[No title available]

Part VI

Department of Health and Human Services

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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

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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.....................................

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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..................................................

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[[Page 21921]]

Centers for Disease Control and Prevention--Final Rule Stage

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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)............

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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........

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Food and Drug Administration--Final Rule Stage

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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

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[[Page 21922]]

Food and Drug Administration--Long-Term Actions

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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

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Food and Drug Administration--Completed Actions

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Regulation

Sequence Title Identifier

Number Number

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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)...............................................................................

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Centers for Medicare & Medicaid Services--Proposed Rule Stage

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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).......................................................

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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)...............................................................................

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[[Page 21923]]

Centers for Medicare & Medicaid Services--Completed Actions

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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)..................

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_______________________________________________________________________

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