[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]
[Unknown Section]
[Pages 64423-64446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28598]


[[Page 64423]]

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Part VI





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 64424]]



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 requires 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 
issue of the Federal Register relate only 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 2010 
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: October 9, 2009.

 Dawn L. Smalls,

Executive Secretary,
Department of Health and Human Services.

                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
306         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) (Reg Plan Seq No. 43)................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
307         Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section       0930-AA14
            610 Review)...........................................................................
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
308         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
309         Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation           0920-AA14
            Regulations...........................................................................
310         Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of    0920-AA23
            HHS/CDC Nonhuman Primate Regulations..................................................
----------------------------------------------------------------------------------------------------------------


[[Page 64425]]


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
311         Control of Communicable Diseases Foreign Quarantine...................................    0920-AA12
312         Control of Communicable Diseases: Interstate Quarantine, Passenger Information........    0920-AA27
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
313         Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review).........    0920-AA32
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
314         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
315         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
316         Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610    0910-AG25
            Review)...............................................................................
317         Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review)..............    0910-AG34
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
318         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg      0910-AC52
            Plan Seq No. 44)......................................................................
319         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
320         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
321         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
322         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
323         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
324         Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
325         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
326         Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug         0910-AG12
            Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........
327         Produce Safety Regulation (Reg Plan Seq No. 46).......................................    0910-AG35
328         Modernization of the Current Food Good Manufacturing Practices Regulation (Reg Plan       0910-AG36
            Seq No. 47)...........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
329         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
330         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
331         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
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.
            48)...................................................................................
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

[[Page 64426]]

 
336         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
337         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
338         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
339         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
340         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
341         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
342         Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
343         Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco     0910-AG33
            to Protect Children and Adolescents (Reg Plan Seq No. 50).............................
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
344         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
345         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
346         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
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         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
352         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
353         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
354         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
355         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
356         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
357         Substances Prohibited From Use in Animal Food or Feed to Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
358         Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs       0938-AP77
            for Contract Year 2011 (CMS-4085-F)...................................................
359         Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care     0938-AP80
            Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates
            (CMS-1498-P) (Reg Plan Seq No. 53)....................................................
360         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP82
            Center Payment System for CY 2011 (CMS-1504-P) (Reg Plan Seq No. 54)..................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


[[Page 64427]]


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
361         Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413-     0938-AP40
            FC)...................................................................................
362         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP41
            Center Payment System for CY 2010 (CMS-1414-FC).......................................
363         Children's Health Insurance Program (CHIP); Allotment Methodology and States' Fiscal      0938-AP53
            Year 2009 CHIP Allotments (CMS-2291-F)................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
364         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
365         Electronic Claims Attachments Standards (CMS-0050-IFC)................................    0938-AK62
366         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610      0938-AO53
            Review)...............................................................................
367         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
368         State Flexibility for Medicaid Benefit Packages (CMS-2232-F4).........................    0938-AP72
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
369         Medicaid Graduate Medical Education (CMS-2279-F)......................................    0938-AO95
370         Genetic Information Nondiscrimination Act of 2008 (CMS-4137-IFC)......................    0938-AP37
371         Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY    0938-AP39
            2010 (CMS-1406-F).....................................................................
372         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AP46
            Update for FY 2010 (CMS-1410-F).......................................................
373         Home Health Prospective Payment System and Rate Update for CY 2010 (CMS-1560-F).......    0938-AP55
374         Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2010 (CMS-      0938-AP56
            1538-F)...............................................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

 Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of 
the Federal Register.

RIN: 0991-AB58

[[Page 64428]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




307. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE 
ADDITION (SECTION 610 REVIEW)

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

Abstract: This 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                    06/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Nicholas Reuter, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
One Choke Cherry Rd, Suite 2-1063, Rockville, MD 20857
Phone: 240 276-2716

RIN: 0930-AA14
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0930-AA10
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




309. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL 
IMPORTATION REGULATIONS

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. The Secretary has designated 
the authority to prevent the introduction of diseases from foreign 
countries to the Director, Centers for Disease Control and Prevention 
(CDC). CDC also enforces entry requirements for certain animals, 
etiologic agents and vectors deemed to be of public health 
significance. Currently the regulations restrict the importation of 
nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts 
and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54). 
In addition, CDC has recently issued a series of emergency orders, 
restricting the importation of African rodents (42 CFR section 71.56) 
and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed 
Rulemaking (NPRM) to revise the regulations for importation of certain 
animals and vectors into the United States (42 CFR parts 71, Subpart 
F).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/31/07                    72 FR 41676
ANPRM Comment Period End        10/01/07
Notice Extending ANPRM Comment 
Period                          10/01/07                    72 FR 55729
ANPRM Extended Comment Period 
End                             12/01/07
NPRM                            06/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA14
_______________________________________________________________________




310. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, 
PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. The Secretary has delegated 
the authority to prevent the

[[Page 64429]]

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                            03/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA23
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




311. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE

Legal Authority: 42 USC 243; 42 USC 248 and 249

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. Quarantine regulations are 
divided into two parts: Part 71 dealing with foreign arrivals and part 
70 dealing with interstate matters. This rule (42 CFR part 71) will 
update and improve CDC's response to both global and domestic disease 
threats by creating a multi-tiered illness detection and response 
process thus substantially enhancing the public health system's ability 
to slow the introduction, transmission, and spread of communicable 
disease. The rule will also modify current Federal regulations 
governing the apprehension, quarantine isolation and conditional 
release of individuals suspected of carrying a quarantinable disease 
while respecting individual autonomy. CDC maintains quarantine stations 
at 20 ports of entry staffed with medical and public health officers 
who respond to reports of diseases from carriers. According to the 
statutory scheme, the President determines through Executive Order 
which diseases may subject individuals to quarantine. The current 
disease list, which was last updated in April 2005, includes cholera, 
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral 
hemorrhagic fevers, severe acute respiratory syndrome (SARS), and 
influenza caused by novel or reemergent influenza viruses that are 
causing, or have the potential to cause a pandemic.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/20/06
Final Action                    03/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA12
_______________________________________________________________________




312. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER 
INFORMATION

Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248; 
42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 
2001

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from one State or possession into another. 
Quarantine regulations are divided into two parts: Part 71 dealing with 
foreign arrivals and part 70 dealing with interstate matters. The CDC 
Director has been delegated the responsibility for carrying out these 
regulations. The Director's authority to investigate suspected cases 
and potential spread of communicable disease among interstate travelers 
is thus not limited to those known or suspected of having a 
quarantinable disease, but rather all communicable diseases that may 
necessitate a public health response.
Among the fundamental components of the public health response to the 
report of a person with a communicable disease is the identification 
and evaluation of individuals who may have been exposed. This 
provision, which was proposed section 70.4, would require any airline 
operating in interstate traffic to solicit and electronically submit 
certain passenger information to CDC for use in contact tracing when 
necessary to protect the vital interests of an individual, or other 
persons, in regard to significant health risks.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/30/06
Final Action                    03/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA27

[[Page 64430]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




313. POSSESSION, USE AND TRANSFER OF SELECT AGENTS AND TOXINS (SECTION 
610 REVIEW)

Legal Authority: PL 107-188

Abstract: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 authorizes the HHS Secretary to regulate the 
possession, use, and transfer of select agents and toxins that have the 
potential to pose a severe threat to public health and safety. These 
regulations are set forth at 42 CFR 73. Criteria used to determine 
whether a select agent or toxin should be included under the provisions 
of these regulations are based on: 1) the effect on human health as a 
reuslt of exposure to the agent or toxin, 2) the degree of 
contagiousness of the agent or toxin, 3) the methods by which the agent 
or toxin is transferred to humans, 4) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent andy illness resulting from infection by the agent or toxin, 
and 5) any other criteria, including the needs of children and other 
vulnerable populations that the HHS Secretary considers appropriate. 
Based on these criteria, we are proposing to amend the list of HHS 
select agents and toxins by adding Chapare virus to the list. After 
consulting with subject matter experts from CDC, the National 
Institutes of Health (NIH), the Food Drug Administration (FDA), the 
United States Department of Agriculture (USDA) /Animal and Plant Health 
Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), 
USDA/CVB (Center for Veterinary Biologics), and the Department of 
Defense (DOD)/United States Army Medical Research Institute for 
Infectious Diseases (USAMRIID) and review of relevant published 
studies, we believe the Chapare virus should be added to the list of 
HHS select agents and toxins based on our conclusion that the Chapare 
virus has been phylogenetically identified as a Clade B arenavirus and 
is closely related to other South American arenaviruses that cause 
haemorrhagic fever, particularly Sabia virus.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/19/09                      74 FR 159
NPRM Comment Period End         10/19/09
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

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

RIN: 0920-AA32
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

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

RIN: 0910-AG06
_______________________________________________________________________




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

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

Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine

[[Page 64431]]

whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 
and 205.50 (as amended in 64 FR 67762 and 67763) should be continued 
without change, or whether they should be amended or rescinded, 
consistent with the stated objectives of applicable statutes, to 
minimize adverse impacts on a substantial number of small entities. FDA 
will consider, and is soliciting comments on, the following: (1) The 
continued need for the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) 
the nature of complaints or comments received from the public 
concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 
and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of 
the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 
(as amended in 64 FR 67762 and 67763); (4) the extent to which the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with 
other Federal rules, and to the extent feasible, with State and local 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      11/24/08
End Review of Current Regulation12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AG14
_______________________________________________________________________




316.  STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG 
PRODUCTS FOR ORAL INHALATION (SECTION 610 REVIEW)

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

Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 
610 of the Regulatory Flexibility Act. The purpose of this review is to 
determine whether this regulation on aqueous-based drug products for 
oral inhalation should be continued without change, or whether it 
should be amended or rescinded, consistent with the stated objectives 
of applicable statues, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for 21 CFR 200.51; (2) the 
nature of complaints or comments received concerning 21 CFR 200.51; (3) 
the complexity of 21 CFR 200.51; (4) the extent to which the regulation 
overlaps, duplicates, or conflicts with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by 21 
CFR 200.51.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/01/09
End Review                      05/00/10

Regulatory Flexibility Analysis Required: No

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

RIN: 0910-AG25
_______________________________________________________________________




317.  OVER-THE-COUNTER HUMAN DRUGS; LABELING 
REQUIREMENTS (SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Part 201.66 (21 CFR section 201.66) established a 
standardized format for the labeling of OTC drug products that 
included: (1) Specific headings and subheadings presented in a 
standardized order, (2) standardized graphical features such as 
Helvetica type style and the use of ``bullet points'' to introduce key 
information, and (3) minimum standards for type size and spacing. FDA 
issued the final rule to improve labeling after considering comments 
submitted to the agency following the publication of the proposed 
regulation in 1997. In 1999, FDA published the final rule and stated 
that a standardized labeling format would significantly improve 
readability by familiarizing consumers with the types of information in 
OTC drug product labeling and the location of that information. In 
addition, a standardized appearance and standardized content, including 
various ``user-friendly'' visual cues, would help consumers locate and 
read important health and safety information and allow quick and 
effective product comparisons, thereby helping consumers to select the 
most appropriate product.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in part 201.66. The purpose of this 
review is to determine whether the regulation in part 201.66 should be 
continued without change, or whether they should be further amended or 
rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on the 
following: (1) The continued need for the regulation in part 201.66; 
(2) the nature of the complaints or comments received concerning the 
regulation in part 201.66; (3) the complexity of the regulations in 
part 201.66; (4) the extent to which the regulation in part 201.66 
overlap, duplicate, or conflict with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed for the products still 
subject to the labeling standard regulations in part 201.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less

[[Page 64432]]

burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      08/03/09
End Review of Current Regulation02/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG34
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

 Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of 
the Federal Register.

RIN: 0910-AC52
_______________________________________________________________________




319. 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)  09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF31
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
NPRM (Professional Labeling--
Sodium Phosphate)               06/00/10
Final Action (Laxative Drug 
Products)                        To Be                       Determined
NPRM (Professional Labeling)     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF38
_______________________________________________________________________




321. 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 combination products containing sunscreen and insect 
repellent ingredients. The second action addresses active ingredients 
reviewed under Time and Extent Applications. The third action addresses 
other effectiveness issues for OTC sunscreen drug products. The fourth 
action is the final action that addresses sunscreen formulation, 
labeling, and testing requirements for both ultraviolet B and 
ultraviolet A radiation protection.

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 (Effectiveness)            05/00/10

[[Page 64433]]

Final Action (UVA/UVB)          05/00/10
NPRM (Sunscreen and Insect 
Repellent)                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF43
_______________________________________________________________________




322. 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)                       09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF44
_______________________________________________________________________




323. 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 (Phenylpropanol -amine)    12/22/05                    70 FR 75988
NPRM (Benzocaine)               05/00/10
Final Action (Phenylpropanol -
amine)                          05/00/10
Final Action (Benzocaine)        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF45
_______________________________________________________________________




324. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT DRUG PRODUCTS

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (IPECAC)                   06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF68
_______________________________________________________________________




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

Legal Authority: 21 USC 342; 21 USC 371; PL 110-85, sec 1002(a)(2)

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/10

[[Page 64434]]

NPRM Comment Period End         01/00/11

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
_______________________________________________________________________




326. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND 
ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED 
AMENDMENT OF FINAL MONOGRAPH

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG12
_______________________________________________________________________




327.  PRODUCE SAFETY REGULATION

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

RIN: 0910-AG35
_______________________________________________________________________




328.  MODERNIZATION OF THE CURRENT FOOD GOOD 
MANUFACTURING PRACTICES REGULATION

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

RIN: 0910-AG36
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




329. 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                    09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Meredith S. Francis, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, 
Room 6238, Silver Spring, MD 20993-0002
Phone: 301 796-3476
Fax: 301-847-8440

RIN: 0910-AA97
_______________________________________________________________________




330. 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

[[Page 64435]]

several incidents involving high-pressure medical gas cylinders that 
have resulted in death and injuries to patients. These amendments, 
together with existing regulations, are intended to ensure that the 
types of incidents that have occurred in the past, as well as other 
types of foreseeable and potentially deadly medical gas accidents, do 
not occur in the future.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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, 10903 New Hampshire Avenue, Bldg. 51, 
Room 6368, Silver Spring, MD 20993-0002
Phone: 301 796-3522
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC53
_______________________________________________________________________




331. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

Legal Authority: PL 105-115, sec 121

Abstract: Section 121 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for 
current good manufacturing practices (CGMPs) for positron emission 
tomography (PET) drugs, a type of radiopharmaceutical. The final rule 
would adopt CGMPs that reflect the unique characteristics of PET drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/20/05                    70 FR 55038
NPRM Comment Period End         12/19/05
Final Action                    12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Office of Regulatory Policy, 
10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993-
0002
Phone: 301 796-3478
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC55
_______________________________________________________________________




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. 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. 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                    04/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation Research, 10903 New Hampshire Avenue, Bldg. 51, Room 
6224, Silver Spring, MD 20993-0002
Phone: 301 796-4288
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. 48 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
Final Action (Technical 
Amendment)                      11/30/07                    72 FR 67639
Final Action (Amendment--
Ephedrine Single Ingredient)    05/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899

[[Page 64436]]

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 
finalizes cough/cold combination products containing oral 
bronchodilators and expectorants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                07/13/05                    70 FR 40232
Final Action (Technical 
Amendment)                      03/19/07                    72 FR 12730
Final Action                    09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF33
_______________________________________________________________________




336. 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 (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenylpropanol -amine)    12/22/05                    70 FR 75988
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenylephrine 
Bitartrate)                     08/01/06                    71 FR 83358
Final Action (Phenylpropanol -
amine)                          09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF34
_______________________________________________________________________




337. 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)                          09/00/10
NPRM (Amendment)                 To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF35
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    12/26/06                    71 FR 77314
NPRM Comment Period End         05/25/07
NPRM (Amendment) (Overindulgence 
/Hangover)                       To Be                       Determined
Final Action (Required Warnings 
and Other Labeling)             04/29/09                    74 FR 19385

[[Page 64437]]

Final Action (Correction)       06/30/09                    74 FR 31177
Final Action (Technical 
Amendment)                      12/00/09
NPRM (Amendment) (Miscellaneous 
Issues)                         09/00/10
NPRM (Amendment) (Pediatric)     To Be                       Determined
NPRM (Amendment) (Combinations 
With Sodium Bicarbonate)         To Be                       Determined
Final Action (Internal 
Analgesics)                      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF36
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        12/12/06                    71 FR 74474
Final Action                    05/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF37
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF42
_______________________________________________________________________




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

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

Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), 
effective immediately, to prohibit the use of certain cattle material 
and to address the potential risk of bovine spongiform encephalopathy 
(BSE) in human food, including dietary supplements, and cosmetics. 
Prohibited cattle materials under the IFR include specified risk 
materials, small intestine of all cattle, material from nonambulatory 
disabled cattle, material from cattle not inspected and passed for 
human consumption, and mechanically separated (MS) beef. Specified risk 
materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, 
vertebral column (excluding the vertebrae of the tail, the transverse 
processes of the thoracic and lumbar vertebrae, and the wings of the 
sacrum), and dorsal root ganglia of cattle 30 months and older; and the 
tonsils and distal ileum of the small intestine of all cattle. 
Prohibited cattle materials do not include tallow that contains no more 
than 0.15 percent hexane-insoluble impurities and tallow derivatives. 
This action minimizes human exposure to materials that scientific 
studies have demonstrated are highly likely to contain the BSE agent in 
cattle infected with the disease. Scientists believe that the human 
disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by 
the consumption of products contaminated with the agent that causes 
BSE.
On September 7, 2005, FDA amended the IFR to permit the use of small 
intestine in human food and cosmetics if it is effectively removed from 
the distal ileum. The amendment also clarified that milk and milk 
products, hides, and tallow derivatives are not prohibited for use in 
human food and cosmetics.
On April 17, 2008, FDA amended the IFR so that FDA may designate a 
country as not subject to certain BSE-related restrictions relating to 
prohibited cattle materials applicable to human food and cosmetics.
Comments submitted in response to the July 14, 2004 IFR that were not 
addressed in the September 7, 2005 and April 17, 2008 amendments will 
be addressed in the final rule. The final

[[Page 64438]]

rule also will respond to comments submitted following the September 7, 
2005 and April 17, 2008 amendments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF47
_______________________________________________________________________




342. OVER-THE-COUNTER (OTC) DRUG REVIEW--ACNE DRUG PRODUCTS CONTAINING 
BENZOYL PEROXIDE

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG00
_______________________________________________________________________




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

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

RIN: 0910-AG33
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Legal Authority: 21 USC 321; 21 USC 342 and 343; 21 USC 348; 21 USC 
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264

Abstract: The Food and Drug Administration published a final rule in 
the Federal Register of June 25, 2007 (72 FR 34752), on current good 
manufacturing practice (CGMP) regulations for dietary supplements. FDA 
also published an Interim Final Rule in the same Federal Register (72 
FR 34959) that provided a procedure for requesting an exemption from 
the final rule requirement that the manufacturer conduct at least one 
appropriate test or examination to verify the identity of any component 
that is a dietary ingredient. This IFR allows for submission to, and 
review by, FDA of an alternative to the required 100 percent identity 
testing of components that are dietary ingredients, provided certain 
conditions are met. This IFR also establishes a requirement for 
retention of records relating to the FDA's response to an exemption 
request.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AB88
_______________________________________________________________________




345. 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

[[Page 64439]]

drugs meeting the conditions of the monograph, or having an approved 
new drug application, may be legally marketed. This action finalizes 
the monograph for emergency first aid eyewash drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF39
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF40
_______________________________________________________________________




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
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [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 bicarbonate as an 
active ingredient. The other action addresses the use of antacids to 
relieve upset stomach associated with overindulgence in food and drink.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [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

[[Page 64440]]

NPRM Comment Period End         12/27/06
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [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: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF56
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/18/08                    73 FR 54106
NPRM Comment Period End         12/02/08
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: John D. Reilly, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, CPK 1, Room 1C-015, (HFS-024), 5100 
Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1530
Fax: 301-436-2637
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________




352. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF63
_______________________________________________________________________




353. 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 health care products. The second action addresses food 
handler products. The third action addresses testing requirements. The 
fourth action addresses consumer products. The final actions listed 
will address the healthcare, consumer, and first aid antiseptic drug 
products respectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Healthcare)               06/17/94                    59 FR 31402
NPRM (Food Handlers)             To Be                       Determined
NPRM (Testing)                   To Be                       Determined
NPRM (Consumer)                 12/00/10
Final Action (Healthcare)        To Be                       Determined
Final Action (Consumer)          To Be                       Determined
Final Action (First Aid 
Antiseptic)                      To Be                       Determined

[[Page 64441]]

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF69
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)         To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF70
_______________________________________________________________________




355. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II 
ACTIVE INGREDIENTS

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF95
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




356. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 
393; 42 USC 243; 42 USC 264; 42 USC 271; . . .

Abstract: Publication of this final rule was an action item in the Food 
Protection Plan announced by the Department of Health and Human 
Services (HHS) in November 2007.
In July 1999, the Food and Drug Administration (FDA) and the Food 
Safety Inspection Service (FSIS) committed to developing an action plan 
to address the presence of Salmonella Enteritidis (SE) in shell eggs 
and egg products using a farm-to-table approach. FDA and FSIS held a 
public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses. The Egg Safety Action Plan consists of eight objectives 
covering all stages of the farm-to-table continuum as well as support 
functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, 
CA), and July 31, 2000 (Washington, DC), joint public meetings were 
held by FDA and FSIS to solicit and discuss information related to the 
implementation of the objectives in the Egg Safety Action Plan.
On September 22, 2004, FDA published a proposed rule that would require 
egg safety measures to prevent the contamination of shell eggs with SE 
during egg production. The proposal also solicited comment on whether 
recordkeeping requirements should include a written SE prevention plan 
and records for compliance with the SE prevention measures, and whether 
safe egg handling and preparation practices should be mandated for 
retail establishments that specifically serve a highly susceptible 
population (e.g., nursing homes, hospitals, day care centers). The 
proposed egg production SE prevention measures included: (1) Provisions 
for procurement of chicks and pullets; (2) a biosecurity program; (3) a 
rodent and pest control program; (4) cleaning and disinfection of 
poultry houses that have had an environmental or egg test positive for 
SE; (5) egg testing when an environmental test is positive; and (6) 
refrigerated storage of eggs held at the farm. Additionally, to verify 
that the measures have been effective, the rule proposes that producers 
test the poultry house environment for SE. If the environmental test is 
positive, eggs from that environment must be tested for SE, and if the 
egg test is positive, the eggs must be diverted to egg products 
processing or a treatment

[[Page 64442]]

process that achieves at least a five-log destruction of SE.
The proposed rule was a step in a broader farm-to-table egg safety 
effort that includes FDA's requirements for safe handling statements on 
egg cartons, and refrigerated storage of shell eggs at retail, and egg 
safety education for consumers and retail establishments. The rule had 
a 90-day comment period, which ended December 21, 2004. To discuss the 
proposed rule and solicit comments from interested stakeholders, FDA 
held three public meetings: October 28, 2004, in College Park, MD; 
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los 
Angeles, CA. The comment period was reopened until July 25, 2005, to 
solicit further comment and information on industry practices and 
programs that prevent SE-monitored chicks from becoming infected by SE 
during the period of pullet rearing until placement into laying hen 
houses.
On July 9, 2009, FDA published the final rule that requires shell egg 
producers to implement measures to prevent SE from contaminating eggs 
on the farm and from further growth during storage and transportation, 
and requires these producers to maintain records concerning their 
compliance with the rule and to register with FDA. FDA took this action 
because SE is among the leading bacterial causes of foodborne illness 
in the United States, and shell eggs are a primary source of human SE 
infections. The final rule will reduce SE-associated illnesses and 
deaths by reducing the risk that shell eggs are contaminated with SE.
Egg producers with 50,000 or more laying hens have 12 months to comply 
with the final rule, as do persons who must comply with only the 
refrigeration requirements. Producers with fewer than 50,000 but at 
least 3,000 laying hens have 36 months to comply. Producers with fewer 
than 3,000 laying hens and those who sell all of their eggs directly to 
consumers are exempt from the rule.
FDA is developing guidance documents and will hold public meetings this 
year to help ensure covered persons understand how to comply with the 
final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/04                    69 FR 56824
NPRM Comment Period End         12/21/04
NPRM Reopened Comment Period End06/09/05                    70 FR 24490
NPRM Extension of Reopened 
Comment Period End              07/25/05                    70 FR 33404
Final Action                    07/09/09                    74 FR 33030

Regulatory Flexibility Analysis Required: Yes

Agency Contact: John F. Sheehan, Director, Department of Health and 
Human Services, Food and Drug Administration, Division of Plant and 
Dairy Food Safety (HFS-315), Room 3B-012, 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-2367
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




357. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT 
THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371

Abstract: On October 6, 2005, the Food and Drug Administration (FDA) 
proposed to amend its regulations to prohibit the use of certain cattle 
origin materials in the food or feed of all animals to further 
strengthen existing safeguards designed to help prevent the spread of 
bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of 
a BSE-positive dairy cow in December 2003 has caused FDA to review its 
policies for prevention of BSE, which resulted in this rulemaking. On 
April 28, 2008, FDA published a final rule prohibiting the use of 
certain cattle origin materials in the food and feed of all animals. On 
October 23, 2008 FDA corrected the final rule on BSE that appeared in 
the Federal Register of April 25, 2008 (73 FR 22719-22758). The final 
rule was inadvertently published with incorrect dollar amounts in two 
separate areas: the summary of economic impacts and the paperwork 
burden table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/14/04                    69 FR 42288
ANPRM Comment Period End        08/13/04
NPRM                            10/06/05                    70 FR 58569
NPRM Comment Period End         12/20/05
Final Rule                      04/25/08                    73 FR 22720
Final Rule-Correction           10/23/08                    73 FR 63072
Final Rule Effective            04/27/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Burt Pritchett, Biologist, Department of Health and 
Human Services, Food and Drug Administration, Center for Veterinary 
Medicine, Room 2654 (MPN-4, HFV-222), 7519 Standish Place, Rockville, 
MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: [email protected]

RIN: 0910-AF46
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




358.  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 proposed rule sets forth programmatic and operational 
changes to the Medicare Advantage and Prescription Drug Benefit 
programs (for example, strengthens beneficiary protections and sponsor 
entrance and exit rules, provides plan offerings with meaningful 
differences, improves payment rules and data collection for oversight 
and quality assessment).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/22/09                    74 FR 54634

[[Page 64443]]

NPRM Comment Period End         12/07/09
Final Action                    10/00/12

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy 
and Quality, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mail Stop C1-26-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6041
Email: [email protected]


RIN: 0938-AP77
_______________________________________________________________________




359.  PROPOSED CHANGES TO THE HOSPITAL INPATIENT 
PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES 
AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P)

 Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of 
the Federal Register.

RIN: 0938-AP80
_______________________________________________________________________




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

 Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of 
the Federal Register.

RIN: 0938-AP82
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




361. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CY 2010 (CMS-1413-FC)

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/09                    74 FR 33520
NPRM Comment Period End         08/31/09
Final Action                    12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Diane Milstead, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicaid Mangement, Mailstop C4-03-06, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-3355
Email: [email protected]

RIN: 0938-AP40
_______________________________________________________________________




362. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-FC)

Legal Authority: BBA; BBA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA

Abstract: This rule revises the Medicare hospital outpatient 
prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system and to implement certain related provisions of the Medicare 
Improvements for Patients and Providers Act of 2008 (MIPPA). In 
addition, the rule describes changes to the amounts and factors used to 
determine the payment rates for Medicare hospital outpatient services 
paid under the prospective payment system. The rule also changes the 
Ambulatory Surgical Center Payment System list of services and rates. 
These changes applicable to services furnished on or after January 1 
annually.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/20/09                    74 FR 35231
NPRM Comment Period End         08/31/09
Final Action                    12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP41
_______________________________________________________________________




363. CHILDREN'S HEALTH INSURANCE PROGRAM (CHIP); ALLOTMENT METHODOLOGY 
AND STATES' FISCAL YEAR 2009 CHIP ALLOTMENTS (CMS-2291-F)

Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) and 
2104(f) of the Social Security Act; CHIPRA of 2009 (PL 111-3)

Abstract: This proposed rule describes the implementation of certain 
funding provisions under existing Medicaid laws, the Children's Health 
Insurance Program (CHIP) and recent legislation, and other related CHIP 
legislation. It proposes methodologies and procedures for determining 
States' fiscal year (FY) 2009 through FY 2013 allotments and payments

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/16/09                    74 FR 47517
NPRM Comment Period End         11/16/09
Final Action                    02/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Richard Strauss, Technical Director, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid State Operations, Mailstop S3-13-15, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1850
Email: [email protected]

RIN: 0938-AP53

[[Page 64444]]

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Second NPRM                      To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Mercedes Benitez-McCray, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards & Quality, Mailstop S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________




365. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-IFC)

Legal Authority: 42 USC 1320d-2(a)(2)(B)

Abstract: This rule sets forth electronic standards for health care 
claims attachments. The standards are required by the Health Insurance 
Portability and Accountability Act of 1996. They will be used to 
transmit clinical or administrative data for claims adjudication 
purposes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/05                    70 FR 55989
NPRM Comment Period End         11/22/05


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AK62
_______________________________________________________________________




366. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-
2249-F) (SECTION 610 REVIEW)

Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086

Abstract: This rule amends the Medicaid regulations to define and 
describe the home- and community-based State plan services implementing 
the new section 1915(i) of the Social Security Act as added by section 
6086 of the Deficit Reduction Act of 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/04/08                    73 FR 18676
NPRM Comment Period End         06/03/08
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Suzanne Bosstick, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1301
Email: [email protected]

RIN: 0938-AO53
_______________________________________________________________________




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

Legal Authority: 42 USC 1302; 42 USC 1395hh

Abstract: This proposed rule would establish requirements that long-
term care (LTC) facilities must have an agreement with hospice agencies 
when hospice care is provided in a long-term care facility to 
participate in the Medicare and Medicaid programs. We are proposing 
these new requirements to ensure that quality hospice care is provided 
to eligible residents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP32
_______________________________________________________________________




368. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS-2232-F4)

Legal Authority: PL 109-171, sec 6044

Abstract: This rule replaces the final rule published on December 3, 
2008 (73 FR 73694) to implement provisions of the Deficit Reduction Act 
(DRA) of 2005. It also provides States increased flexibility under an 
approved State plan to define the scope of covered medical assistance 
by offering coverage of benchmark or benchmark-equivalent benefit 
packages to certain Medicaid-eligible individuals. In addition, this 
final rule responds to public comments on the February 22, 2008 
proposed rule as well as public comments on the December 3, 2009 
``final rule'' which was temporarily delayed twice, once by an interim 
final rule with comment period published on February 2, 2009, and the 
second time by a final rule published on April 3, 2009, further 
delaying the effective date and reopening the comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Chris Gerhardt, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S2-01-16,

[[Page 64445]]

7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0693
Email: [email protected]

RIN: 0938-AP72
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




369. MEDICAID GRADUATE MEDICAL EDUCATION (CMS-2279-F)

Legal Authority: title XIX; Social Security Act

Abstract: As part of the President's 2008 Budget, this rule establishes 
that States may not include GME as a reimbursable cost or program under 
their approved Medicaid State Plan. The rule enhances fiscal integrity 
and improves accountability with respect to payment for medical 
services in the Medicaid program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/23/07                    72 FR 28930
NPRM Comment Period End         06/22/07
Withdrawn                       10/08/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kristin Fan, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Centers for Medicaid State 
Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 
21224
Phone: 410 786-4581
Fax: 410 786-1008
Email: [email protected]

RIN: 0938-AO95
_______________________________________________________________________




370. GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (CMS-4137-IFC)

Legal Authority: Genetic information Nondiscrimination Act of 2008 (PL 
110-223), enacted May 21, 2008.

Abstract: This rule implements statutory changes to the PHSA affecting 
the group and individual health insurance markets, non-federal 
governmental plans, and Medicare supplemental insurance (Medigap) made 
by the Genetic Information Nondiscrimination Act of 2008 (Pub. L. 110-
223).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/10/08                    73 FR 60208
ANPRM Comment Period End        12/09/08
Interim Final Rule              10/07/09                    74 FR 51663

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Adam M Shaw, Senior Technical Adviser, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Mail Stop C1-22-06, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1091
Email: [email protected]

RIN: 0938-AP37
_______________________________________________________________________




371. CHANGES TO THE HOSPITAL INPATIENT AND LONG-TERM CARE PROSPECTIVE 
PAYMENT SYSTEM FOR FY 2010 (CMS-1406-F)

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

Abstract: This rule revises the Medicare hospital inpatient and Long 
Term Care prospective payment systems (IPPS) for operating and capital-
related costs to implement changes arising from our continuing 
experience with these systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/22/09                    74 FR 24080
NPRM Comment Period End         06/30/09
Final Rule                      08/27/09                    74 FR 43753

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP39
_______________________________________________________________________




372. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2010 (CMS-1410-F)

Legal Authority: Social Security Act, sec 1888(e)

Abstract: This rule updates the payment rates used under the SNF PPS 
beginning October 1, 2009.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/12/09                    74 FR 22208
NPRM Comment Period End         06/30/09
Final Action                    08/11/09                    74 FR 40287

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William Ullman, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Centers 
for Medicare Management, Mailstop C5-06-27, 7500 Security Boulvard, 
Baltimore, MD 21244
Phone: 410 786-5667
Fax: 410 786-0765
Email: [email protected]

RIN: 0938-AP46
_______________________________________________________________________




373. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM AND RATE UPDATE FOR CY 2010 
(CMS-1560-F)

Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302 
and 42 USC 1395(hh); Social Security Act, sec 1895; 42 USC 1395(fff)

Abstract: This rule updates the 60-day national episode rate and the 
national per visit rate amounts under the Medicare Prospective Payment 
System for home health agencies, effective January 1, 2010.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/06/09                    74 FR 39435
NPRM Comment Period End         08/28/09
Final Action                    11/10/09                    74 FR 58077
Final Action Effective          01/01/10

[[Page 64446]]

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Randy Throndset, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, Mailstop C5-07-28, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0131
Fax: 410 786-0765
Email: [email protected]

RIN: 0938-AP55
_______________________________________________________________________




374. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES 
FOR FY 2010 (CMS-1538-F)

Legal Authority: Social Security Act, sec 1886(j); PL 106-554; PL 106-
113

Abstract: This rule updates rates for the prospective payment system 
for inpatient rehabilitation facilities for FY 2010.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/06/09                    74 FR 21052
Final Action                    08/13/09                    74 FR 40947
NPRM Comment Period End         06/29/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Julie Stankivic, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Mailstop, 
C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5725
Email: julie.stankivic @ cms.hhs.gov

RIN: 0938-AP56
[FR Doc. E9-28598 Filed 12-04-09; 8:45 am]
BILLING CODE 4150-24-S