[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 24678]]



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 
12866 require that inventories of rulemaking actions under development 
within the Department be made available to the public semiannually. The 
purpose of these requirements is to encourage public participation in 
the regulatory process by providing, at as early a stage as possible, 
summarized information about regulatory actions under consideration.

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

SUPPLEMENTARY INFORMATION: The capsulized information provided in the 
Agenda sets out information rulemaking activities in which the 
Department is currently engaged. We focus primarily on those areas of 
work expected to result in publication of Notices of Proposed 
Rulemaking or Final Rules within the next 12 months.

     Please note that the summaries included below relate only to 
those rulemakings that are likely to have significant economic 
impact on a substantial number of small entities; the Regulatory 
Flexibility Act requires publication of this information in the 
Federal Register. The complete Agenda is now accessible online at 
www.reginfo.gov, where rapid electronic access to information about 
the full range of HHS rulemakings is available.

     The Department welcomes the views of all concerned with regard 
to planned rulemakings. Comments may be directed to the agency 
officials cited in each of the summaries. If early attention at the 
Secretary's level appears needed, comments should be sent to: Ann 
C. Agnew, Executive Secretary to the Department, Room 603H, 200 
Independence Avenue SW., Washington, DC 20201.

Dated: March 27, 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
----------------------------------------------------------------------------------------------------------------
125         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
126         Control of Communicable Diseases, Interstate and Foreign Quarantine...................    0920-AA12
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
127         Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and        0910-AF99
            Pectin (Section 610 Review)...........................................................
128         Biological Products; Reporting of Biological Product Deviations in Manufacturing          0910-AG05
            (Section 610 Review)..................................................................
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
129         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.......    0910-AC52
130         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
131         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
132         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61

[[Page 24679]]

 
133         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
134         Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
135         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements...................................................
136         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
137         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
138         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
139         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
140         Charging for Investigational Drugs....................................................    0910-AF13
141         Expanded Access to Investigational Drugs for Treatment Use............................    0910-AF14
142         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
143         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
144         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
145         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
146         Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
147         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
148         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
149         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
150         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
151         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
152         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
153         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
154         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
155         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
156         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
157         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
158         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
159         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
160         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
161         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
162         Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
163         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
164         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
165         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
166         Health Claims.........................................................................    0910-AF09

[[Page 24680]]

 
167         Status of Certain Additional Over-the-Counter Drug Category II and III Active             0910-AF75
            Ingredients (Completion of a Section 610 Review)......................................
168         Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific    0910-AF76
            Reagents (Completion of a Section 610 Review).........................................
169         Natural Rubber-Containing Medical Device; User Labeling (Completion of a Section 610      0910-AF77
            Review)...............................................................................
170         Financial Disclosure by Clinical Investigators (Completion of a Section 610 Review)...    0910-AF79
171         Beverages: Bottled Water (Completion of a Section 610 Review).........................    0910-AF80
172         Food Labeling; Nutrient Content Claims: Definition for ``High Potency'' and Definition    0910-AF83
            of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and
            Conventional Foods (Completion of a Section 610 Review)...............................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
173         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
174         Revisions to HIPAA Code Sets (CMS-0013-P) (Section 610 Review)........................    0938-AN25
175         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610      0938-AO53
            Review)...............................................................................
176         Hospice Wage Index for FY 2009 (CMS-1548-P)...........................................    0938-AP14
177         Changes to the Hospital Inpatient Prospective Payment Systems and FY 2009 Rates (CMS-     0938-AP15
            1390-P)...............................................................................
178         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP17
            Center Payment System for CY 2009 (CMS-1404-P)........................................
179         Requirements for Long Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
180         Medicare and Medicaid Programs; Hospice Care Conditions of Participation (CMS-3844-F)     0938-AH27
            (Section 610 Review)..................................................................
181         Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year           0938-AO92
            Beginning July 1, 2008 (RY 2009) (CMS-1401-N).........................................
182         Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate      0938-AO94
            Updates (CMS-1393-F)..................................................................
183         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-IFC)................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
184         Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics,          0938-AO84
            Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Section 610 Review)....................
185         Establishing Additional Medicare Provider and Supplier Enrollment Safeguards (CMS-6045-   0938-AP01
            P) (Section 610 Review)...............................................................
----------------------------------------------------------------------------------------------------------------


[[Page 24681]]


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
186         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Completion of a      0938-AG82
            Section 610 Review)...................................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0930-AA10
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




126. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE

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. Quarantine regulations are 
divided into two parts: Part 71 dealing with foreign arrivals and part 
70 dealing with interstate matters. The Secretary has delegated the 
authority to prevent the introduction of diseases from foreign 
countries to the Director, CDC. CDC maintains quarantine stations at 20 
ports of entry staffed with medical and public health officers who 
respond to reports of diseases from carriers. According to the 
statutory scheme, the President determines through Executive order 
which diseases may subject individuals to quarantine. The current 
disease list, which was last updated in April 2005, includes cholera, 
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral 
hemorrhagic fevers, severe acute respiratory syndrome (SARS), and 
influenza caused by novel or reemergent influenza viruses that are 
causing, or have the potential to cause, a pandemic.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
Final Action                    11/00/08

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-AA12
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




127. FOOD LABELING; SERVING SIZES; REFERENCE AMOUNT FOR BAKING POWDER, 
BAKING SODA, AND PECTIN (SECTION 610 REVIEW)

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition 
labeling regulations for the reference amount customarily consumed per 
eating occasion for the food category ``Baking powder, baking soda, 
pectin.'' Section 101.12 (21 CFR part 101.12) includes 1/8 teaspoon 
(tsp) as an additional allowable household measure. FDA is undertaking 
a review of sections 101.9 and 101.12 under section 610 of the

[[Page 24682]]

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

RIN: 0910-AF99
_______________________________________________________________________




128. [bull] BIOLOGICAL PRODUCTS; REPORTING OF BIOLOGICAL PRODUCT 
DEVIATIONS IN MANUFACTURING (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 ; 21 USC 352; 21 
USC 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; 42 USC 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 is initiating a 
review of these regulations in parts 600 and 606 under section 610. The 
purpose of this review is 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 will consider and is soliciting 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/00/08
End Review                      04/00/09

Regulatory Flexibility Analysis Required: No

Agency Contact: Stephen M. Ripley, Team Leader, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), 
Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AG05
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




129. 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                            10/00/08

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: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC52

[[Page 24683]]

_______________________________________________________________________




130. 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 
part 201.56, 201.57, and 201.80).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Christine F. Rogers, 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 6316, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AF11
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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)     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-AF56
_______________________________________________________________________




132. 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; 21 USC 
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                            07/00/08

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
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 last action addresses healthcare antiseptic 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Food Handlers)            12/00/08
NPRM (Testing)                   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

[[Page 24684]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




134. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 
USC 263; 42 USC 263a to 263-n; 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                    04/00/09

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
_______________________________________________________________________




135. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 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                    06/00/08

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: 301 436-1209
Fax: 301 436-2964
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




136. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

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

Abstract: Publication of this final rule is an action item in the Food 
Protection Plan announced by the Department of Health and Human 
Services (HHS) in November 2007.
In July 1999, the Food and Drug Administration (FDA) and the Food 
Safety Inspection Service (FSIS) committed to developing an action plan 
to address the presence of Salmonella Enteritidis (SE) in shell eggs 
and egg products using a farm-to-table approach. FDA and FSIS held a 
public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010. The Egg Safety Action Plan consists of eight 
objectives covering all stages of the farm-to-table continuum as well 
as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 
(Sacramento, CA), and July 31, 2000 (Washington, DC), joint public 
meetings were held by FDA and FSIS to solicit and discuss information 
related to the implementation of the objectives in the Egg Safety 
Action Plan.
On September 22, 2004, FDA published a proposed rule that would require 
egg safety measures to prevent the contamination of shell eggs with SE 
during egg production. The proposal also solicited comment on whether 
recordkeeping requirements should include a written SE prevention plan 
and records for compliance with the SE prevention measures, and whether 
safe egg handling and preparation practices should be mandated for 
retail establishments that specifically serve a highly susceptible 
population (e.g., nursing homes, hospitals, day care

[[Page 24685]]

centers). The proposed egg production SE prevention measures included: 
(1) Provisions for procurement of chicks and pullets; (2) a biosecurity 
program; (3) a rodent and pest control program; (4) cleaning and 
disinfection of poultry houses that have had an environmental or egg 
test positive for SE; (5) egg testing when an environmental test is 
positive; and (6) refrigerated storage of eggs held at the farm. 
Additionally, to verify that the measures have been effective, the rule 
proposes that producers test the poultry house environment for SE. If 
the environmental test is positive, eggs from that environment must be 
tested for SE, and if the egg test is positive, the eggs must be 
diverted to egg products processing or a treatment process that 
achieves at least a five-log destruction of SE.
The proposed rule was a step in a broader farm-to-table egg safety 
effort that includes FDA's requirements for safe handling statements on 
egg cartons, and refrigerated storage of shell eggs at retail, and egg 
safety education for consumers and retail establishments. The rule had 
a 90-day comment period, which ended December 21, 2004. To discuss the 
proposed rule and solicit comments from interested stakeholders, FDA 
held three public meetings: October 28, 2004, in College Park, MD; 
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los 
Angeles, CA. The comment period was reopened until July 25, 2005, to 
solicit further comment and information on industry practices and 
programs that prevent SE-monitored chicks from becoming infected by SE 
during the period of pullet rearing until placement into laying hen 
houses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/04                    69 FR 56824
NPRM Comment Period End         12/21/04
NPRM Reopened Comment Period End06/09/05                    70 FR 24490
NPRM Extension of Reopened 
Comment Period End              07/25/05                    70 FR 33404
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AC14
_______________________________________________________________________




137. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/22/04                    69 FR 21778
NPRM Comment Period End         07/21/04
Interim Final Rule              01/03/08                      73 FR 402
Final Action                    12/00/08

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-AC35
_______________________________________________________________________




138. 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 proposed 
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                    08/00/08

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: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC55
_______________________________________________________________________




139. 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                    05/00/08

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

[[Page 24686]]

_______________________________________________________________________




140. CHARGING FOR INVESTIGATIONAL DRUGS

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371; 42 USC 262

Abstract: On December 14, 2006, (71 FR 75168), FDA published a proposed 
rule to amend FDA's investigational new drug regulation concerning 
charging for investigational drugs. The rule will clarify the 
circumstances in which charging for an investigational drug in a 
clinical trial is appropriate, set forth criteria for charging for an 
investigational drug for the different types of treatment uses 
described in the Agency's rule on expanded access to investigational 
drugs for treatment use, and clarify what costs can be recovered for an 
investigational drug. The rule is intended to permit charging for a 
broader range of investigational uses than is explicitly permitted in 
current regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/06                    71 FR 75168
NPRM Comment Period End         03/14/07
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Christine F. Rogers, 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 6316, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AF13
_______________________________________________________________________




141. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262

Abstract: The Food and Drug Administration proposed in the Federal 
Register of December 14, 2006 (75 FR 75147), to amend the regulations 
governing investigational new drugs (IND) to describe the ways patients 
may obtain investigational drugs for treatment use under expanded 
access programs. Such use of investigational drugs would be available 
to: (1) Individual patients, including in emergencies; (2) intermediate 
size patient populations; and (3) larger populations under a treatment 
protocol or treatment IND.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/06                    71 FR 75147
NPRM Comment Period End         03/14/07
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Christine F. Rogers, 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 6316, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AF14
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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)    01/00/09

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
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 Action                    03/00/09

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
_______________________________________________________________________




144. 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

[[Page 24687]]

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)      04/00/09
NPRM (Amendment) (Pediatric)     To Be                       Determined
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        04/00/09
NPRM (Amendment) (Miscellaneous 
Issues)                         05/00/09
Final Action (Required Warnings 
and Other Labeling)             03/00/09
Final Action (Internal 
Analgesics)                     03/00/09

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-AF36
_______________________________________________________________________




145. 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                    03/00/09

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
_______________________________________________________________________




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

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

Abstract: On October 6, 2005, the Food and Drug Administration (FDA) 
proposed to amend its regulations to prohibit the use of certain cattle 
origin materials in the food or feed of all animals to 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.

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           06/00/08
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
_______________________________________________________________________




147. 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                    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

[[Page 24688]]

Email: [email protected]

RIN: 0910-AF51
_______________________________________________________________________




148. 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)                       04/00/09
Final Action (Overindulgence 
Labeling)                       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-AF52
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




149. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 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                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Christine F. Rogers, 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 6304, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440

RIN: 0910-AC23
_______________________________________________________________________




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

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

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           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-AF31
_______________________________________________________________________




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

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

[[Page 24689]]

NPRM (Phenylpropano lamine)     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 (Phenylpropano 
lamine)                          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-AF34
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                05/00/09
Final Action (GRASE dosage 
forms)                          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-AF35
_______________________________________________________________________




153. 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; 21 USC 360a; 21 USC 371; 21 USC 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. One action will 
address laxative drug products. The other action will address 
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)     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-AF38
_______________________________________________________________________




154. 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
_______________________________________________________________________




155. 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; 21 USC 360a; 21 USC 371; 21 USC 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 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

[[Page 24690]]

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
_______________________________________________________________________




156. 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 (Diaper Rash)      05/00/09
Final Action (Aluminum Acetate) 
(Technical Amendment)           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-AF42
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 
document addresses combination products containing sunscreen and insect 
repellent ingredients. The second document addresses active ingredients 
reviewed under Time and Extent Applications. The third document is the 
final action that addresses sunscreen formulation, labeling, and 
testing requirements for both ultraviolet B and ultraviolet A radiation 
protection.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
NPRM (UVA/UVB)                  08/27/07                    72 FR 49070
NPRM Comment Period End         11/26/07
NPRM (Time and Extent)          05/00/09
Final Action (UVA/UVB)          05/00/09
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
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 360a; 21 USC 360gg to 360ss; 21 USC 
371; 21 USC 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)                       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-AF44
_______________________________________________________________________




159. 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.

[[Page 24691]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenylpropano lamine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               05/00/09
Final Action (Phenylpropano 
lamine)                          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-AF45
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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                    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-AF53
_______________________________________________________________________




161. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

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




162. 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)                   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-AF68
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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)        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-AF70
_______________________________________________________________________




164. [bull] 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; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343;

[[Page 24692]]

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

RIN: 0910-AG06
_______________________________________________________________________




165. [bull] 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
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




166. HEALTH CLAIMS

Legal Authority: 21 USC 343; 21 USC 371

Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance 
notice of proposed rulemaking (ANPRM) to request comments on 
alternatives for regulating qualified health claims in the labeling of 
conventional human foods and dietary supplements. FDA also solicited 
comments on various other issues related to health claims and on the 
appropriateness and nature of dietary guidance statements on 
conventional food and dietary supplement labels. This ANPRM was 
published in the July 11, 2003 (68 FR 41387), notice that announced the 
availability of the final report of the FDA Task Force on the Consumer 
Health Information for Better Nutrition Initiative.
Comments on the regulatory alternatives and additional topics 
identified in the ANPRM will inform FDA decisions about regulation of 
qualified health claims.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/03/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Julie Moss
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

RIN: 0910-AF09
_______________________________________________________________________




167. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND 
III ACTIVE INGREDIENTS (COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 5 USC 610

[[Page 24693]]

Abstract: Section 310.545 (21 CFR part 310.545) codifies a final rule 
that was issued stating certain first aid antiseptic, vaginal 
contraceptive, and antimicrobial diaper rash ingredients in over-the-
counter (OTC) drug products are not generally recognized as safe and 
effective and are misbranded. This rule took into consideration the 
reports and recommendations of various OTC drug advisory review panels 
and public comment on proposed Agency regulations. Based on the absence 
of substantive comments in opposition to the Agency's proposed 
nonmonograph status for various ingredients, as well as the failure of 
interested parties to submit new data or information to FDA, the Agency 
determined that the presence of the subject ingredients in an OTC drug 
product would result in that product not being generally recognized as 
safe and effective and would result in misbranding.
FDA initiated a review under section 610 of the Regulatory Flexibility 
Act for the regulation in section 310.545. The purpose of this review 
was to determine whether the regulation in section 310.545 should be 
continued without change, or whether it should be further amended or 
rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA considered, and solicited comments on the following: (1) 
The continued need for the regulation in section 310.545; (2) the 
nature of the complaints or comments received concerning the regulation 
in section 310.545; (3) the complexity of the regulations in section 
310.545; (4) the extent to which the regulation in section 310.545 
overlaps, duplicates, or conflicts with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed for the products still 
subject to the regulation in section 310.545.
The section 610 review was carried out along with a regulatory review 
under section 5 of Executive Order 12866, which calls for agencies to 
periodically review existing regulations to determine whether any 
should be modified or eliminated so as to make the Agency's regulatory 
program more effective in achieving its goals, less burdensome, or in 
greater alignment with the President's priorities and the principles 
set forth in the Executive order. This review concluded with a FDA 
determination that there is a continual need for this regulation in 
310.545, because this section lists ingredients that have not been 
shown to be safe and effective in OTC drug products for various uses. 
FDA uses this section in evaluating possible regulatory action.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/31/07

Regulatory Flexibility Analysis Required: No

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-AF75
_______________________________________________________________________




168. MEDICAL DEVICES: CLASSIFICATION/RECLASSIFICATION; RESTRICTED 
DEVICES; ANALYTE SPECIFIC REAGENTS (COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j

Abstract: FDA has undertaking a review of 21 CFR sections 809.10 and 
809.30 under section 610 of the Regulatory Flexibility Act. The purpose 
of the review was to determine whether the regulations in sections 
809.10 and 809.30 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 substantial 
numbers of small entities. FDA has solicited comments on, the following 
(1) The continued need for the regulation in part 809; (2) the nature 
of complaints or comments received concerning the regulation in 
sections 809.10 and 809.30; (3) the complexity of the regulation in 
sections 809.10 and 809.30; (4) the extent to which the regulation in 
sections 809.10 and 809.30 overlaps, duplicates, or conflicts with 
other Federal, State, or governmental rules: and (5) the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the regulation in sections 809.10 and 809.30.
The section 610 review has been carried out along with a regulation 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order. The agency did not 
receive any comments during the review process of sections 809.10 and 
809.30 under section 610 review. FDA's review of these regulations 
concluded that they should be continued without change.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/01/07
End Review                      11/30/07

Regulatory Flexibility Analysis Required: No

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-AF76
_______________________________________________________________________




169. NATURAL RUBBER-CONTAINING MEDICAL DEVICE; USER LABELING (COMPLETION 
OF A SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

Abstract: FDA has under taken a review of 21 CFR part 801 under section 
610 of the Regulatory Flexibility Act. The purpose of the review was to 
determine whether the regulations in part 801 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 has

[[Page 24694]]

solicited comments on the following (1) The continued need for the 
regulation in part 801; (2) the nature of complaints or comments 
received concerning the regulation in part 801; (3) the complexity of 
the regulation in part 801; (4) the extent to which the regulation in 
part 801 overlap, duplicates, or conflict with other Federal, State, or 
governmental rules: and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulation in part 801.
The section 610 review has been carried out along with a regulation 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive Order. The agency did not 
receive any comments during the review process of part 801 under 
section 610 review. FDA's review of this regulation concluded that it 
should be continued without change.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/30/97                    62 FR 51021
Begin Review of Current 
Regulation                      01/02/07
End Review of Current Regulation12/28/07

Regulatory Flexibility Analysis Required: No

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-AF77
_______________________________________________________________________




170. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (COMPLETION OF A 
SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360j; 21 USC 371; 21 USC 
372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 21 USC 379; 42 USC 
262

Abstract: FDA has reviewed 21 CFR part 54, under section 610 of the 
Regulatory Flexibility Act. FDA received no comments during the review 
period mandated by section 610 of the Regulatory Flexibility Act. The 
purpose of this review was to determine whether the regulations in part 
54 should be continued without change, or whether they should be 
amended or rescinded, consistent with the stated objectives of 
applicable statues, to minimize adverse impacts on a substantial number 
of small entities. FDA considered and solicited comments on the 
following: (1) The continued need for the regulations in part 54; (2) 
the nature of complaints or comments received concerning the 
regulations in part 54; (3) the complexity of the regulations in part 
54, (4) the extent to which the regulations in part 54 overlap, 
duplicate, or conflict with other Federal, State, or governmental 
rules; and (5) the degree to which technology, economic conditions, or 
other factors have changed for those affected by the regulations in 
part 54.
The section 610 review has been carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order. FDA did not receive 
any comments during the review period mandated by section 610 of the 
Regulatory Flexibility Act. Therefore, no changes will be made to 21 
CFR part 54.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/31/07

Regulatory Flexibility Analysis Required: No

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

Stephen M. Ripley, Team Leader, Department of Health and Human 
Services, Food and Drug Administration, Center for Biologics Evaluation 
and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 
20852-1448
Phone: 301 827-6210

Myrna Hanna, Center for Devices and Radiological Health (HFZ-215), 
Department of Health and Human Services, Food and Drug Administration, 
1350 Piccard Drive, P150 RM 150F, Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF79
_______________________________________________________________________




171. BEVERAGES: BOTTLED WATER (COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 
USC 348; 21 USC 349; 21 USC 371; 21 USC 379e

Abstract: Section 165.110 (21 CFR part 165.110) describes requirements 
for identity and quality standards for bottled water. FDA is 
undertaking a review of section 165.110 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is to determine 
whether the regulations in section 165.110 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 the following: (1) The continued need for the 
regulations in section 165.110; (2) the nature of complaints or 
comments received concerning the regulations in section 165.110; (3) 
the complexity of the regulations; (4) the extent to which the 
regulations in section 165.110 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 section 165.110. FDA

[[Page 24695]]

received two comments on these issues and is considering them.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    03/01/07
End Review                      12/31/07

Regulatory Flexibility Analysis Required: No

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

RIN: 0910-AF80
_______________________________________________________________________




172. FOOD LABELING; NUTRIENT CONTENT CLAIMS: DEFINITION FOR ``HIGH 
POTENCY'' AND DEFINITION OF ``ANTIOXIDANT'' FOR USE IN NUTRIENT CONTENT 
CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS (COMPLETION OF A 
SECTION 610 REVIEW)

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

Abstract: Section 101.54 (21 CFR part 101.54) describes the 
requirements for when the terms ``high potency'' and ``antioxidant'' 
may be used on the label or in the labeling of foods, including dietary 
supplements. Section 101.60 (21 CFR part 101.60) describes the 
requirements for when the terms ``low calorie'' or ``reduced calorie'' 
may be used on the label or in the labeling of such foods. FDA 
undertook a review of sections 101.54 and 101.60 under section 610 of 
the Regulatory Flexibility Act. The purpose of this review was to 
determine whether the regulations 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 
solicited comments on the following: (1) The continued need for the 
regulations in sections 101.54 and 101.60; (2) the nature of complaints 
or comments received concerning the regulations; (3) the complexity of 
the regulations; (4) the extent to which the regulations in sections 
101.54 and 101.60 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 101.54 and 101.60. No comments were received. FDA's review of 
these regulations concluded that they should be continued without 
change.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/01/06
End Review                      11/30/07

Regulatory Flexibility Analysis Required: No

Agency Contact: David Zorn, Lead Economist, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, ORP (HFS-020), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-1825
Fax: 301 436-2505
Email: [email protected]

RIN: 0910-AF83
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




173. 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                     09/00/08

Regulatory Flexibility Analysis Required: No

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]

Lynn M. Riley, Clinical Standards Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1286
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________




174. REVISIONS TO HIPAA CODE SETS (CMS-0013-P) (SECTION 610 REVIEW)

Legal Authority: PL 104-191

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

[[Page 24696]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/08

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
_______________________________________________________________________




175. 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                    09/00/08

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
_______________________________________________________________________




176. HOSPICE WAGE INDEX FOR FY 2009 (CMS-1548-P)

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

Abstract: This rule proposes the annual update to the hospice wage 
index for FY 2009. The wage index is used to reflect local differences 
in wage levels. The hospice wage index methodology and values are based 
on recommendations of a negotiated rulemaking advisory committee and 
were originally published on August 8, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Terri Deutsch, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mailstop 
C5-08-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AP14
_______________________________________________________________________




177. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND 
FY 2009 RATES (CMS-1390-P)

Legal Authority: sec 1886(b) of the Social Security Act

Abstract: This major rule proposes to revise the Medicare hospital 
Inpatient Prospective Payment Systems (IPPS) for operating and capital-
related costs to implement changes arising from our continuing 
experience with these systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Michele Hudson, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5490
Email: [email protected]

RIN: 0938-AP15
_______________________________________________________________________




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

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

Abstract: This rule would revise 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 proposed rule describes proposed changes to the amounts 
and factors used to determine the payment rates for Medicare hospital 
outpatient services paid under the prospective payment system. The rule 
also proposes changes to the Ambulatory Surgical Center Payment System 
list of services and rates. These changes would be applicable to 
services furnished on or after January 1 annually.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/08

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
_______________________________________________________________________




179. [bull] 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                            08/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Adriene Brooks, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare &

[[Page 24697]]

Medicaid Services, Mailstop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4561
Email: [email protected]

RIN: 0938-AP32
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




180. MEDICARE AND MEDICAID PROGRAMS; HOSPICE CARE CONDITIONS OF 
PARTICIPATION (CMS-3844-F) (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                    05/00/08

Regulatory Flexibility Analysis Required: Yes

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 
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
_______________________________________________________________________




181. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Janet Samen, Director, Division of Chronic Care 
Management, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mailstop C5-05-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AO92
_______________________________________________________________________




182. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/29/08                     73 FR 5342
NPRM Comment Period End         03/24/08
Final Action                    05/00/08

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Michele Hudson, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C4-16-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5490
Email: [email protected]

RIN: 0938-AO94
_______________________________________________________________________




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

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 the 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 (12/29/07). 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 4/1/08). 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              05/00/08

[[Page 24698]]

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)         Long-Term Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




184. 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
_______________________________________________________________________




185. ESTABLISHING ADDITIONAL MEDICARE PROVIDER AND SUPPLIER ENROLLMENT 
SAFEGUARDS (CMS-6045-P) (SECTION 610 REVIEW)

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

Abstract: This proposed rule would expand existing provider and 
supplier enrollment requirements to obtain or maintain Medicare billing 
privileges.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: August Nemec, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop C3-07-08, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0612
Email: [email protected]

RIN: 0938-AP01
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




186. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-F) 
(COMPLETION OF A SECTION 610 REVIEW)

Legal Authority: 42 USC 1395rr et al

Abstract: This final rule revises the requirements that end stage renal 
disease (ESRD) facilities must meet to be certified under the Medicare 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6184
Notice                          02/04/08                     73 FR 6451
Final Action                    04/15/08                    73 FR 20369

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Lynn M Riley, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1286
Email: [email protected]

Lauren Oviatt, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Office of 
Clinical Standards and Quality, Mailstop S3-23-27, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4683
Email: [email protected]

RIN: 0938-AG82
[FR Doc. E8-7537 Filed 05-02-08; 8:45 am]
BILLING CODE 4150-24-S