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


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Part V





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 71356]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)






_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Regulatory Agenda

AGENCY: Office of the Secretary, HHS

ACTION: Semiannual Regulatory Agenda

_______________________________________________________________________

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

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, Washington, D.C. 20201.

SUPPLEMENTARY INFORMATION:  The capsulized information provided in the 
Agenda presents for public review a forecast of the rulemaking 
activities that the Department expects to undertake over the 
foreseeable future. We focus primarily on those areas of work expected 
to result in publication of Notices of Proposed Rulemaking or of Final 
Rules within the next 12 months.

     Please note that the rulemaking abstracts included below 
relate only to those prospective rulemakings that are likely to 
have a significant economic impact on a substantial number of small 
entities; the Regulatory Flexibility Act of 1980 requires 
publication of this information in the Federal Register. Also 
available elsewhere in this issue of the Register is the 
Department's submission to the Fiscal Year 2009 Regulatory Plan, as 
required under Executive Order 12866. The complete Regulatory 
Agenda of the Department is accessible online at www.reginfo.gov.

     We welcome the views of all concerned with regard to these 
planned rulemakings. Comments may be directed to the agency 
officials cited at the conclusion of each entry. If early attention 
at the Secretary's level appears needed, comments should be sent 
to: Ann C. Agnew, Executive Secretary to the Department, Suite 
603H, 200 Independence Ave. SW, Washington DC 20201.

Dated: September 23, 2008.

 Ann C. Agnew,

Executive Secretary to the Department.

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


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


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
286         Control of Communicable Diseases Foreign Quarantine (Reg Plan Seq No. 37).............    0920-AA12
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


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


[[Page 71357]]


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
288         Possession, Use, and Transfer of Select Agents and Toxins (Section 610 Review)........    0920-AA29
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
289         Food Labeling; Serving Sizes and Nutrition Labeling (Section 610 Review)..............    0910-AF99
290         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
291         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.......    0910-AC52
292         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
293         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
294         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
295         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
296         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
297         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
298         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
299         Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
300         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
301         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
302         Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug         0910-AG12
            Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
303         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
304         Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 40)..............    0910-AC14
305         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
306         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
307         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
308         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
309         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
310         Obstetrical and Gynecological Devices; Designation of Special Controls for Male           0910-AF21
            Condoms Made of Natural Rubber Latex..................................................
311         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
312         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
313         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
314         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
315         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
316         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
317         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
318         Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
319         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
320         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52

[[Page 71358]]

 
321         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
322         Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
323         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
324         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
325         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
326         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
327         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
328         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
329         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
330         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
331         Biological Products; Reporting of Biological Product Deviations in Manufacturing          0910-AG05
            (Section 610 Review)..................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
332         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
333         Changes to the Hospital Inpatient Prospective Payment System for FY 2010 (CMS-1406-P)     0938-AP39
            (Reg Plan Seq No. 42).................................................................
334         Revisions to Payment Policies under the Physician Fee Schedule for CY 2010 (CMS-1413-     0938-AP40
            P) (Reg Plan Seq No. 43)..............................................................
335         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP41
            Center Payment System for CY 2010 (CMS-1414-P) (Reg Plan Seq No. 44)..................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
336         Updates to Electronic Transactions (Version 5010) (CMS-0009-F) (Section 610 Review)...    0938-AM50
337         Revisions to HIPAA Code Sets (CMS-0013-F) (Section 610 Review)........................    0938-AN25
338         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610      0938-AO53
            Review)...............................................................................
339         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP17
            Center Payment System for CY 2009 (CMS-1404-F)........................................
340         Home Health Prospective Payment System Refinements and Rate Update for CY 2009 (CMS-      0938-AP20
            1555-N)...............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 71359]]


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
341         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
342         Electronic Claims Attachments Standards (CMS-0050-IFC)................................    0938-AK62
343         Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics,          0938-AO84
            Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Section 610 Review)....................
344         Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (CMS-1403-     0938-AP18
            FC)...................................................................................
345         Changes to Long Term Care Prospective Payment System Based on Specific Provisions in      0938-AP33
            the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-F)..................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
346         Medicare and Medicaid Programs; Hospice Care Conditions of Participation (CMS-3844-F)     0938-AH27
            (Completion of a Section 610 Review)..................................................
347         Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year           0938-AO92
            Beginning July 1, 2008 (RY 2009) (CMS-1401-N).........................................
348         Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate      0938-AO94
            Updates (CMS-1393-F)..................................................................
349         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AP11
            Update for FY 2009 (CMS-1534-F).......................................................
350         Hospice Wage Index for FY 2009 (CMS-1548-F)...........................................    0938-AP14
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




283. 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
_______________________________________________________________________




284.  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 proposed rule, when finalized will modify the regulatory 
dispensing restrictions under 42 CFR part 8 for the drug substance 
buprenorphine. This medication is used to treat kersin and other opioid 
addiction.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

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

RIN: 0930-AA14

[[Page 71360]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Legal Authority: Not Yet Determined

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/09

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: 404 718-1056

RIN: 0920-AA23
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




286. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE

 Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of 
the Federal Register.

RIN: 0920-AA12
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




287.  CONTROL OF COMMUNICABLE DISEASES, INTERSTATE 
QUARANTINE, PASSENGER INFORMATION

Legal Authority: Not Yet Determined

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.
Because CDC has separated this provision from the rest of 42 CFR 70, 
CDC is requesting a separate entry in the Unified Agenda and a new RIN 
for this regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
Final Action                    12/00/09

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: 404 718-1056

RIN: 0920-AA27

[[Page 71361]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




288.  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 
result of exposure to the agent or toxin; 2) the degree of 
contagiousness of the agent or toxin; 3) the methods by which the agent 
or toxin is transferred to humans; 4) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent any 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/16/08                    73 FR 61363
Final Action Effective          11/17/08

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-AA29
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




289. FOOD LABELING; SERVING SIZES AND NUTRITION LABELING (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

Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition 
labeling requirements for foods. Section 101.12 (21 CFR part 101.2) 
specifies the reference amount customarily consumed per eating occasion 
for each food category. The reference amount customarily consumed of a 
food is the basis for the serving size that is declared in the food's 
nutrition labeling. Under section 101.9, the serving size must be 
expressed in a common household measure that is appropriate to the 
food. The most recent change to sections 101.9 and 101.12 was in 1999, 
when FDA amended these regulations to reduce the reference amount 
customarily consumed for baking powder, baking soda, and pectin, and to 
include 1/8 teaspoon as an allowable unit of household measure for 
nutrition labeling purposes. FDA is undertaking a review of sections 
101.9 and 101.12 under section 610 of the Regulatory Flexibility Act. 
The purpose of this review is to determine whether the regulations in 
sections 101.9 and 101.12 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 regulations in sections 101.9 and 101.12; (2) the nature of 
complaints or comments received concerning the regulations in sections 
101.9 and 101.12; (3) the complexity of the regulations; (4) the extent 
to which the regulations in sections 101.9 and 101.12 overlap, 
duplicate, or conflict with other Federal rules, and to the extent 
feasible, with State or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed in the 
area affected by the regulations in sections 101.9 and 101.12.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/00/08
End Review                      03/00/09

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Mary Brandt, Statistician, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safey and 
Applied Nutrition, 5100 Paint Branch Parkway, ONLDS (HFS-820), College 
Park, MD 20740
Phone: 301 436-1788
Fax: 301 436-1191
Email: [email protected]

RIN: 0910-AF99
_______________________________________________________________________




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

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

Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in 21 CFR part 203 and 
21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) 
should be continued without change, or whether they should be amended 
or rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on, the 
following: (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);

[[Page 71362]]

(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                      11/00/08
End Review of Current Regulation12/00/09

Regulatory Flexibility Analysis Required: Yes

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, 
Bldg. 51, Room 6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AG14
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262

Abstract: The Food and Drug Administration is proposing to amend the 
regulations governing the format in which clinical study data and 
bioequivalence data are required to be submitted for new drug 
applications (NDAs), biological license applications (BLAs), and 
abbreviated new drug applications (ANDAs). The proposal would revise 
our regulations to require that data submitted for NDAs, BLAs, and 
ANDAs, and their supplements and amendments, be provided in an 
electronic format that FDA can process, review, and archive. The 
proposal would also require that FDA periodically issue guidance on the 
use of standardized data structure, terminology, and code sets (e.g., 
the Study Data Tabulation Model (SDTM) developed by the Clinical Data 
Interchange Standards Consortium) to allow for more efficient and 
comprehensive data review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 
6224, Silver Spring, MD 20993-0002
Phone: 301 796-3471
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________




292. 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 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 
addresses antihistamine labeling claims for the common cold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Common Cold)  09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF31
_______________________________________________________________________




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

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

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action will address laxative drug products. The second action will 
address the professional labeling for sodium phosphate drug products. 
The third action 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
Final Action (Laxative Drug 
Products)                        To Be                       Determined
NPRM (Professional Labeling - 
Sodium Phosphate)               05/00/09
NPRM (Professional Labeling)     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857

[[Page 71363]]

Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF38
_______________________________________________________________________




294. 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 to 360a; 21 USC 371 to 371a

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
NPRM (UVA/UVB)                  08/27/07                    72 FR 49070
NPRM Comment Period End         12/26/07
NPRM (Time and Extent)          05/00/09
Final Action (UVA/UVB)          06/00/09
NPRM (Sunscreen and Insect 
Repellent)                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF43
_______________________________________________________________________




295. 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 to 360a; 21 USC 360gg to 360ss; 21 USC 371 
to 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 
42 USC 264

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)                       09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF44
_______________________________________________________________________




296. 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. One action 
addresses the ingredient phenylpropanolamine, and the other action 
addresses the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenylpropanol amine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               05/00/09
Final Action (Phenylpropanol 
amine)                          09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF45
_______________________________________________________________________




297. 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 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 
addresses the use of stimulant active ingredients to relieve symptoms 
associated with a hangover.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)     09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug

[[Page 71364]]

Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF56
_______________________________________________________________________




298. 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 proposed rule would require owners or consignees to label 
imported food that is refused entry into the United States. The label 
would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would 
describe 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 Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, 
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________




299. 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)                   09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF68
_______________________________________________________________________




300. 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 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 
addresses the products used for urinary pain relief.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)        09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF70
_______________________________________________________________________




301. 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                            05/00/09

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, MPN4, Room 106, HFV-230, 7519 Standish 
Place, Rockville, MD 20855
Phone: 240 276-9207
Email: [email protected]

RIN: 0910-AG10

[[Page 71365]]

_______________________________________________________________________




302.  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 
to 360(a); 21 USC 371 to 371(a)

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                            09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG12
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




303. 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: These regulations are one component of the Secretary's 
initiative to reduce medical errors. The final rule would amend the 
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.

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                    07/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Carol Drew, 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 
6306, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440

RIN: 0910-AA97
_______________________________________________________________________




304. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

 Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of 
the Federal Register.

RIN: 0910-AC14
_______________________________________________________________________




305. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 21 
USC 379

Abstract: The Food and Drug Administration (FDA) published a proposed 
regulation on October 29, 2003 (68 FR 61640), that would amend its 
regulations on submission of bioequivalence (BE) data to require an 
abbreviated new drug application (ANDA) applicant to submit data from 
all BE studies the applicant conducts on a drug product formulation 
submitted for approval. In the past, ANDA applicants have submitted BE 
studies demonstrating that a generic product meets BE criteria for FDA 
to approve the ANDA but have not typically submitted additional BE 
studies conducted on the same drug product formulation. If finalized, 
this rule would require ANDA applicants to submit information, in 
either a complete or summary report, from all additional passing and 
nonpassing BE studies conducted on the same drug product formulation 
submitted for approval.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/29/03                    68 FR 61640
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Jennifer L. Stevens, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room 
6316, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC23
_______________________________________________________________________




306. 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

[[Page 71366]]

requirements and industry standards for medical gases, there have been 
repeated incidents in which cryogenic containers of harmful industrial 
gases have been connected to medical oxygen supply systems in hospitals 
and nursing homes, and subsequently administered to patients. These 
incidents have resulted in death and serious injury. There have also 
been several incidents involving high-pressure medical gas cylinders 
that have resulted in death and injuries to patients. These amendments, 
together with existing regulations, are intended to ensure that the 
types of incidents that have occurred in the past, as well as other 
types of foreseeable and potentially deadly medical gas mixups, 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                    06/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Quynh H. Nguyen, 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 6370, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC53
_______________________________________________________________________




307. 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                    03/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drugs Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, 
Room 6304, Silver Spring, MD 20993-0002
Phone: 301 796-3504
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC55
_______________________________________________________________________




308. 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).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/29/08                    73 FR 30831
NPRM Comment Period End         08/27/08
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Elena N. Cohen, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room 
6356, Silver Spring, MD 20993-0002
Phone: 301 796-3602
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AF11
_______________________________________________________________________




309. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

Legal Authority: 21 USC 379e(b)

Abstract: The Agency published a proposed rule on January 30, 2006, to 
require the label declaration of all foods and cosmetics containing the 
color additives cochineal extract and carmine in order to protect 
consumers with allergies to these additives. This proposal was issued 
in response to adverse event reports received by FDA and to a citizen 
petition submitted to FDA. The comment period ended on May 1, 2006. FDA 
intends to issue a final rule after reviewing comments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/06                     71 FR 4839
NPRM Comment Period End         05/01/06
Final Action                    11/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Mical E. Honigfort, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1278
Fax: 301 436-2972
Email: [email protected]

RIN: 0910-AF12
_______________________________________________________________________




310. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL 
CONTROLS FOR MALE CONDOMS MADE OF NATURAL RUBBER LATEX

Legal Authority: 21 USC 360c

Abstract: The classification regulation for condoms would be amended to 
specify a labeling guidance document as a special control for condoms 
made from natural rubber latex. The new special control guidance 
document would identify issues presented by these devices, and would 
provide detailed recommendations for labeling to address these issues. 
FDA believes that addressing the issues identified in the guidance, 
either by following the recommendations in the guidance or by some 
other means that provide equivalent assurances of safety and 
effectiveness, together with the general controls, will provide a 
reasonable assurance of the safety and effectiveness of these devices. 
These labeling recommendations are also consistent with the labeling 
requirements of 21 CFR part 801. The rule will demonstrate how the 
Agency is addressing the congressional directive of Public Law 106-554 
that FDA review condom labeling to assure that the information 
regarding the overall effectiveness or lack of

[[Page 71367]]

effectiveness of condoms in preventing sexually transmitted diseases is 
medically accurate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/14/05                    70 FR 69102
NPRM Comment Period End         02/13/06
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________




311. 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 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 
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 63679
Final Action (Amendment - 
Ephedrine Single Ingredient)    04/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF32
_______________________________________________________________________




312. 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 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 technical 
amendment revises a paragraph designation in the CFR. The other 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 Rule                      09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF33
_______________________________________________________________________




313. 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 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 
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)                          09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF34
_______________________________________________________________________




314. 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.

[[Page 71368]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (GRASE dosage 
forms)                          05/00/09
NPRM (Amendment)                09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF35
_______________________________________________________________________




315. 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 fifth 
document finalizes the document regarding the required warnings and 
other labeling. 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)      09/00/09
NPRM (Amendment) (Pediatric)     To Be                       Determined
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        09/00/09
NPRM (Amendment) (Miscellaneous 
Issues)                         09/00/09
Final Action (Required Warnings 
and Other Labeling)             03/00/09
Final Action (Internal 
Analgesics)                      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF36
_______________________________________________________________________




316. 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                    09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF37
_______________________________________________________________________




317. 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. The 
third action addresses astringent active ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     02/01/08                     73 FR 6014
Final Action (Fever Blisters/
Cold Sores)                      To Be                       Determined
Final Action (Aluminum Acetate) 
(Technical Amendment)           05/00/09
Final Action (Diaper Rash)      09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF42

[[Page 71369]]

_______________________________________________________________________




318. 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 and 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 help strengthen 
existing safeguards to 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. FDA is correcting 
the final rule on BSE that appeared in the Federal Register of April 
25, 2008 (73 FR 22719-22758). The final rule 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           11/00/08
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, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: [email protected]

RIN: 0910-AF46
_______________________________________________________________________




319. 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                    09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF51
_______________________________________________________________________




320. 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)                       09/00/09
Final Action (Overindulgence 
Labeling)                       09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF52
_______________________________________________________________________




321. 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 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 
addresses skin bleaching drug products containing hydroquinone.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51146
NPRM Comment Period End         12/27/06
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF53
_______________________________________________________________________




322. 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;

[[Page 71370]]

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                    05/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AG00
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




323. 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. The 
final rule (the CGMP rule) was published to establish the minimum CGMPs 
necessary to ensure that, if firms engage in activities related to 
manufacturing, packaging, labeling, or holding dietary supplements, 
they do so in a manner that will ensure the quality of the dietary 
supplements---i.e., to ensure that the dietary supplement consistently 
meets the established specifications for identity, purity, strength, 
and composition, and limits on contaminants, and has been manufactured, 
packaged, labeled, and held under conditions to prevent adulteration 
under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.
FDA also published an interim final rule (IFR) in the June 25, 2007 
Federal Register (72 FR 34959) that sets forth a procedure for 
requesting an exemption from the requirement in the final rule 
described above 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
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF39
_______________________________________________________________________




325. 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

[[Page 71371]]

drug application, may be legally marketed. This 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, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF40
_______________________________________________________________________




326. 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 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 
addresses products containing antidiarrheal drug ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF63
_______________________________________________________________________




327. 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 to 360a; 21 USC 371 to 371a

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Food Handlers)             To Be                       Determined
NPRM (Testing)                   To Be                       Determined
NPRM (Consumer)                  To Be                       Determined
Final Action (Healthcare)        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF69
_______________________________________________________________________




328. 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 to 360a; 21 USC 371 to 371a

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, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF95
_______________________________________________________________________




329. 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) provides that part 16 does not 
apply to a hearing on an order for relabeling, diversion, or 
destruction if 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,

[[Page 71372]]

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, 5100 
Paint Branch Parkway, ONLDS (HFS-820), College Park, MD 20740
Phone: 301 436-1802
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AG06
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




330. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUGS

Legal Authority: 21 USC 355b

Abstract: To require certain labeling of human drugs approved under 
section 505 of the Federal Food, Drug, and Cosmetic Act to include a 
toll-free number for reports of adverse events, and a statement that 
the number is to be used for reporting purposes only and not to receive 
medical advice.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/28/08                    73 FR 63886

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Carol Drew
Phone: 301 796-3601
Fax: 301 847-8440

RIN: 0910-AC35
_______________________________________________________________________




331. BIOLOGICAL PRODUCTS; REPORTING OF BIOLOGICAL PRODUCT DEVIATIONS IN 
MANUFACTURING (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374; 42 USC 
216; 42 USC 262 and 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

Abstract: Section 600.14 (21 CFR 600.14) requires licensed 
manufacturers of biological products to report to FDA biological 
product deviations in manufacturing. Section 606.170 requires licensed 
manufacturers of blood and blood components including Source Plasma, 
unlicensed registered establishments, and transfusion services to 
report to FDA biological product deviations in manufacturing. Under 
section 610 of the Regulatory Flexibility Act, FDA has undertaken a 
review of these regulations in parts 600 and 606 under section 610. The 
purpose of this review was to determine whether the regulations in 
parts 600 and 606 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 solicited comments on the following: 1) 
The continued need for the regulations; 2) the nature of complaints or 
comments received concerning the regulations; 3) the complexity of the 
regulations; 4) the extent to which a regulation in parts 600 or 606 
overlaps, duplicates, or conflicts with other Federal rules, and to the 
extent feasible, with State and local government rules; and 5) the 
degree to which technology, economic conditions, or other factors have 
changed in the area affected by the regulations.
FDA did not receive any comments during the review process of these 
regulations under section 610 review, therefore these regulations will 
continue without change.
The section 610 review has been carried out along with a regulations 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in great alignment with the President's priorities and 
the principles set forth in the Executive order.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/05/08
End Review                      11/03/08

Regulatory Flexibility Analysis Required: No

Agency Contact: Stephen M. Ripley
Phone: 301 827-6210

RIN: 0910-AG05

[[Page 71373]]

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




332. 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                            12/00/08

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
_______________________________________________________________________




333.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE 
PAYMENT SYSTEM FOR FY 2010 (CMS-1406-P)

 Regulatory Plan: This entry is Seq. No. 42 in part II of this issue of 
the Federal Register.

RIN: 0938-AP39
_______________________________________________________________________




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

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

RIN: 0938-AP40
_______________________________________________________________________




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

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

RIN: 0938-AP41
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




336. UPDATES TO ELECTRONIC TRANSACTIONS (VERSION 5010) (CMS-0009-F) 
(SECTION 610 REVIEW)

Legal Authority: sec 1171 to 1179 of the Social Security Act; Deficit 
Reduction Act of 2005, PL 109-171, sec 6035

Abstract: This rule adopt's new versions of the X12 suite of HIPAA 
Transactions and allows the industry to use the most up-to-date 
versions of the HIPAA transactions for claims and remittance advice. 
The rule will also adopt an updated pharmacy transactions standard for 
retail pharmacy claims.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/08                    73 FR 49741
NPRM Comment Period End         10/21/08
Final Action                    11/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of E-Health Standards and Services, Mailstop 
S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: [email protected]

RIN: 0938-AM50
_______________________________________________________________________




337. REVISIONS TO HIPAA CODE SETS (CMS-0013-F) (SECTION 610 REVIEW)

Legal Authority: PL 104-191

Abstract: This rule revise some of the adopted transaction and code set 
standards detailed in regulations published by HHS on August 17, 2000 
and February 20, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/08                    73 FR 49795
NPRM Comment Period End         10/21/08
Final Action                    11/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Denise Buenning, Health Insurance Specialist, Office of 
E-Health Standards and Services, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6711
Email: [email protected]

RIN: 0938-AN25
_______________________________________________________________________




338. 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                    11/00/08

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

[[Page 71374]]

_______________________________________________________________________




339. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 (CMS-1404-F)

Legal Authority: BBA; PPRA; BIPA; MMA; 42 USC 1302 et al

Abstract: This rule revises the Medicare hospital outpatient 
prospective payment system to implement applicable statutory 
requirements and changes arising from continuing experience with this 
system and to implement certain related provisions of the Medicare 
Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In 
addition, the rule describes proposed changes to the amounts and 
factors used to determine the payment rates for Medicare hospital 
outpatient services paid under the prospective payment system. The rule 
also changes to the Ambulatory Surgical Center Payment System list of 
services and rates. These changes would be applicable to services 
furnished on or after January 1 annually.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/18/08                    73 FR 41416
NPRM Comment Period End         09/02/08
Final Action                    11/00/08

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP17
_______________________________________________________________________




340. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE 
FOR CY 2009 (CMS-1555-N)

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

Abstract: Section 1895 of The Act requires that the Home Health PPS be 
adjusted in a prospective manner specified by the Secretary by the home 
health increase percentage applicable to the year involved.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/08

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP20
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




341. 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: Commander Mercedes Benitez-McCrary, Health Insurance 
Specialist, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-05-
14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________




342. 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
Interim Final Rule               To Be                       Determined

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

[[Page 71375]]

_______________________________________________________________________




343. SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT, 
PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-F) (SECTION 610 
REVIEW)

Legal Authority: sec 4312(a) of BBA of 1997

Abstract: This rule implements section 4312(a) of the Balanced Budget 
Act of 1997, which requires a Medicare supplier of durable medical 
equipment (DME) to furnish CMS with a surety bond.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/01/07                    72 FR 42001
NPRM Comment Period End         10/01/07
Final Action                    08/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Frank Whelan, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Mailstop C3-02-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1302
Email: [email protected]

RIN: 0938-AO84
_______________________________________________________________________




344. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CY 2009 (CMS-1403-FC)

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

Abstract: This major rule makes changes affecting Medicare Part B 
payment to physicians and other Part B suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/07/08                    73 FR 38502
NPRM Comment Period End         08/29/08
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP18
_______________________________________________________________________




345. CHANGES TO LONG TERM CARE PROSPECTIVE PAYMENT SYSTEM BASED ON 
SPECIFIC PROVISIONS IN THE MEDICARE, MEDICAID, AND SCHIP EXTENSION ACT 
OF 2007 (CMS-1493-F)

Legal Authority: Provisions of sec 114 of PL 110-173 (MMSE Act of 
2007); sec 1886 (d) of the Social Security Act as amended by sec 114 of 
PL 110-173 (MMSE Act of 2007)

Abstract: This rule implements provisions of the Medicare, Medicaid, 
and SCHIP Extension Act of 2007 relating to long-term care hospitals. 
In addition to amending section 1861 of the Act with a new definition 
of LTCHs, this rule includes provisions that are effective on the date 
of enactment (December 29, 2007). Specifically, the statute imposes a 
3-year delay in implementation of certain payment policies that set 
percentage thresholds for LTCH patients admitted from certain referring 
hospitals and raises the percentage threshold for those LTCHs 
unaffected by the 3-year delay. The legislation imposes the same 3-year 
delay on the implementation of a particular payment adjustment for 
short-stay patients and also for the possible application of a one-time 
adjustment to the standard Federal rate. The statute also required a 
change in the Federal rate for RY 2008, (effective April 1, 2008). 
Additionally, the statute created a 3-year moratorium on the 
establishment of new LTCHs and LTCH satellites and on bed expansion in 
existing LTCHs, subject to significant exceptions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/06/08                    73 FR 24871
Interim Final Rule              05/22/08                    73 FR 29699
Final Action                    05/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Tzvi Hefter, Director, Division of Acute Care & 
Ambulatory Policy Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop C4-08-06, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4487
Email: [email protected]

RIN: 0938-AP33
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




346. MEDICARE AND MEDICAID PROGRAMS; HOSPICE CARE CONDITIONS OF 
PARTICIPATION (CMS-3844-F) (COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 42 USC 1302; 42 USC 1395hh

Abstract: This final rule is a regulatory reform initiative that 
revises existing conditions of participation that hospices must meet to 
participate in the Medicare and Medicaid programs. The requirements 
focus on the actual care delivered to patients and patients' families 
by hospices and the results of that care, reflect an interdisciplinary 
view of patient care, and allow hospices greater flexibility in meeting 
quality standards. 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                            05/27/05                    70 FR 30840
Final Action                    06/05/08                    73 FR 32087

Regulatory Flexibility Analysis Required: No

Agency Contact: Mary Rossi-Coajou, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500

[[Page 71376]]

Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051
Email: [email protected]

Danielle Shearer, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Clinical 
Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AH27
_______________________________________________________________________




347. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE 
FOR RATE YEAR BEGINNING JULY 1, 2008 (RY 2009) (CMS-1401-N)

Legal Authority: PL 106-113, sec 124 BBRA

Abstract: This notice updates the Inpatient Psychiatric Facility 
Prospective Payment System for rate year (RY) 2009.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          05/07/08                    73 FR 25709

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Janet Samen
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AO92
_______________________________________________________________________




348. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2009: 
ANNUAL PAYMENT RATE UPDATES (CMS-1393-F)

Legal Authority: sec 123 PL 106-113; sec 307(b) PL 106-554; sec 114 of 
PL 110-173

Abstract: This major rule finalizes changes to the Medicare long-term 
care hospitals (LTCH) prospective payment system (PPS) and updates the 
payment rates for rate year (RY) 2009.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/09/08                    73 FR 26788

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Michele Hudson
Phone: 410 786-5490
Email: [email protected]

RIN: 0938-AO94
_______________________________________________________________________




349. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2009 (CMS-1534-F)

Legal Authority: Social Security Act, sec 1886(e)

Abstract: This major rule updates the payment rates used under the 
Skilled Nursing Facilities Prospective Payment System beginning October 
1, 2008.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/08                    73 FR 25918
Final Action                    08/08/08                    73 FR 46415

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Bill Ullman
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AP11
_______________________________________________________________________




350. HOSPICE WAGE INDEX FOR FY 2009 (CMS-1548-F)

Legal Authority: 42 USC 1814(i)(1) and 1814(i)(2)

Abstract: This rule updates the annual hospice wage index for FY 2009. 
The wage index is used to reflect local differences in wage levels.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/01/08                    73 FR 24000
Final Action                    08/08/08                    73 FR 46463

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Terri Deutsch
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AP14
[FR Doc. E8-21191 Filed 11-21-08; 8:45 am]
BILLING CODE 4150-24-S