, 64423-64446 [E9-28598]

Download as PDF Monday, December 7, 2009 Part VI Department of Health and Human Services erowe on DSK5CLS3C1PROD with RULES Semiannual Regulatory Agenda VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\07DER9.SGM 07DER9 64424 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / 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: 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 issue of the requires the semi-annual issuance of an Federal Register relate only to those inventory of rulemaking actions under prospective rulemakings that are likely development throughout the to have a significant economic impact Department with a view to offering on a substantial number of small entities summarized information about Office of the Secretary as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Register is the Department’s submission to the fiscal year 2010 Regulatory Plan as required under Executive Order 12866. The purpose of the Agenda is to encourage more effective public participation in the regulatory process, and HHS invites all interested members of the public to comment on the rulemaking actions included in this issuance of the Agenda. The complete regulatory agenda of the Department is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda’s database. Dated: October 9, 2009. Dawn L. Smalls, Executive Secretary, Department of Health and Human Services. Office of the Secretary—Final Rule Stage Regulation Identifier Number Sequence Number Title 306 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review) (Reg Plan Seq No. 43) ......................................................................................................................................................................... 0991–AB58 References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Substance Abuse and Mental Health Services Administration—Final Rule Stage Sequence Number Title Regulation Identifier Number 307 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section 610 Review) ....................... 0930–AA14 Substance Abuse and Mental Health Services Administration—Long-Term Actions Regulation Identifier Number Sequence Number Title 308 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth ................................................................................................................................................ 0930–AA10 erowe on DSK5CLS3C1PROD with RULES Centers for Disease Control and Prevention—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 309 310 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations ......................... Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Nonhuman Primate Regulations .................................................................................................................................................... VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 PO 00000 Frm 00002 Fmt 1254 Sfmt 1254 E:\FR\FM\07DER9.SGM 07DER9 0920–AA14 0920–AA23 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda 64425 HHS Centers for Disease Control and Prevention—Final Rule Stage Sequence Number Title Regulation Identifier Number 311 312 Control of Communicable Diseases Foreign Quarantine ............................................................................................. Control of Communicable Diseases: Interstate Quarantine, Passenger Information ................................................... 0920–AA12 0920–AA27 Centers for Disease Control and Prevention—Long-Term Actions Sequence Number Title Regulation Identifier Number 313 Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review) .................................................. 0920–AA32 Food and Drug Administration—Prerule Stage Regulation Identifier Number Sequence Number Title 314 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review) ................................................................................................................................... Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review) ...................................................................................................... Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 Review) ......................... Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review) ...................................................... 315 316 317 0910–AG06 0910–AG14 0910–AG25 0910–AG34 Food and Drug Administration—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 318 319 320 321 322 323 324 325 326 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg Plan Seq No. 44) ........ Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products .......................................................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................................ Over-the-Counter (OTC) Drug Review—Sunscreen 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—Poison Treatment Drug Products ................................................................. Process Controls for Animal Feed Ingredients and Mixed Animal Feed ...................................................................... Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph ........................................................................................... Produce Safety Regulation (Reg Plan Seq No. 46) .................................................................................................... Modernization of the Current Food Good Manufacturing Practices Regulation (Reg Plan Seq No. 47) .................... 327 328 0910–AC52 0910–AF31 0910–AF38 0910–AF43 0910–AF44 0910–AF45 0910–AF68 0910–AG10 0910–AG12 0910–AG35 0910–AG36 References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration—Final Rule Stage Regulation Identifier Number erowe on DSK5CLS3C1PROD with RULES Sequence Number Title 329 330 331 332 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products .......................................... Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ................................... Positron Emission Tomography Drugs; Current Good Manufacturing Practices ......................................................... 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. 48) .......................................................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products ......................................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products ............................................................ 333 334 335 VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 PO 00000 Frm 00003 Fmt 1254 Sfmt 1254 E:\FR\FM\07DER9.SGM 07DER9 0910–AA97 0910–AC53 0910–AC55 0910–AF11 0910–AF27 0910–AF32 0910–AF33 64426 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS Food and Drug Administration—Final Rule Stage (Continued) Regulation Identifier Number Sequence Number Title 336 337 338 339 340 341 342 343 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products ............................................... Over-the-Counter (OTC) Drug Review—External Analgesic Products ......................................................................... Over-the-Counter (OTC) Drug Review—Internal Analgesic Products .......................................................................... Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use ......................................... Over-the-Counter (OTC) Drug Review—Skin Protectant Products .............................................................................. Use of Materials Derived From Cattle in Human Food and Cosmetics ....................................................................... Over-the-Counter (OTC) Drug Review—Acne Drug Products Containing Benzoyl Peroxide ...................................... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (Reg Plan Seq No. 50) .......................................................................................................................... 0910–AF34 0910–AF35 0910–AF36 0910–AF37 0910–AF42 0910–AF47 0910–AG00 0910–AG33 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 344 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements ...................................................................................................................................................................... Over-the-Counter (OTC) Drug Review—Ophthalmic Products .................................................................................... Over-the-Counter (OTC) Drug Review—Oral Health Care 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 ............................................................................... Label Requirement for Food That Has Been Refused Admission Into the United States ........................................... Over-the-Counter Antidiarrheal Drug Products ............................................................................................................. Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ............................................................ Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products ................................................................. Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients ................................................... 345 346 347 348 349 350 351 352 353 354 355 0910–AB88 0910–AF39 0910–AF40 0910–AF51 0910–AF52 0910–AF53 0910–AF56 0910–AF61 0910–AF63 0910–AF69 0910–AF70 0910–AF95 Food and Drug Administration—Completed Actions Regulation Identifier Number Sequence Number Title 356 357 Prevention of Salmonella Enteritidis in Shell Eggs ....................................................................................................... Substances Prohibited From Use in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy ........................................................................................................................................................... 0910–AC14 0910–AF46 Centers for Medicare & Medicaid Services—Proposed Rule Stage Regulation Identifier Number Title 358 erowe on DSK5CLS3C1PROD with RULES Sequence Number Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs for Contract Year 2011 (CMS-4085-F) .............................................................................................................................................................. Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates (CMS-1498-P) (Reg Plan Seq No. 53) ....... Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2011 (CMS-1504-P) (Reg Plan Seq No. 54) ........................................................................................... 359 360 References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 PO 00000 Frm 00004 Fmt 1254 Sfmt 1254 E:\FR\FM\07DER9.SGM 07DER9 0938–AP77 0938–AP80 0938–AP82 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda 64427 HHS Centers for Medicare & Medicaid Services—Final Rule Stage Regulation Identifier Number Sequence Number Title 361 362 Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413-FC) ............................. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2010 (CMS-1414-FC) ................................................................................................................................ Children’s Health Insurance Program (CHIP); Allotment Methodology and States’ Fiscal Year 2009 CHIP Allotments (CMS-2291-F) ................................................................................................................................................... 363 0938–AP40 0938–AP41 0938–AP53 Centers for Medicare & Medicaid Services—Long-Term Actions Sequence Number Title Regulation Identifier Number 364 365 366 367 368 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) .................... Electronic Claims Attachments Standards (CMS-0050-IFC) ........................................................................................ Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 Review) ............... Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 Review) .................... State Flexibility for Medicaid Benefit Packages (CMS-2232-F4) .................................................................................. 0938–AG81 0938–AK62 0938–AO53 0938–AP32 0938–AP72 Centers for Medicare & Medicaid Services—Completed Actions Regulation Identifier Number Sequence Number Title 369 370 371 372 Medicaid Graduate Medical Education (CMS-2279-F) ................................................................................................. Genetic Information Nondiscrimination Act of 2008 (CMS-4137-IFC) .......................................................................... Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2010 (CMS-1406-F) Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2010 (CMS1410-F) ........................................................................................................................................................................ Home Health Prospective Payment System and Rate Update for CY 2010 (CMS-1560-F) ....................................... Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2010 (CMS-1538-F) ................................ 373 374 Department of Health and Human Services (HHS) Office of the Secretary (OS) erowe on DSK5CLS3C1PROD with RULES 15:13 Dec 04, 2009 Jkt 220001 PO 00000 Frm 00005 Fmt 1254 0938–AP46 0938–AP55 0938–AP56 Final Rule Stage 306. ∑ HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of the Federal Register. RIN: 0991–AB58 VerDate Nov<24>2008 0938–AO95 0938–AP37 0938–AP39 Sfmt 1254 E:\FR\FM\07DER9.SGM 07DER9 64428 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) 307. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDITION (SECTION 610 REVIEW) 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: 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 Action Abstract: This rule will amend the Federal opioid treatment program regulations. It will modify the dispensing requirements for NPRM NPRM Comment Period End Final Action Date FR Cite 06/19/09 74 FR 29153 08/18/09 Final Rule Stage Regulatory Flexibility Analysis Required: No Agency Contact: Nicholas Reuter, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, One Choke Cherry Rd, Suite 2–1063, Rockville, MD 20857 Phone: 240 276–2716 RIN: 0930–AA14 06/00/10 Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) 308. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY–BASED FACILITIES FOR CHILDREN AND YOUTH Legal Authority: PL 106–310, 42 USC 290jj to 290jj–2 Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing Long-Term Actions 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. Regulatory Flexibility Analysis Required: Yes Timetable: RIN: 0930–AA10 Action Date NPRM 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 To Be Determined FR Cite erowe on DSK5CLS3C1PROD with RULES Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 309. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS Legal Authority: 42 USC 264 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has designated the authority to prevent the introduction of diseases from foreign countries to the Director, Centers for Disease Control and Prevention (CDC). CDC also enforces entry requirements for certain animals, etiologic agents and vectors deemed to be of public health significance. Currently the regulations restrict the importation of nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts and vectors, such as bats (42 CFR sections 71.53, 71.51, VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Proposed Rule Stage 71.52, 71.54). In addition, CDC has recently issued a series of emergency orders, restricting the importation of African rodents (42 CFR section 71.56) and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed Rulemaking (NPRM) to revise the regulations for importation of certain animals and vectors into the United States (42 CFR parts 71, Subpart F). Timetable: Action Date ANPRM ANPRM Comment Period End Notice Extending ANPRM Comment Period ANPRM Extended Comment Period End NPRM FR Cite 07/31/07 72 FR 41676 10/01/07 10/01/07 72 FR 55729 12/01/07 06/00/10 Regulatory Flexibility Analysis Required: Yes PO 00000 Frm 00006 Fmt 1254 Sfmt 1254 Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA14 310. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS Legal Authority: 42 USC 264 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has delegated the authority to prevent the E:\FR\FM\07DER9.SGM 07DER9 64429 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—CDC Proposed Rule Stage 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 NPRM 03/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA23 erowe on DSK5CLS3C1PROD with RULES Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 311. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE Legal Authority: 42 USC 243; 42 USC 248 and 249 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. This rule (42 CFR part 71) will update and improve CDC’s response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system’s ability to slow the introduction, transmission, and spread of communicable disease. The rule will also modify current Federal regulations governing the apprehension, quarantine isolation and conditional release of individuals suspected of carrying a quarantinable disease while respecting individual autonomy. CDC maintains quarantine stations at 20 ports of entry staffed with medical and public health officers who respond to reports of diseases from carriers. According to the statutory scheme, the President determines through Executive Order which diseases may subject individuals to quarantine. The current disease list, which was last updated in April 2005, includes cholera, diphtheria, tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 FR Cite Final Rule Stage influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause a pandemic. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 11/30/05 70 FR 71892 01/20/06 03/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA12 312. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER INFORMATION delegated the responsibility for carrying out these regulations. The Director’s authority to investigate suspected cases and potential spread of communicable disease among interstate travelers is thus not limited to those known or suspected of having a quarantinable disease, but rather all communicable diseases that may necessitate a public health response. Among the fundamental components of the public health response to the report of a person with a communicable disease is the identification and evaluation of individuals who may have been exposed. This provision, which was proposed section 70.4, would require any airline operating in interstate traffic to solicit and electronically submit certain passenger information to CDC for use in contact tracing when necessary to protect the vital interests of an individual, or other persons, in regard to significant health risks. Timetable: Action Date FR Cite Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248; 42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 2001 NPRM NPRM Comment Period End Final Action Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. The CDC Director has been Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov PO 00000 Frm 00007 Fmt 1254 Sfmt 1254 11/30/05 70 FR 71892 01/30/06 03/00/10 Regulatory Flexibility Analysis Required: Yes RIN: 0920–AA27 E:\FR\FM\07DER9.SGM 07DER9 64430 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 313. POSSESSION, USE AND TRANSFER OF SELECT AGENTS AND TOXINS (SECTION 610 REVIEW) Legal Authority: PL 107–188 Abstract: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorizes the HHS Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR 73. Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on: 1) the effect on human health as a reuslt of exposure to the agent or toxin, 2) the degree of contagiousness of the agent or toxin, 3) the methods by which the agent or toxin is transferred to humans, 4) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent andy illness Long-Term Actions resulting from infection by the agent or toxin, and 5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate. Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list. After consulting with subject matter experts from CDC, the National Institutes of Health (NIH), the Food Drug Administration (FDA), the United States Department of Agriculture (USDA) /Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the Department of Defense (DOD)/United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and review of relevant published studies, we believe the Chapare virus should be added to the list of HHS select agents and toxins based on our conclusion that the Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus. Timetable: Action Date NPRM NPRM Comment Period End Final Action erowe on DSK5CLS3C1PROD with RULES Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271 Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement. FDA is undertaking a review of 21 CFR sections 101.17(h), VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Action PO 00000 Frm 00008 To Be Determined 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 Prerule Stage 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Timetable: Begin Review End Review 08/19/09 74 FR 159 10/19/09 Regulatory Flexibility Analysis Required: No Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 314. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) FR Cite Date 12/00/09 12/00/10 Fmt 1254 Sfmt 1254 FR Cite 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 315. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES (SECTION 610 REVIEW) Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381 Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine E:\FR\FM\07DER9.SGM 07DER9 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Prerule Stage whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). 316. ∑ STERILITY REQUIREMENT FOR AQUEOUS–BASED DRUG PRODUCTS FOR ORAL INHALATION (SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375 Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether this regulation on 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. Timetable: Timetable: Regulatory Flexibility Analysis Required: No Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6234, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: howard.mullerjr@fda.hhs.gov RIN: 0910–AG25 Action Date FR Cite Begin Review of 11/24/08 Current Regulation End Review of Current 12/00/09 Regulation erowe on DSK5CLS3C1PROD with RULES Regulatory Flexibility Analysis Required: Yes Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room 6234, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847 8440 Email: pdma610(c)review@fda.hhs.gov RIN: 0910–AG14 VerDate Nov<24>2008 64431 15:13 Dec 04, 2009 Jkt 220001 Action Begin Review End Review Date FR Cite 05/01/09 05/00/10 317. ∑ OVER–THE–COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (SECTION 610 REVIEW) Legal Authority: 5 USC 610 Abstract: Part 201.66 (21 CFR section 201.66) established a standardized format for the labeling of OTC drug products that included: (1) Specific PO 00000 Frm 00009 Fmt 1254 Sfmt 1254 headings and subheadings presented in a standardized order, (2) standardized graphical features such as Helvetica type style and the use of ‘‘bullet points’’ to introduce key information, and (3) minimum standards for type size and spacing. FDA issued the final rule to improve labeling after considering comments submitted to the agency following the publication of the proposed regulation in 1997. In 1999, FDA published the final rule and stated that a standardized labeling format would significantly improve readability by familiarizing consumers with the types of information in OTC drug product labeling and the location of that information. In addition, a standardized appearance and standardized content, including various ‘‘user-friendly’’ visual cues, would help consumers locate and read important health and safety information and allow quick and effective product comparisons, thereby helping consumers to select the most appropriate product. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in part 201.66. The purpose of this review is to determine whether the regulation in part 201.66 should be continued without change, or whether they should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in part 201.66; (2) the nature of the complaints or comments received concerning the regulation in part 201.66; (3) the complexity of the regulations in part 201.66; (4) the extent to which the regulation in part 201.66 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling standard regulations in part 201. The section 610 review will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency’s regulatory program more effective in achieving its goals, less E:\FR\FM\07DER9.SGM 07DER9 64432 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Prerule Stage burdensome, or in greater alignment with the President’s priorities and the principles set forth in the Executive order. Action Date FR Cite End Review of Current 02/00/10 Regulation Regulatory Flexibility Analysis Required: Yes Timetable: Action Date Begin Review of Current Regulation FR Cite 08/03/09 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG34 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 318. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of the Federal Register. RIN: 0910–AC52 Proposed Rule Stage Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF31 320. OVER–THE–COUNTER (OTC) DRUG REVIEW—LAXATIVE DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a 319. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (ANTIHISTAMINE) 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. This action addresses antihistamine labeling claims for the common cold. Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action will address laxative drug products. The first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. Timetable: Timetable: Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Action Date Reopening of Administrative Record NPRM (Amendment) (Common Cold) FR Cite 08/25/00 65 FR 51780 09/00/10 erowe on DSK5CLS3C1PROD with RULES Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Action Date FR Cite Final Action (Granular 03/29/07 72 FR 14669 Psyllium) NPRM (Professional 06/00/10 Labeling—Sodium Phosphate) Final Action (Laxative To Be Determined Drug Products) NPRM (Professional To Be Determined Labeling) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, PO 00000 Frm 00010 Fmt 1254 Sfmt 1254 Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF38 321. OVER–THE–COUNTER (OTC) DRUG REVIEW—SUNSCREEN PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses combination products containing sunscreen and insect repellent ingredients. The second action addresses active ingredients reviewed under Time and Extent Applications. The third action addresses other effectiveness issues for OTC sunscreen drug products. The fourth action is the final action that addresses sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. Timetable: Action Date ANPRM (Sunscreen and Insect Repellent) ANPRM Comment Period End NPRM (UVA/UVB) NPRM Comment Period End NPRM (Effectiveness) E:\FR\FM\07DER9.SGM 07DER9 FR Cite 02/22/07 72 FR 7941 05/23/07 08/27/07 72 FR 49070 12/26/07 05/00/10 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Proposed Rule Stage Action Date Final Action (UVA/UVB) NPRM (Sunscreen and Insect Repellent) FR Cite 05/00/10 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF43 322. OVER–THE–COUNTER (OTC) DRUG REVIEW—VAGINAL CONTRACEPTIVE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The proposed rule addresses vaginal contraceptive drug products. Timetable: Action Date FR Cite erowe on DSK5CLS3C1PROD with RULES Final Action 12/19/07 72 FR 71769 (Warnings) NPRM (Vaginal 09/00/10 Contraceptive Drug Products) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF44 VerDate Nov<24>2008 64433 15:13 Dec 04, 2009 Jkt 220001 323. OVER–THE–COUNTER (OTC) DRUG REVIEW—WEIGHT CONTROL PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine. Timetable: Action Date NPRM (Phenylpropanol -amine) NPRM (Benzocaine) Final Action (Phenylpropanol -amine) Final Action (Benzocaine) FR Cite 12/22/05 70 FR 75988 05/00/10 05/00/10 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF45 324. OVER–THE–COUNTER (OTC) DRUG REVIEW—POISON TREATMENT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph PO 00000 Frm 00011 Fmt 1254 Sfmt 1254 (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient ipecac syrup. Timetable: Action Date NPRM (IPECAC) FR Cite 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF68 325. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 371; PL 110–85, sec 1002(a)(2) Abstract: The Food and Drug Administration (FDA) is proposing regulations for process controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA’s Animal Feed Safety System initiative. The proposed process controls will apply to animal feed ingredients and mixed animal feed including pet food. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007. Section 1002(a) directs FDA to establish by regulation processing standards for pet food. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers. Timetable: Action Date NPRM 10/00/10 E:\FR\FM\07DER9.SGM 07DER9 FR Cite 64434 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Proposed Rule Stage Action Date NPRM Comment Period End FR Cite 01/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN–4, HFV–230), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276–9207 Email: kim.young@fda.hhs.gov RIN: 0910–AG10 326. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER–THE–COUNTER HUMAN USE; PROPOSED AMENDMENT OF FINAL MONOGRAPH Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: Action Date NPRM FR Cite 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG12 327. ∑ PRODUCE SAFETY REGULATION Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0910–AG35 328. ∑ MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES REGULATION Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0910–AG36 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 329. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS erowe on DSK5CLS3C1PROD with RULES Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 Abstract: The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Final Rule Stage 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 07/14/03 10/14/03 09/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Meredith S. Francis, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6238, Silver Spring, MD 20993–0002 Phone: 301 796–3476 PO 00000 Frm 00012 Fmt 1254 Sfmt 1254 Fax: 301–847–8440 RIN: 0910–AA97 330. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes, and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been E:\FR\FM\07DER9.SGM 07DER9 64435 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Final Rule Stage 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. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 04/10/06 71 FR 18039 07/10/06 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6368, Silver Spring, MD 20993–0002 Phone: 301 796–3522 Fax: 301 847–8440 Email: patrick.raulerson@fda.hhs.gov RIN: 0910–AC53 331. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Legal Authority: PL 105–115, sec 121 Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The final rule would adopt CGMPs that reflect the unique characteristics of PET drugs. Timetable: Action Date erowe on DSK5CLS3C1PROD with RULES NPRM NPRM Comment Period End Final Action FR Cite 09/20/05 70 FR 55038 12/19/05 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993–0002 Phone: 301 796–3478 Fax: 301 847–8440 Email: michael.bernstein@fda.hhs.gov RIN: 0910–AC55 Hampshire Avenue, Bldg. 51, Room 6224, Silver Spring, MD 20993–0002 Phone: 301 796–4288 Fax: 301 847–8440 Email: rachel.bressler@fda.hhs.gov 332. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA’s current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women’s health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product’s risks to pregnant women and to women of childbearing age. The revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. Timetable: 333. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND QUALITY FACTORS Action Regulatory Flexibility Analysis Required: Yes Date NPRM NPRM Comment Period End Final Action FR Cite 05/29/08 73 FR 30831 08/27/08 04/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research, 10903 New PO 00000 Frm 00013 Fmt 1254 Sfmt 1254 RIN: 0910–AF11 Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0910–AF27 334. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (BRONCHODILATOR) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. Timetable: Action Date FR Cite NPRM (Amendment— 07/13/05 70 FR 40237 Ephedrine Single Ingredient) Final Action (Technical 11/30/07 72 FR 67639 Amendment) Final Action 05/00/10 (Amendment— Ephedrine Single Ingredient) Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 E:\FR\FM\07DER9.SGM 07DER9 64436 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Final Rule Stage marketed. This action addresses the ingredient phenylpropanolamine. Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF32 Timetable: 335. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (COMBINATION) PRODUCTS Action Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes cough/cold combination products containing oral bronchodilators and expectorants. Timetable: Action Date FR Cite NPRM (Amendment) 07/13/05 70 FR 40232 Final Action (Technical 03/19/07 72 FR 12730 Amendment) Final Action 09/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF33 336. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (NASAL DECONGESTANT) PRODUCTS erowe on DSK5CLS3C1PROD with RULES 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 VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Date NPRM (Amendment) (Sinusitis Claim) NPRM (Phenylephrine Bitartrate) NPRM (Phenylpropanol -amine) Final Action (Amendment) (Sinusitis Claim) Final Action (Phenylephrine Bitartrate) Final Action (Phenylpropanol -amine) FR Cite 08/02/04 69 FR 46119 11/02/04 69 FR 63482 12/22/05 70 FR 75988 10/31/05 70 FR 58974 08/01/06 71 FR 83358 09/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF34 337. OVER–THE–COUNTER (OTC) DRUG REVIEW—EXTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: Action Date Final Action (GRASE dosage forms) NPRM (Amendment) PO 00000 Frm 00014 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF35 FR Cite 09/00/10 Fmt 1254 To Be Determined Sfmt 1254 338. OVER–THE–COUNTER (OTC) DRUG REVIEW—INTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children’s products. The third action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The fourth action addresses other miscellaneous issues relating to internal analgesics. The last document finalizes the Internal Analgesic Products monograph. Timetable: Action Date FR Cite NPRM (Amendment) 12/26/06 71 FR 77314 (Required Warnings and Other Labeling) NPRM Comment 05/25/07 Period End NPRM (Amendment) To Be Determined (Overindulgence /Hangover) Final Action (Required 04/29/09 74 FR 19385 Warnings and Other Labeling) E:\FR\FM\07DER9.SGM 07DER9 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Final Rule Stage Action Date FR Cite Final Action 06/30/09 74 FR 31177 (Correction) Final Action (Technical 12/00/09 Amendment) NPRM (Amendment) 09/00/10 (Miscellaneous Issues) NPRM (Amendment) To Be Determined (Pediatric) NPRM (Amendment) To Be Determined (Combinations With Sodium Bicarbonate) Final Action (Internal To Be Determined Analgesics) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF36 339. OVER–THE–COUNTER (OTC) DRUG REVIEW—LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: erowe on DSK5CLS3C1PROD with RULES Action Date NPRM (Convenience Sizes) Final Action FR Cite 12/12/06 71 FR 74474 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human VerDate Nov<24>2008 64437 15:13 Dec 04, 2009 Jkt 220001 Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF37 340. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN PROTECTANT PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses skin protectant products used to treat fever blisters and cold sores. The second action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. Timetable: Action Date Final Action (Technical Amendments) Final Action (Fever Blisters/Cold Sores) Final Action (Aluminum Acetate) (Technical Amendment) Final Action (Diaper Rash) FR Cite 02/01/08 73 FR 6014 06/00/10 03/06/09 74 FR 9759 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF42 PO 00000 Frm 00015 Fmt 1254 Sfmt 1254 341. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent 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. On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics. On April 17, 2008, FDA amended the IFR so that FDA may designate a country as not subject to certain BSErelated restrictions relating to prohibited cattle materials applicable to human food and cosmetics. Comments submitted in response to the July 14, 2004 IFR that were not addressed in the September 7, 2005 and April 17, 2008 amendments will be addressed in the final rule. The final E:\FR\FM\07DER9.SGM 07DER9 64438 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Final Rule Stage rule also will respond to comments submitted following the September 7, 2005 and April 17, 2008 amendments. Timetable: 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 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 09/07/05 70 FR 53063 342. OVER–THE–COUNTER (OTC) DRUG REVIEW—ACNE DRUG PRODUCTS CONTAINING BENZOYL PEROXIDE 10/07/05 11/07/05 04/17/08 73 FR 20785 07/16/08 Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will address acne 07/16/08 10/00/10 Regulatory Flexibility Analysis Required: Yes drug products containing benzoyl peroxide. Timetable: Action Date Final Action Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG00 343. ∑ REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register. RIN: 0910–AG33 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 344. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS erowe on DSK5CLS3C1PROD with RULES Legal Authority: 21 USC 321; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264 Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72 FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 FR Cite 12/00/09 Long-Term Actions allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA’s response to an exemption request. Timetable: 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 Action RIN: 0910–AB88 Date ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Action 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 PO 00000 Frm 00016 Fmt 1254 Sfmt 1254 345. OVER–THE–COUNTER (OTC) DRUG REVIEW—OPHTHALMIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC E:\FR\FM\07DER9.SGM 07DER9 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Long-Term Actions drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes the monograph for emergency first aid eyewash drug products. Timetable: Action Date 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: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF39 346. OVER–THE–COUNTER (OTC) DRUG REVIEW—ORAL HEALTH CARE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: erowe on DSK5CLS3C1PROD with RULES Action Date ANPRM (Plaque Gingivitis) ANPRM Comment Period End NPRM (Plaque Gingivitis) Final Action VerDate Nov<24>2008 64439 FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF40 347. OVER–THE–COUNTER (OTC) DRUG REVIEW—OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: Action Date NPRM (Amendment) Final Action FR Cite 01/05/05 70 FR 741 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF51 05/29/03 68 FR 32232 348. OVER–THE–COUNTER (OTC) DRUG REVIEW—ANTACID PRODUCTS 08/27/03 To Be Determined To Be Determined 15:13 Dec 04, 2009 Jkt 220001 Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 PO 00000 Frm 00017 Fmt 1254 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 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 Final Action (Sodium Bicarbonate Labeling) Final Action (Overindulgence Labeling) To Be Determined FR Cite To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF52 349. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN BLEACHING PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses skin bleaching drug products containing hydroquinone. Timetable: Action Date NPRM E:\FR\FM\07DER9.SGM FR Cite 08/29/06 71 FR 51146 07DER9 64440 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Long-Term Actions Action Date NPRM Comment Period End Final Action FR Cite 12/27/06 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF53 350. OVER–THE–COUNTER (OTC) DRUG REVIEW—STIMULANT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: Action Date NPRM (Amendment) (Hangover) To Be Determined FR Cite erowe on DSK5CLS3C1PROD with RULES Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Action Date NPRM NPRM Comment Period End Final Action FR Cite 09/18/08 73 FR 54106 12/02/08 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: John D. Reilly, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, CPK 1, Room 1C–015, (HFS–024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1530 Fax: 301–436–2637 Email: john.reilly@fda.hhs.gov RIN: 0910–AF61 Regulatory Flexibility Analysis Required: Yes RIN: 0910–AF56 351. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ‘‘UNITED STATES: REFUSED ENTRY.’’ The proposal describes the label’s characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107188). Timetable: 352. OVER–THE–COUNTER ANTIDIARRHEAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new PO 00000 Frm 00018 Fmt 1254 Sfmt 1254 drug application, may be legally marketed. These actions address new labeling for antidiarrheal drug products. Timetable: Action Date FR Cite NPRM (New Labeling) Final Action (New Labeling) To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF63 353. OVER–THE–COUNTER (OTC) DRUG REVIEW—TOPICAL ANTIMICROBIAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses health care products. The second action addresses food handler products. The third action addresses testing requirements. The fourth action addresses consumer products. The final actions listed will address the healthcare, consumer, and first aid antiseptic drug products respectively. Timetable: Action Date NPRM (Healthcare) NPRM (Food Handlers) NPRM (Testing) NPRM (Consumer) Final Action (Healthcare) Final Action (Consumer) Final Action (First Aid Antiseptic) E:\FR\FM\07DER9.SGM 07DER9 FR Cite 06/17/94 59 FR 31402 To Be Determined To Be Determined 12/00/10 To Be Determined To Be Determined To Be Determined 64441 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Long-Term Actions Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF69 354. OVER–THE–COUNTER (OTC) DRUG REVIEW—URINARY ANALGESIC DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the products used for urinary pain relief. Timetable: Action Date NPRM (Urinary Analgesic) To Be Determined FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF70 355. STATUS OF CERTAIN ADDITIONAL OVER–THE–COUNTER DRUG CATEGORY II ACTIVE INGREDIENTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This proposed rule is part of FDA’s ongoing review of OTC drug products. Timetable: Action Date NPRM NPRM Comment Period End Final Action Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243; 42 USC 264; 42 USC 271; . . . erowe on DSK5CLS3C1PROD with RULES Abstract: Publication of this final rule was an action item in the Food Protection Plan announced by the Department of Health and Human Services (HHS) in November 2007. In July 1999, the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) committed to developing an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. FDA and FSIS held a public meeting on August 26, 1999, to obtain stakeholder input on the draft goals, as well as to further develop the objectives and action items for the action plan. The Egg Safety Action Plan was VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF95 Completed Actions announced on December 11, 1999. The goal of the Action Plan is to reduce egg-related SE illnesses. The Egg Safety Action Plan consists of eight objectives covering all stages of the farm-to-table continuum as well as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 (Washington, DC), joint public meetings were held by FDA and FSIS to solicit and discuss information related to the implementation of the objectives in the Egg Safety Action Plan. On September 22, 2004, FDA published a proposed rule that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal also solicited comment on whether recordkeeping requirements should include a written SE prevention plan and records for compliance with the SE prevention measures, and whether safe egg handling and preparation practices PO 00000 Frm 00019 Fmt 1254 To Be Determined Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 356. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS FR Cite 06/19/08 73 FR 34895 09/17/08 Sfmt 1254 should be mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care centers). The proposed egg production SE prevention measures included: (1) Provisions for procurement of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest control program; (4) cleaning and disinfection of poultry houses that have had an environmental or egg test positive for SE; (5) egg testing when an environmental test is positive; and (6) refrigerated storage of eggs held at the farm. Additionally, to verify that the measures have been effective, the rule proposes that producers test the poultry house environment for SE. If the environmental test is positive, eggs from that environment must be tested for SE, and if the egg test is positive, the eggs must be diverted to egg products processing or a treatment E:\FR\FM\07DER9.SGM 07DER9 64442 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—FDA Completed Actions process that achieves at least a five-log destruction of SE. The proposed rule was a step in a broader farm-to-table egg safety effort that includes FDA’s requirements for safe handling statements on egg cartons, and refrigerated storage of shell eggs at retail, and egg safety education for consumers and retail establishments. The rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings: October 28, 2004, in College Park, MD; November 9, 2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA. The comment period was reopened until July 25, 2005, to solicit further comment and information on industry practices and programs that prevent SEmonitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. On July 9, 2009, FDA published the final rule that requires shell egg producers to implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance with the rule and to register with FDA. FDA took this action because SE is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are a primary source of human SE infections. The final rule will reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE. Egg producers with 50,000 or more laying hens have 12 months to comply with the final rule, as do persons who must comply with only the refrigeration requirements. Producers with fewer than 50,000 but at least 3,000 laying hens have 36 months to comply. Producers with fewer than 3,000 laying hens and those who sell all of their eggs directly to consumers are exempt from the rule. FDA is developing guidance documents and will hold public meetings this year to help ensure covered persons understand how to comply with the final rule. Timetable: Action Date NPRM NPRM Comment Period End NPRM Reopened Comment Period End NPRM Extension of Reopened Comment Period End Final Action FR Cite 09/22/04 69 FR 56824 12/21/04 06/09/05 70 FR 24490 07/25/05 70 FR 33404 07/09/09 74 FR 33030 Regulatory Flexibility Analysis Required: Yes Agency Contact: John F. Sheehan, Director, Department of Health and Human Services, Food and Drug Administration, Division of Plant and Dairy Food Safety (HFS–315), Room 3B–012, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–2367 Fax: 301 436–2632 Email: john.sheehan@fda.hhs.gov RIN: 0910–AC14 357. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 Abstract: On October 6, 2005, the Food and Drug Administration (FDA) proposed to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards designed to help prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in December 2003 has caused FDA to review its policies for prevention of BSE, which resulted in this rulemaking. On April 28, 2008, FDA published a final rule prohibiting the use of certain cattle origin materials in the food and feed of all animals. On October 23, 2008 FDA corrected the final rule on BSE that appeared in the Federal Register of April 25, 2008 (73 FR 22719-22758). The final rule was inadvertently published with incorrect dollar amounts in two separate areas: the summary of economic impacts and the paperwork burden table. Timetable: Action Date ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Rule Final Rule–Correction Final Rule Effective erowe on DSK5CLS3C1PROD with RULES Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security Act) VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Frm 00020 Fmt 1254 10/06/05 70 FR 58569 12/20/05 04/25/08 73 FR 22720 10/23/08 73 FR 63072 04/27/09 Agency Contact: Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2654 (MPN–4, HFV–222), 7519 Standish Place, Rockville, MD 20855 Phone: 240 453–6860 Fax: 240 453–6882 Email: burt.pritchett@fda.hhs.gov RIN: 0910–AF46 Proposed Rule Stage Abstract: This proposed rule sets forth programmatic and operational changes to the Medicare Advantage and Prescription Drug Benefit programs (for example, strengthens beneficiary protections and sponsor entrance and exit rules, provides plan offerings with PO 00000 07/14/04 69 FR 42288 08/13/04 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 358. ∑ REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS–4085–F) FR Cite Sfmt 1254 meaningful differences, improves payment rules and data collection for oversight and quality assessment). Timetable: Action Date NPRM E:\FR\FM\07DER9.SGM FR Cite 10/22/09 74 FR 54634 07DER9 64443 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—CMS Proposed Rule Stage Action Date NPRM Comment Period End Final Action FR Cite 12/07/09 10/00/12 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy and Quality, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C1–26–26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–6041 Email: alissa.deboy@cms.hhs.gov RIN: 0938–AP77 359. ∑ PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES AND TO THE LONG–TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS–1498–P) Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of the Federal Register. RIN: 0938–AP80 360. ∑ CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS–1504–P) Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of the Federal Register. RIN: 0938–AP82 Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) Date NPRM NPRM Comment Period End Final Action FR Cite 07/13/09 74 FR 33520 08/31/09 12/00/09 erowe on DSK5CLS3C1PROD with RULES Regulatory Flexibility Analysis Required: Yes Agency Contact: Diane Milstead, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Mangement, Mailstop C4–03–06, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786–3355 Email: diane.milstead@cms.hhs.gov RIN: 0938–AP40 15:13 Dec 04, 2009 Jkt 220001 363. CHILDREN’S HEALTH INSURANCE PROGRAM (CHIP); ALLOTMENT METHODOLOGY AND STATES’ FISCAL YEAR 2009 CHIP ALLOTMENTS (CMS–2291–F) Action Date NPRM NPRM Comment Period End Final Action 362. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS–1414–FC) Legal Authority: BBA; BBA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA VerDate Nov<24>2008 Abstract: This rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, the rule describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. The rule also changes the Ambulatory Surgical Center Payment System list of services and rates. These changes applicable to services furnished on or after January 1 annually. Timetable: Action 361. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2010 (CMS–1413–FC) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. Timetable: Action Final Rule Stage FR Cite 07/20/09 74 FR 35231 08/31/09 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5–01–26, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786–0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938–AP41 PO 00000 Frm 00021 Fmt 1254 Sfmt 1254 Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) and 2104(f) of the Social Security Act; CHIPRA of 2009 (PL 111–3) Abstract: This proposed rule describes the implementation of certain funding provisions under existing Medicaid laws, the Children’s Health Insurance Program (CHIP) and recent legislation, and other related CHIP legislation. It proposes methodologies and procedures for determining States’ fiscal year (FY) 2009 through FY 2013 allotments and payments Timetable: Date NPRM NPRM Comment Period End Final Action FR Cite 09/16/09 74 FR 47517 11/16/09 02/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Richard Strauss, Technical Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S3–13–15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1850 Email: richard.strauss@cms.hhs.gov RIN: 0938–AP53 E:\FR\FM\07DER9.SGM 07DER9 64444 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 364. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS–3819–P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs) that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The requirements focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Timetable: Action Date NPRM NPRM Comment Period End Second NPRM FR Cite 03/10/97 62 FR 11005 06/09/97 To Be Determined Regulatory Flexibility Analysis Required: Undetermined Agency Contact: Mercedes Benitez–McCray, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards & Quality, Mailstop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–5716 Email: mercedes.benitezmccray@cms.hhs.gov RIN: 0938–AG81 365. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS–0050–IFC) erowe on DSK5CLS3C1PROD with RULES Legal Authority: 42 USC 1320d–2(a)(2)(B) Abstract: This rule sets forth electronic standards for health care claims attachments. The standards are required by the Health Insurance Portability and Accountability Act of 1996. They will be used to transmit clinical or administrative data for claims adjudication purposes. VerDate Nov<24>2008 15:13 Dec 04, 2009 Jkt 220001 Long-Term Actions Timetable: Action Date FR Cite NPRM 09/23/05 70 FR 55989 NPRM Comment 11/22/05 Period End Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Agency Contact: Elizabeth Holland, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E–Health Standards and Services, Mailstop S2–26–17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1309 Email: elizabeth.holland@cms.hhs.gov, RIN: 0938–AK62 366. HOME AND COMMUNITY–BASED SERVICES (HCBS) STATE PLAN OPTION (CMS–2249–F) (SECTION 610 REVIEW) Legal Authority: Deficit Reduction Act of 2005; PL 109–171, sec 6086 Abstract: This rule amends the Medicaid regulations to define and describe the home- and communitybased State plan services implementing the new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 04/04/08 73 FR 18676 06/03/08 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Suzanne Bosstick, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1301 Email: suzanne.bosstick@cms.hhs.gov RIN: 0938–AO53 367. REQUIREMENTS FOR LONG–TERM CARE FACILITIES: HOSPICE SERVICES (CMS–3140–P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395hh Abstract: This proposed rule would establish requirements that long-term PO 00000 Frm 00022 Fmt 1254 Sfmt 1254 care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility to participate in the Medicare and Medicaid programs. We are proposing these new requirements to ensure that quality hospice care is provided to eligible residents. Timetable: Action Date NPRM To Be Determined FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Trish Brooks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mailstop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–4561 Email: trish.brooks@cms.hhs.gov RIN: 0938–AP32 368. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS–2232–F4) Legal Authority: PL 109–171, sec 6044 Abstract: This rule replaces the final rule published on December 3, 2008 (73 FR 73694) to implement provisions of the Deficit Reduction Act (DRA) of 2005. It also provides States increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaideligible individuals. In addition, this final rule responds to public comments on the February 22, 2008 proposed rule as well as public comments on the December 3, 2009 ‘‘final rule’’ which was temporarily delayed twice, once by an interim final rule with comment period published on February 2, 2009, and the second time by a final rule published on April 3, 2009, further delaying the effective date and reopening the comment period. Timetable: Action Date FR Cite Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Chris Gerhardt, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2–01–16, E:\FR\FM\07DER9.SGM 07DER9 64445 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—CMS Long-Term Actions Phone: 410 786–0693 7500 Security Boulevard, Baltimore, MD 21244 Email: chris.gerhardt@cms.hhs.gov RIN: 0938–AP72 Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 369. MEDICAID GRADUATE MEDICAL EDUCATION (CMS–2279–F) Legal Authority: title XIX; Social Security Act Abstract: As part of the President’s 2008 Budget, this rule establishes that States may not include GME as a reimbursable cost or program under their approved Medicaid State Plan. The rule enhances fiscal integrity and improves accountability with respect to payment for medical services in the Medicaid program. Timetable: Action Date NPRM NPRM Comment Period End Withdrawn FR Cite 05/23/07 72 FR 28930 06/22/07 erowe on DSK5CLS3C1PROD with RULES VerDate Nov<24>2008 Date 12/09/08 10/07/09 74 FR 51663 372. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES—UPDATE FOR FY 2010 (CMS–1410–F) Regulatory Flexibility Analysis Required: Yes Legal Authority: Social Security Act, sec 1888(e) Agency Contact: Adam M Shaw, Senior Technical Adviser, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C1–22–06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1091 Email: adam.shaw@cms.hhs.gov Abstract: This rule updates the payment rates used under the SNF PPS beginning October 1, 2009. RIN: 0938–AP37 Timetable: FR Cite Jkt 220001 ANPRM Comment Period End Interim Final Rule FR Cite Abstract: This rule revises the Medicare hospital inpatient and Long Term Care prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. 10/10/08 73 FR 60208 15:13 Dec 04, 2009 Date Legal Authority: Sec 1886(d) of the Social Security Act 370. GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (CMS–4137–IFC) Legal Authority: Genetic information Nondiscrimination Act of 2008 (PL 110–223), enacted May 21, 2008. Abstract: This rule implements statutory changes to the PHSA affecting the group and individual health insurance markets, non-federal governmental plans, and Medicare supplemental insurance (Medigap) made by the Genetic Information Nondiscrimination Act of 2008 (Pub. L. 110-223). Timetable: ANPRM Action 371. CHANGES TO THE HOSPITAL INPATIENT AND LONG–TERM CARE PROSPECTIVE PAYMENT SYSTEM FOR FY 2010 (CMS–1406–F) 10/08/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Kristin Fan, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop S3–13–15, 7500 Security Boulevard, Baltimore, MD 21224 Phone: 410 786–4581 Fax: 410 786–1008 Email: kristin.fan@cms.hhs.gov RIN: 0938–AO95 Action Completed Actions Action Date NPRM NPRM Comment Period End Final Rule FR Cite 05/22/09 74 FR 24080 06/30/09 08/27/09 74 FR 43753 Regulatory Flexibility Analysis Required: Yes Agency Contact: Tiffany Swygert, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Div of Acute Care, Hosp and Ambulatory Policy Group, Mailstop C4–25–11, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786–4642 Email: tiffany.swygert@cms.hhs.gov RIN: 0938–AP39 PO 00000 Frm 00023 Fmt 1254 Sfmt 1254 Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 05/12/09 74 FR 22208 06/30/09 08/11/09 74 FR 40287 Regulatory Flexibility Analysis Required: Yes Agency Contact: William Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5–06–27, 7500 Security Boulvard, Baltimore, MD 21244 Phone: 410 786–5667 Fax: 410 786–0765 Email: bill.ullman@cms.hhs.gov RIN: 0938–AP46 373. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM AND RATE UPDATE FOR CY 2010 (CMS–1560–F) Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302 and 42 USC 1395(hh); Social Security Act, sec 1895; 42 USC 1395(fff) Abstract: This rule updates the 60-day national episode rate and the national per visit rate amounts under the Medicare Prospective Payment System for home health agencies, effective January 1, 2010. Timetable: Action Date NPRM NPRM Comment Period End Final Action Final Action Effective E:\FR\FM\07DER9.SGM 07DER9 FR Cite 08/06/09 74 FR 39435 08/28/09 11/10/09 74 FR 58077 01/01/10 64446 Federal Register / Vol. 74, No. 233 / Monday, December 7, 2009 / Unified Agenda HHS—CMS Completed Actions Regulatory Flexibility Analysis Required: Yes Agency Contact: Randy Throndset, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mailstop C5–07–28, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–0131 Fax: 410 786–0765 Email: randy.throndset@cms.hhs.gov erowe on DSK5CLS3C1PROD with RULES 15:13 Dec 04, 2009 Action Date NPRM Final Action NPRM Comment Period End RIN: 0938–AP55 VerDate Nov<24>2008 374. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2010 (CMS–1538–F) Legal Authority: Social Security Act, sec 1886(j); PL 106–554; PL 106–113 Abstract: This rule updates rates for the prospective payment system for inpatient rehabilitation facilities for FY 2010. Timetable: Jkt 220001 PO 00000 Frm 00024 FR Cite 05/06/09 74 FR 21052 08/13/09 74 FR 40947 06/29/09 Fmt 1254 Regulatory Flexibility Analysis Required: Yes Agency Contact: Julie Stankivic, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Department of Health and Human Services, Mailstop, C5–06–27, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–5725 Email: julie.stankivic @ cms.hhs.gov RIN: 0938–AP56 [FR Doc. E9–28598 Filed 12–04–09; 8:45 am] BILLING CODE 4150–24–S Sfmt 1254 E:\FR\FM\07DER9.SGM 07DER9

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]
[Unknown Section]
[Pages 64423-64446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28598]


[[Page 64423]]

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Part VI





Department of Health and Human Services





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



Semiannual Regulatory Agenda

[[Page 64424]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)






_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

_______________________________________________________________________

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

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

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

    Please note that the rulemaking abstracts included in this 
issue of the Federal Register relate only to those prospective 
rulemakings that are likely to have a significant economic impact 
on a substantial number of small entities as required by the 
Regulatory Flexibility Act of 1980. Also available in this issue of 
the Register is the Department's submission to the fiscal year 2010 
Regulatory Plan as required under Executive Order 12866.

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

Dated: October 9, 2009.

 Dawn L. Smalls,

Executive Secretary,
Department of Health and Human Services.

                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
306         Health Information Technology: Initial Set of Standards, Implementation                   0991-AB58
            Specifications, and Certification Criteria for Electronic Health Record Technology
            (Rulemaking Resulting From a Section 610 Review) (Reg Plan Seq No. 43)................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
307         Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section       0930-AA14
            610 Review)...........................................................................
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
308         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
309         Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation           0920-AA14
            Regulations...........................................................................
310         Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of    0920-AA23
            HHS/CDC Nonhuman Primate Regulations..................................................
----------------------------------------------------------------------------------------------------------------


[[Page 64425]]


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
311         Control of Communicable Diseases Foreign Quarantine...................................    0920-AA12
312         Control of Communicable Diseases: Interstate Quarantine, Passenger Information........    0920-AA27
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
313         Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review).........    0920-AA32
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
314         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
315         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
316         Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610    0910-AG25
            Review)...............................................................................
317         Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review)..............    0910-AG34
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
318         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg      0910-AC52
            Plan Seq No. 44)......................................................................
319         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
320         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
321         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
322         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
323         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
324         Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
325         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
326         Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug         0910-AG12
            Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........
327         Produce Safety Regulation (Reg Plan Seq No. 46).......................................    0910-AG35
328         Modernization of the Current Food Good Manufacturing Practices Regulation (Reg Plan       0910-AG36
            Seq No. 47)...........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
329         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
330         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
331         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
332         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
333         Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No.
            48)...................................................................................
334         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
335         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33

[[Page 64426]]

 
336         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
337         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
338         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
339         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
340         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
341         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
342         Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
343         Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco     0910-AG33
            to Protect Children and Adolescents (Reg Plan Seq No. 50).............................
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
344         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
345         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
346         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
347         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
348         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
349         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
350         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
351         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
352         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
353         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
354         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
355         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
356         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
357         Substances Prohibited From Use in Animal Food or Feed to Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
358         Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs       0938-AP77
            for Contract Year 2011 (CMS-4085-F)...................................................
359         Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care     0938-AP80
            Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates
            (CMS-1498-P) (Reg Plan Seq No. 53)....................................................
360         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP82
            Center Payment System for CY 2011 (CMS-1504-P) (Reg Plan Seq No. 54)..................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


[[Page 64427]]


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
361         Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413-     0938-AP40
            FC)...................................................................................
362         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP41
            Center Payment System for CY 2010 (CMS-1414-FC).......................................
363         Children's Health Insurance Program (CHIP); Allotment Methodology and States' Fiscal      0938-AP53
            Year 2009 CHIP Allotments (CMS-2291-F)................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
364         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
365         Electronic Claims Attachments Standards (CMS-0050-IFC)................................    0938-AK62
366         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610      0938-AO53
            Review)...............................................................................
367         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
368         State Flexibility for Medicaid Benefit Packages (CMS-2232-F4).........................    0938-AP72
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
369         Medicaid Graduate Medical Education (CMS-2279-F)......................................    0938-AO95
370         Genetic Information Nondiscrimination Act of 2008 (CMS-4137-IFC)......................    0938-AP37
371         Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY    0938-AP39
            2010 (CMS-1406-F).....................................................................
372         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AP46
            Update for FY 2010 (CMS-1410-F).......................................................
373         Home Health Prospective Payment System and Rate Update for CY 2010 (CMS-1560-F).......    0938-AP55
374         Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2010 (CMS-      0938-AP56
            1538-F)...............................................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

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

RIN: 0991-AB58

[[Page 64428]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




307. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE 
ADDITION (SECTION 610 REVIEW)

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/09                    74 FR 29153
NPRM Comment Period End         08/18/09
Final Action                    06/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Nicholas Reuter, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
One Choke Cherry Rd, Suite 2-1063, Rockville, MD 20857
Phone: 240 276-2716

RIN: 0930-AA14
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0930-AA10
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. The Secretary has designated 
the authority to prevent the introduction of diseases from foreign 
countries to the Director, Centers for Disease Control and Prevention 
(CDC). CDC also enforces entry requirements for certain animals, 
etiologic agents and vectors deemed to be of public health 
significance. Currently the regulations restrict the importation of 
nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts 
and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54). 
In addition, CDC has recently issued a series of emergency orders, 
restricting the importation of African rodents (42 CFR section 71.56) 
and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed 
Rulemaking (NPRM) to revise the regulations for importation of certain 
animals and vectors into the United States (42 CFR parts 71, Subpart 
F).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/31/07                    72 FR 41676
ANPRM Comment Period End        10/01/07
Notice Extending ANPRM Comment 
Period                          10/01/07                    72 FR 55729
ANPRM Extended Comment Period 
End                             12/01/07
NPRM                            06/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA14
_______________________________________________________________________




310. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, 
PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS

Legal Authority: 42 USC 264

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. The Secretary has delegated 
the authority to prevent the

[[Page 64429]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA23
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




311. CONTROL OF COMMUNICABLE DISEASES FOREIGN QUARANTINE

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

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. Quarantine regulations are 
divided into two parts: Part 71 dealing with foreign arrivals and part 
70 dealing with interstate matters. This rule (42 CFR part 71) will 
update and improve CDC's response to both global and domestic disease 
threats by creating a multi-tiered illness detection and response 
process thus substantially enhancing the public health system's ability 
to slow the introduction, transmission, and spread of communicable 
disease. The rule will also modify current Federal regulations 
governing the apprehension, quarantine isolation and conditional 
release of individuals suspected of carrying a quarantinable disease 
while respecting individual autonomy. CDC maintains quarantine stations 
at 20 ports of entry staffed with medical and public health officers 
who respond to reports of diseases from carriers. According to the 
statutory scheme, the President determines through Executive Order 
which diseases may subject individuals to quarantine. The current 
disease list, which was last updated in April 2005, includes cholera, 
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral 
hemorrhagic fevers, severe acute respiratory syndrome (SARS), and 
influenza caused by novel or reemergent influenza viruses that are 
causing, or have the potential to cause a pandemic.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/20/06
Final Action                    03/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA12
_______________________________________________________________________




312. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER 
INFORMATION

Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248; 
42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 
2001

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from one State or possession into another. 
Quarantine regulations are divided into two parts: Part 71 dealing with 
foreign arrivals and part 70 dealing with interstate matters. The CDC 
Director has been delegated the responsibility for carrying out these 
regulations. The Director's authority to investigate suspected cases 
and potential spread of communicable disease among interstate travelers 
is thus not limited to those known or suspected of having a 
quarantinable disease, but rather all communicable diseases that may 
necessitate a public health response.
Among the fundamental components of the public health response to the 
report of a person with a communicable disease is the identification 
and evaluation of individuals who may have been exposed. This 
provision, which was proposed section 70.4, would require any airline 
operating in interstate traffic to solicit and electronically submit 
certain passenger information to CDC for use in contact tracing when 
necessary to protect the vital interests of an individual, or other 
persons, in regard to significant health risks.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/30/06
Final Action                    03/00/10

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA27

[[Page 64430]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Legal Authority: PL 107-188

Abstract: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 authorizes the HHS Secretary to regulate the 
possession, use, and transfer of select agents and toxins that have the 
potential to pose a severe threat to public health and safety. These 
regulations are set forth at 42 CFR 73. Criteria used to determine 
whether a select agent or toxin should be included under the provisions 
of these regulations are based on: 1) the effect on human health as a 
reuslt of exposure to the agent or toxin, 2) the degree of 
contagiousness of the agent or toxin, 3) the methods by which the agent 
or toxin is transferred to humans, 4) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent andy illness resulting from infection by the agent or toxin, 
and 5) any other criteria, including the needs of children and other 
vulnerable populations that the HHS Secretary considers appropriate. 
Based on these criteria, we are proposing to amend the list of HHS 
select agents and toxins by adding Chapare virus to the list. After 
consulting with subject matter experts from CDC, the National 
Institutes of Health (NIH), the Food Drug Administration (FDA), the 
United States Department of Agriculture (USDA) /Animal and Plant Health 
Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), 
USDA/CVB (Center for Veterinary Biologics), and the Department of 
Defense (DOD)/United States Army Medical Research Institute for 
Infectious Diseases (USAMRIID) and review of relevant published 
studies, we believe the Chapare virus should be added to the list of 
HHS select agents and toxins based on our conclusion that the Chapare 
virus has been phylogenetically identified as a Clade B arenavirus and 
is closely related to other South American arenaviruses that cause 
haemorrhagic fever, particularly Sabia virus.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/19/09                      74 FR 159
NPRM Comment Period End         10/19/09
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Agency Contact: Robbin Weyant, Department of Health and Human Services, 
Centers for Disease Control and Prevention, CLFT Building 20, Room 
4202, 1600 Clifton Road NE., Atlanta, GA 30333
Phone: 404 718-2000

RIN: 0920-AA32
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/00/09
End Review                      12/00/10

Regulatory Flexibility Analysis Required: Undetermined

Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and 
Labeling Team, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, (HFS-
820), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1802
Fax: 301 436-2636
Email: geraldine.june@fda.hhs.gov

RIN: 0910-AG06
_______________________________________________________________________




315. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG 
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE 
PROCEDURES (SECTION 610 REVIEW)

Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381

Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine

[[Page 64431]]

whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 
and 205.50 (as amended in 64 FR 67762 and 67763) should be continued 
without change, or whether they should be amended or rescinded, 
consistent with the stated objectives of applicable statutes, to 
minimize adverse impacts on a substantial number of small entities. FDA 
will consider, and is soliciting comments on, the following: (1) The 
continued need for the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) 
the nature of complaints or comments received from the public 
concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 
and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of 
the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 
(as amended in 64 FR 67762 and 67763); (4) the extent to which the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with 
other Federal rules, and to the extent feasible, with State and local 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      11/24/08
End Review of Current Regulation12/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Howard Muller, Office of Regulatory Policy, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room 
6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847 8440
Email: pdma610(c)review@fda.hhs.gov

RIN: 0910-AG14
_______________________________________________________________________




316.  STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG 
PRODUCTS FOR ORAL INHALATION (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375

Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 
610 of the Regulatory Flexibility Act. The purpose of this review is to 
determine whether this regulation on aqueous-based drug products for 
oral inhalation should be continued without change, or whether it 
should be amended or rescinded, consistent with the stated objectives 
of applicable statues, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for 21 CFR 200.51; (2) the 
nature of complaints or comments received concerning 21 CFR 200.51; (3) 
the complexity of 21 CFR 200.51; (4) the extent to which the regulation 
overlaps, duplicates, or conflicts with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by 21 
CFR 200.51.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/01/09
End Review                      05/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, 
Building 51, Room 6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: howard.mullerjr@fda.hhs.gov

RIN: 0910-AG25
_______________________________________________________________________




317.  OVER-THE-COUNTER HUMAN DRUGS; LABELING 
REQUIREMENTS (SECTION 610 REVIEW)

Legal Authority: 5 USC 610

Abstract: Part 201.66 (21 CFR section 201.66) established a 
standardized format for the labeling of OTC drug products that 
included: (1) Specific headings and subheadings presented in a 
standardized order, (2) standardized graphical features such as 
Helvetica type style and the use of ``bullet points'' to introduce key 
information, and (3) minimum standards for type size and spacing. FDA 
issued the final rule to improve labeling after considering comments 
submitted to the agency following the publication of the proposed 
regulation in 1997. In 1999, FDA published the final rule and stated 
that a standardized labeling format would significantly improve 
readability by familiarizing consumers with the types of information in 
OTC drug product labeling and the location of that information. In 
addition, a standardized appearance and standardized content, including 
various ``user-friendly'' visual cues, would help consumers locate and 
read important health and safety information and allow quick and 
effective product comparisons, thereby helping consumers to select the 
most appropriate product.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in part 201.66. The purpose of this 
review is to determine whether the regulation in part 201.66 should be 
continued without change, or whether they should be further amended or 
rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on the 
following: (1) The continued need for the regulation in part 201.66; 
(2) the nature of the complaints or comments received concerning the 
regulation in part 201.66; (3) the complexity of the regulations in 
part 201.66; (4) the extent to which the regulation in part 201.66 
overlap, duplicate, or conflict with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed for the products still 
subject to the labeling standard regulations in part 201.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less

[[Page 64432]]

burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      08/03/09
End Review of Current Regulation02/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AG34
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

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

RIN: 0910-AC52
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Reopening of Administrative 
Record                          08/25/00                    65 FR 51780
NPRM (Amendment) (Common Cold)  09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF31
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
NPRM (Professional Labeling--
Sodium Phosphate)               06/00/10
Final Action (Laxative Drug 
Products)                        To Be                       Determined
NPRM (Professional Labeling)     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF38
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
NPRM (UVA/UVB)                  08/27/07                    72 FR 49070
NPRM Comment Period End         12/26/07
NPRM (Effectiveness)            05/00/10

[[Page 64433]]

Final Action (UVA/UVB)          05/00/10
NPRM (Sunscreen and Insect 
Repellent)                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF43
_______________________________________________________________________




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

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         12/19/07                    72 FR 71769
NPRM (Vaginal Contraceptive Drug 
Products)                       09/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF44
_______________________________________________________________________




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

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

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The NPRM 
addresses the use of benzocaine for weight control. The first final 
action finalizes the 2005 proposed rule for weight control products 
containing phenylpropanolamine. The second final action will finalize 
the proposed rule for weight control products containing benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenylpropanol -amine)    12/22/05                    70 FR 75988
NPRM (Benzocaine)               05/00/10
Final Action (Phenylpropanol -
amine)                          05/00/10
Final Action (Benzocaine)        To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF45
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (IPECAC)                   06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO-22, Room 
5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF68
_______________________________________________________________________




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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/10

[[Page 64434]]

NPRM Comment Period End         01/00/11

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0910-AG10
_______________________________________________________________________




326. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND 
ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED 
AMENDMENT OF FINAL MONOGRAPH

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