Regulatory Agenda, 79763-79786 [2010-30444]

Download as PDF Monday, December 20, 2010 Part VIII Department of Health and Human Services jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Semiannual Regulatory Agenda VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\20DEP11.SGM 20DEP11 79764 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES forthcoming regulatory actions for public review. FOR FURTHER INFORMATION CONTACT: Office of the Secretary Dawn L. Smalls, Executive Secretary, Department of Health and Human 21 CFR Ch. I Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The 42 CFR Chs. I-V information provided in the Agenda presents a forecast of the rulemaking 45 CFR Subtitle A; Subtitle B, Chs. II, activities that the Department of Health III, and XIII and Human Services (HHS) expects to undertake in the foreseeable future. Regulatory Agenda Rulemakings are grouped according to AGENCY: Office of the Secretary, HHS. pre-rulemaking actions, proposed rules, ACTION: Semiannual Regulatory Agenda. final rules, long-term actions, and rulemaking actions completed since the SUMMARY: The Regulatory Flexibility Act Spring 2009 Agenda was published. Please note that the rulemaking of 1980 and Executive Order (EO) 12866 abstracts included in this paper issue of require the semi-annual issuance of an the Federal Register relate strictly to inventory of rulemaking actions under those prospective rulemakings that are development throughout the likely to have a significant economic Department with a view to offering impact on a substantial number of small summarized information about 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 Identifier Number Sequence Number Title 302 Revisions to Regulations Addressing the OIG’s Authority To Impose Civil Money Penalties and Assessments (Section 610 Review) ................................................................................................................................................. 0991–AB03 Office of the Secretary—Final Rule Stage Regulation Identifier Number Sequence Number Title 303 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Reg Plan Seq No. 41) ................................................................................... 0991–AB57 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Office of the Secretary—Completed Actions Regulation Identifier Number Sequence Number Title 304 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review) .......................... 0991–AB58 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Substance Abuse and Mental Health Services Administration—Long-Term Actions Regulation Identifier Number Sequence Number Title 305 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth ................................................................................................................................................ Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review) ...................... 306 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00002 Fmt 1254 Sfmt 1254 E:\FR\FM\20DEP11.SGM 20DEP11 0930–AA10 0930–AA14 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda 79765 HHS Centers for Disease Control and Prevention—Proposed Rule Stage Sequence Number Title Regulation Identifier Number 307 Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman Primate ............................. 0920–AA23 Centers for Disease Control and Prevention—Final Rule Stage Sequence Number Title Regulation Identifier Number 308 309 Control of Communicable Diseases: Foreign and Possessions ................................................................................... Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 Review) ....................... 0920–AA12 0920–AA32 Centers for Disease Control and Prevention—Long-Term Actions Sequence Number Title Regulation Identifier Number 310 Quality Assurance Requirements for Respirators ......................................................................................................... 0920–AA04 Food and Drug Administration—Prerule Stage Regulation Identifier Number Sequence Number Title 311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review) ................................................................................................................................... 0910–AG06 Food and Drug Administration—Proposed Rule Stage jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Sequence Number Title Regulation Identifier Number 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg Plan Seq No. 45) ........ Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products .......................................................... Over-the-Counter (OTC) Drug Review—Internal Analgesic Products .......................................................................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................................ Over-the-Counter (OTC) Drug Review—Sunscreen Products ..................................................................................... Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ............................................................ Import Tolerances for Residues of Unapproved New Animal Drugs in Food .............................................................. Laser Products; Amendment to Performance Standard ............................................................................................... Pet Food Labeling Requirements ................................................................................................................................. Process Controls for Animal Feed Ingredients and Mixed Animal Feed ...................................................................... Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products ................................................... Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products ........................ Unique Device Identification (Reg Plan Seq No. 46) ................................................................................................... Cigars Subject to the Family Smoking Prevention and Tobacco Control Act .............................................................. Cigarette Warning Label Statements (Reg Plan Seq No. 47) ..................................................................................... General Hospital and Personal Use Devices: Designation of Special Controls for Infusion Pumps ........................... Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No. 48) ................................ Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants (Reg Plan Seq No. 49) ............... 0910–AC52 0910–AF31 0910–AF36 0910–AF38 0910–AF43 0910–AF69 0910–AF78 0910–AF87 0910–AG09 0910–AG10 0910–AG12 0910–AG18 0910–AG31 0910–AG38 0910–AG41 0910–AG54 0910–AG56 0910–AG57 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00003 Fmt 1254 Sfmt 1254 E:\FR\FM\20DEP11.SGM 20DEP11 79766 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS Food and Drug Administration—Final Rule Stage Regulation Identifier Number Sequence Number Title 330 331 332 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products .......................................... Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ................................... Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling ........................................................................................................................................................ Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No. 50) .......................................................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products ......................................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products ............................................................ Over-the-Counter (OTC) Drug Review—External Analgesic Products ......................................................................... Over-the-Counter (OTC) Drug Review—Skin Protectant Products .............................................................................. Use of Materials Derived From Cattle in Human Food and Cosmetics ....................................................................... Label Requirement for Food That Has Been Refused Admission Into the United States ........................................... 333 334 335 336 337 338 339 0910–AA97 0910–AC53 0910–AF11 0910–AF27 0910–AF32 0910–AF33 0910–AF35 0910–AF42 0910–AF47 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 Identifier Number Sequence Number Title 340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements ...................................................................................................................................................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products ............................................... Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use ......................................... Over-the-Counter (OTC) Drug Review—Ophthalmic Products .................................................................................... Over-the-Counter (OTC) Drug Review—Oral Health Care Products ........................................................................... Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products ................................................................... Over-the-Counter (OTC) Drug Review—Weight Control Products ............................................................................... Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products ............................................... Over-the-Counter (OTC) Drug Review—Antacid Products ........................................................................................... Over-the-Counter (OTC) Drug Review—Skin Bleaching Products ............................................................................... Over-the-Counter (OTC) Drug Review—Stimulant Drug Products ............................................................................... Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products ......................................................................... Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products ................................................................. Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients ......................................................... Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review) ...................................................................................................... Produce Safety Regulation ........................................................................................................................................... Modernization of the Current Food Good Manufacturing Practices Regulation ........................................................... 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 0910–AB88 0910–AF34 0910–AF37 0910–AF39 0910–AF40 0910–AF44 0910–AF45 0910–AF51 0910–AF52 0910–AF53 0910–AF56 0910–AF63 0910–AF70 0910–AF95 0910–AG14 0910–AG35 0910–AG36 Food and Drug Administration—Completed Actions Regulation Identifier Number Sequence Number Title 357 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Completion of a Section 610 Review) ............................................................................................................................................................................ Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents ................................................................................................................................................................. Over-the-Counter Human Drugs; Labeling Requirements (Completion of a Section 610 Review) .......................... jlentini on DSKJ8SOYB1PROD with PROPOSALS11 358 359 0910–AG25 0910–AG33 0910–AG34 Centers for Medicare & Medicaid Services—Proposed Rule Stage Sequence Number Title Regulation Identifier Number 360 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) .................... 0938–AG81 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00004 Fmt 1254 Sfmt 1254 E:\FR\FM\20DEP11.SGM 20DEP11 79767 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS Centers for Medicare & Medicaid Services—Proposed Rule Stage (Continued) Regulation Identifier Number Sequence Number Title 361 362 363 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 Review) .................... Influenza Vaccination Standard for Certain Medicare Participating Providers and Suppliers(CMS-3213-P) .............. Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System and LTCH Requirements (CMS-3177-P) ........................................ Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates (CMS-1518-P) (Reg Plan Seq No. 55) ....... Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-P) (Reg Plan Seq No. 57) ........................................................................................... Changes to the ESRD Prospective Payment System for CY 2012 (CMS-1577-P) ..................................................... Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-2346-P) ............................... 364 365 366 367 0938–AP32 0938–AP92 0938–AP97 0938–AQ24 0938–AQ26 0938–AQ27 0938–AQ53 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Centers for Medicare & Medicaid Services—Final Rule Stage Regulation Identifier Number Sequence Number Title 368 369 Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 (CMS-1503-C) ............. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2011 (CMS-1504-C) .................................................................................................................................. 0938–AP79 0938–AP82 Centers for Medicare & Medicaid Services—Completed Actions Regulation Identifier Number Sequence Number Title 370 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs for Contract Year 2011 (CMS-4085-F) .............................................................................................................................................................. Electronic Health Record (EHR) Incentive Program (CMS-0033-F) ............................................................................. Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System ......................................................................................................................................................................... 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) ................................................................................................................. 371 372 373 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Department of Health and Human Services (HHS) Office of the Secretary (OS) 302. REVISIONS TO REGULATIONS ADDRESSING THE OIG’S AUTHORITY TO IMPOSE CIVIL MONEY PENALTIES AND ASSESSMENTS (SECTION 610 REVIEW) Legal Authority: 42 USC 1320a–7a; 42 USC 1395mm; 42 USC 1395w–27; 42 USC 1396b; PL 99–660; PL 107–188 Abstract: This proposed rule would revise part 1003, addressing the Office of Inspector General’s authority to propose the imposition of civil money penalties and assessments by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Timetable: Action Date NPRM 04/00/11 Frm 00005 Fmt 1254 0938–AP80 0938–AQ03 Proposed Rule Stage 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. PO 00000 0938–AP77 0938–AP78 Sfmt 1254 FR Cite Action Date NPRM Comment Period End FR Cite 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 E:\FR\FM\20DEP11.SGM 20DEP11 79768 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda Department of Health and Human Services (HHS) Office of the Secretary (OS) Final Rule Stage 303. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register. RIN: 0991–AB57 Department of Health and Human Services (HHS) Office of the Secretary (OS) 304. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Legal Authority: 42 USC 300jj–14 Abstract: The Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology, will issue an interim final rule with a request for comments to adopt an initial set of standards, implementation Completed Actions 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 Interim Final Rule Interim Final Rule Comment Period End FR Cite 01/13/10 75 FR 2014 03/15/10 Action Date Interim Final Rule Effective Final Action jlentini on DSKJ8SOYB1PROD with PROPOSALS11 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Action Date NPRM To Be Determined FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Paolo Del Vecchio, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 13–103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443–2619 RIN: 0930–AA10 306. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDICTION (SECTION 610 REVIEW) Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd–2; 42 USC 300xx–23; 42 USC 300x–27(a); 42 USC 300y–11 Frm 00006 Fmt 1254 07/28/10 75 FR 44590 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 Timetable: PO 00000 02/12/10 Regulatory Flexibility Analysis Required: No Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) 305. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY–BASED FACILITIES FOR CHILDREN AND YOUTH Legal Authority: PL 106–310, 42 USC 290jj to 290jj–2 Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. FR Cite Sfmt 1254 Long-Term Actions 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 NPRM NPRM Comment Period End Final Action FR Cite 06/19/09 74 FR 29153 08/18/09 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 E:\FR\FM\20DEP11.SGM 20DEP11 79769 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—SAMHSA Long-Term Actions Phone: 240 276–2716 RIN: 0930–AA14 2–1063, One Choke Cherry Road, Rockville, MD 20857 Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 307. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS REGULATIONS; NONHUMAN PRIMATE Legal Authority: 42 USC 264 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health Proposed Rule Stage 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 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 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 308. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS Legal Authority: 42 USC 243; 42 USC 264 and 265; 42 USC 267 and 268; 42 USC 270 and 271 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 71) will update and improve CDC’s response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system’s ability to slow the introduction, transmission, and spread of communicable disease. The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships, and the collection of specific traveler VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Final Rule Stage contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 11/30/05 70 FR 71892 01/20/06 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA12 309. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE VIRUS (SECTION 610 REVIEW) Legal Authority: PL 107–188 PO 00000 Frm 00007 Fmt 1254 FR Cite Sfmt 1254 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 E:\FR\FM\20DEP11.SGM 20DEP11 79770 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—CDC Final Rule Stage consulting with subject matter experts from CDC, the National Institutes of Health (NIH), the Food Drug Administration (FDA), the United States Department of Agriculture (USDA) /Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the Department of Defense (DOD)/United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and review of relevant published studies, we believe the Chapare virus should be added to the list of HHS select agents and toxins based on our conclusion that the Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 08/19/09 74 FR 159 10/19/09 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 11/00/11 Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) Long-Term Actions 310. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS approval program; and (3) revised approval label requirements. 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 Timetable: 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 Action Date NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period Reopened End NPRM Comment Period Reopening Extended FR Cite 12/10/08 73 FR 75045 02/09/09 03/04/09 74 FR 9381 04/10/09 05/21/09 74 FR 23815 Action Date NPRM Comment Period End Final Action jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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, VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Frm 00008 Fmt 1254 To Be Determined 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 Prerule Stage 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 PO 00000 10/09/09 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 311. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) FR Cite Sfmt 1254 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. E:\FR\FM\20DEP11.SGM 20DEP11 79771 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Prerule Stage Timetable: Action Date Begin Review End Review FR Cite 12/15/09 12/00/10 Regulatory Flexibility Analysis Required: Undetermined Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS–820), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1802 Fax: 301 436–2636 Email: geraldine.june@fda.hhs.gov RIN: 0910–AG06 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 312. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0910–AC52 313. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (ANTIHISTAMINE) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antihistamine labeling claims for the common cold. Timetable: Action Date Reopening of Administrative Record NPRM (Amendment) (Common Cold) FR Cite 08/25/00 65 FR 51780 10/00/11 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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 VerDate Mar<15>2010 19:28 Dec 17, 2010 314. OVER–THE–COUNTER (OTC) DRUG REVIEW—INTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weightand age-based dosing for children’s products. The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the internal analgesic products monograph. Timetable: Action Regulatory Flexibility Analysis Required: Yes Jkt 223001 Proposed Rule Stage Date NPRM (Amendment) (Required Warnings and Other Labeling) NPRM Comment Period End Final Action (Required Warnings and Other Labeling) Final Action (Correction) Final Action (Technical Amendment) NPRM (Acetaminophen) NPRM (Amendment) (Pediatric) PO 00000 Frm 00009 Fmt 1254 FR Cite 12/26/06 71 FR 77314 05/25/07 04/29/09 74 FR 19385 06/30/09 74 FR 31177 11/25/09 74 FR 61512 03/00/11 To Be Determined Sfmt 1254 Action Date FR Cite NPRM (Amendment) (Sodium Bicarbonate) NPRM (Overindulgence/ Hangover) Final Action (Internal Analgesics) To Be Determined To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: matthew.holman@fda.hhs.gov RIN: 0910–AF36 315. OVER–THE–COUNTER (OTC) DRUG REVIEW—LAXATIVE DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. The final action will address laxative drug products. E:\FR\FM\20DEP11.SGM 20DEP11 79772 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Proposed Rule Stage Timetable: Action Action Date FR Cite Final Action (Granular 03/29/07 72 FR 14669 Psyllium) NPRM (Professional 12/00/10 Labeling—Sodium Phosphate) NPRM (Professional To Be Determined Labeling) Final Action (Laxative To Be Determined Drug Products) jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: micheal.furness@fda.hhs.gov RIN: 0910–AF38 316. OVER–THE–COUNTER (OTC) DRUG REVIEW—SUNSCREEN PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other safety and effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen labeling and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: Action Date ANPRM (Sunscreen and Insect Repellent) ANPRM Comment Period End VerDate Mar<15>2010 FR Cite 02/22/07 72 FR 7941 NPRM (UVA/UVB) NPRM Comment Period End NPRM (Safety and Effectiveness) Final Action (UVA/UVB) NPRM (Time and Extent Applications) ANPRM (Safety) NPRM (Sunscreen and Insect Repellent) Jkt 223001 FR Cite 08/27/07 72 FR 49070 12/26/07 12/00/10 12/00/10 04/00/11 04/00/11 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 Action Date FR Cite NPRM (Testing — Healthcare Professional Products) Final Action (Healthcare) Final Action (Consumer) Final Action (Food Handlers) Final Action (First Aid Antiseptic) To Be Determined To Be Determined To Be Determined To Be Determined 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 RIN: 0910–AF43 317. OVER–THE–COUNTER (OTC) DRUG REVIEW—TOPICAL ANTIMICROBIAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, food handlers, and first aid antiseptic drug products respectively. Action PO 00000 Frm 00010 318. IMPORT TOLERANCES FOR RESIDUES OF UNAPPROVED NEW ANIMAL DRUGS IN FOOD Legal Authority: 21 USC 360b(a)(6); 21 USC 371 Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residue of the new animal drug in the animal-derived food does not exceed that tolerance. Timetable: Action Timetable: Date NPRM (Healthcare) NPRM (Consumer) NPRM (Food Handlers) 05/23/07 19:28 Dec 17, 2010 Date Fmt 1254 FR Cite 06/17/94 59 FR 31402 03/00/11 To Be Determined Sfmt 1254 Date NPRM NPRM Comment Period End FR Cite 03/00/11 06/00/11 Regulatory Flexibility Analysis Required: Yes E:\FR\FM\20DEP11.SGM 20DEP11 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Proposed Rule Stage Agency Contact: Thomas Moskal, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 101, (MPN–4, HFV–232), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276–9242 Fax: 240 276–9241 Email: thomas.moskal@fda.hhs.gov RIN: 0910–AF78 319. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393 Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA’s performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science. In addition, the proposal would include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products. Timetable: Action Date NPRM FR Cite 06/00/11 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–6248 Fax: 301 847–8145 Email: nancy.pirt@fda.hhs.gov RIN: 0910–AF87 320. PET FOOD LABELING REQUIREMENTS Legal Authority: 21 USC 343; 21 USC 371; PL 110–85, sec 1002(a)(3) VerDate Mar<15>2010 79773 19:28 Dec 17, 2010 Jkt 223001 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 NPRM NPRM Comment Period End FR Cite 03/00/11 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2642 (MPN–4, HFV–228), 7519 Standish Place, Rockville, MD 20855 Phone: 240 453–6865 Email: william.burkholder@fda.hhs.gov RIN: 0910–AG09 321. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 USC 264; PL 110–85, sec 1002(a)(2) Abstract: The Food and Drug Administration (FDA) is proposing regulations for process controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA’s Animal Feed Safety System initiative. The proposed process controls will apply to animal feed ingredients and mixed animal feed, including pet food. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of PO 00000 Frm 00011 Fmt 1254 Sfmt 1254 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 NPRM NPRM Comment Period End FR Cite 03/00/11 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN–4, HFV–230), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276–9207 Email: kim.young@fda.hhs.gov RIN: 0910–AG10 322. OVER–THE–COUNTER (OTC) DRUG REVIEW—PEDIATRIC DOSING FOR COUGH/COLD PRODUCTS Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: Action Date NPRM 06/00/11 FR Cite 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 E:\FR\FM\20DEP11.SGM 20DEP11 79774 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Proposed Rule Stage New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: micheal.furness@fda.hhs.gov RIN: 0910–AG12 323. ELECTRONIC DISTRIBUTION OF CONTENT OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Abstract: This rule would require electronic package inserts for human drug and biological prescription products, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. Timetable: Action Date NPRM FR Cite 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 325. CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111–31, The Family Smoking Prevention and Tobacco Control Act Abstract: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the Tobacco Control Act. This proposed rule would deem cigars to be subject to the Tobacco Control Act and include provisions to address public health concerns raised by cigars. Timetable: Action Date NPRM FR Cite 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 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0910–AG31 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Timetable: Action Date NPRM NPRM Comment Period End FR Cite 09/00/11 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 RIN: 0910–AG38 326. CIGARETTE WARNING LABEL STATEMENTS Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0910–AG41 RIN: 0910–AG18 324. UNIQUE DEVICE IDENTIFICATION 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. 327. ∑ GENERAL HOSPITAL AND PERSONAL USE DEVICES: DESIGNATION OF SPECIAL CONTROLS FOR INFUSION PUMPS Legal Authority: 21 USC 351 371; 21 USC 360 and 360c; 21 USC 360e and 360j; 21 USC 371 PO 00000 Frm 00012 Fmt 1254 Sfmt 1254 328. ∑ FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD IN VENDING MACHINES Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0910–AG56 329. ∑ FOOD LABELING: NUTRITION LABELING OF STANDARD MENU ITEMS IN CHAIN RESTAURANTS Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register. RIN: 0910–AG57 E:\FR\FM\20DEP11.SGM 20DEP11 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Final Rule Stage 330. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS 331. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS 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 Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 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 NPRM NPRM Comment Period Extended NPRM Comment Period End NPRM Comment Period Extension End Final Action FR Cite 03/14/03 68 FR 12406 06/18/03 Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving highpressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be permanently attached to the valve body. Timetable: 07/14/03 Action 10/14/03 Date NPRM NPRM Comment Period End Final Action 08/00/11 FR Cite 04/10/06 71 FR 18039 07/10/06 10/00/11 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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 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–AA97 RIN: 0910–AC53 19:28 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00013 Fmt 1254 Sfmt 1254 332. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA’s current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women’s health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product’s risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. Timetable: Action Regulatory Flexibility Analysis Required: Yes VerDate Mar<15>2010 79775 Date NPRM NPRM Comment Period End Final Action FR Cite 05/29/08 73 FR 30831 08/27/08 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 E:\FR\FM\20DEP11.SGM 20DEP11 79776 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Final Rule Stage Fax: 301 847–8440 Email: rachel.bressler@fda.hhs.gov 335. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (COMBINATION) PRODUCTS RIN: 0910–AF11 333. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND QUALITY FACTORS Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register. RIN: 0910–AF27 334. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (BRONCHODILATOR) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Date NPRM (Amendment) NPRM Comment Period End Final Action (Technical Amendment) Final Action 07/13/05 70 FR 40232 11/10/05 03/19/07 72 FR 12730 10/00/11 Regulatory Flexibility Analysis Required: Yes RIN: 0910–AF33 01/00/11 336. OVER–THE–COUNTER (OTC) DRUG REVIEW—EXTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 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 19:28 Dec 17, 2010 Jkt 223001 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, PO 00000 Frm 00014 Fmt 1254 Sfmt 1254 Action Date Final Action (GRASE dosage forms) NPRM (Amendment) FR Cite 10/00/11 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 FR Cite 11/30/07 72 FR 67639 FR Cite 07/13/05 70 FR 40237 Regulatory Flexibility Analysis Required: Yes VerDate Mar<15>2010 Timetable: Action 11/10/05 Date NPRM (Amendment— Ephedrine Single Ingredient) NPRM Comment Period End Final Action (Technical Amendment) Final Action (Amendment— Single Ingredient Labeling) 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. 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 Timetable: Action Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: 337. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN PROTECTANT PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. The second action addresses skin protectant products used to treat fever blisters and cold sores. Timetable: Action Date Final Action (Aluminum Acetate) (Technical Amendment) Final Action (Technical Amendments) Final Action (Diaper Rash) Final Action (Fever Blisters/Cold Sores) FR Cite 03/06/09 74 FR 9759 02/01/08 73 FR 6014 10/00/11 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug E:\FR\FM\20DEP11.SGM 20DEP11 79777 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Final Rule Stage Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: matthew.holman@fda.hhs.gov RIN: 0910–AF42 338. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexaneinsoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. 339. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Timetable: 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 Action Date Interim Final Rule Interim Final Rule Effective Interim Final Rule Comment Period End Interim Final Rule (Amendments) Interim Final Rule (Amendments) Effective Interim Final Rule (Amendments) Comment Period End Interim Final Rule (Amendments) Interim Final Rule (Amendments) Comment Period End Interim Final Rule (Amendments) Effective Final Action FR Cite 07/14/04 69 FR 42256 07/14/04 10/12/04 09/07/05 70 FR 53063 10/07/05 11/07/05 04/17/08 73 FR 20785 07/16/08 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. 107188). Timetable: 07/16/08 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 Date NPRM NPRM Comment Period End Final Action jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 371; 21 USC VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 09/18/08 73 FR 54106 12/02/08 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–4706 Email: daniel.sigelman@fda.hhs.gov RIN: 0910–AF61 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 340. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS FR Cite Long-Term Actions 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 PO 00000 Frm 00015 Fmt 1254 Sfmt 1254 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 E:\FR\FM\20DEP11.SGM 20DEP11 79778 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Long-Term Actions by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA’s response to an exemption request. Timetable: Action Date ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Rule Interim Final Rule Interim Final Rule Comment Period End Final Action FR Cite 02/06/97 62 FR 5700 06/06/97 03/13/03 68 FR 12157 08/11/03 06/25/07 72 FR 34752 06/25/07 72 FR 34959 10/24/07 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS–024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–2784 Fax: 301 436–2657 Email: linda.kahl@fda.hhs.gov RIN: 0910–AB88 341. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (NASAL DECONGESTANT) PRODUCTS jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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 NPRM (Amendment) (Sinusitis Claim) NPRM Comment Period End VerDate Mar<15>2010 FR Cite 08/02/04 69 FR 46119 11/01/04 19:28 Dec 17, 2010 Jkt 223001 Action Date NPRM (Phenylephrine Bitartrate) NPRM Comment Period End NPRM (Phenylpropanolamine) NPRM Comment Period End Final Action (Amendment) (Sinusitis Claim) Final Action (Phenylephrine Bitartrate) Final Action (Phenylpropanolamine) FR Cite 11/02/04 69 FR 63482 01/31/05 12/22/05 70 FR 75988 03/22/06 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 10/31/05 70 FR 58974 08/01/06 71 FR 83358 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 343. OVER–THE–COUNTER (OTC) DRUG REVIEW—OPHTHALMIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes the monograph for emergency first aid eyewash drug products. Timetable: Action 342. OVER–THE–COUNTER (OTC) DRUG REVIEW—LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: Action Date NPRM (Convenience Sizes) NPRM Comment Period End Final Action Frm 00016 Fmt 1254 04/11/07 To Be Determined Sfmt 1254 NPRM (Amendment) (Emergency First Aid Eyewashes) Final Action (Amendment) (Emergency First Aid Eyewashes) FR Cite 02/19/03 68 FR 7917 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 FR Cite 12/12/06 71 FR 74474 Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human PO 00000 Date 344. OVER–THE–COUNTER (OTC) DRUG REVIEW—ORAL HEALTH CARE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which E:\FR\FM\20DEP11.SGM 20DEP11 79779 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Long-Term Actions OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: Action Date ANPRM (Plaque Gingivitis) ANPRM Comment Period End NPRM (Plaque Gingivitis) Final Action FR Cite 08/27/03 To Be Determined To Be Determined Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: matthew.holman@fda.hhs.gov RIN: 0910–AF40 345. OVER–THE–COUNTER (OTC) DRUG REVIEW—VAGINAL CONTRACEPTIVE PRODUCTS jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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: Date FR Cite Final Action 12/19/07 72 FR 71769 (Warnings) NPRM (Vaginal To Be Determined Contraceptive Drug Products) VerDate Mar<15>2010 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 05/29/03 68 FR 32232 Regulatory Flexibility Analysis Required: Yes Action Regulatory Flexibility Analysis Required: Yes 19:28 Dec 17, 2010 Jkt 223001 346. OVER–THE–COUNTER (OTC) DRUG REVIEW—WEIGHT CONTROL PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine. Timetable: Action Date NPRM (Phenylpropanolamine) NPRM Comment Period End NPRM (Benzocaine) Final Action (Phenylpropanolamine) Final Action (Benzocaine) FR Cite 12/22/05 70 FR 75988 Fmt 1254 347. OVER–THE–COUNTER (OTC) DRUG REVIEW—OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: Action Date NPRM (Amendment) NPRM Comment Period End Final Action FR Cite 01/05/05 70 FR 741 04/05/05 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 To Be Determined To Be Determined 348. OVER–THE–COUNTER (OTC) DRUG REVIEW—ANTACID PRODUCTS To Be Determined Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 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 Frm 00017 RIN: 0910–AF45 RIN: 0910–AF51 03/22/06 Regulatory Flexibility Analysis Required: Yes PO 00000 Email: micheal.furness@fda.hhs.gov Sfmt 1254 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 E:\FR\FM\20DEP11.SGM 20DEP11 79780 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Long-Term Actions bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: Action Date FR Cite Final Action (Sodium Bicarbonate Labeling) Final Action (Overindulgence Labeling) To Be Determined 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 Phone: 301 796–2090 Fax: 301 796–9899 Email: matthew.holman@fda.hhs.gov 350. OVER–THE–COUNTER (OTC) DRUG REVIEW—STIMULANT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: Date 349. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN BLEACHING PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses skin bleaching drug products containing hydroquinone. Timetable: NPRM (Amendment) (Hangover) To Be Determined Action Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 NPRM NPRM Comment Period End Final Action FR Cite 08/29/06 71 FR 51146 12/27/06 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 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 FR Cite 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 Action Date NPRM (New Labeling) Final Action (New Labeling) RIN: 0910–AF53 Action Date Timetable: FR Cite To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: micheal.furness@fda.hhs.gov RIN: 0910–AF63 352. OVER–THE–COUNTER (OTC) DRUG REVIEW—URINARY ANALGESIC DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the products used for urinary pain relief. Timetable: Action 351. OVER–THE–COUNTER (OTC) DRUG REVIEW—ANTIDIARRHEAL DRUG PRODUCTS 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. PO 00000 Frm 00018 Fmt 1254 Sfmt 1254 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 E:\FR\FM\20DEP11.SGM 20DEP11 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Long-Term Actions 353. OVER–THE–COUNTER (OTC) DRUG REVIEW—CERTAIN CATEGORY II ACTIVE INGREDIENTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 06/19/08 73 FR 34895 09/17/08 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: matthew.holman@fda.hhs.gov RIN: 0910–AF95 354. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES (SECTION 610 REVIEW) jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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 VerDate Mar<15>2010 79781 19:28 Dec 17, 2010 Jkt 223001 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 11/24/08 Current Regulation End Review of Current 12/00/11 Regulation 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 PO 00000 Frm 00019 Fmt 1254 Sfmt 1254 Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: pdma610(c)review@fda.hhs.gov RIN: 0910–AG14 355. PRODUCE SAFETY REGULATION Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264 Abstract: The Food and Drug Administration (FDA) has determined that enforceable standards (as opposed to voluntary recommendations) for the production and packing of fresh produce are necessary to ensure best practices are commonly adopted. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables’’ (GAPs Guide). The proposed rule also will reflect comments received on the agency’s 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA’s proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance after the proposed rule is finalized to assist industry in E:\FR\FM\20DEP11.SGM 20DEP11 79782 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Long-Term Actions complying with the requirements of the new regulation. Timetable: Action Date FR Cite NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Samir Assar, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1636 Email: samir.assar@fda.hhs.gov RIN: 0910–AG35 356. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES REGULATION action to better address changes that have occurred in the food industry and protect public health. Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264 Action Date NPRM To Be Determined 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 Regulatory Flexibility Analysis Required: Yes Timetable: Agency Contact: Paul South, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS–317), Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1640 Email: paul.south@fda.hhs.gov RIN: 0910–AG36 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 357. STERILITY REQUIREMENT FOR AQUEOUS–BASED DRUG PRODUCTS FOR ORAL INHALATION (COMPLETION OF A SECTION 610 REVIEW) jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375 Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether this regulation on aqueousbased drug products for oral inhalation should be continued without change, or whether it should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for 21 CFR 200.51; (2) the nature of complaints or comments received concerning 21 CFR 200.51; (3) the complexity of 21 CFR 200.51; (4) the extent to which the regulation overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by 21 CFR 200.51. No comments were required. FDA’s review VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Completed Actions of these regulations concluded that they should be continued without change. Timetable: Action Date Begin Review End Review FR Cite 05/01/09 05/31/10 Regulatory Flexibility Analysis Required: No Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: howard.mullerjr@fda.hhs.gov RIN: 0910–AG25 358. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111–31, Family Smoking Prevention and Tobacco Control Act Abstract: This rule establishes regulations restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents, implementing section 102 of the Family PO 00000 Frm 00020 Fmt 1254 FR Cite Sfmt 1254 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 E:\FR\FM\20DEP11.SGM 20DEP11 79783 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—FDA Completed Actions distribution of brand-identified promotional, non-tobacco items such as hats and tee shirts. Furthermore, the rule prohibits sponsorship of sporting and other events, teams, and entries in a brand name of a tobacco product, but permits such sponsorship in a corporate name. FDA also published in the same issue of the Federal Register an advance notice of proposed rulemaking requesting comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco. Timetable: Action Date ANPRM Final Rule ANPRM Comment Period End Final Rule Effective FR Cite 03/19/10 75 FR 13241 03/19/10 75 FR 13225 05/18/10 06/22/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, 100K, Rockville, MD 20850 Phone: 877 287–1373 Fax: 240 276–3904 Email: annette.marthaler@fda.hhs.gov RIN: 0910–AG33 359. OVER–THE–COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 5 USC 610 Abstract: Section 201.66 (21 CFR section 201.66) established a standardized format for the labeling of OTC drug products that included: (1) Specific headings and subheadings presented in a standardized order, (2) standardized graphical features such as headings in bold type and the use of ‘‘bullet points’’ to introduce key information, and (3) minimum standards for type size and spacing. FDA issued the final rule to improve labeling after considering comments submitted to the agency following the publication of the proposed regulation in 1997. In 1999, FDA published the final rule and stated that a standardized labeling format would significantly improve readability by familiarizing consumers with the types of information in OTC drug product labeling and the location of that information. In addition, a standardized appearance and standardized content, including various ‘‘user-friendly’’ visual cues, would help consumers locate and read important health and safety information and allow quick and effective product comparisons, thereby helping consumers to select the most appropriate product. FDA undertook a review of section 201.66 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulation in section 201.66 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 201.66; (2) the nature of the complaints or comments received concerning the regulation in section 201.66; (3) the complexity of the regulations in section 201.66; (4) the extent to which the regulations in section 201.66 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling standard regulations in section 201. No comments were received. FDA’s review of these regulations concluded that they should be continued without change. Timetable: Action Date Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: micheal.furness@fda.hhs.gov RIN: 0910–AG34 Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) jlentini on DSKJ8SOYB1PROD with PROPOSALS11 360. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS–3819–P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs) that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The CoPs were last revised in 1989. The new requirements will focus on the actual care delivered to patients by VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 Proposed Rule Stage 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 NPRM PO 00000 Frm 00021 FR Cite 03/10/97 62 FR 11005 Fmt 1254 FR Cite Begin Review of 08/03/09 Current Regulation End Review of Current 05/27/10 Regulation Sfmt 1254 Action Date NPRM Comment Period End Second NPRM FR Cite 06/09/97 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 E:\FR\FM\20DEP11.SGM 20DEP11 79784 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—CMS Proposed Rule Stage Phone: 410 786–6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938–AG81 Regulatory Flexibility Analysis Required: Yes 361. REQUIREMENTS FOR LONG–TERM CARE FACILITIES: HOSPICE SERVICES (CMS–3140–F) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395hh Abstract: This rule establishes that in order to participate in the Medicare and Medicaid programs, long-term care facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility. The rule also contains quality of care requirements. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 10/22/10 75 FR 65282 12/21/10 10/00/13 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Patricia Brooks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mailstop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–4561 Email: patricia.brooks@cms.hhs.gov RIN: 0938–AP32 362. INFLUENZA VACCINATION STANDARD FOR CERTAIN MEDICARE PARTICIPATING PROVIDERS AND SUPPLIERS(CMS–3213–P) Legal Authority: Social Security Act sec 1881, 1861, 1920, 1102, 1871, 1965 Abstract: This proposed rule would require certain Medicare providers and suppliers to offer all patients an annual influenza vaccination, unless medically inadvisable or if the patient declines vaccination. This proposed rule is intended to increase the number of patients receiving annual vaccination against seasonal influenza and to decrease the morbidity and mortality rate from influenza. Timetable: Action Date NPRM 01/00/11 VerDate Mar<15>2010 19:28 Dec 17, 2010 FR Cite Jkt 223001 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 364. ∑ PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2012 RATES AND TO THE LONG–TERM CARE HOSPITAL PPS AND RY 2012 RATES (CMS–1518–P) Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of the Federal Register. RIN: 0938–AQ24 RIN: 0938–AP92 363. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HOSPITAL INPATIENT PSYCHIATRIC AND REHABILITATION UNITS EXCLUDED FROM THE PROSPECTIVE PAYMENT SYSTEM AND LTCH REQUIREMENTS (CMS–3177–P) 365. ∑ CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2012 (CMS–1525–P) Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of the Federal Register. Legal Authority: 42 USC 1385 X; 42 USC 1396 d; 42 USC 1395 hh RIN: 0938–AQ26 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. 366. ∑ CHANGES TO THE ESRD PROSPECTIVE PAYMENT SYSTEM FOR CY 2012 (CMS–1577–P) Timetable: Regulatory Flexibility Analysis Required: Yes Action Date NPRM FR Cite 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 PO 00000 Frm 00022 Fmt 1254 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 NPRM FR Cite 06/00/11 Agency Contact: Janet Samen, Director, Division of Chronic Care Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5–05–27, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–4533 Email: janet.samen@cms.hhs.gov RIN: 0938–AQ27 367. ∑ FEDERAL FUNDING FOR MEDICAID ELIGIBILITY DETERMINATION AND ENROLLMENT ACTIVITIES (CMS–2346–P) Legal Authority: PL 111–148, sec 1413 Sfmt 1254 E:\FR\FM\20DEP11.SGM 20DEP11 79785 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—CMS Proposed Rule Stage Abstract: The Affordable Care Act requires States’ residents to apply, enroll, receive determinations, and participate in the State health subsidy programs known as ‘‘the Exchange’’. The ACA requires many changes to State eligibility and enrollment systems and each State is responsible for developing a secure, electronic interface allowing the exchange of data. Existing legacy eligibility systems are not able to implement the numerous requirements. This proposed rule is key to informing States about the higher rates that CMS will provide to help them update or build legacy eligibility systems that meet the ACA requirements. Timetable: Action Date NPRM NPRM Comment Period End FR Cite 11/08/10 75 FR 68583 01/07/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Richard H. Friedman, Director, Division of State Systems, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3–18–13, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–4451 Email: richard.friedman@cms.hhs.gov RIN: 0938–AQ53 Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 368. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND PART B FOR CY 2011 (CMS–1503–C) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This annual final rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B for CY 2011. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 07/13/10 75 FR 40040 09/24/10 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 & Final Rule Stage Medicaid Services, Mail Stop C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–6960 Email: carol.bazell@cms.hhs gov RIN: 0938–AP79 369. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS–1504–C) Legal Authority: sec 1833 of the Social Security Act; BBA, BA, BIPA, MMA, PPACA Abstract: This final rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule changes the Ambulatory Surgical Center Payment System list of services and rates. Timetable: Action Date NPRM NPRM Comment Period End Final Action jlentini on DSKJ8SOYB1PROD with PROPOSALS11 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 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 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 Completed Actions 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. PO 00000 Frm 00023 Fmt 1254 12/00/10 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 370. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS–4085–F) FR Cite 08/03/10 75 FR 46169 08/31/10 Sfmt 1254 Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 10/22/09 74 FR 54634 12/07/09 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 E:\FR\FM\20DEP11.SGM 20DEP11 79786 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Unified Agenda HHS—CMS Completed Actions C1–26–26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–6041 Email: alissa.deboy@cms.hhs.gov 372. PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND THE LONG–TERM CARE HOSPITAL PROSPECTIVE PAYMENT SYSTEM RIN: 0938–AP77 371. ELECTRONIC HEALTH RECORD (EHR) INCENTIVE PROGRAM (CMS–0033–F) Legal Authority: PL 111–5 (The American Recovery and Reinvestment Act of 2009, Title IV of Division B, Medicare and Medicaid Health Information Technology) Abstract: This rule would implement provisions of the American Recovery Act of 2009 (Recovery Act) that authorize incentive payments to eligible professionals (EPS) and eligible hospitals participating in the Medicare and Medicaid programs for adopting and becoming meaningful users of certified electronic health records (HER) technology. In accordance with the Recovery Act, the rule will establish maximum annual incentive amounts and include Medicare penalties for failing to meaningfully use EHRs beginning in 2015. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 01/13/10 75 FR 1843 03/15/10 07/28/10 75 FR 44413 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 NPRM NPRM Comment Period End Second NPRM Second NPRM Comment Period End Final Action FR Cite 05/04/10 75 FR 23851 06/18/10 06/02/10 75 FR 30917 07/02/10 08/16/10 75 FR 50041 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 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–AP78 jlentini on DSKJ8SOYB1PROD with PROPOSALS11 Regulatory Flexibility Analysis Required: Yes RIN: 0938–AP80 VerDate Mar<15>2010 19:28 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00024 Fmt 1254 373. ∑ HOSPITAL IPPS FOR ACUTE CARE HOSPITALS AND FISCAL YEAR 2010 RATES AND TO THE LONG–TERM CARE HOSPITAL PPS AND RATE YEAR 2010 RATES (CMS–1406–N) Legal Authority: PL 111 148; PL 111–152 Abstract: This notice contains the final wage indices, hospital reclassifications, payment rates, impacts, and other related tables effective for the fiscal year (FY) 2010 hospital inpatient prospective payment systems (IPPS) and rate year 2010 long-term care hospital (LTCH) prospective payment system (PPS) . The rates, tables, and impacts included in this notice reflect changes required or resulting from the implementation of several provisions of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010. These provisions require the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2010, and certain market basket updates for the IPPS and LTCH PPS effective April 1, 2010. Timetable: Action Date Final Action 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 Sfmt 1254 FR Cite 06/02/10 75 FR 31118 E:\FR\FM\20DEP11.SGM 20DEP11

Agencies

[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Unknown Section]
[Pages 79763-79786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30444]


[[Page 79763]]

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Part VIII





Department of Health and Human Services





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



###Semiannual Regulatory Agenda###

[[Page 79764]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)






_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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


Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
(EO) 12866 require the semi-annual issuance of an inventory of 
rulemaking actions under development throughout the Department with a 
view to offering summarized information about forthcoming regulatory 
actions for public review.

FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary, 
Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The information provided in the Agenda 
presents a forecast of the rulemaking activities that the Department of 
Health and Human Services (HHS) expects to undertake in the foreseeable 
future. Rulemakings are grouped according to pre-rulemaking actions, 
proposed rules, final rules, long-term actions, and rulemaking actions 
completed since the Spring 2009 Agenda was published.

    Please note that the rulemaking abstracts included in this 
paper issue of the Federal Register relate strictly to those 
prospective rulemakings that are likely to have a significant 
economic impact on a substantial number of small entities, as 
required by the Regulatory Flexibility Act of 1980. Also available 
in this issue of the Register is the Department's submission to the 
Fiscal Year 2011 Regulatory Plan, as required under Executive Order 
12866.

    The purpose of the Agenda is to encourage more effective public 
participation in the regulatory process, and HHS invites all 
interested members of the public to comment on the rulemaking 
actions included in this issuance of the Agenda. The complete 
Regulatory Agenda of the Department is accessible online at 
www.reginfo.gov in an interactive format that offers users enhanced 
capabilities to obtain information from the Agenda's database.

Dated:  September 21, 2010.

 Dawn L. Smalls,

Executive Secretary,
Department of Health and Human Services.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     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)...........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 79765]]


                         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.


[[Page 79766]]


                                 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)...............................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________


<###DOC>

302. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE 
CIVIL MONEY PENALTIES AND ASSESSMENTS (SECTION 610 REVIEW)

Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 
USC 1396b; PL 99-660; PL 107-188

Abstract: This proposed rule would revise part 1003, addressing the 
Office of Inspector General's authority to propose the imposition of 
civil money penalties and assessments by reorganizing and simplifying 
existing regulatory text and eliminating obsolete references contained 
in the current regulations. Among the proposed revisions, this rule 
would establish separate subparts within part 1003 for various 
categories of violations; clarify the availability of exclusion for 
certain violations in addition to civil money penalties and 
assessments; date various references to managed care organization 
authorities; and clarify the application of section 1140 of the Social 
Security Act with respect to the misuse of certain Departmental 
symbols, emblems, or names through Internet and e mail communications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/11
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

[[Page 79768]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________


<###DOC>

303. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES 
UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH 
ACT

 Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of 
the Federal Register.

RIN: 0991-AB57
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________


<###DOC>

304. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, 
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC 
HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 
REVIEW)

Legal Authority: 42 USC 300jj-14

Abstract: The Department of Health and Human Services (HHS), Office of 
the National Coordinator for Health Information Technology, will issue 
an interim final rule with a request for comments to adopt an initial 
set of standards, implementation specifications, and certification 
criteria, as required by section 3004(b)(1) of the Public Health 
Service Act. The certification criteria adopted in this initial set 
establish the technical capabilities and related standards that 
certified electronic health record (EHR) technology will need to 
include in support of the Medicare and Medicaid EHR Incentive Programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/13/10                     75 FR 2014
Interim Final Rule Comment 
Period End                      03/15/10
Interim Final Rule Effective    02/12/10
Final Action                    07/28/10                    75 FR 44590

Regulatory Flexibility Analysis Required: No

Agency Contact: Steven Posnack, Policy Analyst, Department of Health 
and Human Services, Office of the Secretary, Office of the National 
Coordinator for Health Information Technology, 200 Independence Avenue 
SW., Washington, DC 20201
Phone: 202 690-7151

RIN: 0991-AB58
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________


<###DOC>

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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0930-AA10
_______________________________________________________________________


<###DOC>

306. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE 
ADDICTION (SECTION 610 REVIEW)

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

Abstract: This rule will amend the Federal opioid treatment program 
regulations. It will modify the dispensing requirements for 
buprenorphine and buprenorphine combination products that are approved 
by the Food and Drug Administration (FDA) for opioid dependence and 
used in federally certified and registered opioid treatment programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/09                    74 FR 29153
NPRM Comment Period End         08/18/09
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Agency Contact: Nicholas Reuter, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
Suite

[[Page 79769]]

2-1063, One Choke Cherry Road, Rockville, MD 20857
Phone: 240 276-2716

RIN: 0930-AA14
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________


<###DOC>

307. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS 
REGULATIONS; NONHUMAN PRIMATE

Legal Authority: 42 USC 264

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/11

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA23
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________


<###DOC>

308. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS

Legal Authority: 42 USC 243; 42 USC 264 and 265; 42 USC 267 and 268; 42 
USC 270 and 271

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. Communicable disease 
regulations are divided into two parts: Part 71 pertaining to foreign 
arrivals and part 70 pertaining to interstate matters. This rule (42 
CFR Part 71) will update and improve CDC's response to both global and 
domestic disease threats by creating a multi-tiered illness detection 
and response process thus substantially enhancing the public health 
system's ability to slow the introduction, transmission, and spread of 
communicable disease. The final rule focuses primarily on requirements 
relating to the reporting of deaths and illnesses onboard aircrafts and 
ships, and the collection of specific traveler contact information for 
the purpose of CDC contacting travelers in the event of an exposure to 
a communicable disease.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/20/06
Final Action                    12/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA12
_______________________________________________________________________


<###DOC>

309. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE 
VIRUS (SECTION 610 REVIEW)

Legal Authority: PL 107-188

Abstract: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 authorizes the HHS Secretary to regulate the 
possession, use, and transfer of select agents and toxins that have the 
potential to pose a severe threat to public health and safety. These 
regulations are set forth at 42 CFR 73. Criteria used to determine 
whether a select agent or toxin should be included under the provisions 
of these regulations are based on: (1) The effect on human health as a 
result of exposure to the agent or toxin, (2) the degree of 
contagiousness of the agent or toxin, (3) the methods by which the 
agent or toxin is transferred to humans, (4) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent and illness resulting from infection by the agent or toxin, and 
(5) any other criteria, including the needs of children and other 
vulnerable populations that the HHS Secretary considers appropriate. 
Based on these criteria, we are proposing to amend the list of HHS 
select agents and toxins by adding Chapare virus to the list. After

[[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
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________


<###DOC>

310. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842(h); 30 USC 844

Abstract: NIOSH plans to modify the Administrative/Quality Assurance 
sections of 42 CFR part 84, Approval of Respiratory Protective Devices. 
Areas for potential modification in this module are: (1) Upgrade of 
quality assurance requirements; (2) ability to use private sector 
quality auditors and private sector testing laboratories in the 
approval program; and (3) revised approval label requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/08                    73 FR 75045
NPRM Comment Period End         02/09/09
NPRM Comment Period Reopened    03/04/09                     74 FR 9381
NPRM Comment Period Reopened 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
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________


<###DOC>

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

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

Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements 
for the labeling of the cartons of shell eggs that have not been 
treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 
115.50) describes requirements for refrigeration of shell eggs held for 
retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides 
that part 16 does not apply to a hearing on an order for relabeling, 
diversion, or destruction of shell eggs under section 361 of the Public 
Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. 
FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit 
the safe handling statement to appear on the inside lid of egg cartons 
to provide the industry greater flexibility in the placement of the 
statement, provided the words ``keep refrigerated'' appear on the 
principal display panel or information panel. FDA is undertaking a 
review of 21 CFR sections 101.17(h), 115.50, and 16.5(a)(4) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in sections 101.17(h), 
115.50 and 16.5(a)(4) should be continued without change, or whether 
they should be amended or rescinded, consistent with the stated 
objectives of applicable statutes, to minimize any significant economic 
impact on a substantial number of small entities. FDA will consider, 
and is soliciting comments on, the following: (1) The continued need 
for the rule; (2) the nature of complaints or comments received 
concerning the rule from the public; (3) the complexity of the rule; 
(4) the extent to which the rule overlaps, duplicates, or conflicts 
with other Federal rules, and, to the extent feasible, with State and 
local governmental rules; and (5) the length of time since the rule has 
been evaluated or the degree to which technology, economic conditions, 
or other factors have changed in the area affected by the rule.

[[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
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________


<###DOC>

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

 Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of 
the Federal Register.

RIN: 0910-AC52
_______________________________________________________________________


<###DOC>

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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Reopening of Administrative 
Record                          08/25/00                    65 FR 51780
NPRM (Amendment) (Common Cold)  10/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: micheal.furness@fda.hhs.gov

RIN: 0910-AF31
_______________________________________________________________________


<###DOC>

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

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

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action addresses products labeled to relieve upset stomach associated 
with overindulgence in food and drink and to relieve symptoms 
associated with a hangover. The second action addresses acetaminophen 
safety. The third action addresses products marketed for children under 
2 years old and 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
_______________________________________________________________________


<###DOC>

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

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

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

[[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
_______________________________________________________________________


<###DOC>

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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
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
_______________________________________________________________________


<###DOC>

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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Healthcare)               06/17/94                    59 FR 31402
NPRM (Consumer)                 03/00/11
NPRM (Food Handlers)             To Be                       Determined
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
_______________________________________________________________________


<###DOC>

318. IMPORT TOLERANCES FOR RESIDUES OF UNAPPROVED NEW ANIMAL DRUGS IN 
FOOD

Legal Authority: 21 USC 360b(a)(6); 21 USC 371

Abstract: The Food and Drug Administration (FDA) plans to publish a 
proposed rule related to the implementation of the import tolerances 
provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA 
authorizes FDA to establish tolerances for unapproved new animal drugs 
where edible portions of animals imported into the United States may 
contain residues of such drugs (import tolerances). It is unlawful to 
import animal-derived food that bears or contains residues of a new 
animal drug that is not approved in the United States, unless FDA has 
established an import tolerance for that new animal drug and the 
residue of the new animal drug in the animal-derived food does not 
exceed that tolerance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: Yes

[[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
_______________________________________________________________________


<###DOC>

319. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD

Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393

Abstract: FDA is proposing to amend the performance standard for laser 
products to achieve closer harmonization between the current standard 
and the International Electrotechnical Commission (IEC) standard for 
laser products and medical laser products. The proposed amendment is 
intended to update FDA's performance standard to reflect advancements 
in technology. The proposal would adopt portions of an IEC standard to 
achieve greater harmonization and reflect current science. In addition, 
the proposal would include an alternative mechanism for providing 
certification and identification, address novelty laser products, and 
clarify the military exemption for laser products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993
Phone: 301 796-6248
Fax: 301 847-8145
Email: nancy.pirt@fda.hhs.gov

RIN: 0910-AF87
_______________________________________________________________________


<###DOC>

320. PET FOOD LABELING REQUIREMENTS

Legal Authority: 21 USC 343; 21 USC 371; PL 110-85, sec 1002(a)(3)

Abstract: The President signed into law the Food and Drug 
Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 
(Pub. L. 110-85). Title X of the FDAAA includes several provisions 
pertaining to food safety, including the safety of pet food. Section 
1002(a) of the new law directs FDA to issue new regulations to 
establish updated standards for the labeling of pet food that include 
nutritional and ingredient information. This same provision of the law 
also directs that, in developing these new regulations, FDA obtain 
input from its stakeholders, including the Association of American Feed 
Control Officials, veterinary medical associations, animal health 
organizations, and pet food manufacturers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William Burkholder, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 
Standish Place, Rockville, MD 20855
Phone: 240 453-6865
Email: william.burkholder@fda.hhs.gov

RIN: 0910-AG09
_______________________________________________________________________


<###DOC>

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

Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 
USC 264; PL 110-85, sec 1002(a)(2)

Abstract: The Food and Drug Administration (FDA) is proposing 
regulations for process controls for animal feed ingredients and mixed 
animal feed to provide greater assurance that marketed animal feed 
ingredients and mixed feeds intended for all animals, including pets, 
are safe. This action is being taken as part of the FDA's Animal Feed 
Safety System initiative. The proposed process controls will apply to 
animal feed ingredients and mixed animal feed, including pet food. This 
action is also being taken to carry out the requirements of the Food 
and Drug Administration Amendments Act of 2007. Section 1002(a) directs 
FDA to establish by regulation processing standards for pet food. This 
same provision of the law also directs that, in developing these new 
regulations, FDA obtain input from its stakeholders, including the 
Association of American Feed Control Officials, veterinary medical 
associations, animal health organizations, and pet food manufacturers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/11
NPRM Comment Period End         06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Kim Young, Deputy Director, Division of Compliance, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 
Standish Place, Rockville, MD 20855
Phone: 240 276-9207
Email: kim.young@fda.hhs.gov

RIN: 0910-AG10
_______________________________________________________________________


<###DOC>

322. OVER-THE-COUNTER (OTC) DRUG REVIEW--PEDIATRIC DOSING FOR COUGH/COLD 
PRODUCTS

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: M. Scott Furness, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO22, 10903

[[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
_______________________________________________________________________


<###DOC>

323. ELECTRONIC DISTRIBUTION OF CONTENT OF LABELING FOR HUMAN 
PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 
360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

Abstract: This rule would require electronic package inserts for human 
drug and biological prescription products, in lieu of paper, which is 
currently used. These inserts contain prescribing information intended 
for he