Regulatory Agenda:
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-1
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Part VIII
Department of Health and Human Services
Semiannual Regulatory Agenda
Page 79764
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
Regulation
Sequence
Title
Identifier
Number
Number
302
Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money
0991-AB03
Penalties and Assessments (Section 610 Review)........................................
Office of the Secretary--Final Rule Stage
Regulation
Sequence
Title
Identifier
Number
Number
303
Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health
0991-AB57
Information Technology for Economic and Clinical Health Act (Reg Plan Seq No. 41).....
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.
Office of the Secretary--Completed Actions
Regulation
Sequence
Title
Identifier
Number
Number
304
Health Information Technology: Initial Set of Standards, Implementation
0991-AB58
Specifications, and Certification Criteria for Electronic Health Record Technology
(Rulemaking Resulting From a Section 610 Review)......................................
Substance Abuse and Mental Health Services Administration--Long-Term Actions
Regulation
Sequence
Title
Identifier
Number
Number
305
Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical
0930-AA10
Community-Based Facilities for Children and Youth..................................... 306
Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section
0930-AA14 610 Review)...........................................................................
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Centers for Disease Control and Prevention--Proposed Rule Stage
Regulation
Sequence
Title
Identifier
Number
Number
307
Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman
0920-AA23
Primate...............................................................................
Centers for Disease Control and Prevention--Final Rule Stage
Regulation
Sequence
Title
Identifier
Number
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
0920-AA32
Review)...............................................................................
Centers for Disease Control and Prevention--Long-Term Actions
Regulation
Sequence
Title
Identifier
Number
Number
310
Quality Assurance Requirements for Respirators........................................ 0920-AA04
Food and Drug Administration--Prerule Stage
Regulation
Sequence
Title
Identifier
Number
Number
311
Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of
0910-AG06
Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
Food and Drug Administration--Proposed Rule Stage
Regulation
Sequence
Title
Identifier
Number
Number
312
Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg
0910-AC52
Plan Seq No. 45)...................................................................... 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
0910-AG18
Biological Products................................................................... 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
0910-AG54
Infusion Pumps........................................................................ 328
Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No.
0910-AG56 48)................................................................................... 329
Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants (Reg
0910-AG57
Plan Seq No. 49)......................................................................
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.
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Food and Drug Administration--Final Rule Stage
Regulation
Sequence
Title
Identifier
Number
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;
0910-AF11
Requirements for Pregnancy and Lactation Labeling..................................... 333
Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;
0910-AF27
Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No. 50)................................................................................... 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
Regulation
Sequence
Title
Identifier
Number
Number
340
Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding
0910-AB88
Operations for Dietary Supplements.................................................... 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;
0910-AG14
Policies, Requirements, and Administrative Procedures (Section 610 Review)............ 355
Produce Safety Regulation............................................................. 0910-AG35 356
Modernization of the Current Food Good Manufacturing Practices Regulation............. 0910-AG36
Food and Drug Administration--Completed Actions
Regulation
Sequence
Title
Identifier
Number
Number
357
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Completion
0910-AG25 of a Section 610 Review).............................................................. 358
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
0910-AG33
To Protect Children and Adolescents................................................... 359
Over-the-Counter Human Drugs; Labeling Requirements (Completion of a Section 610
0910-AG34
Review)...............................................................................
Centers for Medicare & Medicaid Services--Proposed Rule Stage
Regulation
Sequence
Title
Identifier
Number
Number
360
Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610
0938-AG81
Review)...............................................................................
Page 79767
361
Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 0938-AP32
Review)............................................................................... 362
Influenza Vaccination Standard for Certain Medicare Participating Providers and
0938-AP92
Suppliers(CMS-3213-P)................................................................. 363
Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric
0938-AP97 and Rehabilitation Units Excluded From the Prospective Payment System and LTCH
Requirements (CMS-3177-P)............................................................. 364
Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care
0938-AQ24
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).................................................... 365
Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical
0938-AQ26
Center Payment System for CY 2012 (CMS-1525-P) (Reg Plan Seq No. 57).................. 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- 0938-AQ53 2346-P)...............................................................................
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
Regulation
Sequence
Title
Identifier
Number
Number
368
Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011
0938-AP79
(CMS-1503-C).......................................................................... 369
Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical
0938-AP82
Center Payment System for CY 2011 (CMS-1504-C)........................................
Centers for Medicare & Medicaid Services--Completed Actions
Regulation
Sequence
Title
Identifier
Number
Number
370
Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs
0938-AP77 for Contract Year 2011 (CMS-4085-F)................................................... 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
0938-AP80
Prospective Payment System............................................................ 373
Hospital IPPS for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term 0938-AQ03
Care Hospital PPS and Rate Year 2010 Rates (CMS-1406-N)...............................
December 20, 2010 (Volume 75, Number 243)
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Office of the Secretary (OS)
-
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
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
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Department of Health and Human Services (HHS)
Final Rule Stage
Office of the Secretary (OS)
-
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
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Department of Health and Human Services (HHS)
Completed Actions
Office of the Secretary (OS)
-
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
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
-
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
-
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
Page 79769
2-1063, One Choke Cherry Road, Rockville, MD 20857
Phone: 240 276-2716
RIN: 0930-AA14
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
-
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
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Department of Health and Human Services (HHS)
Final Rule Stage
Centers for Disease Control and Prevention (CDC)
-
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
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Department of Health and Human Services (HHS)
Final Rule Stage
Centers for Disease Control and Prevention (CDC)
-
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
Page 79770
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Centers for Disease Control and Prevention (CDC)
-
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 End04/10/09
NPRM Comment Period Reopening
Extended
05/21/09
74 FR 23815
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
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Department of Health and Human Services (HHS)
Prerule Stage
Food and Drug Administration (FDA)
-
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.
Page 79771
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-12
Page 79771
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-13
Page 79771
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-14
Page 79771
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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 weight- and 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
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-15
Page 79771-79772
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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.
Page 79772
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-16
Page 79772
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-17
Page 79772
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
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DOCID:ua20de10_008-18
Page 79772-79773
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
Page 79773
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-19
Page 79773
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-20
Page 79773
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-21
Page 79773
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-22
Page 79773-79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
Page 79774
New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: micheal.furness@fda.hhs.gov
RIN: 0910-AG12
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
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DOCID:ua20de10_008-23
Page 79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-24
Page 79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
UNIQUE DEVICE IDENTIFICATION
Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register.
RIN: 0910-AG31
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-25
Page 79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
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DOCID:ua20de10_008-26
Page 79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-27
Page 79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-28
Page 79774
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
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DOCID:ua20de10_008-29
Page 79774-79775
Department of Health and Human Services (HHS)
Proposed Rule Stage
Food and Drug Administration (FDA)
-
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
Page 79775
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DOCID:ua20de10_008-30
Page 79775
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-31
Page 79775
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING
PRACTICE REQUIREMENTS
Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353
Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas 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
December 20, 2010 (Volume 75, Number 243)
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Page 79775-79776
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
Page 79776
Fax: 301 847-8440
Email: rachel.bressler@fda.hhs.gov
RIN: 0910-AF11
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-33
Page 79776
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-34
Page 79776
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-35
Page 79776
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-36
Page 79776
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-37
Page 79776-79777
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
Page 79777
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-38
Page 79777
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS
Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371
Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy
(BSE) in human food, including dietary supplements, and cosmetics.
Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle.
Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives.
This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes
BSE.
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
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DOCID:ua20de10_008-39
Page 79777
Department of Health and Human Services (HHS)
Final Rule Stage
Food and Drug Administration (FDA)
-
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
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DOCID:ua20de10_008-40
Page 79777-79778
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
Page 79778
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-41
Page 79778
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
NPRM (Phenylephrine Bitartrate) 11/02/04
69 FR 63482
NPRM Comment Period End
01/31/05
NPRM (Phenyl- propanolamine) 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 (Phenyl- propanolamine)
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-42
Page 79778
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-43
Page 79778
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
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DOCID:ua20de10_008-44
Page 79778-79779
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
Page 79779
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
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DOCID:ua20de10_008-45
Page 79779
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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DOCID:ua20de10_008-46
Page 79779
Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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 (Phenyl- propanolamine) 12/22/05
70 FR 75988
NPRM Comment Period End
03/22/06
NPRM (Benzocaine)
To Be
Determined
Final Action (Phenyl- propanolamine)
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
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DOCID:ua20de10_008-47
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
Page 79780
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
December 20, 2010 (Volume 75, Number 243)
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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 Regulation12/00/11
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
Page 79782
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
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Department of Health and Human Services (HHS)
Long-Term Actions
Food and Drug Administration (FDA)
-
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
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Department of Health and Human Services (HHS)
Completed Actions
Food and Drug Administration (FDA)
-
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 aqueous-based drug products for oral inhalation should be continued without change, or whether it should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for 21 CFR 200.51; (2) the nature of complaints or comments received concerning 21 CFR 200.51; (3) the complexity of 21 CFR 200.51; (4) the extent to which the regulation overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by 21
CFR 200.51. 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
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Department of Health and Human Services (HHS)
Completed Actions
Food and Drug Administration (FDA)
-
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
Page 79783
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
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Department of Health and Human Services (HHS)
Completed Actions
Food and Drug Administration (FDA)
-
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 Regulation05/27/10
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
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
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
Page 79784
Phone: 410 786-6617
Email: danielle.shearer@cms.hhs.gov
RIN: 0938-AG81
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
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Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-65
Page 79784
Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-66
Page 79784
Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-67
Page 79784-79785
Department of Health and Human Services (HHS)
Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
FEDERAL FUNDING FOR MEDICAID ELIGIBILITY
DETERMINATION AND ENROLLMENT ACTIVITIES (CMS-2346-P)
Legal Authority: PL 111-148, sec 1413
Page 79785
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-68
Page 79785
Department of Health and Human Services (HHS)
Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-69
Page 79785
Department of Health and Human Services (HHS)
Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-70
Page 79785-79786
Department of Health and Human Services (HHS)
Completed Actions
Centers for Medicare & Medicaid Services (CMS)
-
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
Page 79786
C1-26-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6041
Email: alissa.deboy@cms.hhs.gov
RIN: 0938-AP77
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-71
Page 79786
Department of Health and Human Services (HHS)
Completed Actions
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-72
Page 79786
Department of Health and Human Services (HHS)
Completed Actions
Centers for Medicare & Medicaid Services (CMS)
-
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
December 20, 2010 (Volume 75, Number 243)
Unified Agenda
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:ua20de10_008-73
Page 79786
Department of Health and Human Services (HHS)
Completed Actions
Centers for Medicare & Medicaid Services (CMS)
-
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