[May 5, 2008 (Volume 73, Number 87)] [Unified Agenda] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID: f:ua080505.wais] [Page 24678-24698] Department of Health and Human Services ----------------------------------------------------------------------- Part V ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 24678]] 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 12866 require that inventories of rulemaking actions under development within the Department be made available to the public semiannually. The purpose of these requirements is to encourage public participation in the regulatory process by providing, at as early a stage as possible, summarized information about regulatory actions under consideration. FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary to the Department, Department of Health and Human Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The capsulized information provided in the Agenda sets out information rulemaking activities in which the Department is currently engaged. We focus primarily on those areas of work expected to result in publication of Notices of Proposed Rulemaking or Final Rules within the next 12 months. Please note that the summaries included below relate only to those rulemakings that are likely to have significant economic impact on a substantial number of small entities; the Regulatory Flexibility Act requires publication of this information in the Federal Register. The complete Agenda is now accessible online at www.reginfo.gov, where rapid electronic access to information about the full range of HHS rulemakings is available. The Department welcomes the views of all concerned with regard to planned rulemakings. Comments may be directed to the agency officials cited in each of the summaries. If early attention at the Secretary's level appears needed, comments should be sent to: Ann C. Agnew, Executive Secretary to the Department, Room 603H, 200 Independence Avenue SW., Washington, DC 20201. Dated: March 27, 2008. Ann C. Agnew, Executive Secretary to the Department. Substance Abuse and Mental Health Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 125 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--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 126 Control of Communicable Diseases, Interstate and Foreign Quarantine................... 0920-AA12 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 127 Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and 0910-AF99 Pectin (Section 610 Review)........................................................... 128 Biological Products; Reporting of Biological Product Deviations in Manufacturing 0910-AG05 (Section 610 Review).................................................................. ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 129 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52 130 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling..................................... 131 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 132 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61 [[Page 24679]] 133 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 134 Safety Reporting Requirements for Human Drug and Biological Products.................. 0910-AA97 135 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88 Ingredients and Dietary Supplements................................................... 136 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14 137 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs............. 0910-AC35 138 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 139 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 140 Charging for Investigational Drugs.................................................... 0910-AF13 141 Expanded Access to Investigational Drugs for Treatment Use............................ 0910-AF14 142 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 143 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 144 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 145 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 146 Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of 0910-AF46 Bovine Spongiform Encephalopathy...................................................... 147 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 148 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 149 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 150 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 151 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 152 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 153 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 154 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 155 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 156 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 157 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 158 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 159 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 160 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 161 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63 162 Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68 163 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 164 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06 Shell Eggs Held for Retail Distribution (Section 610 Review).......................... 165 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 166 Health Claims......................................................................... 0910-AF09 [[Page 24680]] 167 Status of Certain Additional Over-the-Counter Drug Category II and III Active 0910-AF75 Ingredients (Completion of a Section 610 Review)...................................... 168 Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific 0910-AF76 Reagents (Completion of a Section 610 Review)......................................... 169 Natural Rubber-Containing Medical Device; User Labeling (Completion of a Section 610 0910-AF77 Review)............................................................................... 170 Financial Disclosure by Clinical Investigators (Completion of a Section 610 Review)... 0910-AF79 171 Beverages: Bottled Water (Completion of a Section 610 Review)......................... 0910-AF80 172 Food Labeling; Nutrient Content Claims: Definition for ``High Potency'' and Definition 0910-AF83 of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Completion of a Section 610 Review)............................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 173 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 174 Revisions to HIPAA Code Sets (CMS-0013-P) (Section 610 Review)........................ 0938-AN25 175 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 0938-AO53 Review)............................................................................... 176 Hospice Wage Index for FY 2009 (CMS-1548-P)........................................... 0938-AP14 177 Changes to the Hospital Inpatient Prospective Payment Systems and FY 2009 Rates (CMS- 0938-AP15 1390-P)............................................................................... 178 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP17 Center Payment System for CY 2009 (CMS-1404-P)........................................ 179 Requirements for Long Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 0938-AP32 Review)............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 180 Medicare and Medicaid Programs; Hospice Care Conditions of Participation (CMS-3844-F) 0938-AH27 (Section 610 Review).................................................................. 181 Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year 0938-AO92 Beginning July 1, 2008 (RY 2009) (CMS-1401-N)......................................... 182 Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate 0938-AO94 Updates (CMS-1393-F).................................................................. 183 Changes to Long Term Care Prospective Payment System Based on Specific Provisions in 0938-AP33 the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-IFC)................ ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 184 Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, 0938-AO84 Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Section 610 Review).................... 185 Establishing Additional Medicare Provider and Supplier Enrollment Safeguards (CMS-6045- 0938-AP01 P) (Section 610 Review)............................................................... ---------------------------------------------------------------------------------------------------------------- [[Page 24681]] Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 186 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Completion of a 0938-AG82 Section 610 Review)................................................................... ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 125. 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) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 126. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE Legal Authority: Not Yet Determined 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. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. 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 Final Action 11/00/08 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: 404 718-1056 RIN: 0920-AA12 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 127. FOOD LABELING; SERVING SIZES; REFERENCE AMOUNT FOR BAKING POWDER, BAKING SODA, AND PECTIN (SECTION 610 REVIEW) Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition labeling regulations for the reference amount customarily consumed per eating occasion for the food category ``Baking powder, baking soda, pectin.'' Section 101.12 (21 CFR part 101.12) includes 1/8 teaspoon (tsp) as an additional allowable household measure. FDA is undertaking a review of sections 101.9 and 101.12 under section 610 of the [[Page 24682]] Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.9 and 101.12 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 regulations in sections 101.9 and 101.12; (2) the nature of complaints or comments received concerning the regulations in sections 101.9 and 101.12; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.9 and 101.12 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.9 and 101.12. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/00/08 End Review 03/00/09 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, 5100 Paint Brach Parkway, ONLDS (HFS-820), College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: geraldine.june@fda.hhs.gov RIN: 0910-AF99 _______________________________________________________________________ 128. [bull] BIOLOGICAL PRODUCTS; REPORTING OF BIOLOGICAL PRODUCT DEVIATIONS IN MANUFACTURING (SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 ; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25 Abstract: Section 600.14 (21 CFR 600.14) requires licensed manufacturers of biological products to report to FDA biological product deviations in manufacturing. Section 606.170 requires licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered establishments, and transfusion services to report to FDA biological product deviations in manufacturing. Under section 610 of the Regulatory Flexibility Act, FDA is initiating a review of these regulations in parts 600 and 606 under section 610. The purpose of this review is to determine whether the regulations in parts 600 and 606 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; 2) the nature of complaints or comments received concerning the regulations; 3) the complexity of the regulations; 4) the extent to which a regulation in parts 600 or 606 overlaps, duplicates, or conflicts with other Federal rules, and to the extent feasible, with State and local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 05/00/08 End Review 04/00/09 Regulatory Flexibility Analysis Required: No Agency Contact: Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone: 301 827-6210 RIN: 0910-AG05 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 129. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. The proposal would also require that FDA periodically issue guidance on the use of standardized data structure, terminology, and code sets (e.g., the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Martha Nguyen, 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 6224, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AC52 [[Page 24683]] _______________________________________________________________________ 130. 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 part 201.56, 201.57, and 201.80). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Christine F. Rogers, 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 6316, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF11 _______________________________________________________________________ 131. 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 360a; 21 USC 371; 21 USC 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 addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Hangover) 04/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF56 _______________________________________________________________________ 132. 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; 21 USC 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 Abstract: The proposed rule would require owners or consignees to label imported food that is refused entry into the United States. The label would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would describe the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AF61 _______________________________________________________________________ 133. 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 360a; 21 USC 371; 21 USC 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses food handler products. The second action addresses testing requirements. The last action addresses healthcare antiseptic products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Food Handlers) 12/00/08 NPRM (Testing) To Be Determined Final Action (Healthcare) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF69 [[Page 24684]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 134. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC 263a to 263-n; 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: These regulations are one component of the Secretary's initiative to reduce medical errors. The final rule would amend the 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/14/03 68 FR 12406 NPRM Comment Period Extended 06/18/03 NPRM Comment Period End 07/14/03 NPRM Comment Period Extension End 10/14/03 Final Action 04/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Carol Drew, 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 6306, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301-847-8440 RIN: 0910-AA97 _______________________________________________________________________ 135. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS Legal Authority: 21 USC 321; 21 USC 342; 21 USC 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. The final rule (the CGMP rule) was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, labeling, or holding dietary supplements, they do so in a manner that will ensure the quality of the dietary supplements -- i.e., to ensure that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. FDA also published an interim final rule (IFR) in the June 25, 2007 Federal Register (72 FR 34959) that sets forth a procedure for requesting an exemption from the requirement in the final rule described above that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 02/06/97 62 FR 5700 ANPRM Comment Period End 06/06/97 NPRM 03/13/03 68 FR 12157 NPRM Comment Period End 08/11/03 Final Action 06/25/07 72 FR 34752 Interim Final Rule 06/25/07 72 FR 34959 Interim Final Rule Comment Period End 10/24/07 Final Action 06/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1209 Fax: 301 436-2964 Email: linda.kahl@fda.hhs.gov RIN: 0910-AB88 _______________________________________________________________________ 136. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243; 42 USC 264; 42 USC 271; Abstract: Publication of this final rule is an action item in the Food Protection Plan announced by the Department of Health and Human Services (HHS) in November 2007. In July 1999, the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) committed to developing an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. FDA and FSIS held a public meeting on August 26, 1999, to obtain stakeholder input on the draft goals, as well as to further develop the objectives and action items for the action plan. The Egg Safety Action Plan was announced on December 11, 1999. The goal of the Action Plan is to reduce egg-related SE illnesses by 50 percent by 2005 and eliminate egg-related SE illnesses by 2010. The Egg Safety Action Plan consists of eight objectives covering all stages of the farm-to-table continuum as well as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 (Washington, DC), joint public meetings were held by FDA and FSIS to solicit and discuss information related to the implementation of the objectives in the Egg Safety Action Plan. On September 22, 2004, FDA published a proposed rule that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal also solicited comment on whether recordkeeping requirements should include a written SE prevention plan and records for compliance with the SE prevention measures, and whether safe egg handling and preparation practices should be mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care [[Page 24685]] 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 process that achieves at least a five-log destruction of SE. The proposed rule was a step in a broader farm-to-table egg safety effort that includes FDA's requirements for safe handling statements on egg cartons, and refrigerated storage of shell eggs at retail, and egg safety education for consumers and retail establishments. The rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings: October 28, 2004, in College Park, MD; November 9, 2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA. The comment period was reopened until July 25, 2005, to solicit further comment and information on industry practices and programs that prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/22/04 69 FR 56824 NPRM Comment Period End 12/21/04 NPRM Reopened Comment Period End06/09/05 70 FR 24490 NPRM Extension of Reopened Comment Period End 07/25/05 70 FR 33404 Final Action 06/00/08 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 _______________________________________________________________________ 137. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN DRUGS Legal Authority: 21 USC 355b Abstract: To require certain labeling of human drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free number for reports of adverse events, and a statement that the number is to be used for reporting purposes only and not to receive medical advice. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/22/04 69 FR 21778 NPRM Comment Period End 07/21/04 Interim Final Rule 01/03/08 73 FR 402 Final Action 12/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Carol Drew, 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 6306, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301-847-8440 RIN: 0910-AC35 _______________________________________________________________________ 138. 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 proposed rule would adopt CGMPs that reflect the unique characteristics of PET drugs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/20/05 70 FR 55038 NPRM Comment Period End 12/19/05 Final Action 08/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drugs Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6304, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: brian.pendleton@fda.hhs.gov RIN: 0910-AC55 _______________________________________________________________________ 139. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Legal Authority: 21 USC 379e(b) Abstract: The Agency published a proposed rule on January 30, 2006, to require the label declaration of all foods and cosmetics containing the color additives cochineal extract and carmine in order to protect consumers with allergies to these additives. This proposal was issued in response to adverse event reports received by FDA and to a citizen petition submitted to FDA. The comment period ended on May 1, 2006. FDA intends to issue a final rule after reviewing comments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/30/06 71 FR 4839 NPRM Comment Period End 05/01/06 Final Action 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Mical E. Honigfort, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-265, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1278 Fax: 301 436-2972 Email: mical.honigfort@fda.hhs.gov RIN: 0910-AF12 [[Page 24686]] _______________________________________________________________________ 140. CHARGING FOR INVESTIGATIONAL DRUGS Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 USC 262 Abstract: On December 14, 2006, (71 FR 75168), FDA published a proposed rule to amend FDA's investigational new drug regulation concerning charging for investigational drugs. The rule will clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, set forth criteria for charging for an investigational drug for the different types of treatment uses described in the Agency's rule on expanded access to investigational drugs for treatment use, and clarify what costs can be recovered for an investigational drug. The rule is intended to permit charging for a broader range of investigational uses than is explicitly permitted in current regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/14/06 71 FR 75168 NPRM Comment Period End 03/14/07 Final Action 10/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Christine F. Rogers, 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 6316, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF13 _______________________________________________________________________ 141. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 Abstract: The Food and Drug Administration proposed in the Federal Register of December 14, 2006 (75 FR 75147), to amend the regulations governing investigational new drugs (IND) to describe the ways patients may obtain investigational drugs for treatment use under expanded access programs. Such use of investigational drugs would be available to: (1) Individual patients, including in emergencies; (2) intermediate size patient populations; and (3) larger populations under a treatment protocol or treatment IND. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/14/06 71 FR 75147 NPRM Comment Period End 03/14/07 Final Action 10/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Christine F. Rogers, 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 6316, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF14 _______________________________________________________________________ 142. 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 360a; 21 USC 371; 21 USC 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 addresses labeling for single ingredient bronchodilator products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment - Ephedrine Single Ingredient) 07/13/05 70 FR 40237 Final Action (Technical Amendment) 11/30/07 72 FR 63679 Final Action (Amendment - Ephedrine Single Ingredient) 01/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF32 _______________________________________________________________________ 143. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 technical amendment revises a paragraph designation in the CFR. The other action finalizes cough/cold combination products containing oral bronchodilators and expectorants. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40232 Final Action (Technical Amendment) 03/19/07 72 FR 12730 Final Action 03/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF33 _______________________________________________________________________ 144. 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 [[Page 24687]] 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 fifth document finalizes the document regarding the required warnings and other labeling. The last document finalizes the Internal Analgesic Products monograph. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Required Warnings and Other Labeling) 12/26/06 71 FR 77314 NPRM Comment Period End 05/25/07 NPRM (Amendment) (Overindulgence/ Hangover) 04/00/09 NPRM (Amendment) (Pediatric) To Be Determined NPRM (Amendment) (Combinations with Sodium Bicarbonate) 04/00/09 NPRM (Amendment) (Miscellaneous Issues) 05/00/09 Final Action (Required Warnings and Other Labeling) 03/00/09 Final Action (Internal Analgesics) 03/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF36 _______________________________________________________________________ 145. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Convenience Sizes) 12/12/06 71 FR 74474 Final Action 03/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF37 _______________________________________________________________________ 146. 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 help strengthen existing safeguards to 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 07/14/04 69 FR 42288 ANPRM Comment Period End 08/13/04 NPRM 10/06/05 70 FR 58569 NPRM Comment Period End 12/20/05 Final Rule 04/25/08 73 FR 22720 Final Rule-Correction 06/00/08 Final Rule Effective 04/27/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855 Phone: 240 453-6860 Fax: 240 453-6882 Email: burt.pritchett@fda.hhs.gov RIN: 0910-AF46 _______________________________________________________________________ 147. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 01/05/05 70 FR 741 Final Action 04/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 [[Page 24688]] Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF51 _______________________________________________________________________ 148. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Sodium Bicarbonate Labeling) 04/00/09 Final Action (Overindulgence Labeling) 04/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF52 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 149. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 21 USC 379 Abstract: The Food and Drug Administration (FDA) published a proposed regulation on October 29, 2003 (68 FR 61640), that would amend its regulations on submission of bioequivalence (BE) data to require an abbreviated new drug application (ANDA) applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets BE criteria for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation. If finalized, this rule would require ANDA applicants to submit information, in either a complete or summary report, from all additional passing and nonpassing BE studies conducted on the same drug product formulation submitted for approval. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/29/03 68 FR 61640 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Christine F. Rogers, 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 6304, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301 847-8440 RIN: 0910-AC23 _______________________________________________________________________ 150. 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 360a; 21 USC 371; 21 USC 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 addresses antihistamine labeling claims for the common cold. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Amendment) (Common Cold) 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF31 _______________________________________________________________________ 151. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 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 addresses the ingredient phenylpropanolamine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Sinusitis Claim) 08/02/04 69 FR 46119 NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482 [[Page 24689]] NPRM (Phenylpropano lamine) 12/22/05 70 FR 75988 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358 Final Action (Phenylpropano lamine) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF34 _______________________________________________________________________ 152. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 05/00/09 Final Action (GRASE dosage forms) 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF35 _______________________________________________________________________ 153. 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; 21 USC 360a; 21 USC 371; 21 USC 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. One action will address laxative drug products. The other action will address professional labeling requirements for laxative drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Granular Psyllium)03/29/07 72 FR 14669 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF38 _______________________________________________________________________ 154. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses emergency first aid eyewash products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Emergency First Aid Eyewashes) 02/19/03 68 FR 7917 NPRM (Amendment) (Emergency First Aid Eyelashes) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF39 _______________________________________________________________________ 155. 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; 21 USC 360a; 21 USC 371; 21 USC 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 oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Plaque Gingivitis) 05/29/03 68 FR 32232 ANPRM Comment Period End 08/27/03 NPRM (Plaque Gingivitis) To Be Determined Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes [[Page 24690]] Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF40 _______________________________________________________________________ 156. 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. The third action addresses astringent active ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Technical Amendments) 02/01/08 73 FR 6014 Final Action (Fever Blisters/ Cold Sores) To Be Determined Final Action (Diaper Rash) 05/00/09 Final Action (Aluminum Acetate) (Technical Amendment) 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF42 _______________________________________________________________________ 157. 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 360a; 21 USC 371; 21 USC 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first document addresses combination products containing sunscreen and insect repellent ingredients. The second document addresses active ingredients reviewed under Time and Extent Applications. The third document 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 11/26/07 NPRM (Time and Extent) 05/00/09 Final Action (UVA/UVB) 05/00/09 NPRM (Sunscreen and Insect Repellent) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF43 _______________________________________________________________________ 158. 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 360a; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 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) 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF44 _______________________________________________________________________ 159. 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. One action addresses the ingredient phenylpropanolamine, and the other action addresses the ingredient benzocaine. [[Page 24691]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenylpropano lamine) 12/22/05 70 FR 75988 NPRM (Benzocaine) 05/00/09 Final Action (Phenylpropano lamine) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF45 _______________________________________________________________________ 160. 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 360a; 21 USC 371; 21 USC 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 addresses skin bleaching drug products containing hydroquinone. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/29/06 71 FR 51146 NPRM Comment Period End 12/27/06 Final Action 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF53 _______________________________________________________________________ 161. 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 360a; 21 USC 371; 21 USC 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 addresses products containing antidiarrheal drug ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF63 _______________________________________________________________________ 162. 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) 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF68 _______________________________________________________________________ 163. 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 360a; 21 USC 371; 21 USC 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 addresses the products used for urinary pain relief. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Urinary Analgesic) 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF70 _______________________________________________________________________ 164. [bull] 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; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; [[Page 24692]] 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) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction if 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, 5100 Paint Brach Parkway, ONLDS (HFS-820), College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: geraldine.june@fda.hhs.gov RIN: 0910-AG06 _______________________________________________________________________ 165. [bull] 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 05/00/09 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, MPN4, Room 106, HFV-230, 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9207 Email: kim.young@fda.hhs.gov RIN: 0910-AG10 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 166. HEALTH CLAIMS Legal Authority: 21 USC 343; 21 USC 371 Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance notice of proposed rulemaking (ANPRM) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA also solicited comments on various other issues related to health claims and on the appropriateness and nature of dietary guidance statements on conventional food and dietary supplement labels. This ANPRM was published in the July 11, 2003 (68 FR 41387), notice that announced the availability of the final report of the FDA Task Force on the Consumer Health Information for Better Nutrition Initiative. Comments on the regulatory alternatives and additional topics identified in the ANPRM will inform FDA decisions about regulation of qualified health claims. Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 03/03/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Julie Moss Phone: 301 436-2373 Fax: 301 436-2639 Email: julie.moss@fda.hhs.gov RIN: 0910-AF09 _______________________________________________________________________ 167. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND III ACTIVE INGREDIENTS (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 5 USC 610 [[Page 24693]] Abstract: Section 310.545 (21 CFR part 310.545) codifies a final rule that was issued stating certain first aid antiseptic, vaginal contraceptive, and antimicrobial diaper rash ingredients in over-the- counter (OTC) drug products are not generally recognized as safe and effective and are misbranded. This rule took into consideration the reports and recommendations of various OTC drug advisory review panels and public comment on proposed Agency regulations. Based on the absence of substantive comments in opposition to the Agency's proposed nonmonograph status for various ingredients, as well as the failure of interested parties to submit new data or information to FDA, the Agency determined that the presence of the subject ingredients in an OTC drug product would result in that product not being generally recognized as safe and effective and would result in misbranding. FDA initiated a review under section 610 of the Regulatory Flexibility Act for the regulation in section 310.545. The purpose of this review was to determine whether the regulation in section 310.545 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA considered, and solicited comments on the following: (1) The continued need for the regulation in section 310.545; (2) the nature of the complaints or comments received concerning the regulation in section 310.545; (3) the complexity of the regulations in section 310.545; (4) the extent to which the regulation in section 310.545 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 for the products still subject to the regulation in section 310.545. The section 610 review was 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 burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. This review concluded with a FDA determination that there is a continual need for this regulation in 310.545, because this section lists ingredients that have not been shown to be safe and effective in OTC drug products for various uses. FDA uses this section in evaluating possible regulatory action. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/01/06 End Review 12/31/07 Regulatory Flexibility Analysis Required: No Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF75 _______________________________________________________________________ 168. MEDICAL DEVICES: CLASSIFICATION/RECLASSIFICATION; RESTRICTED DEVICES; ANALYTE SPECIFIC REAGENTS (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j Abstract: FDA has undertaking a review of 21 CFR sections 809.10 and 809.30 under section 610 of the Regulatory Flexibility Act. The purpose of the review was to determine whether the regulations in sections 809.10 and 809.30 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 substantial numbers of small entities. FDA has solicited comments on, the following (1) The continued need for the regulation in part 809; (2) the nature of complaints or comments received concerning the regulation in sections 809.10 and 809.30; (3) the complexity of the regulation in sections 809.10 and 809.30; (4) the extent to which the regulation in sections 809.10 and 809.30 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 the regulation in sections 809.10 and 809.30. The section 610 review has been carried out along with a regulation 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 burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. The agency did not receive any comments during the review process of sections 809.10 and 809.30 under section 610 review. FDA's review of these regulations concluded that they should be continued without change. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 04/01/07 End Review 11/30/07 Regulatory Flexibility Analysis Required: No Agency Contact: Myrna Hanna, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF76 _______________________________________________________________________ 169. NATURAL RUBBER-CONTAINING MEDICAL DEVICE; USER LABELING (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374 Abstract: FDA has under taken a review of 21 CFR part 801 under section 610 of the Regulatory Flexibility Act. The purpose of the review was to determine whether the regulations in part 801 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 has [[Page 24694]] solicited comments on the following (1) The continued need for the regulation in part 801; (2) the nature of complaints or comments received concerning the regulation in part 801; (3) the complexity of the regulation in part 801; (4) the extent to which the regulation in part 801 overlap, duplicates, or conflict 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 the regulation in part 801. The section 610 review has been carried out along with a regulation 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 burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive Order. The agency did not receive any comments during the review process of part 801 under section 610 review. FDA's review of this regulation concluded that it should be continued without change. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/30/97 62 FR 51021 Begin Review of Current Regulation 01/02/07 End Review of Current Regulation12/28/07 Regulatory Flexibility Analysis Required: No Agency Contact: Myrna Hanna, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF77 _______________________________________________________________________ 170. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360j; 21 USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 21 USC 379; 42 USC 262 Abstract: FDA has reviewed 21 CFR part 54, under section 610 of the Regulatory Flexibility Act. FDA received no comments during the review period mandated by section 610 of the Regulatory Flexibility Act. The purpose of this review was to determine whether the regulations in part 54 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA considered and solicited comments on the following: (1) The continued need for the regulations in part 54; (2) the nature of complaints or comments received concerning the regulations in part 54; (3) the complexity of the regulations in part 54, (4) the extent to which the regulations in part 54 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 those affected by the regulations in part 54. The section 610 review has been 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 burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. FDA did not receive any comments during the review period mandated by section 610 of the Regulatory Flexibility Act. Therefore, no changes will be made to 21 CFR part 54. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/01/06 End Review 12/31/07 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, Bldg. 51, Room 6234, Silver Spring, MD 20993-0002 Phone: 301 796-3601 Fax: 301-847-8440 Email: howard.mullerjr@fda.hhs.gov Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-17), Rockville, MD 20852-1448 Phone: 301 827-6210 Myrna Hanna, Center for Devices and Radiological Health (HFZ-215), Department of Health and Human Services, Food and Drug Administration, 1350 Piccard Drive, P150 RM 150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF79 _______________________________________________________________________ 171. BEVERAGES: BOTTLED WATER (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 USC 348; 21 USC 349; 21 USC 371; 21 USC 379e Abstract: Section 165.110 (21 CFR part 165.110) describes requirements for identity and quality standards for bottled water. FDA is undertaking a review of section 165.110 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in section 165.110 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 the following: (1) The continued need for the regulations in section 165.110; (2) the nature of complaints or comments received concerning the regulations in section 165.110; (3) the complexity of the regulations; (4) the extent to which the regulations in section 165.110 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in section 165.110. FDA [[Page 24695]] received two comments on these issues and is considering them. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 03/01/07 End Review 12/31/07 Regulatory Flexibility Analysis Required: No 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, 5100 Paint Brach Parkway, ONLDS (HFS-820), College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: geraldine.june@fda.hhs.gov RIN: 0910-AF80 _______________________________________________________________________ 172. FOOD LABELING; NUTRIENT CONTENT CLAIMS: DEFINITION FOR ``HIGH POTENCY'' AND DEFINITION OF ``ANTIOXIDANT'' FOR USE IN NUTRIENT CONTENT CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 Abstract: Section 101.54 (21 CFR part 101.54) describes the requirements for when the terms ``high potency'' and ``antioxidant'' may be used on the label or in the labeling of foods, including dietary supplements. Section 101.60 (21 CFR part 101.60) describes the requirements for when the terms ``low calorie'' or ``reduced calorie'' may be used on the label or in the labeling of such foods. FDA undertook a review of sections 101.54 and 101.60 under section 610 of the Regulatory Flexibility Act. The purpose of this review was to determine whether the regulations 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 solicited comments on the following: (1) The continued need for the regulations in sections 101.54 and 101.60; (2) the nature of complaints or comments received concerning the regulations; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.54 and 101.60 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.54 and 101.60. No comments were received. FDA's review of these regulations concluded that they should be continued without change. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/01/06 End Review 11/30/07 Regulatory Flexibility Analysis Required: No Agency Contact: David Zorn, Lead Economist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, ORP (HFS-020), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1825 Fax: 301 436-2505 Email: david.zorn@fda.hhs.gov RIN: 0910-AF83 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 173. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS- 3819-P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs) that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The requirements focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/10/97 62 FR 11005 NPRM Comment Period End 06/09/97 Second NPRM 09/00/08 Regulatory Flexibility Analysis Required: No Agency Contact: Commander Mercedes Benitez-McCrary, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-05- 14, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5716 Email: mercedes.benitezmccrary@cms.hhs.gov Lynn M. Riley, Clinical Standards Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1286 Email: lynn.riley@cms.hhs.gov RIN: 0938-AG81 _______________________________________________________________________ 174. REVISIONS TO HIPAA CODE SETS (CMS-0013-P) (SECTION 610 REVIEW) Legal Authority: PL 104-191 Abstract: This proposed rule would revise some of the adopted transaction and code set standards detailed in regulations published by HHS on August 17, 2000 and February 20, 2003. [[Page 24696]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Denise Buenning, Health Insurance Specialist, Office of E-Health Standards and Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6711 Email: denise.buenning@cms.hhs.gov RIN: 0938-AN25 _______________________________________________________________________ 175. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS- 2249-F) (SECTION 610 REVIEW) Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086 Abstract: This rule amends the Medicaid regulations to define and describe the home and community-based State plan services implementing the new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/04/08 73 FR 18676 NPRM Comment Period End 06/03/08 Final Action 09/00/08 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 _______________________________________________________________________ 176. HOSPICE WAGE INDEX FOR FY 2009 (CMS-1548-P) Legal Authority: 42 USC 1814(i)(1) and 1814(i)(2) Abstract: This rule proposes the annual update to the hospice wage index for FY 2009. The wage index is used to reflect local differences in wage levels. The hospice wage index methodology and values are based on recommendations of a negotiated rulemaking advisory committee and were originally published on August 8, 1997. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Terri Deutsch, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-08-18, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9462 Email: terri.deutsch@cms.hhs.gov RIN: 0938-AP14 _______________________________________________________________________ 177. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND FY 2009 RATES (CMS-1390-P) Legal Authority: sec 1886(b) of the Social Security Act Abstract: This major rule proposes to revise the Medicare hospital Inpatient Prospective Payment Systems (IPPS) for operating and capital- related costs to implement changes arising from our continuing experience with these systems. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Michele Hudson, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5490 Email: michele.hudson@cms.hhs.gov RIN: 0938-AP15 _______________________________________________________________________ 178. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 (CMS-1404-P) Legal Authority: BBA; PPRA; BIPA; MMA; 42 USC 1302 et al Abstract: This rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the proposed rule describes proposed 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 proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. These changes would be applicable to services furnished on or after January 1 annually. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-01-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AP17 _______________________________________________________________________ 179. [bull] REQUIREMENTS FOR LONG TERM CARE FACILITIES: HOSPICE SERVICES (CMS-3140-P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395hh Abstract: This proposed rule would establish requirements that long- term care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility to participate in the Medicare and Medicaid programs. We are proposing these new requirements to ensure that quality hospice care is provided to eligible residents. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Adriene Brooks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & [[Page 24697]] Medicaid Services, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4561 Email: adriene.brooks@cms.hhs.gov RIN: 0938-AP32 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 180. MEDICARE AND MEDICAID PROGRAMS; HOSPICE CARE CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395hh Abstract: This final rule is a regulatory reform initiative that revises existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The requirements focus on the actual care delivered to patients and patients' families by hospices and the results of that care, reflect an interdisciplinary view of patient care, and allow hospices greater flexibility in meeting quality standards. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/27/05 70 FR 30840 Final Action 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Mary Rossi-Coajou, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6051 Email: mary.rossicoajou@cms.hhs.gov Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AH27 _______________________________________________________________________ 181. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE FOR RATE YEAR BEGINNING JULY 1, 2008 (RY 2009) (CMS-1401-N) Legal Authority: PL 106-113, sec 124 BBRA Abstract: This notice updates the Inpatient Psychiatric Facility Prospective Payment System for rate year (RY) 2009. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Janet Samen, Director, Division of Chronic Care Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-05-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4533 Email: janet.samen@cms.hhs.gov RIN: 0938-AO92 _______________________________________________________________________ 182. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2009: ANNUAL PAYMENT RATE UPDATES (CMS-1393-F) Legal Authority: sec 123 PL 106-113; sec 307(b) PL 106-554; sec 114 of PL 110-173 Abstract: This major rule finalizes changes to the Medicare long-term care hospitals (LTCH) prospective payment system (PPS) and updates the payment rates for rate year (RY) 2009. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/29/08 73 FR 5342 NPRM Comment Period End 03/24/08 Final Action 05/00/08 Regulatory Flexibility Analysis Required: Yes Agency Contact: Michele Hudson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-16-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5490 Email: michele.hudson@cms.hhs.gov RIN: 0938-AO94 _______________________________________________________________________ 183. [bull] CHANGES TO LONG TERM CARE PROSPECTIVE PAYMENT SYSTEM BASED ON SPECIFIC PROVISIONS IN THE MEDICARE, MEDICAID, AND SCHIP EXTENSION ACT OF 2007 (CMS-1493-IFC) Legal Authority: Provisions of sec 114 of PL 110-173 (MMSE Act of 2007); sec 1886 (d) of the Social Security Act as amended by the sec 114 of PL 110-173 (MMSE Act of 2007) Abstract: This rule implements provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long term care hospitals. In addition to amending section 1861 of the Act with a new definition of LTCHs, this rule includes provisions that are effective on the date of enactment (12/29/07). Specifically, the statute imposes a 3-year delay in implementation of certain payment policies that set percentage thresholds for LTCH patients admitted from certain referring hospitals and raises the percentage threshold for those LTCHs unaffected by the 3-year delay. The legislation imposes the same 3-year delay on the implementation of a particular payment adjustment for short-stay patients and also for the possible application of a one-time adjustment to the standard Federal rate. The statute also required a change in the Federal rate for RY 2008, (effective 4/1/08). Additionally, the statute created a 3-year moratorium on the establishment of new LTCHs and LTCH satellites and on bed expansion in existing LTCHs, subject to significant exceptions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 05/00/08 [[Page 24698]] Regulatory Flexibility Analysis Required: Yes Agency Contact: Tzvi Hefter, Director, Division of A