[No title available]

Part VI

Department of Health and Human Services

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Semiannual Regulatory Agenda

[[Page 64424]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order

(EO) 12866 requires the semi-annual issuance of an inventory of

rulemaking actions under development throughout the Department with a

view to offering summarized information about forthcoming regulatory

actions for public review.

FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary,

Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The information provided in the Agenda

presents a forecast of the rulemaking activities that the Department of

Health and Human Services (HHS) expects to undertake in the foreseeable

future. Rulemakings are grouped according to pre-rulemaking actions,

proposed rules, final rules, long-term actions, and rulemaking actions

completed since the spring 2009 Agenda was published.

Please note that the rulemaking abstracts included in this

issue of the Federal Register relate only to those prospective

rulemakings that are likely to have a significant economic impact

on a substantial number of small entities as required by the

Regulatory Flexibility Act of 1980. Also available in this issue of

the Register is the Department's submission to the fiscal year 2010

Regulatory Plan as required under Executive Order 12866.

The purpose of the Agenda is to encourage more effective public

participation in the regulatory process, and HHS invites all

interested members of the public to comment on the rulemaking

actions included in this issuance of the Agenda. The complete

regulatory agenda of the Department is accessible online at

www.reginfo.gov in an interactive format that offers users enhanced

capabilities to obtain information from the Agenda's database.

Dated: October 9, 2009.

Dawn L. Smalls,

Executive Secretary,

Department of Health and Human Services.

Office of the Secretary--Final Rule Stage

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Regulation

Sequence Title Identifier

Number Number

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

306 Health Information Technology: Initial Set of Standards, Implementation 0991-AB58

Specifications, and Certification Criteria for Electronic Health Record Technology

(Rulemaking Resulting From a Section 610 Review) (Reg Plan Seq No. 43)................

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References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Substance Abuse and Mental Health Services Administration--Final Rule Stage

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

Regulation

Sequence Title Identifier

Number Number

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307 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section 0930-AA14

610 Review)...........................................................................

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Substance Abuse and Mental Health Services Administration--Long-Term Actions

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

Regulation

Sequence Title Identifier

Number Number

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

308 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10

Community-Based Facilities for Children and Youth.....................................

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Centers for Disease Control and Prevention--Proposed Rule Stage

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Regulation

Sequence Title Identifier

Number Number

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

309 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation 0920-AA14

Regulations...........................................................................

310 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of 0920-AA23

HHS/CDC Nonhuman Primate Regulations..................................................

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[[Page 64425]]

Centers for Disease Control and Prevention--Final Rule Stage

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Regulation

Sequence Title Identifier

Number Number

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

311 Control of Communicable Diseases Foreign Quarantine................................... 0920-AA12

312 Control of Communicable Diseases: Interstate Quarantine, Passenger Information........ 0920-AA27

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Centers for Disease Control and Prevention--Long-Term Actions

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

Regulation

Sequence Title Identifier

Number Number

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

313 Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review)......... 0920-AA32

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Food and Drug Administration--Prerule Stage

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

Regulation

Sequence Title Identifier

Number Number

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

314 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06

Shell Eggs Held for Retail Distribution (Section 610 Review)..........................

315 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14

Policies, Requirements, and Administrative Procedures (Section 610 Review)............

316 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 0910-AG25

Review)...............................................................................

317 Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review).............. 0910-AG34

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Food and Drug Administration--Proposed Rule Stage

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

Regulation

Sequence Title Identifier

Number Number

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

318 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg 0910-AC52

Plan Seq No. 44)......................................................................

319 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31

320 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38

321 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43

322 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44

323 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45

324 Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68

325 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10

326 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug 0910-AG12

Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........

327 Produce Safety Regulation (Reg Plan Seq No. 46)....................................... 0910-AG35

328 Modernization of the Current Food Good Manufacturing Practices Regulation (Reg Plan 0910-AG36

Seq No. 47)...........................................................................

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References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration--Final Rule Stage

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Regulation

Sequence Title Identifier

Number Number

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329 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97

330 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53

331 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55

332 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11

Requirements for Pregnancy and Lactation Labeling.....................................

333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27

Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No.

48)...................................................................................

334 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32

335 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33

[[Page 64426]]

336 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34

337 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35

338 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36

339 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37

340 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42

341 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47

342 Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00

343 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco 0910-AG33

to Protect Children and Adolescents (Reg Plan Seq No. 50).............................

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References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration--Long-Term Actions

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Regulation

Sequence Title Identifier

Number Number

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344 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88

Operations for Dietary Supplements....................................................

345 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39

346 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40

347 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51

348 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52

349 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53

350 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56

351 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61

352 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63

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

354 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70

355 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95

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Food and Drug Administration--Completed Actions

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Regulation

Sequence Title Identifier

Number Number

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356 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14

357 Substances Prohibited From Use in Animal Food or Feed to Prevent the Transmission of 0910-AF46

Bovine Spongiform Encephalopathy......................................................

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Centers for Medicare & Medicaid Services--Proposed Rule Stage

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Regulation

Sequence Title Identifier

Number Number

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

358 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs 0938-AP77

for Contract Year 2011 (CMS-4085-F)...................................................

359 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care 0938-AP80

Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates

(CMS-1498-P) (Reg Plan Seq No. 53)....................................................

360 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP82

Center Payment System for CY 2011 (CMS-1504-P) (Reg Plan Seq No. 54)..................

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References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

[[Page 64427]]

Centers for Medicare & Medicaid Services--Final Rule Stage

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Regulation

Sequence Title Identifier

Number Number

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

361 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413- 0938-AP40

FC)...................................................................................

362 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP41

Center Payment System for CY 2010 (CMS-1414-FC).......................................

363 Children's Health Insurance Program (CHIP); Allotment Methodology and States' Fiscal 0938-AP53

Year 2009 CHIP Allotments (CMS-2291-F)................................................

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Centers for Medicare & Medicaid Services--Long-Term Actions

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Regulation

Sequence Title Identifier

Number Number

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

364 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81

Review)...............................................................................

365 Electronic Claims Attachments Standards (CMS-0050-IFC)................................ 0938-AK62

366 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 0938-AO53

Review)...............................................................................

367 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32

Review)...............................................................................

368 State Flexibility for Medicaid Benefit Packages (CMS-2232-F4)......................... 0938-AP72

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Centers for Medicare & Medicaid Services--Completed Actions

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Regulation

Sequence Title Identifier

Number Number

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

369 Medicaid Graduate Medical Education (CMS-2279-F)...................................... 0938-AO95

370 Genetic Information Nondiscrimination Act of 2008 (CMS-4137-IFC)...................... 0938-AP37

371 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 0938-AP39

2010 (CMS-1406-F).....................................................................

372 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AP46

Update for FY 2010 (CMS-1410-F).......................................................

373 Home Health Prospective Payment System and Rate Update for CY 2010 (CMS-1560-F)....... 0938-AP55

374 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2010 (CMS- 0938-AP56

1538-F)...............................................................................

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_______________________________________________________________________

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

Office of the Secretary (OS)

_______________________________________________________________________

306. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF

STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR

ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION

610 REVIEW)

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

the Federal Register.

RIN: 0991-AB58

[[Page 64428]]

_______________________________________________________________________

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

Substance Abuse and Mental Health Services Administration (SAMHSA)

_______________________________________________________________________

307. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE

ADDITION (SECTION 610 REVIEW)

Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC

290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11

Abstract: This rule will amend the Federal opioid treatment program

regulations. It will modify the dispensing requirements for

buprenorphine and buprenorphine combination products that are approved

by the Food and Drug Administration (FDA) for opioid dependence and

used in federally certified and registered opioid treatment programs.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 06/19/09 74 FR 29153

NPRM Comment Period End 08/18/09

Final Action 06/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Nicholas Reuter, Department of Health and Human

Services, Substance Abuse and Mental Health Services Administration,

One Choke Cherry Rd, Suite 2-1063, Rockville, MD 20857

Phone: 240 276-2716

RIN: 0930-AA14

_______________________________________________________________________

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

Substance Abuse and Mental Health Services Administration (SAMHSA)

_______________________________________________________________________

308. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN

CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

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

Abstract: The Secretary is required by statute to publish regulations

governing States that license nonmedical, community-based residential

facilities for children and youth. The regulation requires States to

develop licensing rules and monitoring requirements concerning behavior

management practice that will ensure compliance; requires States to

develop and implement such licensing rules and implementation

requirements within one year; and ensures that States require such

facilities to have adequate staff, and that the States provide training

for professional staff.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Paolo Del Vecchio, Department of Health and Human

Services, Substance Abuse and Mental Health Services Administration,

Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857

Phone: 301 443-2619

RIN: 0930-AA10

_______________________________________________________________________

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

Centers for Disease Control and Prevention (CDC)

_______________________________________________________________________

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

IMPORTATION REGULATIONS

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has

broad authority to prevent introduction, transmission, and spread of

communicable diseases from foreign countries into the United States and

from one State or possession into another. The Secretary has designated

the authority to prevent the introduction of diseases from foreign

countries to the Director, Centers for Disease Control and Prevention

(CDC). CDC also enforces entry requirements for certain animals,

etiologic agents and vectors deemed to be of public health

significance. Currently the regulations restrict the importation of

nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts

and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54).

In addition, CDC has recently issued a series of emergency orders,

restricting the importation of African rodents (42 CFR section 71.56)

and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed

Rulemaking (NPRM) to revise the regulations for importation of certain

animals and vectors into the United States (42 CFR parts 71, Subpart

F).

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

ANPRM 07/31/07 72 FR 41676

ANPRM Comment Period End 10/01/07

Notice Extending ANPRM Comment

Period 10/01/07 72 FR 55729

ANPRM Extended Comment Period

End 12/01/07

NPRM 06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services,

Centers for Disease Control and Prevention, CLFT Building 16, Room

4324, MS E03, Atlanta, GA 30329

Phone: 404 498-1600

Email: [email protected]

RIN: 0920-AA14

_______________________________________________________________________

310. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS,

PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has

broad authority to prevent introduction, transmission, and spread of

communicable diseases from foreign countries into the United States and

from one State or possession into another. The Secretary has delegated

the authority to prevent the

[[Page 64429]]

introduction of diseases from foreign countries to the Director, CDC.

CDC also enforces entry requirements for certain animals, etiologic

agents, and vectors deemed to be of public health significance. CDC is

proposing to amend its regulations related to the importation of live

nonhuman primates (NHPs) by extending existing requirements for the

importation of cynomolgus, African green, and rhesus monkeys to all

NHPs. The agency also is proposing to reduce the frequency at which

importers of the three species are required to renew their

registrations, (from every 180 days to every two years). CDC proposes

to incorporate existing guidelines into the regulations and add new

provisions to address NHPs imported as part of a circus or trained

animal act, NHPs imported by zoological societies, the transfer of NHPs

from approved laboratories, and non-live imported NHP products. CDC is

also proposing that all NHPs be imported only through ports of entry

where a CDC quarantine station is located.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 03/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services,

Centers for Disease Control and Prevention, CLFT Building 16, Room

4324, MS E03, Atlanta, GA 30329

Phone: 404 498-1600

Email: [email protected]

RIN: 0920-AA23

_______________________________________________________________________

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

Centers for Disease Control and Prevention (CDC)

_______________________________________________________________________

311. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE

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

Abstract: By statute, the Secretary of Health and Human Services has

broad authority to prevent introduction, transmission, and spread of

communicable diseases from foreign countries into the United States and

from one State or possession into another. Quarantine regulations are

divided into two parts: Part 71 dealing with foreign arrivals and part

70 dealing with interstate matters. This rule (42 CFR part 71) will

update and improve CDC's response to both global and domestic disease

threats by creating a multi-tiered illness detection and response

process thus substantially enhancing the public health system's ability

to slow the introduction, transmission, and spread of communicable

disease. The rule will also modify current Federal regulations

governing the apprehension, quarantine isolation and conditional

release of individuals suspected of carrying a quarantinable disease

while respecting individual autonomy. CDC maintains quarantine stations

at 20 ports of entry staffed with medical and public health officers

who respond to reports of diseases from carriers. According to the

statutory scheme, the President determines through Executive Order

which diseases may subject individuals to quarantine. The current

disease list, which was last updated in April 2005, includes cholera,

diphtheria, tuberculosis, plague, smallpox, yellow fever, viral

hemorrhagic fevers, severe acute respiratory syndrome (SARS), and

influenza caused by novel or reemergent influenza viruses that are

causing, or have the potential to cause a pandemic.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 11/30/05 70 FR 71892

NPRM Comment Period End 01/20/06

Final Action 03/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services,

Centers for Disease Control and Prevention, CLFT Building 16, Room

4324, MS E03, Atlanta, GA 30329

Phone: 404 498-1600

Email: [email protected]

RIN: 0920-AA12

_______________________________________________________________________

312. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER

INFORMATION

Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248;

42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC

2001

Abstract: By statute, the Secretary of Health and Human Services has

broad authority to prevent introduction, transmission, and spread of

communicable diseases from one State or possession into another.

Quarantine regulations are divided into two parts: Part 71 dealing with

foreign arrivals and part 70 dealing with interstate matters. The CDC

Director has been delegated the responsibility for carrying out these

regulations. The Director's authority to investigate suspected cases

and potential spread of communicable disease among interstate travelers

is thus not limited to those known or suspected of having a

quarantinable disease, but rather all communicable diseases that may

necessitate a public health response.

Among the fundamental components of the public health response to the

report of a person with a communicable disease is the identification

and evaluation of individuals who may have been exposed. This

provision, which was proposed section 70.4, would require any airline

operating in interstate traffic to solicit and electronically submit

certain passenger information to CDC for use in contact tracing when

necessary to protect the vital interests of an individual, or other

persons, in regard to significant health risks.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 11/30/05 70 FR 71892

NPRM Comment Period End 01/30/06

Final Action 03/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services,

Centers for Disease Control and Prevention, CLFT Building 16, Room

4324, MS E03, Atlanta, GA 30329

Phone: 404 498-1600

Email: [email protected]

RIN: 0920-AA27

[[Page 64430]]

_______________________________________________________________________

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

Centers for Disease Control and Prevention (CDC)

_______________________________________________________________________

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

610 REVIEW)

Legal Authority: PL 107-188

Abstract: The Public Health Security and Bioterrorism Preparedness and

Response Act of 2002 authorizes the HHS Secretary to regulate the

possession, use, and transfer of select agents and toxins that have the

potential to pose a severe threat to public health and safety. These

regulations are set forth at 42 CFR 73. Criteria used to determine

whether a select agent or toxin should be included under the provisions

of these regulations are based on: 1) the effect on human health as a

reuslt of exposure to the agent or toxin, 2) the degree of

contagiousness of the agent or toxin, 3) the methods by which the agent

or toxin is transferred to humans, 4) the availability and

effectiveness of pharmacotherapies and immunizations to treat and

prevent andy illness resulting from infection by the agent or toxin,

and 5) any other criteria, including the needs of children and other

vulnerable populations that the HHS Secretary considers appropriate.

Based on these criteria, we are proposing to amend the list of HHS

select agents and toxins by adding Chapare virus to the list. After

consulting with subject matter experts from CDC, the National

Institutes of Health (NIH), the Food Drug Administration (FDA), the

United States Department of Agriculture (USDA) /Animal and Plant Health

Inspection Service (APHIS), USDA/Agricultural Research Service (ARS),

USDA/CVB (Center for Veterinary Biologics), and the Department of

Defense (DOD)/United States Army Medical Research Institute for

Infectious Diseases (USAMRIID) and review of relevant published

studies, we believe the Chapare virus should be added to the list of

HHS select agents and toxins based on our conclusion that the Chapare

virus has been phylogenetically identified as a Clade B arenavirus and

is closely related to other South American arenaviruses that cause

haemorrhagic fever, particularly Sabia virus.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 08/19/09 74 FR 159

NPRM Comment Period End 10/19/09

Final Action To Be Determined

Regulatory Flexibility Analysis Required: No

Agency Contact: Robbin Weyant, Department of Health and Human Services,

Centers for Disease Control and Prevention, CLFT Building 20, Room

4202, 1600 Clifton Road NE., Atlanta, GA 30333

Phone: 404 718-2000

RIN: 0920-AA32

_______________________________________________________________________

Department of Health and Human Services (HHS) Prerule Stage

Food and Drug Administration (FDA)

_______________________________________________________________________

314. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS;

REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610

REVIEW)

Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC

342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271

Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements

for the labeling of the cartons of shell eggs that have not been

treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR

115.50) describes requirements for refrigeration of shell eggs held for

retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides

that part 16 does not apply to a hearing on an order for relabeling,

diversion, or destruction of shell eggs under section 361 of the Public

Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50.

FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit

the safe handling statement to appear on the inside lid of egg cartons

to provide the industry greater flexibility in the placement of the

statement. FDA is undertaking a review of 21 CFR sections 101.17(h),

115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility

Act. The purpose of this review is to determine whether the regulations

in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued

without change, or whether they should be amended or rescinded,

consistent with the stated objectives of applicable statutes, to

minimize any significant economic impact on a substantial number of

small entities. FDA will consider, and is soliciting comments on, the

following: (1) The continued need for the rule; (2) the nature of

complaints or comments received concerning the rule from the public;

(3) the complexity of the rule; (4) the extent to which the rule

overlaps, duplicates, or conflicts with other Federal rules, and, to

the extent feasible, with State and local governmental rules; and (5)

the length of time since the rule has been evaluated or the degree to

which technology, economic conditions, or other factors have changed in

the area affected by the rule.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Begin Review 12/00/09

End Review 12/00/10

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and

Labeling Team, Department of Health and Human Services, Food and Drug

Administration, Center for Food Safety and Applied Nutrition, (HFS-

820), 5100 Paint Branch Parkway, College Park, MD 20740

Phone: 301 436-1802

Fax: 301 436-2636

Email: [email protected]

RIN: 0910-AG06

_______________________________________________________________________

315. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG

AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE

PROCEDURES (SECTION 610 REVIEW)

Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC

353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381

Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR

sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under

section 610 of the Regulatory Flexibility Act. The purpose of this

review is to determine

[[Page 64431]]

whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3

and 205.50 (as amended in 64 FR 67762 and 67763) should be continued

without change, or whether they should be amended or rescinded,

consistent with the stated objectives of applicable statutes, to

minimize adverse impacts on a substantial number of small entities. FDA

will consider, and is soliciting comments on, the following: (1) The

continued need for the regulations in 21 CFR part 203 and 21 CFR

sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2)

the nature of complaints or comments received from the public

concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3

and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of

the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50

(as amended in 64 FR 67762 and 67763); (4) the extent to which the

regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as

amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with

other Federal rules, and to the extent feasible, with State and local

governmental rules; and (5) the degree to which technology, economic

conditions, or other factors have changed in the area affected by the

regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as

amended in 64 FR 67762 and 67763).

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Begin Review of Current

Regulation 11/24/08

End Review of Current Regulation12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Howard Muller, Office of Regulatory Policy, Department

of Health and Human Services, Food and Drug Administration, Center for

Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room

6234, Silver Spring, MD 20993-0002

Phone: 301 796-3601

Fax: 301 847 8440

Email: pdma610(c)[email protected]

RIN: 0910-AG14

_______________________________________________________________________

316. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG

PRODUCTS FOR ORAL INHALATION (SECTION 610 REVIEW)

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

21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375

Abstract: FDA is undertaking a review of 21 CFR 200.51, under section

610 of the Regulatory Flexibility Act. The purpose of this review is to

determine whether this regulation on aqueous-based drug products for

oral inhalation should be continued without change, or whether it

should be amended or rescinded, consistent with the stated objectives

of applicable statues, to minimize adverse impacts on a substantial

number of small entities. FDA will consider, and is soliciting comments

on the following: (1) The continued need for 21 CFR 200.51; (2) the

nature of complaints or comments received concerning 21 CFR 200.51; (3)

the complexity of 21 CFR 200.51; (4) the extent to which the regulation

overlaps, duplicates, or conflicts with other Federal, State, or

governmental rules; and (5) the degree to which technology, economic

conditions, or other factors have changed in the area affected by 21

CFR 200.51.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Begin Review 05/01/09

End Review 05/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Howard P. Muller, Office of Regulatory Policy,

Department of Health and Human Services, Food and Drug Administration,

Center for Drug Evaluation and Research, 10903 New Hampshire Avenue,

Building 51, Room 6234, Silver Spring, MD 20993-0002

Phone: 301 796-3601

Fax: 301 847-8440

Email: [email protected]

RIN: 0910-AG25

_______________________________________________________________________

317. OVER-THE-COUNTER HUMAN DRUGS; LABELING

REQUIREMENTS (SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Part 201.66 (21 CFR section 201.66) established a

standardized format for the labeling of OTC drug products that

included: (1) Specific headings and subheadings presented in a

standardized order, (2) standardized graphical features such as

Helvetica type style and the use of ``bullet points'' to introduce key

information, and (3) minimum standards for type size and spacing. FDA

issued the final rule to improve labeling after considering comments

submitted to the agency following the publication of the proposed

regulation in 1997. In 1999, FDA published the final rule and stated

that a standardized labeling format would significantly improve

readability by familiarizing consumers with the types of information in

OTC drug product labeling and the location of that information. In

addition, a standardized appearance and standardized content, including

various ``user-friendly'' visual cues, would help consumers locate and

read important health and safety information and allow quick and

effective product comparisons, thereby helping consumers to select the

most appropriate product.

FDA is initiating a review under section 610 of the Regulatory

Flexibility Act for the regulation in part 201.66. The purpose of this

review is to determine whether the regulation in part 201.66 should be

continued without change, or whether they should be further amended or

rescinded, consistent with the stated objectives of applicable

statutes, to minimize adverse impacts on a substantial number of small

entities. FDA will consider, and is soliciting comments on the

following: (1) The continued need for the regulation in part 201.66;

(2) the nature of the complaints or comments received concerning the

regulation in part 201.66; (3) the complexity of the regulations in

part 201.66; (4) the extent to which the regulation in part 201.66

overlap, duplicate, or conflict with other Federal, State, or

governmental rules; and (5) the degree to which technology, economic

conditions, or other factors have changed for the products still

subject to the labeling standard regulations in part 201.

The section 610 review will be carried out along with a regulatory

review under section 5 of Executive Order 12866, which calls for

agencies to periodically review existing regulations to determine

whether any should be modified or eliminated so as to make the agency's

regulatory program more effective in achieving its goals, less

[[Page 64432]]

burdensome, or in greater alignment with the President's priorities and

the principles set forth in the Executive order.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Begin Review of Current

Regulation 08/03/09

End Review of Current Regulation02/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AG34

_______________________________________________________________________

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

Food and Drug Administration (FDA)

_______________________________________________________________________

318. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS

AND BIOLOGICS

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

the Federal Register.

RIN: 0910-AC52

_______________________________________________________________________

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

PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses antihistamine labeling claims for the common cold.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Reopening of Administrative

Record 08/25/00 65 FR 51780

NPRM (Amendment) (Common Cold) 09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF31

_______________________________________________________________________

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

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

355; 21 USC 360 to 360a; 21 USC 371 to 371a

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The final

action will address laxative drug products. The first NPRM listed will

address the professional labeling for sodium phosphate drug products.

The second NPRM listed will address all other professional labeling

requirements for laxative drug products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07 72 FR 14669

NPRM (Professional Labeling--

Sodium Phosphate) 06/00/10

Final Action (Laxative Drug

Products) To Be Determined

NPRM (Professional Labeling) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF38

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The first

action addresses combination products containing sunscreen and insect

repellent ingredients. The second action addresses active ingredients

reviewed under Time and Extent Applications. The third action addresses

other effectiveness issues for OTC sunscreen drug products. The fourth

action is the final action that addresses sunscreen formulation,

labeling, and testing requirements for both ultraviolet B and

ultraviolet A radiation protection.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect

Repellent) 02/22/07 72 FR 7941

ANPRM Comment Period End 05/23/07

NPRM (UVA/UVB) 08/27/07 72 FR 49070

NPRM Comment Period End 12/26/07

NPRM (Effectiveness) 05/00/10

[[Page 64433]]

Final Action (UVA/UVB) 05/00/10

NPRM (Sunscreen and Insect

Repellent) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF43

_______________________________________________________________________

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

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

355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The proposed

rule addresses vaginal contraceptive drug products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action (Warnings) 12/19/07 72 FR 71769

NPRM (Vaginal Contraceptive Drug

Products) 09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF44

_______________________________________________________________________

323. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The NPRM

addresses the use of benzocaine for weight control. The first final

action finalizes the 2005 proposed rule for weight control products

containing phenylpropanolamine. The second final action will finalize

the proposed rule for weight control products containing benzocaine.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Phenylpropanol -amine) 12/22/05 70 FR 75988

NPRM (Benzocaine) 05/00/10

Final Action (Phenylpropanol -

amine) 05/00/10

Final Action (Benzocaine) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF45

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses the ingredient ipecac syrup.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (IPECAC) 06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF68

_______________________________________________________________________

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

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

Abstract: The Food and Drug Administration (FDA) is proposing

regulations for process controls for animal feed ingredients and mixed

animal feed to provide greater assurance that marketed animal feed

ingredients and mixed feeds intended for all animals, including pets,

are safe. This action is being taken as part of the FDA's Animal Feed

Safety System initiative. The proposed process controls will apply to

animal feed ingredients and mixed animal feed including pet food. This

action is also being taken to carry out the requirements of the Food

and Drug Administration Amendments Act of 2007. Section 1002(a) directs

FDA to establish by regulation processing standards for pet food. This

same provision of the law also directs that, in developing these new

regulations, FDA obtain input from its stakeholders, including the

Association of American Feed Control Officials, veterinary medical

associations, animal health organizations, and pet food manufacturers.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 10/00/10

[[Page 64434]]

NPRM Comment Period End 01/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kim Young, Deputy Director, Division of Compliance,

Department of Health and Human Services, Food and Drug Administration,

Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519

Standish Place, Rockville, MD 20855

Phone: 240 276-9207

Email: [email protected]

RIN: 0910-AG10

_______________________________________________________________________

326. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND

ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED

AMENDMENT OF FINAL MONOGRAPH

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

21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a monograph is issued, only OTC drugs meeting the

conditions of the monograph, or having an approved new drug

application, may be legally marketed. This action will propose changes

to the final monograph to address safety and efficacy issues associated

with pediatric cough and cold products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AG12

_______________________________________________________________________

327. PRODUCE SAFETY REGULATION

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

the Federal Register.

RIN: 0910-AG35

_______________________________________________________________________

328. MODERNIZATION OF THE CURRENT FOOD GOOD

MANUFACTURING PRACTICES REGULATION

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

the Federal Register.

RIN: 0910-AG36

_______________________________________________________________________

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

Food and Drug Administration (FDA)

_______________________________________________________________________

329. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND

BIOLOGICAL PRODUCTS

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and

263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC

331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21

USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381

Abstract: The final rule would amend the postmarketing expedited and

periodic safety reporting regulations for human drugs and biological

products to revise certain definitions and reporting formats as

recommended by the International Conference on Harmonisation and to

define new terms; to add to or revise current reporting requirements;

to revise certain reporting time frames; and to propose other revisions

to these regulations to enhance the quality of safety reports received

by FDA. These revisions were proposed as part of a single rulemaking

(68 FR 12406) to clarify and revise both premarketing and postmarketing

safety reporting requirements for human drug and biological products.

FDA plans to finalize the premarket and postmarket safety reporting

requirements in separate final rules.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 03/14/03 68 FR 12406

NPRM Comment Period Extended 06/18/03

NPRM Comment Period End 07/14/03

NPRM Comment Period Extension

End 10/14/03

Final Action 09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Meredith S. Francis, Regulatory Counsel, Department of

Health and Human Services, Food and Drug Administration, Center for

Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51,

Room 6238, Silver Spring, MD 20993-0002

Phone: 301 796-3476

Fax: 301-847-8440

RIN: 0910-AA97

_______________________________________________________________________

330. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING

PRACTICE REQUIREMENTS

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

Abstract: The Food and Drug Administration is amending its current good

manufacturing practice regulations and other regulations to clarify and

strengthen requirements for the label, color, dedication, and design of

medical gas containers and closures. Despite existing regulatory

requirements and industry standards for medical gases, there have been

repeated incidents in which cryogenic containers of harmful industrial

gases have been connected to medical oxygen supply systems in hospitals

and nursing homes, and subsequently administered to patients. These

incidents have resulted in death and serious injury. There have also

been

[[Page 64435]]

several incidents involving high-pressure medical gas cylinders that

have resulted in death and injuries to patients. These amendments,

together with existing regulations, are intended to ensure that the

types of incidents that have occurred in the past, as well as other

types of foreseeable and potentially deadly medical gas accidents, do

not occur in the future.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 04/10/06 71 FR 18039

NPRM Comment Period End 07/10/06

Final Action 06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of

Health and Human Services, Food and Drug Administration, Center for

Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51,

Room 6368, Silver Spring, MD 20993-0002

Phone: 301 796-3522

Fax: 301 847-8440

Email: [email protected]

RIN: 0910-AC53

_______________________________________________________________________

331. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING

PRACTICES

Legal Authority: PL 105-115, sec 121

Abstract: Section 121 of the Food and Drug Administration Modernization

Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for

current good manufacturing practices (CGMPs) for positron emission

tomography (PET) drugs, a type of radiopharmaceutical. The final rule

would adopt CGMPs that reflect the unique characteristics of PET drugs.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 09/20/05 70 FR 55038

NPRM Comment Period End 12/19/05

Final Action 12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel,

Department of Health and Human Services, Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Regulatory Policy,

10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993-

0002

Phone: 301 796-3478

Fax: 301 847-8440

Email: [email protected]

RIN: 0910-AC55

_______________________________________________________________________

332. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND

BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

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

21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371;

21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264

Abstract: To amend the regulations governing the format and content of

labeling for human prescription drugs and biological products (21 CFR

parts 201.56, 201.57, and 201.80). Under FDA's current regulations,

labeling concerning the use of prescription drugs in pregnancy uses

letter categories (A, B, C, D, X) to characterize the risk to the fetus

of using the drug in pregnancy. Dissatisfaction with the category

system has been expressed by health care providers, medical

organizations, experts in the study of birth defects, women's health

researchers, and women of childbearing age. Stakeholders consulted

through a public hearing, several focus groups, and several advisory

committees have recommended that FDA replace the category system with a

concise narrative summarizing a product's risks to pregnant women and

to women of childbearing age. The revised format and the information

provided in the labeling would make it easier for health care providers

to understand the risks and benefits of drug use during pregnancy and

lactation.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 05/29/08 73 FR 30831

NPRM Comment Period End 08/27/08

Final Action 04/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of

Health and Human Services, Food and Drug Administration, Center for

Drug Evaluation Research, 10903 New Hampshire Avenue, Bldg. 51, Room

6224, Silver Spring, MD 20993-0002

Phone: 301 796-4288

Fax: 301 847-8440

Email: [email protected]

RIN: 0910-AF11

_______________________________________________________________________

333. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY

CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND

QUALITY FACTORS

Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of

the Federal Register.

RIN: 0910-AF27

_______________________________________________________________________

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

PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses labeling for single ingredient bronchodilator products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment--Ephedrine

Single Ingredient) 07/13/05 70 FR 40237

Final Action (Technical

Amendment) 11/30/07 72 FR 67639

Final Action (Amendment--

Ephedrine Single Ingredient) 05/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

[[Page 64436]]

Email: [email protected]

RIN: 0910-AF32

_______________________________________________________________________

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

PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

finalizes cough/cold combination products containing oral

bronchodilators and expectorants.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment) 07/13/05 70 FR 40232

Final Action (Technical

Amendment) 03/19/07 72 FR 12730

Final Action 09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF33

_______________________________________________________________________

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

PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses the ingredient phenylpropanolamine.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis

Claim) 08/02/04 69 FR 46119

NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482

NPRM (Phenylpropanol -amine) 12/22/05 70 FR 75988

Final Action (Amendment)

(Sinusitis Claim) 10/31/05 70 FR 58974

Final Action (Phenylephrine

Bitartrate) 08/01/06 71 FR 83358

Final Action (Phenylpropanol -

amine) 09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF34

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The final

action addresses the 2003 proposed rule on patches, plasters, and

poultices. The proposed rule will address issues not addressed in

previous rulemakings.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action (GRASE dosage

forms) 09/00/10

NPRM (Amendment) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF35

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The first

action addresses products labeled to relieve upset stomach associated

with overindulgence in food and drink and to relieve symptoms

associated with a hangover. The second action addresses products

marketed for children under 2 years old and weight- and age-based

dosing for children's products. The third action addresses combination

products containing the analgesic acetaminophen or aspirin and sodium

bicarbonate used as an antacid ingredient. The fourth action addresses

other miscellaneous issues relating to internal analgesics. The last

document finalizes the Internal Analgesic Products monograph.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment) (Required

Warnings and Other Labeling) 12/26/06 71 FR 77314

NPRM Comment Period End 05/25/07

NPRM (Amendment) (Overindulgence

/Hangover) To Be Determined

Final Action (Required Warnings

and Other Labeling) 04/29/09 74 FR 19385

[[Page 64437]]

Final Action (Correction) 06/30/09 74 FR 31177

Final Action (Technical

Amendment) 12/00/09

NPRM (Amendment) (Miscellaneous

Issues) 09/00/10

NPRM (Amendment) (Pediatric) To Be Determined

NPRM (Amendment) (Combinations

With Sodium Bicarbonate) To Be Determined

Final Action (Internal

Analgesics) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF36

_______________________________________________________________________

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

OTC HUMAN USE

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

355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses labeling for convenience (small) size OTC drug packages.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Convenience Sizes) 12/12/06 71 FR 74474

Final Action 05/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF37

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The first

action addresses skin protectant products used to treat fever blisters

and cold sores. The second action identifies safe and effective skin

protectant active ingredients to treat and prevent diaper rash.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action (Technical

Amendments) 02/01/08 73 FR 6014

Final Action (Fever Blisters/

Cold Sores) 06/00/10

Final Action (Aluminum Acetate)

(Technical Amendment) 03/06/09 74 FR 9759

Final Action (Diaper Rash) 06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF42

_______________________________________________________________________

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

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

Abstract: On July 14, 2004, FDA issued an interim final rule (IFR),

effective immediately, to prohibit the use of certain cattle material

and to address the potential risk of bovine spongiform encephalopathy

(BSE) in human food, including dietary supplements, and cosmetics.

Prohibited cattle materials under the IFR include specified risk

materials, small intestine of all cattle, material from nonambulatory

disabled cattle, material from cattle not inspected and passed for

human consumption, and mechanically separated (MS) beef. Specified risk

materials are the brain, skull, eyes, trigeminal ganglia, spinal cord,

vertebral column (excluding the vertebrae of the tail, the transverse

processes of the thoracic and lumbar vertebrae, and the wings of the

sacrum), and dorsal root ganglia of cattle 30 months and older; and the

tonsils and distal ileum of the small intestine of all cattle.

Prohibited cattle materials do not include tallow that contains no more

than 0.15 percent hexane-insoluble impurities and tallow derivatives.

This action minimizes human exposure to materials that scientific

studies have demonstrated are highly likely to contain the BSE agent in

cattle infected with the disease. Scientists believe that the human

disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by

the consumption of products contaminated with the agent that causes

BSE.

On September 7, 2005, FDA amended the IFR to permit the use of small

intestine in human food and cosmetics if it is effectively removed from

the distal ileum. The amendment also clarified that milk and milk

products, hides, and tallow derivatives are not prohibited for use in

human food and cosmetics.

On April 17, 2008, FDA amended the IFR so that FDA may designate a

country as not subject to certain BSE-related restrictions relating to

prohibited cattle materials applicable to human food and cosmetics.

Comments submitted in response to the July 14, 2004 IFR that were not

addressed in the September 7, 2005 and April 17, 2008 amendments will

be addressed in the final rule. The final

[[Page 64438]]

rule also will respond to comments submitted following the September 7,

2005 and April 17, 2008 amendments.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Interim Final Rule 07/14/04 69 FR 42256

Interim Final Rule Effective 07/14/04

Interim Final Rule Comment

Period End 10/12/04

Interim Final Rule (Amendments) 09/07/05 70 FR 53063

Interim Final Rule (Amendments)

Effective 10/07/05

Interim Final Rule (Amendments)

Comment Period End 11/07/05

Interim Final Rule (Amendments) 04/17/08 73 FR 20785

Interim Final Rule (Amendments)

Comment Period End 07/16/08

Interim Final Rule (Amendments)

Effective 07/16/08

Final Action 10/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Amber McCoig, Consumer Safety Officer, Department of

Health and Human Services, Food and Drug Administration, Center for

Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch

Parkway, College Park, MD 20740

Phone: 301 436-2131

Fax: 301 436-2644

Email: [email protected]

RIN: 0910-AF47

_______________________________________________________________________

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

BENZOYL PEROXIDE

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

355; 21 USC 360 to 360a; 21 USC 371 to 371a

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

will address acne drug products containing benzoyl peroxide.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action 12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AG00

_______________________________________________________________________

343. REGULATIONS RESTRICTING THE SALE AND

DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND

ADOLESCENTS

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

the Federal Register.

RIN: 0910-AG33

_______________________________________________________________________

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

Food and Drug Administration (FDA)

_______________________________________________________________________

344. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING,

LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

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

371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264

Abstract: The Food and Drug Administration published a final rule in

the Federal Register of June 25, 2007 (72 FR 34752), on current good

manufacturing practice (CGMP) regulations for dietary supplements. FDA

also published an Interim Final Rule in the same Federal Register (72

FR 34959) that provided a procedure for requesting an exemption from

the final rule requirement that the manufacturer conduct at least one

appropriate test or examination to verify the identity of any component

that is a dietary ingredient. This IFR allows for submission to, and

review by, FDA of an alternative to the required 100 percent identity

testing of components that are dietary ingredients, provided certain

conditions are met. This IFR also establishes a requirement for

retention of records relating to the FDA's response to an exemption

request.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

ANPRM 02/06/97 62 FR 5700

ANPRM Comment Period End 06/06/97

NPRM 03/13/03 68 FR 12157

NPRM Comment Period End 08/11/03

Final Action 06/25/07 72 FR 34752

Interim Final Rule 06/25/07 72 FR 34959

Interim Final Rule Comment

Period End 10/24/07

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health

and Human Services, Food and Drug Administration, Center for Food

Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway,

College Park, MD 20740

Phone: 301 436-2784

Fax: 301 436-2657

Email: [email protected]

RIN: 0910-AB88

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC

[[Page 64439]]

drugs meeting the conditions of the monograph, or having an approved

new drug application, may be legally marketed. This action finalizes

the monograph for emergency first aid eyewash drug products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment) (Emergency

First Aid Eyewashes) 02/19/03 68 FR 7917

Final Action (Amendment)

(Emergency First Aid Eyewashes) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF39

_______________________________________________________________________

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

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

355; 21 USC 360 to 360a; 21 USC 371 to 371a

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The NPRM and

final action will address oral health care products used to reduce or

prevent dental plaque and gingivitis.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

ANPRM (Plaque Gingivitis) 05/29/03 68 FR 32232

ANPRM Comment Period End 08/27/03

NPRM (Plaque Gingivitis) To Be Determined

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF40

_______________________________________________________________________

347. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND

DRINK PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses products containing bismuth subsalicylate for relief of

symptoms of upset stomach due to overindulgence resulting from food and

drink.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment) 01/05/05 70 FR 741

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF51

_______________________________________________________________________

348. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. One action

addresses the labeling of products containing sodium bicarbonate as an

active ingredient. The other action addresses the use of antacids to

relieve upset stomach associated with overindulgence in food and drink.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action (Sodium Bicarbonate

Labeling) To Be Determined

Final Action (Overindulgence

Labeling) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF52

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses skin bleaching drug products containing hydroquinone.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 08/29/06 71 FR 51146

[[Page 64440]]

NPRM Comment Period End 12/27/06

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF53

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses the use of stimulant active ingredients to relieve symptoms

associated with a hangover.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF56

_______________________________________________________________________

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

UNITED STATES

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

21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264

Abstract: The final rule will require owners or consignees to label

imported food that is refused entry into the United States. The label

will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the

label's characteristics (such as its size) and processes for verifying

that the label has been affixed properly. We are taking this action to

prevent the introduction of unsafe food into the United States, to

facilitate the examination of imported food, and to implement section

308 of the Public Health Security and Bioterrorism Preparedness and

Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 09/18/08 73 FR 54106

NPRM Comment Period End 12/02/08

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: John D. Reilly, Regulatory Counsel, Department of

Health and Human Services, Food and Drug Administration, Center for

Food Safety and Applied Nutrition, CPK 1, Room 1C-015, (HFS-024), 5100

Paint Branch Parkway, College Park, MD 20740

Phone: 301 436-1530

Fax: 301-436-2637

Email: [email protected]

RIN: 0910-AF61

_______________________________________________________________________

352. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. These actions

address new labeling for antidiarrheal drug products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (New Labeling) To Be Determined

Final Action (New Labeling) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF63

_______________________________________________________________________

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

PRODUCTS

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. The first

action addresses health care products. The second action addresses food

handler products. The third action addresses testing requirements. The

fourth action addresses consumer products. The final actions listed

will address the healthcare, consumer, and first aid antiseptic drug

products respectively.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Healthcare) 06/17/94 59 FR 31402

NPRM (Food Handlers) To Be Determined

NPRM (Testing) To Be Determined

NPRM (Consumer) 12/00/10

Final Action (Healthcare) To Be Determined

Final Action (Consumer) To Be Determined

Final Action (First Aid

Antiseptic) To Be Determined

[[Page 64441]]

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF69

_______________________________________________________________________

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

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

355; 21 USC 360; 21 USC 371

Abstract: The OTC drug review establishes conditions under which OTC

drugs are considered generally recognized as safe and effective and not

misbranded. After a final monograph (i.e., final rule) is issued, only

OTC drugs meeting the conditions of the monograph, or having an

approved new drug application, may be legally marketed. This action

addresses the products used for urinary pain relief.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic) To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF70

_______________________________________________________________________

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

ACTIVE INGREDIENTS

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

355; 21 USC 360; 21 USC 371

Abstract: The Food and Drug Administration (FDA) is proposing that

certain ingredients in over-the-counter (OTC) drug products are not

generally recognized as safe and effective or are misbranded. FDA is

issuing this proposed rule because we did not receive any data and

information on these ingredients in response to our request on December

31, 2003 (68 FR 75585). This proposed rule is part of FDA's ongoing

review of OTC drug products.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 06/19/08 73 FR 34895

NPRM Comment Period End 09/17/08

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management

Officer, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research, WO-22, Room

5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-2090

Fax: 301 796-9899

Email: [email protected]

RIN: 0910-AF95

_______________________________________________________________________

Department of Health and Human Services (HHS) Completed Actions

Food and Drug Administration (FDA)

_______________________________________________________________________

356. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC

393; 42 USC 243; 42 USC 264; 42 USC 271; . . .

Abstract: Publication of this final rule was an action item in the Food

Protection Plan announced by the Department of Health and Human

Services (HHS) in November 2007.

In July 1999, the Food and Drug Administration (FDA) and the Food

Safety Inspection Service (FSIS) committed to developing an action plan

to address the presence of Salmonella Enteritidis (SE) in shell eggs

and egg products using a farm-to-table approach. FDA and FSIS held a

public meeting on August 26, 1999, to obtain stakeholder input on the

draft goals, as well as to further develop the objectives and action

items for the action plan. The Egg Safety Action Plan was announced on

December 11, 1999. The goal of the Action Plan is to reduce egg-related

SE illnesses. The Egg Safety Action Plan consists of eight objectives

covering all stages of the farm-to-table continuum as well as support

functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento,

CA), and July 31, 2000 (Washington, DC), joint public meetings were

held by FDA and FSIS to solicit and discuss information related to the

implementation of the objectives in the Egg Safety Action Plan.

On September 22, 2004, FDA published a proposed rule that would require

egg safety measures to prevent the contamination of shell eggs with SE

during egg production. The proposal also solicited comment on whether

recordkeeping requirements should include a written SE prevention plan

and records for compliance with the SE prevention measures, and whether

safe egg handling and preparation practices should be mandated for

retail establishments that specifically serve a highly susceptible

population (e.g., nursing homes, hospitals, day care centers). The

proposed egg production SE prevention measures included: (1) Provisions

for procurement of chicks and pullets; (2) a biosecurity program; (3) a

rodent and pest control program; (4) cleaning and disinfection of

poultry houses that have had an environmental or egg test positive for

SE; (5) egg testing when an environmental test is positive; and (6)

refrigerated storage of eggs held at the farm. Additionally, to verify

that the measures have been effective, the rule proposes that producers

test the poultry house environment for SE. If the environmental test is

positive, eggs from that environment must be tested for SE, and if the

egg test is positive, the eggs must be diverted to egg products

processing or a treatment

[[Page 64442]]

process that achieves at least a five-log destruction of SE.

The proposed rule was a step in a broader farm-to-table egg safety

effort that includes FDA's requirements for safe handling statements on

egg cartons, and refrigerated storage of shell eggs at retail, and egg

safety education for consumers and retail establishments. The rule had

a 90-day comment period, which ended December 21, 2004. To discuss the

proposed rule and solicit comments from interested stakeholders, FDA

held three public meetings: October 28, 2004, in College Park, MD;

November 9, 2004, in Chicago, IL; and November 16, 2004, in Los

Angeles, CA. The comment period was reopened until July 25, 2005, to

solicit further comment and information on industry practices and

programs that prevent SE-monitored chicks from becoming infected by SE

during the period of pullet rearing until placement into laying hen

houses.

On July 9, 2009, FDA published the final rule that requires shell egg

producers to implement measures to prevent SE from contaminating eggs

on the farm and from further growth during storage and transportation,

and requires these producers to maintain records concerning their

compliance with the rule and to register with FDA. FDA took this action

because SE is among the leading bacterial causes of foodborne illness

in the United States, and shell eggs are a primary source of human SE

infections. The final rule will reduce SE-associated illnesses and

deaths by reducing the risk that shell eggs are contaminated with SE.

Egg producers with 50,000 or more laying hens have 12 months to comply

with the final rule, as do persons who must comply with only the

refrigeration requirements. Producers with fewer than 50,000 but at

least 3,000 laying hens have 36 months to comply. Producers with fewer

than 3,000 laying hens and those who sell all of their eggs directly to

consumers are exempt from the rule.

FDA is developing guidance documents and will hold public meetings this

year to help ensure covered persons understand how to comply with the

final rule.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 09/22/04 69 FR 56824

NPRM Comment Period End 12/21/04

NPRM Reopened Comment Period End06/09/05 70 FR 24490

NPRM Extension of Reopened

Comment Period End 07/25/05 70 FR 33404

Final Action 07/09/09 74 FR 33030

Regulatory Flexibility Analysis Required: Yes

Agency Contact: John F. Sheehan, Director, Department of Health and

Human Services, Food and Drug Administration, Division of Plant and

Dairy Food Safety (HFS-315), Room 3B-012, 5100 Paint Branch Parkway,

College Park, MD 20740

Phone: 301 436-2367

Fax: 301 436-2632

Email: [email protected]

RIN: 0910-AC14

_______________________________________________________________________

357. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT

THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY

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

371

Abstract: On October 6, 2005, the Food and Drug Administration (FDA)

proposed to amend its regulations to prohibit the use of certain cattle

origin materials in the food or feed of all animals to further

strengthen existing safeguards designed to help prevent the spread of

bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of

a BSE-positive dairy cow in December 2003 has caused FDA to review its

policies for prevention of BSE, which resulted in this rulemaking. On

April 28, 2008, FDA published a final rule prohibiting the use of

certain cattle origin materials in the food and feed of all animals. On

October 23, 2008 FDA corrected the final rule on BSE that appeared in

the Federal Register of April 25, 2008 (73 FR 22719-22758). The final

rule was inadvertently published with incorrect dollar amounts in two

separate areas: the summary of economic impacts and the paperwork

burden table.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

ANPRM 07/14/04 69 FR 42288

ANPRM Comment Period End 08/13/04

NPRM 10/06/05 70 FR 58569

NPRM Comment Period End 12/20/05

Final Rule 04/25/08 73 FR 22720

Final Rule-Correction 10/23/08 73 FR 63072

Final Rule Effective 04/27/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Burt Pritchett, Biologist, Department of Health and

Human Services, Food and Drug Administration, Center for Veterinary

Medicine, Room 2654 (MPN-4, HFV-222), 7519 Standish Place, Rockville,

MD 20855

Phone: 240 453-6860

Fax: 240 453-6882

Email: [email protected]

RIN: 0910-AF46

_______________________________________________________________________

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

Centers for Medicare & Medicaid Services (CMS)

_______________________________________________________________________

358. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE

PRESCRIPTION DRUG BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS-4085-F)

Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security

Act)

Abstract: This proposed rule sets forth programmatic and operational

changes to the Medicare Advantage and Prescription Drug Benefit

programs (for example, strengthens beneficiary protections and sponsor

entrance and exit rules, provides plan offerings with meaningful

differences, improves payment rules and data collection for oversight

and quality assessment).

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 10/22/09 74 FR 54634

[[Page 64443]]

NPRM Comment Period End 12/07/09

Final Action 10/00/12

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy

and Quality, Department of Health and Human Services, Centers for

Medicare & Medicaid Services, Mail Stop C1-26-26, 7500 Security

Boulevard, Baltimore, MD 21244

Phone: 410 786-6041

Email: [email protected]

RIN: 0938-AP77

_______________________________________________________________________

359. PROPOSED CHANGES TO THE HOSPITAL INPATIENT

PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES

AND TO THE LONG-TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P)

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

the Federal Register.

RIN: 0938-AP80

_______________________________________________________________________

360. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE

PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011

(CMS-1504-P)

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

the Federal Register.

RIN: 0938-AP82

_______________________________________________________________________

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

Centers for Medicare & Medicaid Services (CMS)

_______________________________________________________________________

361. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR

CY 2010 (CMS-1413-FC)

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

sec 1871

Abstract: This rule revises payment polices under the physician fee

schedule, as well as other policy changes to payment under Part B.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 07/13/09 74 FR 33520

NPRM Comment Period End 08/31/09

Final Action 12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Diane Milstead, Health Insurance Specialist, Department

of Health and Human Services, Centers for Medicare & Medicaid Services,

Centers for Medicaid Mangement, Mailstop C4-03-06, 7500 Security Blvd,

Baltimore, MD 21244

Phone: 410 786-3355

Email: [email protected]

RIN: 0938-AP40

_______________________________________________________________________

362. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND

AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS-1414-FC)

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

Abstract: This rule revises the Medicare hospital outpatient

prospective payment system to implement applicable statutory

requirements and changes arising from our continuing experience with

this system and to implement certain related provisions of the Medicare

Improvements for Patients and Providers Act of 2008 (MIPPA). In

addition, the rule describes changes to the amounts and factors used to

determine the payment rates for Medicare hospital outpatient services

paid under the prospective payment system. The rule also changes the

Ambulatory Surgical Center Payment System list of services and rates.

These changes applicable to services furnished on or after January 1

annually.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 07/20/09 74 FR 35231

NPRM Comment Period End 08/31/09

Final Action 12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Alberta Dwivedi, Health Insurance Specialist,

Department of Health and Human Services, Centers for Medicare &

Medicaid Services, Centers for Medicare Management, Mailstop C5-01-26,

7500 Security Blvd, Baltimore, MD 21244

Phone: 410 786-0763

Email: [email protected]

RIN: 0938-AP41

_______________________________________________________________________

363. CHILDREN'S HEALTH INSURANCE PROGRAM (CHIP); ALLOTMENT METHODOLOGY

AND STATES' FISCAL YEAR 2009 CHIP ALLOTMENTS (CMS-2291-F)

Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) and

2104(f) of the Social Security Act; CHIPRA of 2009 (PL 111-3)

Abstract: This proposed rule describes the implementation of certain

funding provisions under existing Medicaid laws, the Children's Health

Insurance Program (CHIP) and recent legislation, and other related CHIP

legislation. It proposes methodologies and procedures for determining

States' fiscal year (FY) 2009 through FY 2013 allotments and payments

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 09/16/09 74 FR 47517

NPRM Comment Period End 11/16/09

Final Action 02/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Richard Strauss, Technical Director, Department of

Health and Human Services, Centers for Medicare & Medicaid Services,

Center for Medicaid State Operations, Mailstop S3-13-15, 7500 Security

Boulevard, Baltimore, MD 21244

Phone: 410 786-1850

Email: [email protected]

RIN: 0938-AP53

[[Page 64444]]

_______________________________________________________________________

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

Centers for Medicare & Medicaid Services (CMS)

_______________________________________________________________________

364. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-

3819-P) (SECTION 610 REVIEW)

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

1395hh; 42 USC 1395bb

Abstract: This proposed rule would revise the existing Conditions of

Participation (CoPs) that Home Health Agencies (HHAs) must meet to

participate in the Medicare program. The requirements focus on the

actual care delivered to patients by HHAs, reflect an interdisciplinary

view of patient care, allow HHAs greater flexibility in meeting quality

standards, and eliminate unnecessary procedural requirements. These

changes are an integral part of our efforts to achieve broad-based

improvements and measurements of the quality of care furnished through

Federal programs while at the same time reducing procedural burdens on

providers.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 03/10/97 62 FR 11005

NPRM Comment Period End 06/09/97

Second NPRM To Be Determined

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Mercedes Benitez-McCray, Health Insurance Specialist,

Department of Health and Human Services, Centers for Medicare &

Medicaid Services, Clinical Standards & Quality, Mailstop S3-02-01,

7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-5716

Email: [email protected]

RIN: 0938-AG81

_______________________________________________________________________

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

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

Abstract: This rule sets forth electronic standards for health care

claims attachments. The standards are required by the Health Insurance

Portability and Accountability Act of 1996. They will be used to

transmit clinical or administrative data for claims adjudication

purposes.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 09/23/05 70 FR 55989

NPRM Comment Period End 11/22/05

Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Elizabeth Holland, Health Insurance Specialist,

Department of Health and Human Services, Centers for Medicare &

Medicaid Services, Office of E-Health Standards and Services, Mailstop

S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-1309

Email: [email protected],

RIN: 0938-AK62

_______________________________________________________________________

366. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-

2249-F) (SECTION 610 REVIEW)

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

Abstract: This rule amends the Medicaid regulations to define and

describe the home- and community-based State plan services implementing

the new section 1915(i) of the Social Security Act as added by section

6086 of the Deficit Reduction Act of 2005.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 04/04/08 73 FR 18676

NPRM Comment Period End 06/03/08

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Suzanne Bosstick, Department of Health and Human

Services, Centers for Medicare & Medicaid Services, 7500 Security

Boulevard, Baltimore, MD 21244

Phone: 410 786-1301

Email: [email protected]

RIN: 0938-AO53

_______________________________________________________________________

367. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS-

3140-P) (SECTION 610 REVIEW)

Legal Authority: 42 USC 1302; 42 USC 1395hh

Abstract: This proposed rule would establish requirements that long-

term care (LTC) facilities must have an agreement with hospice agencies

when hospice care is provided in a long-term care facility to

participate in the Medicare and Medicaid programs. We are proposing

these new requirements to ensure that quality hospice care is provided

to eligible residents.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Trish Brooks, Health Insurance Specialist, Department

of Health and Human Services, Centers for Medicare & Medicaid Services,

Office of Clinical Standards and Quality, Mailstop S3-02-01, 7500

Security Boulevard, Baltimore, MD 21244

Phone: 410 786-4561

Email: [email protected]

RIN: 0938-AP32

_______________________________________________________________________

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

Legal Authority: PL 109-171, sec 6044

Abstract: This rule replaces the final rule published on December 3,

2008 (73 FR 73694) to implement provisions of the Deficit Reduction Act

(DRA) of 2005. It also provides States increased flexibility under an

approved State plan to define the scope of covered medical assistance

by offering coverage of benchmark or benchmark-equivalent benefit

packages to certain Medicaid-eligible individuals. In addition, this

final rule responds to public comments on the February 22, 2008

proposed rule as well as public comments on the December 3, 2009

``final rule'' which was temporarily delayed twice, once by an interim

final rule with comment period published on February 2, 2009, and the

second time by a final rule published on April 3, 2009, further

delaying the effective date and reopening the comment period.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

Final Action To Be Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Chris Gerhardt, Department of Health and Human

Services, Centers for Medicare & Medicaid Services, Mailstop S2-01-16,

[[Page 64445]]

7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-0693

Email: [email protected]

RIN: 0938-AP72

_______________________________________________________________________

Department of Health and Human Services (HHS) Completed Actions

Centers for Medicare & Medicaid Services (CMS)

_______________________________________________________________________

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

Legal Authority: title XIX; Social Security Act

Abstract: As part of the President's 2008 Budget, this rule establishes

that States may not include GME as a reimbursable cost or program under

their approved Medicaid State Plan. The rule enhances fiscal integrity

and improves accountability with respect to payment for medical

services in the Medicaid program.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 05/23/07 72 FR 28930

NPRM Comment Period End 06/22/07

Withdrawn 10/08/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kristin Fan, Department of Health and Human Services,

Centers for Medicare & Medicaid Services, Centers for Medicaid State

Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD

21224

Phone: 410 786-4581

Fax: 410 786-1008

Email: [email protected]

RIN: 0938-AO95

_______________________________________________________________________

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

Legal Authority: Genetic information Nondiscrimination Act of 2008 (PL

110-223), enacted May 21, 2008.

Abstract: This rule implements statutory changes to the PHSA affecting

the group and individual health insurance markets, non-federal

governmental plans, and Medicare supplemental insurance (Medigap) made

by the Genetic Information Nondiscrimination Act of 2008 (Pub. L. 110-

223).

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

ANPRM 10/10/08 73 FR 60208

ANPRM Comment Period End 12/09/08

Interim Final Rule 10/07/09 74 FR 51663

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Adam M Shaw, Senior Technical Adviser, Department of

Health and Human Services, Centers for Medicare & Medicaid Services,

Mail Stop C1-22-06, 7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-1091

Email: [email protected]

RIN: 0938-AP37

_______________________________________________________________________

371. CHANGES TO THE HOSPITAL INPATIENT AND LONG-TERM CARE PROSPECTIVE

PAYMENT SYSTEM FOR FY 2010 (CMS-1406-F)

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

Abstract: This rule revises the Medicare hospital inpatient and Long

Term Care prospective payment systems (IPPS) for operating and capital-

related costs to implement changes arising from our continuing

experience with these systems.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 05/22/09 74 FR 24080

NPRM Comment Period End 06/30/09

Final Rule 08/27/09 74 FR 43753

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Tiffany Swygert, Health Insurance Specialist,

Department of Health and Human Services, Centers for Medicare &

Medicaid Services, Div of Acute Care, Hosp and Ambulatory Policy Group,

Mailstop C4-25-11, 7500 Security Blvd, Baltimore, MD 21244

Phone: 410 786-4642

Email: [email protected]

RIN: 0938-AP39

_______________________________________________________________________

372. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED

NURSING FACILITIES--UPDATE FOR FY 2010 (CMS-1410-F)

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

Abstract: This rule updates the payment rates used under the SNF PPS

beginning October 1, 2009.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 05/12/09 74 FR 22208

NPRM Comment Period End 06/30/09

Final Action 08/11/09 74 FR 40287

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William Ullman, Technical Advisor, Department of Health

and Human Services, Centers for Medicare & Medicaid Services, Centers

for Medicare Management, Mailstop C5-06-27, 7500 Security Boulvard,

Baltimore, MD 21244

Phone: 410 786-5667

Fax: 410 786-0765

Email: [email protected]

RIN: 0938-AP46

_______________________________________________________________________

373. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM AND RATE UPDATE FOR CY 2010

(CMS-1560-F)

Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302

and 42 USC 1395(hh); Social Security Act, sec 1895; 42 USC 1395(fff)

Abstract: This rule updates the 60-day national episode rate and the

national per visit rate amounts under the Medicare Prospective Payment

System for home health agencies, effective January 1, 2010.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 08/06/09 74 FR 39435

NPRM Comment Period End 08/28/09

Final Action 11/10/09 74 FR 58077

Final Action Effective 01/01/10

[[Page 64446]]

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Randy Throndset, Technical Advisor, Department of

Health and Human Services, Centers for Medicare & Medicaid Services,

Center for Medicare Management, Mailstop C5-07-28, 7500 Security

Boulevard, Baltimore, MD 21244

Phone: 410 786-0131

Fax: 410 786-0765

Email: [email protected]

RIN: 0938-AP55

_______________________________________________________________________

374. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES

FOR FY 2010 (CMS-1538-F)

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

113

Abstract: This rule updates rates for the prospective payment system

for inpatient rehabilitation facilities for FY 2010.

Timetable:

________________________________________________________________________

Action Date FR Cite

________________________________________________________________________

NPRM 05/06/09 74 FR 21052

Final Action 08/13/09 74 FR 40947

NPRM Comment Period End 06/29/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Julie Stankivic, Health Insurance Specialist,

Department of Health and Human Services, Centers for Medicare &

Medicaid Services, Department of Health and Human Services, Mailstop,

C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-5725

Email: julie.stankivic @ cms.hhs.gov

RIN: 0938-AP56

[FR Doc. E9-28598 Filed 12-04-09; 8:45 am]

BILLING CODE 4150-24-S