING: NUTRITION LABELING OF STANDARD 
MENU ITEMS IN CHAIN RESTAURANTS

 Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of 
the Federal Register.

RIN: 0910-AG57

[[Page 79775]]

_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

330. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND 
BIOLOGICAL PRODUCTS

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 
263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 
331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 
USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381

Abstract: The final rule would amend the postmarketing expedited and 
periodic safety reporting regulations for human drugs and biological 
products to revise certain definitions and reporting formats as 
recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and to propose other revisions 
to these regulations to enhance the quality of safety reports received 
by FDA. These revisions were proposed as part of a single rulemaking 
(68 FR 12406) to clarify and revise both premarketing and postmarketing 
safety reporting requirements for human drug and biological products. 
FDA plans to finalize the premarket and postmarket safety reporting 
requirements in separate final rules.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12406
NPRM Comment Period Extended    06/18/03
NPRM Comment Period End         07/14/03
NPRM Comment Period Extension 
End                             10/14/03
Final Action                    08/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6362, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3469
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AA97
_______________________________________________________________________

331. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING 
PRACTICE REQUIREMENTS

Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353

Abstract: The Food and Drug Administration is amending its current good 
manufacturing practice regulations and other regulations to clarify and 
strengthen requirements for the label, color, dedication, and design of 
medical gas containers and closures. Despite existing regulatory 
requirements and industry standards for medical gases, there have been 
repeated incidents in which cryogenic containers of harmful industrial 
gases have been connected to medical oxygen supply systems in hospitals 
and nursing homes and subsequently administered to patients. These 
incidents have resulted in death and serious injury. There have also 
been several incidents involving high-pressure medical gas cylinders 
that have resulted in death and injuries to patients. These amendments, 
together with existing regulations, are intended to ensure that the 
types of incidents that have occurred in the past, as well as other 
types of foreseeable and potentially deadly medical gas accidents, do 
not occur in the future. FDA has described a number of proposals in the 
proposed rule including requiring that gas use outlet connections on 
portable cryogenic medical gas containers be permanently attached to 
the valve body.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/10/06                    71 FR 18039
NPRM Comment Period End         07/10/06
Final Action                    10/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3522
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC53
_______________________________________________________________________

332. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND 
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 
21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264

Abstract: To amend the regulations governing the format and content of 
labeling for human prescription drugs and biological products (21 CFR 
parts 201.56, 201.57, and 201.80). Under FDA's current regulations, 
labeling concerning the use of prescription drugs in pregnancy uses 
letter categories (A, B, C, D, X) to characterize the risk to the fetus 
of using the drug in pregnancy. One of the deficiencies of the category 
system is that drugs may be assigned to the same category when the 
severity, incidence, and types of risk are quite different. 
Dissatisfaction with the category system has been expressed by health 
care providers, medical organizations, experts in the study of birth 
defects, women's health researchers, and women of childbearing age. 
Stakeholders consulted through a public hearing, several focus groups, 
and several advisory committees have recommended that FDA replace the 
category system with a concise narrative summarizing a product's risks 
to pregnant women and to women of childbearing age. Therefore, the 
revised format and the information provided in the labeling would make 
it easier for health care providers to understand the risks and 
benefits of drug use during pregnancy and lactation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/29/08                    73 FR 30831
NPRM Comment Period End         08/27/08
Final Action                    10/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993-0002
Phone: 301 796-4288

[[Page 79776]]

Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AF11
_______________________________________________________________________

333. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY 
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND 
QUALITY FACTORS

 Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of 
the Federal Register.

RIN: 0910-AF27
_______________________________________________________________________

334. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses labeling for single ingredient bronchodilator products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment--Ephedrine 
Single Ingredient)              07/13/05                    70 FR 40237
NPRM Comment Period End         11/10/05
Final Action (Technical 
Amendment)                      11/30/07                    72 FR 67639
Final Action (Amendment--Single 
Ingredient Labeling)            01/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF32
_______________________________________________________________________

335. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses cough/cold drug products containing an oral bronchodilator 
(ephedrine and its salts) in combination with any expectorant or any 
oral nasal decongestant.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                07/13/05                    70 FR 40232
NPRM Comment Period End         11/10/05
Final Action (Technical 
Amendment)                      03/19/07                    72 FR 12730
Final Action                    10/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF33
_______________________________________________________________________

336. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The final 
action addresses the 2003 proposed rule on patches, plasters, and 
poultices. The proposed rule will address issues not addressed in 
previous rulemakings.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (GRASE dosage 
forms)                          10/00/11
NPRM (Amendment)                 To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF35
_______________________________________________________________________

337. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action identifies safe and effective skin protectant active ingredients 
to treat and prevent diaper rash. The second action addresses skin 
protectant products used to treat fever blisters and cold sores.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Aluminum Acetate) 
(Technical Amendment)           03/06/09                     74 FR 9759
Final Action (Technical 
Amendments)                     02/01/08                     73 FR 6014
Final Action (Diaper Rash)      10/00/11
Final Action (Fever Blisters/
Cold Sores)                     10/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug

[[Page 79777]]

Administration, Center for Drug Evaluation and Research, WO 22, 10903 
New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF42
_______________________________________________________________________

338. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS

Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371

Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), 
effective immediately, to prohibit the use of certain cattle material 
and to address the potential risk of bovine spongiform encephalopathy 
(BSE) in human food, including dietary supplements, and cosmetics. 
Prohibited cattle materials under the IFR include specified risk 
materials, small intestine of all cattle, material from nonambulatory 
disabled cattle, material from cattle not inspected and passed for 
human consumption, and mechanically separated (MS) beef. Specified risk 
materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, 
vertebral column (excluding the vertebrae of the tail, the transverse 
processes of the thoracic and lumbar vertebrae, and the wings of the 
sacrum), and dorsal root ganglia of cattle 30 months and older; and the 
tonsils and distal ileum of the small intestine of all cattle. 
Prohibited cattle materials do not include tallow that contains no more 
than 0.15 percent hexane-insoluble impurities and tallow derivatives. 
This action minimizes human exposure to materials that scientific 
studies have demonstrated are highly likely to contain the BSE agent in 
cattle infected with the disease. Scientists believe that the human 
disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by 
the consumption of products contaminated with the agent that causes 
BSE.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/14/04                    69 FR 42256
Interim Final Rule Effective    07/14/04
Interim Final Rule Comment 
Period End                      10/12/04
Interim Final Rule (Amendments) 09/07/05                    70 FR 53063
Interim Final Rule (Amendments) 
Effective                       10/07/05
Interim Final Rule (Amendments) 
Comment Period End              11/07/05
Interim Final Rule (Amendments) 04/17/08                    73 FR 20785
Interim Final Rule (Amendments) 
Comment Period End              07/16/08
Interim Final Rule (Amendments) 
Effective                       07/16/08
Final Action                    04/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Amber McCoig, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2644
Email: [email protected]

RIN: 0910-AF47
_______________________________________________________________________

339. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE 
UNITED STATES

Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 
21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264

Abstract: The final rule will require owners or consignees to label 
imported food that is refused entry into the United States. The label 
will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the 
label's characteristics (such as its size) and processes for verifying 
that the label has been affixed properly. We are taking this action to 
prevent the introduction of unsafe food into the United States, to 
facilitate the examination of imported food, and to implement section 
308 of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/18/08                    73 FR 54106
NPRM Comment Period End         12/02/08
Final Action                    03/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-4706
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________

340. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, 
LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 371; 21 USC 
374; 21 USC 381; 21 USC 393; 42 USC 264

Abstract: The Food and Drug Administration published a final rule in 
the Federal Register of June 25, 2007 (72 FR 34752), on current good 
manufacturing practice (CGMP) regulations for dietary supplements. FDA 
also published an Interim Final Rule in the same Federal Register (72 
FR 34959) that provided a procedure for requesting an exemption from 
the final rule requirement that the manufacturer conduct at least one 
appropriate test or examination to verify the identity of any component 
that is a dietary ingredient. This IFR allows for submission to, and 
review

[[Page 79778]]

by, FDA of an alternative to the required 100 percent identity testing 
of components that are dietary ingredients, provided certain conditions 
are met. This IFR also establishes a requirement for retention of 
records relating to the FDA's response to an exemption request.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/06/97                     62 FR 5700
ANPRM Comment Period End        06/06/97
NPRM                            03/13/03                    68 FR 12157
NPRM Comment Period End         08/11/03
Final Rule                      06/25/07                    72 FR 34752
Interim Final Rule              06/25/07                    72 FR 34959
Interim Final Rule Comment 
Period End                      10/24/07
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-2784
Fax: 301 436-2657
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________

341. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the ingredient phenylpropanolamine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM Comment Period End         11/01/04
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM Comment Period End         01/31/05
NPRM (Phenyl- propanolamine)    12/22/05                    70 FR 75988
NPRM Comment Period End         03/22/06
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenylephrine 
Bitartrate)                     08/01/06                    71 FR 83358
Final Action (Phenyl- 
propanolamine)                   To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF34
_______________________________________________________________________

342. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR 
OTC HUMAN USE

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses labeling for convenience (small) size OTC drug packages.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        12/12/06                    71 FR 74474
NPRM Comment Period End         04/11/07
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF37
_______________________________________________________________________

343. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
finalizes the monograph for emergency first aid eyewash drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Emergency 
First Aid Eyewashes)            02/19/03                     68 FR 7917
Final Action (Amendment) 
(Emergency First Aid Eyewashes)  To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF39
_______________________________________________________________________

344. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360 to 360a; 21 USC 371 to 371a

Abstract: The OTC drug review establishes conditions under which

[[Page 79779]]

OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The NPRM and 
final action will address oral health care products used to reduce or 
prevent dental plaque and gingivitis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Plaque Gingivitis)       05/29/03                    68 FR 32232
ANPRM Comment Period End        08/27/03
NPRM (Plaque Gingivitis)         To Be                       Determined
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF40
_______________________________________________________________________

345. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The proposed 
rule addresses vaginal contraceptive drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         12/19/07                    72 FR 71769
NPRM (Vaginal Contraceptive Drug 
Products)                        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF44
_______________________________________________________________________

346. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The NPRM 
addresses the use of benzocaine for weight control. The first final 
action finalizes the 2005 proposed rule for weight control products 
containing phenylpropanolamine. The second final action will finalize 
the proposed rule for weight control products containing benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl- propanolamine)    12/22/05                    70 FR 75988
NPRM Comment Period End         03/22/06
NPRM (Benzocaine)                To Be                       Determined
Final Action (Phenyl- 
propanolamine)                   To Be                       Determined
Final Action (Benzocaine)        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF45
_______________________________________________________________________

347. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND 
DRINK PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses products containing bismuth subsalicylate for relief of 
symptoms of upset stomach due to overindulgence resulting from food and 
drink.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                01/05/05                      70 FR 741
NPRM Comment Period End         04/05/05
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF51
_______________________________________________________________________

348. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses the labeling of products containing sodium

[[Page 79780]]

bicarbonate as an active ingredient. The other action addresses the use 
of antacids to relieve upset stomach associated with overindulgence in 
food and drink.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Sodium Bicarbonate 
Labeling)                        To Be                       Determined
Final Action (Overindulgence 
Labeling)                        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF52
_______________________________________________________________________

349. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses skin bleaching drug products containing hydroquinone.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51146
NPRM Comment Period End         12/27/06
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF53
_______________________________________________________________________

350. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the use of stimulant active ingredients to relieve symptoms 
associated with a hangover.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF56
_______________________________________________________________________

351. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTIDIARRHEAL DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. These actions 
address new labeling for antidiarrheal drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (New Labeling)              To Be                       Determined
Final Action (New Labeling)      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF63
_______________________________________________________________________

352. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the products used for urinary pain relief.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)         To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF70

[[Page 79781]]

_______________________________________________________________________

353. OVER-THE-COUNTER (OTC) DRUG REVIEW--CERTAIN CATEGORY II ACTIVE 
INGREDIENTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371

Abstract: The Food and Drug Administration (FDA) is proposing that 
certain ingredients in over-the-counter (OTC) drug products are not 
generally recognized as safe and effective or are misbranded. FDA 
issued this proposed rule because we did not receive any data and 
information on these ingredients in response to our request on December 
31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/08                    73 FR 34895
NPRM Comment Period End         09/17/08
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Matthew R. Holman, Ph.D., Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF95
_______________________________________________________________________

354. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG 
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE 
PROCEDURES (SECTION 610 REVIEW)

Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381

Abstract: Pursuant to section 610 of the Regulatory Flexibility Act, 
FDA is currently undertaking a review of regulations promulgated under 
the Prescription Drug Marketing Act (PDMA) including those contained in 
21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 
FR 67762 and 67763). The purpose of this review is to determine whether 
the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 
(as amended in 64 FR 67762 and 67763) should be continued without 
change, or whether they should be amended or rescinded, consistent with 
the stated objectives of applicable statues, to minimize adverse 
impacts on a substantial number of small entities. FDA solicited 
comments on the following: (1) The continued need for the regulations 
in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 
64 FR 67762 and 67763); (2) the nature of complaints or comments 
received from the public concerning the regulations in 21 CFR part 203 
and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 
67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 
CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); 
(4) the extent to which the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) 
overlap, duplicate, or conflict with other Federal rules, and to the 
extent feasible, with State and local governmental rules, and (5) the 
degree to which technology, economic conditions, or other factors have 
changed in the area affected by the regulations in 21 CFR part 203 and 
21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763).
FDA received one comment on this review; and FDA notes that portions of 
the PDMA have been stayed in connection with RxUSA Wholesale, Inc., v. 
HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006), aff'd, 2008 U.S. App. LEXIS 
14661 (2d Cir. 2008)); and that the litigation itself has been 
administratively closed (with either party having the right to reopen) 
through June 30, 2011. FDA is certifying that it is not feasible for 
the agency to complete its review by December 4, 2010, and therefore is 
extending the completion date by one year.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      11/24/08
End Review of Current Regulation12/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Howard Muller, Office of Regulatory Policy, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: pdma610(c)[email protected]

RIN: 0910-AG14
_______________________________________________________________________

355. PRODUCE SAFETY REGULATION

Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264

Abstract: The Food and Drug Administration (FDA) has determined that 
enforceable standards (as opposed to voluntary recommendations) for the 
production and packing of fresh produce are necessary to ensure best 
practices are commonly adopted. FDA is proposing to promulgate 
regulations setting enforceable standards for fresh produce safety at 
the farm and packing house. The purpose of the proposed rule is to 
reduce the risk of illness associated with contaminated fresh produce. 
The proposed rule will be based on prevention-oriented public health 
principles and incorporate what we have learned in the past decade 
since the agency issued general good agricultural practice guidelines 
entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh 
Fruits and Vegetables'' (GAPs Guide). The proposed rule also will 
reflect comments received on the agency's 1998 update of its GAPs guide 
and its July 2009 draft commodity specific guidances for tomatoes, 
leafy greens, and melons. Although the proposed rule will be based on 
recommendations that are included in the GAPs guide, FDA does not 
intend to make the entire guidance mandatory. FDA's proposed rule 
would, however, set out clear standards for implementation of modern 
preventive controls. The proposed rule also would emphasize the 
importance of environmental assessments to identify hazards and 
possible pathways of contamination and provide examples of risk 
reduction practices recognizing that operators must tailor their 
preventive controls to particular hazards and conditions affecting 
their operations. The requirements of the proposed rule would be scale 
appropriate and commensurate with the relative risks and complexity of 
individual operations. FDA intends to issue guidance after the proposed 
rule is finalized to assist industry in

[[Page 79782]]

complying with the requirements of the new regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Samir Assar, Department of Health and Human Services, 
Food and Drug Administration, Center for Food Safety and Applied 
Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College 
Park, MD 20740
Phone: 301 436-1636
Email: [email protected]

RIN: 0910-AG35
_______________________________________________________________________

356. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES 
REGULATION

Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its current good manufacturing practices (CGMP) regulations (21 CFR 
part 110) for manufacturing, packing, or holding human food. This 
proposed rule would require food facilities to address issues such as 
environmental pathogens, food allergens, mandatory employee training, 
and sanitation of food contact surfaces. The proposed rule also would 
require food facilities to develop and implement preventive control 
systems. FDA is taking this action to better address changes that have 
occurred in the food industry and protect public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Paul South, Department of Health and Human Services, 
Food and Drug Administration, Center for Food Safety and Applied 
Nutrition (HFS-317), Office of Food Safety, 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-1640
Email: [email protected]

RIN: 0910-AG36
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________

357. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL 
INHALATION (COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375

Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 
610 of the Regulatory Flexibility Act. The purpose of this review is to 
determine whether this regulation on aqueous-based drug products for 
oral inhalation should be continued without change, or whether it 
should be amended or rescinded, consistent with the stated objectives 
of applicable statues, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for 21 CFR 200.51; (2) the 
nature of complaints or comments received concerning 21 CFR 200.51; (3) 
the complexity of 21 CFR 200.51; (4) the extent to which the regulation 
overlaps, duplicates, or conflicts with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by 21 
CFR 200.51. No comments were required. FDA's review of these 
regulations concluded that they should be continued without change.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/01/09
End Review                      05/31/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AG25
_______________________________________________________________________

358. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND 
SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS

Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and 
Cosmetic Act; PL 111-31, Family Smoking Prevention and Tobacco Control 
Act

Abstract: This rule establishes regulations restricting the sale and 
distribution of cigarettes and smokeless tobacco to children and 
adolescents, implementing section 102 of the Family Smoking Prevention 
and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) 
require the Secretary to publish, within 270 days of enactment, a final 
rule regarding cigarettes and smokeless tobacco. This final rule must 
be identical, except for several changes identified in section 
102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the 
Secretary of HHS in the August 28, 1996, issue of the Federal Register 
(61 FR 44396).
This final rule prohibits the sale of cigarettes and smokeless tobacco 
to individuals under the age of 18 and requires manufacturers, 
distributors, and retailers to comply with certain conditions regarding 
access to, and promotion of, these products. Among other things, the 
final rule requires retailers to verify a purchaser's age by 
photographic identification. It also prohibits, with limited exception, 
free samples and prohibits the sale of these products through vending 
machines and self-service displays except in facilities where 
individuals under the age of 18 are not present or permitted at any 
time. The rule also limits the advertising and labeling to which 
children and adolescents are exposed. The rule accomplishes this by 
generally restricting advertising to which children and adolescents are 
exposed to a black-and-white, text-only format. The rule also prohibits 
the sale or

[[Page 79783]]

distribution of brand-identified promotional, non-tobacco items such as 
hats and tee shirts. Furthermore, the rule prohibits sponsorship of 
sporting and other events, teams, and entries in a brand name of a 
tobacco product, but permits such sponsorship in a corporate name.
FDA also published in the same issue of the Federal Register an advance 
notice of proposed rulemaking requesting comments, data, research, or 
other information on the regulation of outdoor advertising of 
cigarettes and smokeless tobacco.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/19/10                    75 FR 13241
Final Rule                      03/19/10                    75 FR 13225
ANPRM Comment Period End        05/18/10
Final Rule Effective            06/22/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 9200 Corporate 
Boulevard, 100K, Rockville, MD 20850
Phone: 877 287-1373
Fax: 240 276-3904
Email: [email protected]

RIN: 0910-AG33
_______________________________________________________________________

359. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (COMPLETION OF 
A SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Section 201.66 (21 CFR section 201.66) established a 
standardized format for the labeling of OTC drug products that 
included: (1) Specific headings and subheadings presented in a 
standardized order, (2) standardized graphical features such as 
headings in bold type and the use of ``bullet points'' to introduce key 
information, and (3) minimum standards for type size and spacing. FDA 
issued the final rule to improve labeling after considering comments 
submitted to the agency following the publication of the proposed 
regulation in 1997. In 1999, FDA published the final rule and stated 
that a standardized labeling format would significantly improve 
readability by familiarizing consumers with the types of information in 
OTC drug product labeling and the location of that information. In 
addition, a standardized appearance and standardized content, including 
various ``user-friendly'' visual cues, would help consumers locate and 
read important health and safety information and allow quick and 
effective product comparisons, thereby helping consumers to select the 
most appropriate product.
FDA undertook a review of section 201.66 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is to determine 
whether the regulation in section 201.66 should be continued without 
change, or whether it should be further amended or rescinded, 
consistent with the stated objectives of applicable statutes, to 
minimize adverse impacts on a substantial number of small entities. FDA 
will consider, and is soliciting comments on the following: (1) The 
continued need for the regulation in section 201.66; (2) the nature of 
the complaints or comments received concerning the regulation in 
section 201.66; (3) the complexity of the regulations in section 
201.66; (4) the extent to which the regulations in section 201.66 
overlap, duplicate, or conflict with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed for the products still 
subject to the labeling standard regulations in section 201.
No comments were received. FDA's review of these regulations concluded 
that they should be continued without change.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      08/03/09
End Review of Current Regulation05/27/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG34
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

360. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-P) (SECTION 610 REVIEW)

Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 1395bb

Abstract: This proposed rule would revise the existing Conditions of 
Participation (CoPs) that Home Health Agencies (HHAs) must meet to 
participate in the Medicare program. The CoPs were last revised in 
1989. The new requirements will focus on the actual care delivered to 
patients by HHAs, reflect an interdisciplinary view of patient care, 
allow HHAs greater flexibility in meeting quality standards, and 
eliminate unnecessary procedural requirements. These changes are an 
integral part of our efforts to achieve broad-based improvements and 
measurements of the quality of care furnished through federal programs 
while at the same time reducing procedural burdens on providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Second NPRM                     07/00/11

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Danielle Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards & Quality, Mailstop S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244

[[Page 79784]]

Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________

361. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS-
3140-F) (SECTION 610 REVIEW)

Legal Authority: 42 USC 1302; 42 USC 1395hh

Abstract: This rule establishes that in order to participate in the 
Medicare and Medicaid programs, long-term care facilities must have an 
agreement with hospice agencies when hospice care is provided in a 
long-term care facility. The rule also contains quality of care 
requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/22/10                    75 FR 65282
NPRM Comment Period End         12/21/10
Final Action                    10/00/13

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Patricia Brooks, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, Mailstop 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4561
Email: [email protected]

RIN: 0938-AP32
_______________________________________________________________________

362. INFLUENZA VACCINATION STANDARD FOR CERTAIN MEDICARE PARTICIPATING 
PROVIDERS AND SUPPLIERS(CMS-3213-P)

Legal Authority: Social Security Act sec 1881, 1861, 1920, 1102, 1871, 
1965

Abstract: This proposed rule would require certain Medicare providers 
and suppliers to offer all patients an annual influenza vaccination, 
unless medically inadvisable or if the patient declines vaccination. 
This proposed rule is intended to increase the number of patients 
receiving annual vaccination against seasonal influenza and to decrease 
the morbidity and mortality rate from influenza.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4683
Email: [email protected]

RIN: 0938-AP92
_______________________________________________________________________

363. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HOSPITAL 
INPATIENT PSYCHIATRIC AND REHABILITATION UNITS EXCLUDED FROM THE 
PROSPECTIVE PAYMENT SYSTEM AND LTCH REQUIREMENTS (CMS-3177-P)

Legal Authority: 42 USC 1385 X; 42 USC 1396 d; 42 USC 1395 hh

Abstract: This proposed rule would transfer the existing process 
requirements for hospital inpatient psychiatric and rehabilitation 
units that are excluded from prospective payment systems to the 
hospital conditions of participation (CoPs) part of the Act. This would 
allow accrediting organizations to deem these units as part of their 
hospital accreditation process providing a timely and cost effective 
survey and certification process under the CoPs. In addition, this rule 
would propose long term care hospital requirements mandated by the 
Medicare, Medicaid and SCHIP Extension Act of 2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Capt. Katherine Berkhousen, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Mailstop S3-02-01, Baltimore, MD 21244
Phone: 410 786-1154
Email: [email protected]

RIN: 0938-AP97
_______________________________________________________________________

364.  PROPOSED CHANGES TO THE HOSPITAL INPATIENT 
PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2012 RATES 
AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2012 RATES (CMS-1518-P)

 Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of 
the Federal Register.

RIN: 0938-AQ24
_______________________________________________________________________

365.  CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE 
PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2012 
(CMS-1525-P)

 Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of 
the Federal Register.

RIN: 0938-AQ26
_______________________________________________________________________

366.  CHANGES TO THE ESRD PROSPECTIVE PAYMENT SYSTEM 
FOR CY 2012 (CMS-1577-P)

Legal Authority: Sec 1881 of the Social Security Act

Abstract: This proposed rule would update the bundled payment system 
for End Stage Renal Disease (ESRD) facilities as required by the 
Medicare Improvments for Patients and Providers Act (MIPPA). These 
changes would be applicable to services furnished on or after January 1 
annually.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Janet Samen, Director, Division of Chronic Care 
Management, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mailstop C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AQ27
_______________________________________________________________________

367.  FEDERAL FUNDING FOR MEDICAID ELIGIBILITY 
DETERMINATION AND ENROLLMENT ACTIVITIES (CMS-2346-P)

Legal Authority: PL 111-148, sec 1413

[[Page 79785]]

Abstract: The Affordable Care Act requires States' residents to apply, 
enroll, receive determinations, and participate in the State health 
subsidy programs known as ``the Exchange''. The ACA requires many 
changes to State eligibility and enrollment systems and each State is 
responsible for developing a secure, electronic interface allowing the 
exchange of data. Existing legacy eligibility systems are not able to 
implement the numerous requirements. This proposed rule is key to 
informing States about the higher rates that CMS will provide to help 
them update or build legacy eligibility systems that meet the ACA 
requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/08/10                    75 FR 68583
NPRM Comment Period End         01/07/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Richard H. Friedman, Director, Division of State 
Systems, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4451
Email: [email protected]

RIN: 0938-AQ53
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

368. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND 
PART B FOR CY 2011 (CMS-1503-C)

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1871

Abstract: This annual final rule revises payment polices under the 
physician fee schedule, as well as other policy changes to payment 
under Part B for CY 2011.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/10                    75 FR 40040
NPRM Comment Period End         09/24/10
Final Action                    12/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Carol Bazell, Director, Division of Practitioner 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Mail Stop C4-03-06, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6960
Email: [email protected] gov

RIN: 0938-AP79
_______________________________________________________________________

369. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS-1504-C)

Legal Authority: sec 1833 of the Social Security Act; BBA, BA, BIPA, 
MMA, PPACA

Abstract: This final rule revises the Medicare hospital outpatient 
prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system. The rule also describes changes to the amounts and factors 
used to determine payment rates for services. In addition, the rule 
changes the Ambulatory Surgical Center Payment System list of services 
and rates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/03/10                    75 FR 46169
NPRM Comment Period End         08/31/10
Final Action                    12/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Alberta Dwivedi, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop C5-01-26, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-0763
Email: [email protected]

RIN: 0938-AP82
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________

370. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG 
BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS-4085-F)

Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security 
Act)

Abstract: This final rule makes revisions to the regulations governing 
the Medicare Advantage (MA) program (Part C) and prescription drug 
benefit program (Part D) based on our continued experience in the 
administration of the Part C and D programs. The revisions strengthen 
various program participation and exit requirements; strengthen 
beneficiary protections; ensure that plan offerings to beneficiaries 
include meaningful differences; improve plan payment rules and 
processes; improve data collection for oversight and quality 
assessment; implement new policy such as a Part D formulary policy; and 
clarify program policy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/22/09                    74 FR 54634
NPRM Comment Period End         12/07/09
Final Action                    04/15/10                    75 FR 19678

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy 
and Quality, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mail Stop

[[Page 79786]]

C1-26-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6041
Email: [email protected]

RIN: 0938-AP77
_______________________________________________________________________

371. ELECTRONIC HEALTH RECORD (EHR) INCENTIVE PROGRAM (CMS-0033-F)

Legal Authority: PL 111-5 (The American Recovery and Reinvestment Act 
of 2009, Title IV of Division B, Medicare and Medicaid Health 
Information Technology)

Abstract: This rule would implement provisions of the American Recovery 
Act of 2009 (Recovery Act) that authorize incentive payments to 
eligible professionals (EPS) and eligible hospitals participating in 
the Medicare and Medicaid programs for adopting and becoming meaningful 
users of certified electronic health records (HER) technology. In 
accordance with the Recovery Act, the rule will establish maximum 
annual incentive amounts and include Medicare penalties for failing to 
meaningfully use EHRs beginning in 2015.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/13/10                     75 FR 1843
NPRM Comment Period End         03/15/10
Final Action                    07/28/10                    75 FR 44413

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Elizabeth S. Holland, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop S2-26-17, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-1309
Email: [email protected]

RIN: 0938-AP78
_______________________________________________________________________

372. PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND THE LONG-
TERM CARE HOSPITAL PROSPECTIVE PAYMENT SYSTEM

Legal Authority: Sec 1886(d) of the Social Security Act

Abstract: This rule updates the fiscal year (FY) 2011 hospital 
inpatient prospective payment systems (IPPS) and long-term care 
prospective payment system (LTCH PPS). This rule payments to hospitals 
for inpatient services that are contained in the Patient Protection and 
Affordable Care Act (the Affordable Care Act) as amended by the Health 
Care and Education Reconciliation Act of 2010 (HCERA) (collectively 
known as the Affordable Care Act). It would also specify statutorily 
required changes to the amounts and factors used to determine the rates 
for Medicare acute care hospital inpatient services for operating costs 
and capital-related costs, and for long-term care hospital costs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/04/10                    75 FR 23851
NPRM Comment Period End         06/18/10
Second NPRM                     06/02/10                    75 FR 30917
Second NPRM Comment Period End  07/02/10
Final Action                    08/16/10                    75 FR 50041

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Tiffany Swygert, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C4-25-11, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4642
Email: [email protected]

RIN: 0938-AP80
_______________________________________________________________________

373.  HOSPITAL IPPS FOR ACUTE CARE HOSPITALS AND 
FISCAL YEAR 2010 RATES AND TO THE LONG-TERM CARE HOSPITAL PPS AND RATE 
YEAR 2010 RATES (CMS-1406-N)

Legal Authority: PL 111 148; PL 111-152

Abstract: This notice contains the final wage indices, hospital 
reclassifications, payment rates, impacts, and other related tables 
effective for the fiscal year (FY) 2010 hospital inpatient prospective 
payment systems (IPPS) and rate year 2010 long-term care hospital 
(LTCH) prospective payment system (PPS) . The rates, tables, and 
impacts included in this notice reflect changes required or resulting 
from the implementation of several provisions of the Patient Protection 
and Affordable Care Act as amended by the Health Care and Education 
Reconciliation Act of 2010. These provisions require the extension of 
the expiration date for certain geographic reclassifications and 
special exception wage indices through September 30, 2010, and certain 
market basket updates for the IPPS and LTCH PPS effective April 1, 
2010.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/02/10                    75 FR 31118

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Tzvi Hefter, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4487
Email: [email protected]

RIN: 0938-AQ03
[FR Doc. 2010-30444 Filed 12-17-10; 8:45 am]
BILLING CODE 4150-24-S
