Monday, 

December 20, 2010 

Part VIII 

Department of 

Health and Human 

Services 

Semiannual Regulatory Agenda 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
79764 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

21 CFR Ch. I 

42 CFR Chs. I-V 

45 CFR Subtitle A; Subtitle B, Chs. II, 

III, and XIII 

Regulatory Agenda 

AGENCY: Office of the Secretary, HHS. 

ACTION: Semiannual Regulatory Agenda. 

SUMMARY: The Regulatory Flexibility Act 

of 1980 and Executive Order (EO) 12866 

require the semi-annual issuance of an 

inventory of rulemaking actions under 

development throughout the 

Department with a view to offering 

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 paper issue of 

the Federal Register relate strictly 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 2011 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: September 21, 2010. 

Dawn L. Smalls, 

Executive Secretary, 

Department of Health and Human Services. 

Office of the Secretary—Proposed Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

302 Revisions to Regulations Addressing the OIG’s Authority To Impose Civil Money Penalties and Assessments 

(Section 610 Review) ................................................................................................................................................. 0991–AB03 

Office of the Secretary—Final Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

303 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology 

for Economic and Clinical Health Act (Reg Plan Seq No. 41) ................................................................................... 0991–AB57 

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

Office of the Secretary—Completed Actions 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

304 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria 

for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review) .......................... 0991–AB58 

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

Sequence 

Number Title 

Regulation 

Identifier 

Number 

305 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities 

for Children and Youth ................................................................................................................................................ 0930–AA10 

306 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review) ...................... 0930–AA14 


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HHS 

Centers for Disease Control and Prevention—Proposed Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

307 Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman Primate ............................. 0920–AA23 

Centers for Disease Control and Prevention—Final Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

308 Control of Communicable Diseases: Foreign and Possessions ................................................................................... 0920–AA12 

309 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 Review) ....................... 0920–AA32 

Centers for Disease Control and Prevention—Long-Term Actions 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

310 Quality Assurance Requirements for Respirators ......................................................................................................... 0920–AA04 

Food and Drug Administration—Prerule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review) ................................................................................................................................... 0910–AG06 

Food and Drug Administration—Proposed Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

312 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg Plan Seq No. 45) ........ 0910–AC52 

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

314 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products .......................................................................... 0910–AF36 

315 Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................................ 0910–AF38 

316 Over-the-Counter (OTC) Drug Review—Sunscreen Products ..................................................................................... 0910–AF43 

317 Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ............................................................ 0910–AF69 

318 Import Tolerances for Residues of Unapproved New Animal Drugs in Food .............................................................. 0910–AF78 

319 Laser Products; Amendment to Performance Standard ............................................................................................... 0910–AF87 

320 Pet Food Labeling Requirements ................................................................................................................................. 0910–AG09 

321 Process Controls for Animal Feed Ingredients and Mixed Animal Feed ...................................................................... 0910–AG10 

322 Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products ................................................... 0910–AG12 

323 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products ........................ 0910–AG18 

324 Unique Device Identification (Reg Plan Seq No. 46) ................................................................................................... 0910–AG31 

325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act .............................................................. 0910–AG38 

326 Cigarette Warning Label Statements (Reg Plan Seq No. 47) ..................................................................................... 0910–AG41 

327 General Hospital and Personal Use Devices: Designation of Special Controls for Infusion Pumps ........................... 0910–AG54 

328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No. 48) ................................ 0910–AG56 

329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants (Reg Plan Seq No. 49) ............... 0910–AG57 

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


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HHS 

Food and Drug Administration—Final Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

330 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products .......................................... 0910–AA97 

331 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ................................... 0910–AC53 

332 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and 

Lactation Labeling ........................................................................................................................................................ 0910–AF11 

333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; 

Records and Reports; and Quality Factors (Reg Plan Seq No. 50) .......................................................................... 0910–AF27 

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 

336 Over-the-Counter (OTC) Drug Review—External Analgesic Products ......................................................................... 0910–AF35 

337 Over-the-Counter (OTC) Drug Review—Skin Protectant Products .............................................................................. 0910–AF42 

338 Use of Materials Derived From Cattle in Human Food and Cosmetics ....................................................................... 0910–AF47 

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

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 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements ...................................................................................................................................................................... 0910–AB88 

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

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

343 Over-the-Counter (OTC) Drug Review—Ophthalmic Products .................................................................................... 0910–AF39 

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

345 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products ................................................................... 0910–AF44 

346 Over-the-Counter (OTC) Drug Review—Weight Control Products ............................................................................... 0910–AF45 

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 Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products ......................................................................... 0910–AF63 

352 Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products ................................................................. 0910–AF70 

353 Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients ......................................................... 0910–AF95 

354 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and 

Administrative Procedures (Section 610 Review) ...................................................................................................... 0910–AG14 

355 Produce Safety Regulation ........................................................................................................................................... 0910–AG35 

356 Modernization of the Current Food Good Manufacturing Practices Regulation ........................................................... 0910–AG36 

Food and Drug Administration—Completed Actions 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

357 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Completion of a Section 610 Review) ............................................................................................................................................................................ 0910–AG25 

358 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and 

Adolescents ................................................................................................................................................................. 0910–AG33 

359 Over-the-Counter Human Drugs; Labeling Requirements (Completion of a Section 610 Review) .......................... 0910–AG34 

Centers for Medicare & Medicaid Services—Proposed Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

360 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) .................... 0938–AG81 


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HHS 

Centers for Medicare & Medicaid Services—Proposed Rule Stage (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

361 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 Review) .................... 0938–AP32 

362 Influenza Vaccination Standard for Certain Medicare Participating Providers and Suppliers(CMS-3213-P) .............. 0938–AP92 

363 Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System and LTCH Requirements (CMS-3177-P) ........................................ 0938–AP97 

364 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 

Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates (CMS-1518-P) (Reg Plan Seq No. 55) ....... 0938–AQ24 

365 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-P) (Reg Plan Seq No. 57) ........................................................................................... 0938–AQ26 

366 Changes to the ESRD Prospective Payment System for CY 2012 (CMS-1577-P) ..................................................... 0938–AQ27 

367 Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-2346-P) ............................... 0938–AQ53 

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

Centers for Medicare & Medicaid Services—Final Rule Stage 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

368 Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 (CMS-1503-C) ............. 0938–AP79 

369 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2011 (CMS-1504-C) .................................................................................................................................. 0938–AP82 

Centers for Medicare & Medicaid Services—Completed Actions 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

370 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs for Contract Year 2011 

(CMS-4085-F) .............................................................................................................................................................. 0938–AP77 

371 Electronic Health Record (EHR) Incentive Program (CMS-0033-F) ............................................................................. 0938–AP78 

372 Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment 

System ......................................................................................................................................................................... 0938–AP80 

373 Hospital IPPS for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term Care Hospital PPS 

and Rate Year 2010 Rates (CMS-1406-N) ................................................................................................................. 0938–AQ03 

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

Office of the Secretary (OS) 

302. REVISIONS TO REGULATIONS 

ADDRESSING THE OIG’S AUTHORITY 

TO IMPOSE CIVIL MONEY PENALTIES 

AND ASSESSMENTS (SECTION 610 

REVIEW) 

Legal Authority: 42 USC 1320a–7a; 42 

USC 1395mm; 42 USC 1395w–27; 42 

USC 1396b; PL 99–660; PL 107–188 

Abstract: This proposed rule would 

revise part 1003, addressing the Office 

of Inspector General’s authority to 

propose the imposition of civil money 

penalties and assessments by 

reorganizing and simplifying existing 

regulatory text and eliminating obsolete 

references contained in the current 

regulations. Among the proposed 

revisions, this rule would establish 

separate subparts within part 1003 for 

various categories of violations; clarify 

the availability of exclusion for certain 

violations in addition to civil money 

penalties and assessments; date various 

references to managed care organization 

authorities; and clarify the application 

of section 1140 of the Social Security 

Act with respect to the misuse of 

certain Departmental symbols, 

emblems, or names through Internet 

and e mail communications. 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Action Date FR Cite 

NPRM Comment 

Period End 

06/00/11 

Regulatory Flexibility Analysis 

Required: No 

Agency Contact: Patrice S. Drew, 

Department of Health and Human 

Services, Office of the Secretary, Office 

of the Inspector General, 330 

Independence Avenue SW., 

Washington, DC 20201 

Phone: 202 619–1368 

Email: patrice.drew@hhs.gov 

RIN: 0991–AB03 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
79768 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 

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

Office of the Secretary (OS) 

303. MODIFICATIONS TO THE HIPAA 

PRIVACY, SECURITY, AND 

ENFORCEMENT RULES UNDER THE 

HEALTH INFORMATION 

TECHNOLOGY FOR ECONOMIC AND 

CLINICAL HEALTH ACT 

Regulatory Plan: This entry is Seq. No. 

41 in part II of this issue of the Federal 

Register. 

RIN: 0991–AB57 

Department of Health and Human Services (HHS) Completed Actions 

Office of the Secretary (OS) 

304. HEALTH INFORMATION 

TECHNOLOGY: INITIAL SET OF 

STANDARDS, IMPLEMENTATION 

SPECIFICATIONS, AND 

CERTIFICATION CRITERIA FOR 

ELECTRONIC HEALTH RECORD 

TECHNOLOGY (RULEMAKING 

RESULTING FROM A SECTION 610 

REVIEW) 

Legal Authority: 42 USC 300jj–14 

Abstract: The Department of Health 

and Human Services (HHS), Office of 

the National Coordinator for Health 

Information Technology, will issue an 

interim final rule with a request for 

comments to adopt an initial set of 

standards, implementation 

specifications, and certification criteria, 

as required by section 3004(b)(1) of the 

Public Health Service Act. The 

certification criteria adopted in this 

initial set establish the technical 

capabilities and related standards that 

certified electronic health record (EHR) 

technology will need to include in 

support of the Medicare and Medicaid 

EHR Incentive Programs. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 01/13/10 75 FR 2014 

Interim Final Rule 

Comment Period 

End 

03/15/10 

Action Date FR Cite 

Interim Final Rule 

Effective 

02/12/10 

Final Action 07/28/10 75 FR 44590 

Regulatory Flexibility Analysis 

Required: No 

Agency Contact: Steven Posnack, 

Policy Analyst, Department of Health 

and Human Services, Office of the 

Secretary, Office of the National 

Coordinator for Health Information 

Technology, 200 Independence Avenue 

SW., Washington, DC 20201 

Phone: 202 690–7151 

RIN: 0991–AB58 

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

Substance Abuse and Mental Health Services Administration (SAMHSA) 

305. 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 

306. OPIOID DRUGS IN 

MAINTENANCE OR DETOXIFICATION 

TREATMENT OF OPIATE ADDICTION 

(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 To Be Determined 

Regulatory Flexibility Analysis 

Required: No 

Agency Contact: Nicholas Reuter, 

Department of Health and Human 

Services, Substance Abuse and Mental 

Health Services Administration, Suite 


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HHS—SAMHSA Long-Term Actions 

2–1063, One Choke Cherry Road, 

Rockville, MD 20857 

Phone: 240 276–2716 

RIN: 0930–AA14 

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

Centers for Disease Control and Prevention (CDC) 

307. CONTROL OF COMMUNICABLE 

DISEASES: FOREIGN AND 

POSSESSIONS REGULATIONS; 

NONHUMAN PRIMATE 

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 

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 01/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Stacy Howard, 

Department of Health and Human 

Services, Centers for Disease Control 

and Prevention, MS E03, CLFT 

Building 16, Room 4324, Atlanta, GA 

30329 

Phone: 404 498–1600 

Email: showard@cdc.gov 

RIN: 0920–AA23 

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

Centers for Disease Control and Prevention (CDC) 

308. CONTROL OF COMMUNICABLE 

DISEASES: FOREIGN AND 

POSSESSIONS 

Legal Authority: 42 USC 243; 42 USC 

264 and 265; 42 USC 267 and 268; 42 

USC 270 and 271 

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. Communicable disease 

regulations are divided into two parts: 

Part 71 pertaining to foreign arrivals 

and part 70 pertaining to 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 final rule 

focuses primarily on requirements 

relating to the reporting of deaths and 

illnesses onboard aircrafts and ships, 

and the collection of specific traveler 

contact information for the purpose of 

CDC contacting travelers in the event 

of an exposure to a communicable 

disease. 

Timetable: 

Action Date FR Cite 

NPRM 11/30/05 70 FR 71892 

NPRM Comment 

Period End 

01/20/06 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Stacy Howard, 

Department of Health and Human 

Services, Centers for Disease Control 

and Prevention, MS E03, CLFT 

Building 16, Room 4324, Atlanta, GA 

30329 

Phone: 404 498–1600 

Email: showard@cdc.gov 

RIN: 0920–AA12 

309. POSSESSION, USE, AND 

TRANSFER OF SELECT AGENTS AND 

TOXINS: CHAPARE VIRUS (SECTION 

610 REVIEW) 

Legal Authority: PL 107–188 

Abstract: The Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 authorizes the 

HHS Secretary to regulate the 

possession, use, and transfer of select 

agents and toxins that have the 

potential to pose a severe threat to 

public health and safety. These 

regulations are set forth at 42 CFR 73. 

Criteria used to determine whether a 

select agent or toxin should be 

included under the provisions of these 

regulations are based on: (1) The effect 

on human health as a result of 

exposure to the agent or toxin, (2) the 

degree of contagiousness of the agent 

or toxin, (3) the methods by which the 

agent or toxin is transferred to humans, 

(4) the availability and effectiveness of 

pharmacotherapies and immunizations 

to treat and prevent and 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 


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HHS—CDC Final Rule Stage 

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 11/00/11 

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) Long-Term Actions 

Centers for Disease Control and Prevention (CDC) 

310. QUALITY ASSURANCE 

REQUIREMENTS FOR RESPIRATORS 

Legal Authority: 29 USC 651 et seq; 

30 USC 3; 30 USC 5; 30 USC 7; 30 

USC 811; 30 USC 842(h); 30 USC 844 

Abstract: NIOSH plans to modify the 

Administrative/Quality Assurance 

sections of 42 CFR part 84, Approval 

of Respiratory Protective Devices. Areas 

for potential modification in this 

module are: (1) Upgrade of quality 

assurance requirements; (2) ability to 

use private sector quality auditors and 

private sector testing laboratories in the 

approval program; and (3) revised 

approval label requirements. 

Timetable: 

Action Date FR Cite 

NPRM 12/10/08 73 FR 75045 

NPRM Comment 

Period End 

02/09/09 

NPRM Comment 

Period Reopened 

03/04/09 74 FR 9381 

NPRM Comment 

Period Reopened 

End 

04/10/09 

NPRM Comment 

Period Reopening 

Extended 

05/21/09 74 FR 23815 

Action Date FR Cite 

NPRM Comment 

Period End 

10/09/09 

Final Action To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: William E. Newcomb, 

Physical Scientist, Department of 

Health and Human Services, Centers for 

Disease Control and Prevention, 626 

Cochran Mill Road, PO Box 18070, 

Pittsburgh, PA 15236 

Phone: 412 386–5200 

RIN: 0920–AA04 

Department of Health and Human Services (HHS) Prerule Stage 

Food and Drug Administration (FDA) 

311. 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, provided the words 

‘‘keep refrigerated’’ appear on the 

principal display panel or information 

panel. 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. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 79771 

HHS—FDA Prerule Stage 

Timetable: 

Action Date FR Cite 

Begin Review 12/15/09 

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: geraldine.june@fda.hhs.gov 

RIN: 0910–AG06 

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

Food and Drug Administration (FDA) 

312. ELECTRONIC SUBMISSION OF 

DATA FROM STUDIES EVALUATING 

HUMAN DRUGS AND BIOLOGICS 

Regulatory Plan: This entry is Seq. No. 

45 in part II of this issue of the Federal 

Register. 

RIN: 0910–AC52 

313. 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) 

10/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF31 

314. 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 

acetaminophen safety. The third action 

addresses products marketed for 

children under 2 years old and weightand age-based dosing for children’s 

products. The fourth action addresses 

combination products containing the 

analgesic acetaminophen or aspirin and 

sodium bicarbonate used as an antacid 

ingredient. 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 

Final Action (Required 

Warnings and Other 

Labeling) 

04/29/09 74 FR 19385 

Final Action 

(Correction) 

06/30/09 74 FR 31177 

Final Action (Technical 

Amendment) 

11/25/09 74 FR 61512 

NPRM 

(Acetaminophen) 

03/00/11 

NPRM (Amendment) 

(Pediatric) 

To Be Determined 

Action Date FR Cite 

NPRM (Amendment) 

(Sodium 

Bicarbonate) 

To Be Determined 

NPRM 

(Overindulgence/ 

Hangover) 

To Be Determined 

Final Action (Internal 

Analgesics) 

To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF36 

315. OVER–THE–COUNTER (OTC) 

DRUG REVIEW—LAXATIVE DRUG 

PRODUCTS 

Legal Authority: 21 USC 321p; 21 USC 

331; 21 USC 351 to 353; 21 USC 355; 

21 USC 360 to 360a; 21 USC 371 to 

371a 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. The first 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. The final action will address 

laxative drug products. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
79772 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 

HHS—FDA Proposed Rule Stage 

Timetable: 

Action Date FR Cite 

Final Action (Granular 

Psyllium) 

03/29/07 72 FR 14669 

NPRM (Professional 

Labeling—Sodium 

Phosphate) 

12/00/10 

NPRM (Professional 

Labeling) 

To Be Determined 

Final Action (Laxative 

Drug Products) 

To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF38 

316. 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 

active ingredients reviewed under Time 

and Extent Applications. The second 

action addresses other safety and 

effectiveness issues for OTC sunscreen 

drug products. The third action 

finalizes sunscreen labeling and testing 

requirements for both ultraviolet B and 

ultraviolet A radiation protection. The 

fourth action addresses the safety of 

sunscreen products. The last action 

addresses combination products 

containing sunscreen and insect 

repellent ingredients. 

Timetable: 

Action Date FR Cite 

ANPRM (Sunscreen 

and Insect 

Repellent) 

02/22/07 72 FR 7941 

ANPRM Comment 

Period End 

05/23/07 

Action Date FR Cite 

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

NPRM Comment 

Period End 

12/26/07 

NPRM (Safety and 

Effectiveness) 

12/00/10 

Final Action 

(UVA/UVB) 

12/00/10 

NPRM (Time and 

Extent Applications) 

04/00/11 

ANPRM (Safety) 04/00/11 

NPRM (Sunscreen 

and Insect 

Repellent) 

To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF43 

317. 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 

food handler products. The second 

action addresses testing requirements 

for healthcare professional products. 

The third action addresses the safety 

and effectiveness of consumer products. 

The final actions listed will address the 

healthcare, consumer, food handlers, 

and first aid antiseptic drug products 

respectively. 

Timetable: 

Action Date FR Cite 

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

NPRM (Consumer) 03/00/11 

NPRM (Food 

Handlers) 

To Be Determined 

Action Date FR Cite 

NPRM (Testing — 

Healthcare 

Professional 

Products) 

To Be Determined 

Final Action 

(Healthcare) 

To Be Determined 

Final Action 

(Consumer) 

To Be Determined 

Final Action (Food 

Handlers) 

To Be Determined 

Final Action (First Aid 

Antiseptic) 

To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF69 

318. IMPORT TOLERANCES FOR 

RESIDUES OF UNAPPROVED NEW 

ANIMAL DRUGS IN FOOD 

Legal Authority: 21 USC 360b(a)(6); 21 

USC 371 

Abstract: The Food and Drug 

Administration (FDA) plans to publish 

a proposed rule related to the 

implementation of the import 

tolerances provision of the Animal 

Drug Availability Act of 1996 (ADAA). 

The ADAA authorizes FDA to establish 

tolerances for unapproved new animal 

drugs where edible portions of animals 

imported into the United States may 

contain residues of such drugs (import 

tolerances). It is unlawful to import 

animal-derived food that bears or 

contains residues of a new animal drug 

that is not approved in the United 

States, unless FDA has established an 

import tolerance for that new animal 

drug and the residue of the new animal 

drug in the animal-derived food does 

not exceed that tolerance. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

NPRM Comment 

Period End 

06/00/11 

Regulatory Flexibility Analysis 

Required: Yes 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 79773 

HHS—FDA Proposed Rule Stage 

Agency Contact: Thomas Moskal, 

Consumer Safety Officer, Department of 

Health and Human Services, Food and 

Drug Administration, Center for 

Veterinary Medicine, Room 101, 

(MPN–4, HFV–232), 7519 Standish 

Place, Rockville, MD 20855 

Phone: 240 276–9242 

Fax: 240 276–9241 

Email: thomas.moskal@fda.hhs.gov 

RIN: 0910–AF78 

319. LASER PRODUCTS; 

AMENDMENT TO PERFORMANCE 

STANDARD 

Legal Authority: 21 USC 360hh to 

360ss; 21 USC 371; 21 USC 393 

Abstract: FDA is proposing to amend 

the performance standard for laser 

products to achieve closer 

harmonization between the current 

standard and the International 

Electrotechnical Commission (IEC) 

standard for laser products and medical 

laser products. The proposed 

amendment is intended to update 

FDA’s performance standard to reflect 

advancements in technology. The 

proposal would adopt portions of an 

IEC standard to achieve greater 

harmonization and reflect current 

science. In addition, the proposal 

would include an alternative 

mechanism for providing certification 

and identification, address novelty laser 

products, and clarify the military 

exemption for laser products. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Nancy Pirt, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for 

Devices and Radiological Health, WO 

66 Room 4438, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993 

Phone: 301 796–6248 

Fax: 301 847–8145 

Email: nancy.pirt@fda.hhs.gov 

RIN: 0910–AF87 

320. PET FOOD LABELING 

REQUIREMENTS 

Legal Authority: 21 USC 343; 21 USC 

371; PL 110–85, sec 1002(a)(3) 

Abstract: The President signed into law 

the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) on 

September 27, 2007 (Pub. L. 110-85). 

Title X of the FDAAA includes several 

provisions pertaining to food safety, 

including the safety of pet food. Section 

1002(a) of the new law directs FDA to 

issue new regulations to establish 

updated standards for the labeling of 

pet food that include nutritional and 

ingredient information. 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 03/00/11 

NPRM Comment 

Period End 

06/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: William Burkholder, 

Veterinary Medical Officer, Department 

of Health and Human Services, Food 

and Drug Administration, Center for 

Veterinary Medicine, Room 2642 

(MPN–4, HFV–228), 7519 Standish 

Place, Rockville, MD 20855 

Phone: 240 453–6865 

Email: william.burkholder@fda.hhs.gov 

RIN: 0910–AG09 

321. PROCESS CONTROLS FOR 

ANIMAL FEED INGREDIENTS AND 

MIXED ANIMAL FEED 

Legal Authority: 21 USC 342; 21 USC 

350e; 21 USC 371; 21 USC 374; 42 USC 

264; 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 03/00/11 

NPRM Comment 

Period End 

06/00/11 

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: kim.young@fda.hhs.gov 

RIN: 0910–AG10 

322. OVER–THE–COUNTER (OTC) 

DRUG REVIEW—PEDIATRIC DOSING 

FOR COUGH/COLD PRODUCTS 

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 06/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
79774 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 

HHS—FDA Proposed Rule Stage 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AG12 

323. ELECTRONIC DISTRIBUTION OF 

CONTENT OF LABELING FOR HUMAN 

PRESCRIPTION DRUG AND 

BIOLOGICAL PRODUCTS 

Legal Authority: 21 USC 321; 21 USC 

331; 21 USC 351; 21 USC 352; 21 USC 

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: This rule would require 

electronic package inserts for human 

drug and biological prescription 

products, in lieu of paper, which is 

currently used. These inserts contain 

prescribing information intended for 

healthcare practitioners. This would 

ensure that the information 

accompanying the product is the most 

up-to-date information regarding 

important safety and efficacy issues 

about these products. 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Connie T. Jung, 

Senior Advisor for Pharmacy Affairs, 

Department of Health and Human 

Services, Food and Drug 

Administration, Office of Policy, WO32, 

Room 4254, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993 

Phone: 301 796–4830 

Email: connie.jung@fda.hhs.gov 

RIN: 0910–AG18 

324. UNIQUE DEVICE IDENTIFICATION 

Regulatory Plan: This entry is Seq. No. 

46 in part II of this issue of the Federal 

Register. 

RIN: 0910–AG31 

325. CIGARS SUBJECT TO THE 

FAMILY SMOKING PREVENTION AND 

TOBACCO CONTROL ACT 

Legal Authority: 21 USC 301 et seq, 

The Federal Food, Drug, and Cosmetic 

Act; PL 111–31, The Family Smoking 

Prevention and Tobacco Control Act 

Abstract: The Family Smoking 

Prevention and Tobacco Control Act 

(the Tobacco Control Act) provides 

FDA authority to regulate cigarettes, 

cigarette tobacco, roll-your-own 

tobacco, and smokeless tobacco. 

Section 901 of the Federal Food, Drug, 

and Cosmetic Act, as amended by the 

Tobacco Control Act, permits FDA to 

issue regulations deeming other tobacco 

products to be subject to the Tobacco 

Control Act. This proposed rule would 

deem cigars to be subject to the 

Tobacco Control Act and include 

provisions to address public health 

concerns raised by cigars. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: May Nelson, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, 9200 Corporate 

Boulevard, Rockville, MD 20850 

Phone: 877 287–1373 

Fax: 240 276–3904 

Email: may.nelson@fda.hhs.gov 

RIN: 0910–AG38 

326. CIGARETTE WARNING LABEL 

STATEMENTS 

Regulatory Plan: This entry is Seq. No. 

47 in part II of this issue of the Federal 

Register. 

RIN: 0910–AG41 

327. ∑ GENERAL HOSPITAL AND 

PERSONAL USE DEVICES: 

DESIGNATION OF SPECIAL 

CONTROLS FOR INFUSION PUMPS 

Legal Authority: 21 USC 351 371; 21 

USC 360 and 360c; 21 USC 360e and 

360j; 21 USC 371 

Abstract: Since 2003, FDA has seen a 

dramatic increase in the number of 

device recalls, as well as an increase 

in the number of death and serious 

injury reports submitted regarding 

infusion pumps. An analysis of the 

reports reveals that a majority of the 

recalls and failures were caused by user 

error and/or device design flaw. As a 

result of these incidents, FDA is 

proposing to designate a special 

controls guidance document as the 

special controls for infusion pumps. 

The agency believes that establishing 

these special controls for infusion 

pumps is necessary to provide 

reasonable assurance of the safety and 

effectiveness of these devices. 

Timetable: 

Action Date FR Cite 

NPRM 09/00/11 

NPRM Comment 

Period End 

12/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Nancy Pirt, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for 

Devices and Radiological Health, WO 

66 Room 4438, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993 

Phone: 301 796–6248 

Fax: 301 847–8145 

Email: nancy.pirt@fda.hhs.gov 

RIN: 0910–AG54 

328. ∑ FOOD LABELING: NUTRITION 

LABELING FOR FOOD SOLD IN 

VENDING MACHINES 

Regulatory Plan: This entry is Seq. No. 

48 in part II of this issue of the Federal 

Register. 

RIN: 0910–AG56 

329. ∑ FOOD LABELING: NUTRITION 

LABELING OF STANDARD MENU 

ITEMS IN CHAIN RESTAURANTS 

Regulatory Plan: This entry is Seq. No. 

49 in part II of this issue of the Federal 

Register. 

RIN: 0910–AG57 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 79775 

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

Food and Drug Administration (FDA) 

330. 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 08/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Jane E. Baluss, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Drug 

Evaluation and Research, WO 51, Room 

6362, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993–0002 

Phone: 301 796–3469 

Fax: 301 847–8440 

Email: jane.baluss@fda.hhs.gov 

RIN: 0910–AA97 

331. MEDICAL GAS CONTAINERS 

AND CLOSURES; CURRENT GOOD 

MANUFACTURING PRACTICE 

REQUIREMENTS 

Legal Authority: 21 USC 321; 21 USC 

351 to 21 USC 353 

Abstract: The Food and Drug 

Administration is amending its current 

good manufacturing practice 

regulations and other regulations to 

clarify and strengthen requirements for 

the label, color, dedication, and design 

of medical gas containers and closures. 

Despite existing regulatory 

requirements and industry standards 

for medical gases, there have been 

repeated incidents in which cryogenic 

containers of harmful industrial gases 

have been connected to medical oxygen 

supply systems in hospitals and 

nursing homes and subsequently 

administered to patients. These 

incidents have resulted in death and 

serious injury. There have also been 

several incidents involving highpressure 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. 

FDA has described a number of 

proposals in the proposed rule 

including requiring that gas use outlet 

connections on portable cryogenic 

medical gas containers be permanently 

attached to the valve body. 

Timetable: 

Action Date FR Cite 

NPRM 04/10/06 71 FR 18039 

NPRM Comment 

Period End 

07/10/06 

Final Action 10/00/11 

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, WO 51, Room 

6368, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993–0002 

Phone: 301 796–3522 

Fax: 301 847–8440 

Email: patrick.raulerson@fda.hhs.gov 

RIN: 0910–AC53 

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. One of the deficiencies 

of the category system is that drugs 

may be assigned to the same category 

when the severity, incidence, and types 

of risk are quite different. 

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. Therefore, 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 10/00/11 

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, WO 51, Room 

6224, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993–0002 

Phone: 301 796–4288 


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HHS—FDA Final Rule Stage 

Fax: 301 847–8440 

Email: rachel.bressler@fda.hhs.gov 

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. 

50 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 

NPRM Comment 

Period End 

11/10/05 

Final Action (Technical 

Amendment) 

11/30/07 72 FR 67639 

Final Action 

(Amendment— 

Single Ingredient 

Labeling) 

01/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

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 addresses 

cough/cold drug products containing an 

oral bronchodilator (ephedrine and its 

salts) in combination with any 

expectorant or any oral nasal 

decongestant. 

Timetable: 

Action Date FR Cite 

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

NPRM Comment 

Period End 

11/10/05 

Final Action (Technical 

Amendment) 

03/19/07 72 FR 12730 

Final Action 10/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF33 

336. 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) 

10/00/11 

NPRM (Amendment) To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF35 

337. 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 identifies 

safe and effective skin protectant active 

ingredients to treat and prevent diaper 

rash. The second action addresses skin 

protectant products used to treat fever 

blisters and cold sores. 

Timetable: 

Action Date FR Cite 

Final Action 

(Aluminum Acetate) 

(Technical 

Amendment) 

03/06/09 74 FR 9759 

Final Action (Technical 

Amendments) 

02/01/08 73 FR 6014 

Final Action (Diaper 

Rash) 

10/00/11 

Final Action (Fever 

Blisters/Cold Sores) 

10/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 


jlentini on DSKJ8SOYB1PROD with PROPOSALS11
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HHS—FDA Final Rule Stage 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF42 

338. 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 hexaneinsoluble 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. 

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 04/00/11 

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: amber.mccoig@fda.hhs.gov 

RIN: 0910–AF47 

339. 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 03/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Daniel Sigelman, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Food 

Safety and Applied Nutrition, WO 

Building 1, Room 4245, 10903 New 

Hampshire Avenue, Silver Spring, MD 

20993 

Phone: 301 796–4706 

Email: daniel.sigelman@fda.hhs.gov 

RIN: 0910–AF61 

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

Food and Drug Administration (FDA) 

340. CURRENT GOOD 

MANUFACTURING PRACTICE IN 

MANUFACTURING, PACKING, 

LABELING, OR HOLDING 

OPERATIONS FOR DIETARY 

SUPPLEMENTS 

Legal Authority: 21 USC 321; 21 USC 

342; 21 USC 343; 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 


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HHS—FDA Long-Term Actions 

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 Rule 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: linda.kahl@fda.hhs.gov 

RIN: 0910–AB88 

341. 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 Comment 

Period End 

11/01/04 

Action Date FR Cite 

NPRM (Phenylephrine 

Bitartrate) 

11/02/04 69 FR 63482 

NPRM Comment 

Period End 

01/31/05 

NPRM (Phenylpropanolamine) 12/22/05 70 FR 75988 

NPRM Comment 

Period End 

03/22/06 

Final Action 

(Amendment) 

(Sinusitis Claim) 

10/31/05 70 FR 58974 

Final Action 

(Phenylephrine 

Bitartrate) 

08/01/06 71 FR 83358 

Final Action (Phenylpropanolamine) To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF34 

342. 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 

NPRM Comment 

Period End 

04/11/07 

Final Action To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF37 

343. OVER–THE–COUNTER (OTC) 

DRUG REVIEW—OPHTHALMIC 

PRODUCTS 

Legal Authority: 21 USC 321p; 21 USC 

331; 21 USC 351 to 353; 21 USC 355; 

21 USC 360; 21 USC 371 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. This action 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: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF39 

344. 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 


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HHS—FDA Long-Term Actions 

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: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF40 

345. 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) 

To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF44 

346. 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 (Phenylpropanolamine) 12/22/05 70 FR 75988 

NPRM Comment 

Period End 

03/22/06 

NPRM (Benzocaine) To Be Determined 

Final Action (Phenylpropanolamine) To Be Determined 

Final Action 

(Benzocaine) 

To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF45 

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 

NPRM Comment 

Period End 

04/05/05 

Final Action To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

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 


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HHS—FDA Long-Term Actions 

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: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

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 

NPRM Comment 

Period End 

12/27/06 

Final Action To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

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: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF56 

351. OVER–THE–COUNTER (OTC) 

DRUG REVIEW—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: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF63 

352. 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: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AF70 


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HHS—FDA Long-Term Actions 

353. OVER–THE–COUNTER (OTC) 

DRUG REVIEW—CERTAIN 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 issued 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 rule will finalize the 2008 

proposed rule. 

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: Matthew R. Holman, 

Ph.D., Department of Health and 

Human Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: matthew.holman@fda.hhs.gov 

RIN: 0910–AF95 

354. 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: Pursuant to section 610 of the 

Regulatory Flexibility Act, FDA is 

currently undertaking a review of 

regulations promulgated under the 

Prescription Drug Marketing Act 

(PDMA) including those contained in 

21 CFR part 203 and 21 CFR sections 

205.3 and 205.50 (as amended in 64 

FR 67762 and 67763). The purpose of 

this review is to determine whether the 

regulations in 21 CFR part 203 and 21 

CFR sections 205.3 and 205.50 (as 

amended in 64 FR 67762 and 67763) 

should be continued without change, or 

whether they should be amended or 

rescinded, consistent with the stated 

objectives of applicable statues, to 

minimize adverse impacts on a 

substantial number of small entities. 

FDA solicited 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). 

FDA received one comment on this 

review; and FDA notes that portions of 

the PDMA have been stayed in 

connection with RxUSA Wholesale, 

Inc., v. HHS, 467 F. Supp.2d 285 

(E.D.N.Y. 2006), aff’d, 2008 U.S. App. 

LEXIS 14661 (2d Cir. 2008)); and that 

the litigation itself has been 

administratively closed (with either 

party having the right to reopen) 

through June 30, 2011. FDA is 

certifying that it is not feasible for the 

agency to complete its review by 

December 4, 2010, and therefore is 

extending the completion date by one 

year. 

Timetable: 

Action Date FR Cite 

Begin Review of 

Current Regulation 

11/24/08 

End Review of Current 

Regulation 

12/00/11 

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, WO 51, 

Room 6234, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993–0002 

Phone: 301 796–3601 

Fax: 301 847–8440 

Email: pdma610(c)review@fda.hhs.gov 

RIN: 0910–AG14 

355. PRODUCE SAFETY REGULATION 

Legal Authority: 21 USC 342; 21 USC 

371; 42 USC 264 

Abstract: The Food and Drug 

Administration (FDA) has determined 

that enforceable standards (as opposed 

to voluntary recommendations) for the 

production and packing of fresh 

produce are necessary to ensure best 

practices are commonly adopted. FDA 

is proposing to promulgate regulations 

setting enforceable standards for fresh 

produce safety at the farm and packing 

house. The purpose of the proposed 

rule is to reduce the risk of illness 

associated with contaminated fresh 

produce. The proposed rule will be 

based on prevention-oriented public 

health principles and incorporate what 

we have learned in the past decade 

since the agency issued general good 

agricultural practice guidelines entitled 

‘‘Guide to Minimize Microbial Food 

Safety Hazards for Fresh Fruits and 

Vegetables’’ (GAPs Guide). The 

proposed rule also will reflect 

comments received on the agency’s 

1998 update of its GAPs guide and its 

July 2009 draft commodity specific 

guidances for tomatoes, leafy greens, 

and melons. Although the proposed 

rule will be based on recommendations 

that are included in the GAPs guide, 

FDA does not intend to make the entire 

guidance mandatory. FDA’s proposed 

rule would, however, set out clear 

standards for implementation of 

modern preventive controls. The 

proposed rule also would emphasize 

the importance of environmental 

assessments to identify hazards and 

possible pathways of contamination 

and provide examples of risk reduction 

practices recognizing that operators 

must tailor their preventive controls to 

particular hazards and conditions 

affecting their operations. The 

requirements of the proposed rule 

would be scale appropriate and 

commensurate with the relative risks 

and complexity of individual 

operations. FDA intends to issue 

guidance after the proposed rule is 

finalized to assist industry in 


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HHS—FDA Long-Term Actions 

complying with the requirements of the 

new regulation. 

Timetable: 

Action Date FR Cite 

NPRM To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Samir Assar, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, Office of Food 

Safety, 5100 Paint Branch Parkway, 

College Park, MD 20740 

Phone: 301 436–1636 

Email: samir.assar@fda.hhs.gov 

RIN: 0910–AG35 

356. MODERNIZATION OF THE 

CURRENT FOOD GOOD 

MANUFACTURING PRACTICES 

REGULATION 

Legal Authority: 21 USC 342; 21 USC 

371; 42 USC 264 

Abstract: The Food and Drug 

Administration (FDA) is proposing to 

amend its current good manufacturing 

practices (CGMP) regulations (21 CFR 

part 110) for manufacturing, packing, or 

holding human food. This proposed 

rule would require food facilities to 

address issues such as environmental 

pathogens, food allergens, mandatory 

employee training, and sanitation of 

food contact surfaces. The proposed 

rule also would require food facilities 

to develop and implement preventive 

control systems. FDA is taking this 

action to better address changes that 

have occurred in the food industry and 

protect public health. 

Timetable: 

Action Date FR Cite 

NPRM To Be Determined 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Paul South, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition (HFS–317), 

Office of Food Safety, 5100 Paint 

Branch Parkway, College Park, MD 

20740 

Phone: 301 436–1640 

Email: paul.south@fda.hhs.gov 

RIN: 0910–AG36 

Department of Health and Human Services (HHS) Completed Actions 

Food and Drug Administration (FDA) 

357. STERILITY REQUIREMENT FOR 

AQUEOUS–BASED DRUG PRODUCTS 

FOR ORAL INHALATION 

(COMPLETION OF A 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 aqueousbased 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. No 

comments were required. FDA’s review 

of these regulations concluded that they 

should be continued without change. 

Timetable: 

Action Date FR Cite 

Begin Review 05/01/09 

End Review 05/31/10 

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, WO 51, 

Room 6234, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993–0002 

Phone: 301 796–3601 

Fax: 301 847–8440 

Email: howard.mullerjr@fda.hhs.gov 

RIN: 0910–AG25 

358. REGULATIONS RESTRICTING 

THE SALE AND DISTRIBUTION OF 

CIGARETTES AND SMOKELESS 

TOBACCO TO PROTECT CHILDREN 

AND ADOLESCENTS 

Legal Authority: 21 USC 301 et seq, 

The Federal Food, Drug, and Cosmetic 

Act; PL 111–31, Family Smoking 

Prevention and Tobacco Control Act 

Abstract: This rule establishes 

regulations restricting the sale and 

distribution of cigarettes and smokeless 

tobacco to children and adolescents, 

implementing section 102 of the Family 

Smoking Prevention and Tobacco 

Control Act (FSPTCA). FSPTCA 

sections 102 and 6(c)(1) require the 

Secretary to publish, within 270 days 

of enactment, a final rule regarding 

cigarettes and smokeless tobacco. This 

final rule must be identical, except for 

several changes identified in section 

102(a)(2) of FSPTCA, to part 897 of the 

regulations promulgated by the 

Secretary of HHS in the August 28, 

1996, issue of the Federal Register (61 

FR 44396). 

This final rule prohibits the sale of 

cigarettes and smokeless tobacco to 

individuals under the age of 18 and 

requires manufacturers, distributors, 

and retailers to comply with certain 

conditions regarding access to, and 

promotion of, these products. Among 

other things, the final rule requires 

retailers to verify a purchaser’s age by 

photographic identification. It also 

prohibits, with limited exception, free 

samples and prohibits the sale of these 

products through vending machines 

and self-service displays except in 

facilities where individuals under the 

age of 18 are not present or permitted 

at any time. The rule also limits the 

advertising and labeling to which 

children and adolescents are exposed. 

The rule accomplishes this by generally 

restricting advertising to which 

children and adolescents are exposed 

to a black-and-white, text-only format. 

The rule also prohibits the sale or 


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HHS—FDA Completed Actions 

distribution of brand-identified 

promotional, non-tobacco items such as 

hats and tee shirts. Furthermore, the 

rule prohibits sponsorship of sporting 

and other events, teams, and entries in 

a brand name of a tobacco product, but 

permits such sponsorship in a 

corporate name. 

FDA also published in the same issue 

of the Federal Register an advance 

notice of proposed rulemaking 

requesting comments, data, research, or 

other information on the regulation of 

outdoor advertising of cigarettes and 

smokeless tobacco. 

Timetable: 

Action Date FR Cite 

ANPRM 03/19/10 75 FR 13241 

Final Rule 03/19/10 75 FR 13225 

ANPRM Comment 

Period End 

05/18/10 

Final Rule Effective 06/22/10 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Annette L. Marthaler, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, 9200 Corporate 

Boulevard, 100K, Rockville, MD 20850 

Phone: 877 287–1373 

Fax: 240 276–3904 

Email: annette.marthaler@fda.hhs.gov 

RIN: 0910–AG33 

359. OVER–THE–COUNTER HUMAN 

DRUGS; LABELING REQUIREMENTS 

(COMPLETION OF A SECTION 610 

REVIEW) 

Legal Authority: 5 USC 610 

Abstract: Section 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 

headings in bold type 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 undertook a review of section 

201.66 under section 610 of the 

Regulatory Flexibility Act. The purpose 

of this review is to determine whether 

the regulation in section 201.66 should 

be continued without change, or 

whether it should be further amended 

or rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize adverse impacts on a 

substantial number of small entities. 

FDA will consider, and is soliciting 

comments on the following: (1) The 

continued need for the regulation in 

section 201.66; (2) the nature of the 

complaints or comments received 

concerning the regulation in section 

201.66; (3) the complexity of the 

regulations in section 201.66; (4) the 

extent to which the regulations in 

section 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 

section 201. 

No comments were received. FDA’s 

review of these regulations concluded 

that they should be continued without 

change. 

Timetable: 

Action Date FR Cite 

Begin Review of 

Current Regulation 

08/03/09 

End Review of Current 

Regulation 

05/27/10 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: M. Scott Furness, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO22, 10903 

New Hamphsire Avenue, Silver Spring, 

MD 20993 

Phone: 301 796–2090 

Fax: 301 796–9899 

Email: micheal.furness@fda.hhs.gov 

RIN: 0910–AG34 

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

Centers for Medicare & Medicaid Services (CMS) 

360. 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 CoPs were last revised in 1989. 

The new requirements will 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 

Action Date FR Cite 

NPRM Comment 

Period End 

06/09/97 

Second NPRM 07/00/11 

Regulatory Flexibility Analysis 

Required: Undetermined 

Agency Contact: Danielle Shearer, 

Health Insurance Specialist, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Clinical Standards & 

Quality, Mailstop S3–02–01, 7500 

Security Boulevard, Baltimore, MD 

21244 


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HHS—CMS Proposed Rule Stage 

Phone: 410 786–6617 

Email: danielle.shearer@cms.hhs.gov 

RIN: 0938–AG81 

361. REQUIREMENTS FOR 

LONG–TERM CARE FACILITIES: 

HOSPICE SERVICES (CMS–3140–F) 

(SECTION 610 REVIEW) 

Legal Authority: 42 USC 1302; 42 USC 

1395hh 

Abstract: This rule establishes that in 

order to participate in the Medicare and 

Medicaid programs, long-term care 

facilities must have an agreement with 

hospice agencies when hospice care is 

provided in a long-term care facility. 

The rule also contains quality of care 

requirements. 

Timetable: 

Action Date FR Cite 

NPRM 10/22/10 75 FR 65282 

NPRM Comment 

Period End 

12/21/10 

Final Action 10/00/13 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Patricia 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: patricia.brooks@cms.hhs.gov 

RIN: 0938–AP32 

362. INFLUENZA VACCINATION 

STANDARD FOR CERTAIN MEDICARE 

PARTICIPATING PROVIDERS AND 

SUPPLIERS(CMS–3213–P) 

Legal Authority: Social Security Act 

sec 1881, 1861, 1920, 1102, 1871, 1965 

Abstract: This proposed rule would 

require certain Medicare providers and 

suppliers to offer all patients an annual 

influenza vaccination, unless medically 

inadvisable or if the patient declines 

vaccination. This proposed rule is 

intended to increase the number of 

patients receiving annual vaccination 

against seasonal influenza and to 

decrease the morbidity and mortality 

rate from influenza. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Lauren Oviatt, Health 

Insurance Specialist, Department of 

Health and Human Services, Centers for 

Medicare & Medicaid Services, Mail 

Stop S3–02–01, 7500 Security 

Boulevard, Baltimore, MD 21244 

Phone: 410 786–4683 

Email: lauren.oviatt@cms.hhs.gov 

RIN: 0938–AP92 

363. HOSPITAL CONDITIONS OF 

PARTICIPATION: REQUIREMENTS 

FOR HOSPITAL INPATIENT 

PSYCHIATRIC AND REHABILITATION 

UNITS EXCLUDED FROM THE 

PROSPECTIVE PAYMENT SYSTEM 

AND LTCH REQUIREMENTS 

(CMS–3177–P) 

Legal Authority: 42 USC 1385 X; 42 

USC 1396 d; 42 USC 1395 hh 

Abstract: This proposed rule would 

transfer the existing process 

requirements for hospital inpatient 

psychiatric and rehabilitation units that 

are excluded from prospective payment 

systems to the hospital conditions of 

participation (CoPs) part of the Act. 

This would allow accrediting 

organizations to deem these units as 

part of their hospital accreditation 

process providing a timely and cost 

effective survey and certification 

process under the CoPs. In addition, 

this rule would propose long term care 

hospital requirements mandated by the 

Medicare, Medicaid and SCHIP 

Extension Act of 2007. 

Timetable: 

Action Date FR Cite 

NPRM 05/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Capt. Katherine 

Berkhousen, Department of Health and 

Human Services, Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Mailstop S3–02–01, 

Baltimore, MD 21244 

Phone: 410 786–1154 

Email: 

katherine.berkhousen@cms.hhs.gov 

RIN: 0938–AP97 

364. ∑ PROPOSED CHANGES TO THE 

HOSPITAL INPATIENT PROSPECTIVE 

PAYMENT SYSTEMS FOR ACUTE 

CARE HOSPITALS AND FY 2012 

RATES AND TO THE LONG–TERM 

CARE HOSPITAL PPS AND RY 2012 

RATES (CMS–1518–P) 

Regulatory Plan: This entry is Seq. No. 

55 in part II of this issue of the Federal 

Register. 

RIN: 0938–AQ24 

365. ∑ CHANGES TO THE HOSPITAL 

OUTPATIENT PROSPECTIVE 

PAYMENT SYSTEM AND 

AMBULATORY SURGICAL CENTER 

PAYMENT SYSTEM FOR CY 2012 

(CMS–1525–P) 

Regulatory Plan: This entry is Seq. No. 

57 in part II of this issue of the Federal 

Register. 

RIN: 0938–AQ26 

366. ∑ CHANGES TO THE ESRD 

PROSPECTIVE PAYMENT SYSTEM 

FOR CY 2012 (CMS–1577–P) 

Legal Authority: Sec 1881 of the Social 

Security Act 

Abstract: This proposed rule would 

update the bundled payment system for 

End Stage Renal Disease (ESRD) 

facilities as required by the Medicare 

Improvments for Patients and Providers 

Act (MIPPA). These changes would be 

applicable to services furnished on or 

after January 1 annually. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Janet Samen, Director, 

Division of Chronic Care Management, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mailstop C5–05–27, 

7500 Security Boulevard, Baltimore, 

MD 21244 

Phone: 410 786–4533 

Email: janet.samen@cms.hhs.gov 

RIN: 0938–AQ27 

367. ∑ FEDERAL FUNDING FOR 

MEDICAID ELIGIBILITY 

DETERMINATION AND ENROLLMENT 

ACTIVITIES (CMS–2346–P) 

Legal Authority: PL 111–148, sec 1413 


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HHS—CMS Proposed Rule Stage 

Abstract: The Affordable Care Act 

requires States’ residents to apply, 

enroll, receive determinations, and 

participate in the State health subsidy 

programs known as ‘‘the Exchange’’. 

The ACA requires many changes to 

State eligibility and enrollment systems 

and each State is responsible for 

developing a secure, electronic 

interface allowing the exchange of data. 

Existing legacy eligibility systems are 

not able to implement the numerous 

requirements. This proposed rule is key 

to informing States about the higher 

rates that CMS will provide to help 

them update or build legacy eligibility 

systems that meet the ACA 

requirements. 

Timetable: 

Action Date FR Cite 

NPRM 11/08/10 75 FR 68583 

NPRM Comment 

Period End 

01/07/11 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Richard H. Friedman, 

Director, Division of State Systems, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mail Stop 

S3–18–13, 7500 Security Boulevard, 

Baltimore, MD 21244 

Phone: 410 786–4451 

Email: richard.friedman@cms.hhs.gov 

RIN: 0938–AQ53 

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

Centers for Medicare & Medicaid Services (CMS) 

368. REVISIONS TO PAYMENT 

POLICIES UNDER THE PHYSICIAN 

FEE SCHEDULE AND PART B FOR CY 

2011 (CMS–1503–C) 

Legal Authority: Social Security Act, 

sec 1102; Social Security Act, sec 1871 

Abstract: This annual final rule revises 

payment polices under the physician 

fee schedule, as well as other policy 

changes to payment under Part B for 

CY 2011. 

Timetable: 

Action Date FR Cite 

NPRM 07/13/10 75 FR 40040 

NPRM Comment 

Period End 

09/24/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Carol Bazell, Director, 

Division of Practitioner Services, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mail Stop 

C4–03–06, 7500 Security Boulevard, 

Baltimore, MD 21244 

Phone: 410 786–6960 

Email: carol.bazell@cms.hhs gov 

RIN: 0938–AP79 

369. CHANGES TO THE HOSPITAL 

OUTPATIENT PROSPECTIVE 

PAYMENT SYSTEM AND 

AMBULATORY SURGICAL CENTER 

PAYMENT SYSTEM FOR CY 2011 

(CMS–1504–C) 

Legal Authority: sec 1833 of the Social 

Security Act; BBA, BA, BIPA, MMA, 

PPACA 

Abstract: This final rule revises the 

Medicare hospital outpatient 

prospective payment system to 

implement applicable statutory 

requirements and changes arising from 

our continuing experience with this 

system. The rule also describes changes 

to the amounts and factors used to 

determine payment rates for services. 

In addition, the rule changes the 

Ambulatory Surgical Center Payment 

System list of services and rates. 

Timetable: 

Action Date FR Cite 

NPRM 08/03/10 75 FR 46169 

NPRM Comment 

Period End 

08/31/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Alberta Dwivedi, 

Health Insurance Specialist, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mail Stop 

C5–01–26, 7500 Security Boulevard, 

Baltimore, MD 21244 

Phone: 410 786–0763 

Email: alberta.dwivedi@cms.hhs.gov 

RIN: 0938–AP82 

Department of Health and Human Services (HHS) Completed Actions 

Centers for Medicare & Medicaid Services (CMS) 

370. 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 final rule makes 

revisions to the regulations governing 

the Medicare Advantage (MA) program 

(Part C) and prescription drug benefit 

program (Part D) based on our 

continued experience in the 

administration of the Part C and D 

programs. The revisions strengthen 

various program participation and exit 

requirements; strengthen beneficiary 

protections; ensure that plan offerings 

to beneficiaries include meaningful 

differences; improve plan payment 

rules and processes; improve data 

collection for oversight and quality 

assessment; implement new policy 

such as a Part D formulary policy; and 

clarify program policy. 

Timetable: 

Action Date FR Cite 

NPRM 10/22/09 74 FR 54634 

NPRM Comment 

Period End 

12/07/09 

Final Action 04/15/10 75 FR 19678 

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 


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79786 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 

HHS—CMS Completed Actions 

C1–26–26, 7500 Security Boulevard, 

Baltimore, MD 21244 

Phone: 410 786–6041 

Email: alissa.deboy@cms.hhs.gov 

RIN: 0938–AP77 

371. ELECTRONIC HEALTH RECORD 

(EHR) INCENTIVE PROGRAM 

(CMS–0033–F) 

Legal Authority: PL 111–5 (The 

American Recovery and Reinvestment 

Act of 2009, Title IV of Division B, 

Medicare and Medicaid Health 

Information Technology) 

Abstract: This rule would implement 

provisions of the American Recovery 

Act of 2009 (Recovery Act) that 

authorize incentive payments to eligible 

professionals (EPS) and eligible 

hospitals participating in the Medicare 

and Medicaid programs for adopting 

and becoming meaningful users of 

certified electronic health records 

(HER) technology. In accordance with 

the Recovery Act, the rule will 

establish maximum annual incentive 

amounts and include Medicare 

penalties for failing to meaningfully use 

EHRs beginning in 2015. 

Timetable: 

Action Date FR Cite 

NPRM 01/13/10 75 FR 1843 

NPRM Comment 

Period End 

03/15/10 

Final Action 07/28/10 75 FR 44413 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Elizabeth S. Holland, 

Health Insurance Specialist, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mailstop S2–26–17, 

7500 Security Boulevard, Baltimore, 

MD 21244 

Phone: 410 786–1309 

Email: elizabeth.holland@cms.hhs.gov 

RIN: 0938–AP78 

372. PROSPECTIVE PAYMENT 

SYSTEMS FOR ACUTE CARE 

HOSPITALS AND THE LONG–TERM 

CARE HOSPITAL PROSPECTIVE 

PAYMENT SYSTEM 

Legal Authority: Sec 1886(d) of the 

Social Security Act 

Abstract: This rule updates the fiscal 

year (FY) 2011 hospital inpatient 

prospective payment systems (IPPS) 

and long-term care prospective 

payment system (LTCH PPS). This rule 

payments to hospitals for inpatient 

services that are contained in the 

Patient Protection and Affordable Care 

Act (the Affordable Care Act) as 

amended by the Health Care and 

Education Reconciliation Act of 2010 

(HCERA) (collectively known as the 

Affordable Care Act). It would also 

specify statutorily required changes to 

the amounts and factors used to 

determine the rates for Medicare acute 

care hospital inpatient services for 

operating costs and capital-related 

costs, and for long-term care hospital 

costs. 

Timetable: 

Action Date FR Cite 

NPRM 05/04/10 75 FR 23851 

NPRM Comment 

Period End 

06/18/10 

Second NPRM 06/02/10 75 FR 30917 

Second NPRM 

Comment Period 

End 

07/02/10 

Final Action 08/16/10 75 FR 50041 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Tiffany Swygert, 

Health Insurance Specialist, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mailstop C4–25–11, 

7500 Security Boulevard, Baltimore, 

MD 21244 

Phone: 410 786–4642 

Email: tiffany.swygert@cms.hhs.gov 

RIN: 0938–AP80 

373. ∑ HOSPITAL IPPS FOR ACUTE 

CARE HOSPITALS AND FISCAL YEAR 

2010 RATES AND TO THE 

LONG–TERM CARE HOSPITAL PPS 

AND RATE YEAR 2010 RATES 

(CMS–1406–N) 

Legal Authority: PL 111 148; PL 

111–152 

Abstract: This notice contains the final 

wage indices, hospital reclassifications, 

payment rates, impacts, and other 

related tables effective for the fiscal 

year (FY) 2010 hospital inpatient 

prospective payment systems (IPPS) 

and rate year 2010 long-term care 

hospital (LTCH) prospective payment 

system (PPS) . The rates, tables, and 

impacts included in this notice reflect 

changes required or resulting from the 

implementation of several provisions of 

the Patient Protection and Affordable 

Care Act as amended by the Health 

Care and Education Reconciliation Act 

of 2010. These provisions require the 

extension of the expiration date for 

certain geographic reclassifications and 

special exception wage indices through 

September 30, 2010, and certain market 

basket updates for the IPPS and LTCH 

PPS effective April 1, 2010. 

Timetable: 

Action Date FR Cite 

Final Action 06/02/10 75 FR 31118 

Regulatory Flexibility Analysis 

Required: Yes 

Agency Contact: Tzvi Hefter, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244 

Phone: 410 786–4487 

Email: tzvi.hefter@cms.hhs.gov 

RIN: 0938–AQ03 

[FR Doc. 2010–30444 Filed 12–17–10; 8:45 

am] 

BILLING CODE 4150–24–S 


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