[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Unknown Section]
[Pages 21919-21941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10274]


[[Page 21919]]

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Part VI





Department of Health and Human Services





-----------------------------------------------------------------------



Semiannual Regulatory Agenda

[[Page 21920]]



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, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulations agenda.

_______________________________________________________________________

SUMMARY:  The Department's semiannual Agenda of Regulatory and 
Deregulatory Actions forecasts the rulemaking activities that we expect 
to undertake over the foreseeable future. We focus primarily on those 
areas of work anticipated to result in publication of Notices of 
Proposed Rulemaking or of Final Rules within the next 12 months. 
(Please note that the abstracts included below relate only to those 
prospective rulemakings that are likely to have a significant economic 
impact on a substantial number of small entities; the Regulatory 
Flexibility Act of 1980 requires dissemination of this information in 
the paper edition of the Federal Register. The complete HHS Agenda is 
accessible online at www.reginfo.gov.)

FOR FURTHER INFORMATION CONTACT: by e-mail, [email protected]; by 
fax, (202) 205-2135; by telephone, (202) 205-9165.

SUPPLEMENTARY INFORMATION: 

    The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require semi-annual publication of an inventory outlining all 
current and projected rulemakings. The purpose of this exercise is 
to inform the public about regulatory actions under development 
across the Department, and to provide an opportunity for all 
concerned with the impact of these actions to participate in their 
development at an early stage.

    The regulatory actions capsulized in this Agenda do not 
necessarily reflect the policy perspectives of the Obama 
Administration. The statutorily dictated timing of the Agenda 
caused the Department to initiate preparation of the requisite 
information before the Department's policy officials had the 
opportunity to conduct a full review. This Agenda thus reflects 
ongoing efforts by HHS to comply with existing statutory 
obligations, or to effect improvements at the program-
implementation level based on experience in administering existing 
programs. By contrast, the timing of the October 2009 Agenda will, 
obviously, provide the Department with an opportunity to set out a 
regulatory agenda that does reflect current policy directions of 
the Obama Administration.

    Public commentary is invited. Comments may be directed to the 
agency officials cited at the conclusion of each entry. If early 
attention at the Secretary's level appears needed, comments should 
be sent to: Ashley Files Flory, Acting Executive Secretary to the 
Department, Suite 603H, 200 Independence Avenue SW., Washington, DC 
20201.

Dated: April 3, 2009.

 Ashley Files Flory,

Acting Executive Secretary to the Department.

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


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


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


[[Page 21921]]


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


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


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
154         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
155         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
156         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.......    0910-AC52
157         Over-The-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
158         Over-The-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
159         Over-The-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
160         Over-The-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
161         Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug         0910-AG12
            Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph........
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
162         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
163         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
164         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
165         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
166         Over-The-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
167         Over-The-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
168         Over-The-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
169         Over-The-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
170         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
171         Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
172         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
173         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
174         Over-The-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
----------------------------------------------------------------------------------------------------------------


[[Page 21922]]


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
175         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
176         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
177         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
178         Over-The-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
179         Over-The-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
180         Over-The-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
181         Over-The-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
182         Over-The-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
183         Over-The-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
184         Over-The-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
185         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
186         Over-The-Counter Antidiarrheal Drug Products..........................................    0910-AF63
187         Over-The-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
188         Over-The-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
189         Over-The-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
190         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
191         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
192         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
193         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
194         Obstetrical and Gynecological Devices; Designation of Special Controls for Male           0910-AF21
            Condoms Made of Natural Rubber Latex..................................................
195         Food Labeling; Serving Sizes and Nutrition Labeling (Completion of a Section 610          0910-AF99
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
196         Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY    0938-AP39
            2010 (CMS-1406-P).....................................................................
197         Revisions to Payment Policies Under the Physician Fee Schedule For CY 2010 (CMS-1413-     0938-AP40
            P)....................................................................................
198         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP41
            Center Payment System for CY 2010 (CMS-1414-P)........................................
199         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AP46
            Update for FY 2010 (CMS-1410-P).......................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
200         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
201         Electronic Claims Attachments Standards (CMS-0050-IFC)................................    0938-AK62
202         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610      0938-AO53
            Review)...............................................................................
203         Medicaid Graduate Medical Education (CMS-2279-F)......................................    0938-AO95
204         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 21923]]


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
205         Updates to Electronic Transactions (Version 5010) (CMS-0009-F) (Completion of a           0938-AM50
            Section 610 Review)...................................................................
206         Revisions to HIPAA Code Sets (CMS-0013-F) (Completion of a Section 610 Review)........    0938-AN25
207         Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics,          0938-AO84
            Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Completion of a Section 610 Review)....
208         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP17
            Center Payment System for CY 2009 (CMS-1404-F)........................................
209         Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (CMS-1403-     0938-AP18
            FC)...................................................................................
210         Home Health Prospective Payment System Refinements and Rate Update for CY 2009 (CMS-      0938-AP20
            1555-N)...............................................................................
211         Changes to Long-Term Care Prospective Payment System Based on Specific Provisions in      0938-AP33
            the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-F)..................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

Regulatory Flexibility Analysis Required: No

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

RIN: 0930-AA14
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0930-AA10
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________



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

Legal Authority: Not Yet Determined

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

[[Page 21924]]

countries to the Director, Centers for Disease Control and Prevention 
(CDC). CDC also enforces entry requirements for certain animals, 
etiologic agents and vectors deemed to be of public health 
significance. Currently the regulations restrict the importation of 
nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts 
and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54). 
In addition, CDC has recently issued a series of emergency orders, 
restricting the importation of African rodents (42 CFR section 71.56) 
and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed 
Rulemaking (NPRM) to revise the regulations for importation of certain 
animals and vectors into the Unite States (42 CFR parts 71, Subpart F).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/31/07                    72 FR 41676
Notice Extending ANPRM Comment 
Period                          10/01/07                    72 FR 55729
NPRM                            12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA14
_______________________________________________________________________



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

Legal Authority: 42 U.S.C. 264

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA23
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________



151. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA12
_______________________________________________________________________



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

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

[[Page 21925]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA27
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________



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

Legal Authority: PL 107-188

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

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

RIN: 0920-AA32
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________



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

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

Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements 
for the labeling of the cartons of shell eggs that have not been 
treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 
115.50) describes requirements for refrigeration of shell eggs held for 
retail distribution. Section 16.5(a)(4) provides that part 16 does not 
apply to a hearing on an order for relabeling, diversion, or 
destruction if shell eggs under section 361 of the Public Health 
Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. FDA 
amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the 
safe handling statement to appear on the inside lid of egg cartons to 
provide the industry greater flexibility in the placement of the 
statement. FDA is undertaking a review of 21 CFR sections 101.17(h), 
115.50,

[[Page 21926]]

and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The 
purpose of this review is to determine whether the regulations in 
sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without 
change, or whether they should be amended or rescinded, consistent with 
the stated objectives of applicable statutes, to minimize any 
significant economic impact on a substantial number of small entities. 
FDA will consider, and is soliciting comments on, the following: (1) 
The continued need for the rule; (2) the nature of complaints or 
comments received concerning the rule from the public; (3) the 
complexity of the rule; (4) the extent to which the rule overlaps, 
duplicates, or conflicts with other Federal rules, and, to the extent 
feasible, with State and local governmental rules; and (5) the length 
of time since the rule has been evaluated or the degree to which 
technology, economic conditions, or other factors have changed in the 
area affected by the rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

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

RIN: 0910-AG06
_______________________________________________________________________



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

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

Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in 21 CFR part 203 and 
21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) 
should be continued without change, or whether they should be amended 
or rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on, the 
following: (1) The continued need for the regulations in 21 CFR part 
203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 
67763); (2) the nature of complaints or comments received from the 
public concerning the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) 
the complexity of the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) 
the extent to which the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) 
overlap, duplicate, or conflict with other Federal rules, and to the 
extent feasible, with State and local governmental rules; and (5) the 
degree to which technology, economic conditions, or other factors have 
changed in the area affected by the regulations in 21 CFR part 203 and 
21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AG14
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

Regulatory Flexibility Analysis Required: Yes

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

[[Page 21927]]

Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Reopening of Administrative 
Record                          08/25/00                    65 FR 51780
NPRM (Amendment) (Common Cold)  04/00/10

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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
Final Action (Laxative Drug 
Products)                        To Be                       Determined
NPRM (Professional Labeling--
Sodium Phosphate)               09/00/09
NPRM (Professional Labeling)     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF38
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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



160. 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 actions 
address the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenylpropanol amine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               09/00/09
Final Action (Phenylpropanol 
amine)                          05/00/10
Final Action (Benzocaine)        To Be                       Determined

[[Page 21928]]

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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AG12
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________



162. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

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

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

[[Page 21929]]

NPRM Extension of Reopened 
Comment Period End              07/25/05                    70 FR 33404
Final Action                    07/00/09

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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/10/06                    71 FR 18039
NPRM Comment Period End         07/10/06
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, 
Room 6370, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC53
_______________________________________________________________________



164. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

Legal Authority: PL 105-115, sec 121

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/20/05                    70 FR 55038
NPRM Comment Period End         12/19/05
Final Action                    08/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AC55
_______________________________________________________________________



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

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

Abstract: To amend the regulations governing the format and content of 
labeling for human prescription drugs and biological products (21 CFR 
parts 201.56, 201.57, and 201.80).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/29/08                    73 FR 30831
NPRM Comment Period End         08/27/08
Final Action                    03/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation Research, 10903 New Hampshire Ave., Bldg. 51, Room 
6224, Silver Spring, MD 20993-0002
Phone: 301 796-4288
Fax: 301-847-8440
Email: [email protected]

RIN: 0910-AF11
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment--Ephedrine 
Single Ingredient)              07/13/05                    70 FR 40237
Final Action (Technical 
Amendment)                      11/30/07                    72 FR 63679
Final Action (Amendment--
Ephedrine Single Ingredient)    09/00/09

Regulatory Flexibility Analysis Required: Yes

[[Page 21930]]

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
_______________________________________________________________________



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

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

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The technical 
amendment revises a paragraph designation in the CFR. The other action 
finalizes cough/cold combination products containing oral 
bronchodilators and expectorants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF33
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (GRASE dosage 
forms)                          12/00/09
NPRM (Amendment)                 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-AF35
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    12/26/06                    71 FR 77314
NPRM Comment Period End         05/25/07
NPRM (Amendment) 
(Overindulgence/ Hangover)      05/00/10
NPRM (Amendment) (Pediatric)     To Be                       Determined
NPRM (Amendment) (Combinations 
With Sodium Bicarbonate)        05/00/10
NPRM (Amendment) (Miscellaneous 
Issues)                         05/00/10
Final Action (Required Warnings 
and Other Labeling)             05/00/09
Final Action (Internal 
Analgesics)                      To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF36
_______________________________________________________________________



170. 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

[[Page 21931]]

skin protectant products used to treat fever blisters and cold sores. 
The second action addresses astringent active ingredients. The third 
action identifies safe and effective skin protectant active ingredients 
to treat and prevent diaper rash.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     02/01/08                     73 FR 6014
Final Action (Fever Blisters/
Cold Sores)                      To Be                       Determined
Final Action (Aluminum Acetate) 
(Technical Amendment)           03/06/09                     74 FR 9759
Final Action (Diaper Rash)      12/00/09

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
_______________________________________________________________________



171. 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. FDA is correcting 
the final rule on BSE that appeared in the Federal Register of April 
25, 2008 (73 FR 22719-22758). The final rule inadvertently published 
with incorrect dollar amounts in two separate areas: the summary of 
economic impacts and the paperwork burden table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF46
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Amber McCoig, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition,

[[Page 21932]]

(HFS-316), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2644
Email: [email protected]

RIN: 0910-AF47
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kevin O. Kwon, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition, (HFS-024), Room 1B-032, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2780
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AG00
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________



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

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

Abstract: These regulations are one component of the Secretary's 
initiative to reduce medical errors. The final rule would amend the 
expedited and periodic safety reporting regulations for human drugs and 
biological products to revise certain definitions and reporting formats 
as recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and to propose other revisions 
to these regulations to enhance the quality of safety reports received 
by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12406
NPRM Comment Period Extended    06/18/03
NPRM Comment Period End         07/14/03
NPRM Comment Period Extension 
End                             10/14/03
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AA97
_______________________________________________________________________



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

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

Abstract: The Food and Drug Administration published a final rule in 
the Federal Register of June 25, 2007 (72 FR 34752), on current good 
manufacturing practice (CGMP) regulations for dietary supplements. The 
final rule (the CGMP rule) was published to establish the minimum CGMPs 
necessary to ensure that, if firms engage in activities related to 
manufacturing, packaging, labeling, or

[[Page 21933]]

holding dietary supplements, they do so in a manner that will ensure 
the quality of the dietary supplements--i.e., to ensure that the 
dietary supplement consistently meets the established specifications 
for identity, purity, strength, and composition, and limits on 
contaminants, and has been manufactured, packaged, labeled, and held 
under conditions to prevent adulteration under section 402(a)(1), 
(a)(2), (a)(3), and (a)(4) of the act.
FDA also published an interim final rule (IFR) in the June 25, 2007 
Federal Register (72 FR 34959) that sets forth a procedure for 
requesting an exemption from the requirement in the final rule 
described above that the manufacturer conduct at least one appropriate 
test or examination to verify the identity of any component that is a 
dietary ingredient. This IFR allows for submission to, and review by, 
FDA of an alternative to the required 100 percent identity testing of 
components that are dietary ingredients, provided certain conditions 
are met. This IFR also establishes a requirement for retention of 
records relating to the FDA's response to an exemption request.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AB88
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenylpropanol amine)     12/22/05                    70 FR 75988
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenylephrine 
Bitartrate)                     08/01/06                    71 FR 83358
Final Action (Phenylpropanol 
amine)                          05/00/10

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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, 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
_______________________________________________________________________



179. 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 Eyewashes)             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

[[Page 21934]]

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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF40
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         12/19/07                    72 FR 71769
NPRM (Vaginal Contraceptive Drug 
Products)                       05/00/10

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
_______________________________________________________________________



182. 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                    05/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF51
_______________________________________________________________________



183. 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)                       05/00/10
Final Action (Overindulgence 
Labeling)                       05/00/10

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
_______________________________________________________________________



184. 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;

[[Page 21935]]

21 USC 360 to 360a; 21 USC 371 to 371a

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51146
NPRM Comment Period End         12/27/06
Final Action                     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-AF53
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)     05/00/10

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
_______________________________________________________________________



186. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, 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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (IPECAC)                   06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, 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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Healthcare)               06/17/94                    59 FR 31402
NPRM (Food Handlers)             To Be                       Determined
NPRM (Testing)                   To Be                       Determined
NPRM (Consumer)                  To Be                       Determined
Final Action (Healthcare)        To Be                       Determined
Final Action (Consumer)          To Be                       Determined

[[Page 21936]]

Final Action (First Aid 
Antiseptic)                      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
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)         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-AF70
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AF95
_______________________________________________________________________



191. 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                            04/00/10
NPRM Comment Period End         07/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kim Young, Deputy Director, Division of Compliance, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, MPN4, Room 106, HFV-230, 7519 Standish 
Place, Rockville, MD 20855
Phone: 240 276-9207
Email: [email protected]

RIN: 0910-AG10

[[Page 21937]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________



192. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/16/09                     74 FR 2849

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Jennifer L. Stevens
Phone: 301 796-3601
Fax: 301 847-8440
Email: [email protected]

RIN: 0910-AC23
_______________________________________________________________________



193. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

Legal Authority: 21 USC 379e(b)

Abstract: The Agency published a final rule on January 5, 2009, 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 final rule was issued 
in response to adverse event reports received by FDA and to a citizen 
petition submitted to FDA.

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/05/09                      74 FR 207
Final Rule--Objection Period End02/04/09
Final Rule-Confirmation of 
Effective Date                  03/11/09                    74 FR 10483

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Mical E. Honigfort
Phone: 301 436-1278
Fax: 301 436-2972
Email: [email protected]

RIN: 0910-AF12
_______________________________________________________________________



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

Legal Authority: 21 USC 360c

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/10/08                    73 FR 66522

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Myrna Hanna
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________



195. FOOD LABELING; SERVING SIZES AND NUTRITION LABELING (COMPLETION OF 
A SECTION 610 REVIEW)

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

Abstract: Section 101.9 (21 CFR 101.9) describes the nutrition labeling 
requirements for foods. Section 101.12 (21 CFR 101.12) specifies the 
reference amount customarily consumed per eating occasion for each food 
category. The reference amount customarily consumed of a food is the 
basis for the serving size that is declared in the food's nutrition 
labeling. Under section 101.9, the serving size must be expressed in a 
common household measure that is appropriate to the food. The most 
recent change to sections 101.9 and 101.12 was in 1999, when FDA 
amended these regulations to reduce the reference amount customarily 
consumed for baking powder, baking soda, and pectin, and to include 1/8 
teaspoon as an allowable unit of household measure for nutrition 
labeling purposes. FDA has completed a review of sections 101.9 and 
101.12 under section 610 of the Regulatory Flexibility Act. The purpose 
of this review was 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 solicited 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. FDA received no comments and concluded that 
there is a continuing

[[Page 21938]]

need for the nutrition labeling and serving size regulations in 
sections 101.9 and 101.12 and that these regulations should be retained 
without change.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/12/08
End Review                      02/10/09

Regulatory Flexibility Analysis Required: No

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

RIN: 0910-AF99
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP39
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP40
_______________________________________________________________________



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

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

Abstract: This major rule would revise the Medicare hospital outpatient 
prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system and to implement certain related provisions of the Medicare 
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                            06/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP41
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP46

[[Page 21939]]

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: 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: 410 786-5716
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________



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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/05                    70 FR 55989
Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AK62
_______________________________________________________________________



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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AO53
_______________________________________________________________________



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

Legal Authority: title XIX; Social Security Act

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/23/07                    72 FR 28930
NPRM Comment Period End         06/22/07
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Dianne Heffron, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Centers for 
Medicaid State Operations, Mailstop S3-13-15, 7500 Security Boulevard, 
Baltimore, MD 21224
Phone: 410 786-3247
Fax: 410 786-1008
Email: [email protected]

RIN: 0938-AO95
_______________________________________________________________________



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

Legal Authority: 42 USC 1302; 42 USC 1395hh

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AP32

[[Page 21940]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________



205. UPDATES TO ELECTRONIC TRANSACTIONS (VERSION 5010) (CMS-0009-F) 
(COMPLETION OF A SECTION 610 REVIEW)

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/08                    73 FR 49741
NPRM Comment Period End         10/21/08
Final Action                    01/16/09                     74 FR 3296

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AM50
_______________________________________________________________________



206. REVISIONS TO HIPAA CODE SETS (CMS-0013-F) (COMPLETION OF A SECTION 
610 REVIEW)

Legal Authority: PL 104-191

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/08                    73 FR 49795
NPRM Comment Period End         10/21/08
Final Action                    01/16/09                     74 FR 3328

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
_______________________________________________________________________



207. SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT, 
PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-F) (COMPLETION 
OF A 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                    01/02/09                      74 FR 166

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
_______________________________________________________________________



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

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/18/08                    73 FR 68501

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Alberta Dwivedi
Phone: 410 786-0763
Email: [email protected]

RIN: 0938-AP17
_______________________________________________________________________



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

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/19/08                    73 FR 69725

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Diane Milstead
Phone: 410 786-3355
Email: [email protected]

RIN: 0938-AP18
_______________________________________________________________________



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

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

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

[[Page 21941]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          11/03/08                    73 FR 65351

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Randy Throndset
Phone: 410 786-0131
Fax: 410 786-0765
Email: [email protected]

RIN: 0938-AP20
_______________________________________________________________________



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

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       01/29/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Tzvi Hefter
Phone: 410 786-4487
Email: [email protected]

RIN: 0938-AP33
[FR Doc. E9-10274 Filed 05-08-09; 8:45 am]
BILLING CODE 4150-24-S