[April 24, 2006 (Volume 71, Number 78)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [DOCID: f:ua060408.wais] [Page 22538-22621] Department of Health and Human Services ----------------------------------------------------------------------- Part VIII ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 22538]] 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 agenda _______________________________________________________________________ SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require this semi-annual publication inventorying all rulemaking actions under development by the Department. The purpose 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. Members of the public wishing to communicate to the Department their views on the potential rule- makings outlined below are invited to do so. FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The capsulized information provided below presents for public scrutiny a forecast of the rulemaking activities that the Department expects to undertake over the foreseeable future. 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. We welcome the views of all concerned with regard to the planned rulemakings referenced below. Comments may be directed to the Agency officials cited in each of the summaries, or, if early attention at the Secretary's level is seen as required, comments should be sent to: Ann C. Agnew, Executive Secretary to the Department, Room 603H, 200 Independence Avenue SW, Washington, DC 20201. Dated: March 20, 2006. Ann C. Agnew, Executive Secretary to the Department. Office of the Secretary--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 833 Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money 0991-AB03 Penalties and Assessments............................................................. ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 834 Shared Risk Exception to the Safe Harbor Provisions................................... 0991-AA91 835 Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a 0991-AB16 Medicare SELECT Policy................................................................ 836 Clarification of Terms and Application of Program Exclusion Authority for Submitting 0991-AB23 Claims Containing Excessive Charges................................................... 837 Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally 0991-AB38 Qualified Health Centers Under the Anti-Kickback Statute.............................. 838 Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain 0991-AB39 Electronic Prescribing Arrangements Under the Anti-Kickback Statute................... ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 839 Debt Collection....................................................................... 0991-AB18 840 Salary Offset......................................................................... 0991-AB19 841 Revisions to the Waiver Provisions of the Office of Inspector General's (OIG) 0991-AB33 Exclusion Authorities................................................................. ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 842 Health Insurance Portability and Accountability Act--Enforcement...................... 0991-AB29 ---------------------------------------------------------------------------------------------------------------- [[Page 22539]] Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 843 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10 Community-Based Facilities for Children and Youth..................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 844 Mandatory Guidelines for the Federal Workplace Drug Testing Program................... 0930-AA12 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 845 Foreign Quarantine Regulations, Proposed Revision of CDC Animal Importation 0920-AA14 Regulations........................................................................... 846 Amendments to Powered Air-Purifying Respirator Requirements for Approval of 0920-AA16 Respiratory Protection Devices........................................................ 847 Amendments to Performance Requirements for Chemical Biological, Radiological, and 0920-AA17 Nuclear (CBRN) Approval of Respiratory Protection Devices............................. ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 848 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04 Respiratory Protective Devices........................................................ 849 Amendments to Self-Contained Breathing Apparatus Requirements for Approval of 0920-AA10 Respiratory Protective Devices........................................................ 850 Control of Communicable Diseases, Interstate and Foreign Quarantine................... 0920-AA12 851 Amendments to Requirements for Coal Mine Dust Personal Sampler Units.................. 0920-AA18 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 852 Procedures for Designating Classes of Employees as Members of the Special Exposure 0920-AA13 Cohort Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Amendments...................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 853 Control of Communicable Diseases...................................................... 0920-AA15 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 854 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality 0910-AF71 Systems Regulations (Section 610 Review).............................................. [[Page 22540]] 855 Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction 0910-AF73 Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use (Section 610 Review).................................................................. 856 Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for 0910-AF74 Internal Use: Required Alcohol Warning (Section 610 Review)........................... 857 Status of Certain Additional Over-the-Counter Drug Category II and III Active 0910-AF75 Ingredients (Section 610 Review)...................................................... 858 Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific 0910-AF76 Reagents (Section 610 Review)......................................................... 859 Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber- 0910-AF77 Containing Medical Device (Section 610 Review)........................................ 860 Financial Disclosure by Clinical Investigators (Section 610 Review)................... 0910-AF79 861 Beverages: Bottled Water (Section 610 Review)......................................... 0910-AF80 862 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 (Section 610 Review)............................................... ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 863 Foreign and Domestic Establishment Registration and Listing Requirements for Human 0910-AA49 Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.......................................................................... 864 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure 0910-AC30 Regulators for Use With Medical Oxygen................................................ 865 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52 866 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 867 Reporting Information Regarding Falsification of Data................................. 0910-AC59 868 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling..................................... 869 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 870 Charging for Investigational Drugs.................................................... 0910-AF13 871 Expanded Access to Investigational Drugs for Treatment Use............................ 0910-AF14 872 Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as 0910-AF16 Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures............................................................. 873 Blood Initiative--Requirements for Human Blood and Blood Components Intended for 0910-AF25 Transfusion or for Further Manufacturing Use.......................................... 874 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 875 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 876 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 877 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 878 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 879 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 880 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 881 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61 882 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63 883 Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation..... 0910-AF65 884 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species............... 0910-AF67 885 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 886 Import Tolerances for Animal Drugs.................................................... 0910-AF78 887 Current Good Manufacturing Practice for Combination Products.......................... 0910-AF81 888 Postmarket Safety Reporting for Combination Products.................................. 0910-AF82 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 889 Safety Reporting Requirements for Human Drug and Biological Products.................. 0910-AA97 [[Page 22541]] 890 Applications for FDA Approval To Market a New Drug; Complete Response Letter; 0910-AB34 Amendments to Unapproved Applications................................................. 891 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion 0910-AB76 Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback).................................................................. 892 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88 Ingredients and Dietary Supplements................................................... 893 Additional Safeguards for Children in Clinical Investigations of FDA-Regulated 0910-AC07 Products.............................................................................. 894 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14 895 Institutional Review Boards: Registration Requirements................................ 0910-AC17 896 Exception From General Requirements for Informed Consent; Request for Comments and 0910-AC25 Information........................................................................... 897 Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration............... 0910-AC32 898 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs............. 0910-AC35 899 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism 0910-AC41 Preparedness and Response Act of 2002................................................. 900 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 901 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an 0910-AF15 Investigational New Drug Application.................................................. 902 Revocation of the Status of Specific Products; Group A Streptococcus.................. 0910-AF20 903 Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and 0910-AF21 Condoms With Spermicidal Lubricant.................................................... 904 Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, 0910-AF26 Including Source Plasma; and Technical Amendment...................................... 905 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27 Notification Requirements; Records and Reports........................................ 906 Infant Formula Quality Factors........................................................ 0910-AF28 907 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 908 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 909 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 910 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 911 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 912 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 913 Substances Prohibited From Use in Animal Food or Feed................................. 0910-AF46 914 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 915 Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed 0910-AF48 With, or Otherwise Containing Material From Cattle.................................... 916 Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis 0910-AF49 Products.............................................................................. 917 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 918 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 919 Supplements and Other Changes to Approved New Animal Drug Applications................ 0910-AF59 920 Designation of New Animal Drugs for Minor Uses or Minor Species....................... 0910-AF60 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 921 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed 0910-AC21 Animal Populations.................................................................... 922 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 923 Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider 0910-AC50 Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements..... 924 Food Standards: General Principles and Food Standards Modernization................... 0910-AC54 925 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding 0910-AF08 of Drugs; Revision of Certain Labeling Controls....................................... 926 Health Claims......................................................................... 0910-AF09 927 Food Labeling; Prominence of Calories................................................. 0910-AF22 928 Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating 0910-AF23 Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes.................................................... 929 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 [[Page 22542]] 930 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 931 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 932 Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans 0910-AF54 and Drugs Intended for Use in Ruminants............................................... 933 Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68 934 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 935 Investigational New Drugs: Export Requirements for Unapproved New Drug Products....... 0910-AA61 936 Requirements on Content and Format of Labeling for Human Prescription Drugs and 0910-AA94 Biological Products................................................................... 937 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review 0910-AF62 938 Lowfat and Skim Milk and Lowfat and Nonfat Yogurt Products, Lowfat Cottage Cheese: 0910-AF64 Rev. of Stand. of Ident.; Food Lab., Nutrient Cont. Claims for Fat, Fatty Acids, and Cholesterol Cont. of Foods (Section 610 Review)....................................... ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 939 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44 Areas................................................................................. 940 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA57 Care Practitioners: Reporting Adverse and Negative Actions............................ 941 National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health 0906-AA68 Insurance Policy...................................................................... ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 942 Smallpox Emergency Personnel Protection Program: Smallpox (Vaccinia) Vaccine Injury 0906-AA60 Table................................................................................. 943 Smallpox Vaccine Injury Compensation Program: Administrative Implementation........... 0906-AA61 944 Intestines Added to the Definition of Organs Covered by the Rules Governing the 0906-AA62 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 945 Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act 0906-AA65 Title IV Grants for Coordinated Services and Access to Research....................... 946 Healthy Tomorrow's Partnership for Children (HTPC) Program............................ 0906-AA70 ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 947 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA41 Care Practitioners: Medical Malpractice Payments Reporting Requirements............... 948 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 0906-AA63 ---------------------------------------------------------------------------------------------------------------- [[Page 22543]] Health Resources and Services Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 949 Public Health Service (PHS) Grant Appeals Procedure................................... 0906-AA69 ---------------------------------------------------------------------------------------------------------------- Indian Health Service--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 950 Section 506--Limitation on Charges for Services Furnished by Medicare-Participating 0917-AA07 Inpatient Hospital to Indians......................................................... ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 951 Grants for Research Projects.......................................................... 0925-AA42 952 National Institutes of Health Loan Repayment Programs................................. 0925-AA43 953 National Library of Medicine Training Grants.......................................... 0925-AA44 954 Minority Biomedical Research Support Program.......................................... 0925-AA45 955 National Institute of Environmental Health Sciences Hazardous Substances Basic 0925-AA46 Research and Training Grants.......................................................... 956 Endowment Program..................................................................... 0925-AA47 957 Undergraduate Scholarship Program Regarding Professions Needed by the National 0925-AA48 Institutes of Health.................................................................. ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 958 National Institutes of Health Training Grants......................................... 0925-AA28 959 Standards for a National Chimpanzee Sanctuary System.................................. 0925-AA31 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 960 Human Subjects Protection Regulations: Additional Protections for Adult Individuals 0940-AA11 With Impaired Decisionmaking Capacity................................................. ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 961 Human Subjects Protection Regulations: Institutional Review Boards Registration 0940-AA06 Requirements.......................................................................... ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 962 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01 Whistleblowers........................................................................ [[Page 22544]] 963 Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional 0940-AA08 Officials, Institutional Review Board Members and Staff, Human Protections Administrators, and Investigators..................................................... ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 964 Federal Policy for the Protection of Human Subjects Technical Amendment............... 0940-AA10 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 965 Innovations in Fee-for-Service Payment Systems to Improve Quality and Outcomes (CMS- 0938-AN91 1298-ANPR)............................................................................ ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 966 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 967 Appeals of CMS or Contractor Determinations When a Provider or Supplier Fails To Meet 0938-AI49 or Maintain the Requirements for Medicare Billing Privileges (CMS-6003-P2)............ 968 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AJ17 and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2)....... 969 Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That 0938-AL26 Provide Inpatient or Residential Care (CMS-2130-P).................................... 970 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..... 0938-AL80 971 Modifications to Electronic Transactions and Code Sets (CMS-0009-P)................... 0938-AM50 972 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)............. 0938-AM87 973 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, 0938-AN14 Orthotics, and Supplies (CMS-1270-P).................................................. 974 Revisions to HIPAA Code Sets (CMS-0013-P)............................................. 0938-AN25 975 Limitation on Recoupment of Overpayments (CMS-6025-P)................................. 0938-AN42 976 Revisions to the Oversight and Validation Program for Accrediting Organizations 0938-AN62 Approved for Deeming Authority (CMS-2255-P)........................................... 977 Changes to the Disclosure of Information Requirements for Quality Improvement 0938-AN73 Organizations (CMS-3156-P)............................................................ 978 Home Health Payment System Rate Update for Calendar Year 2007 (CMS-1304-P)............ 0938-AN76 979 Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-P) 0938-AN79 980 Payments for Service Provided Without Charge (CMS-2489-P)............................. 0938-AO07 981 Quality Standards for Genetic Testing (CMS-2121-P).................................... 0938-AO09 982 Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P)............. 0938-AO10 983 Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for 0938-AO11 Ambulance Services (CMS-1317-P)....................................................... 984 Changes to the Hospital Inpatient Prospective Payment Systems and FY 2007 Rates (CMS- 0938-AO12 1488-P)............................................................................... 985 Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2007 0938-AO15 Payment Rates (CMS-1506-P)............................................................ 986 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2007 (CMS- 0938-AO16 1540-P)............................................................................... 987 Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P).. 0938-AO17 988 Best Price Requirements for Authorized Generic Drugs (CMS-2238-P)..................... 0938-AO20 989 Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS- 0938-AO22 1512-PN).............................................................................. 990 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007 0938-AO24 (CMS-1321-P).......................................................................... 991 Use of Repayment Plans (CMS-6032-P)................................................... 0938-AO27 [[Page 22545]] 992 Redistribution of Unexpended State Children's Health Insurance Program (SCHIP) Funds 0938-AO28 From the Appropriation for Fiscal Year 2004 (CMS-2241-NC)............................. 993 Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate 0938-AO30 Updates (CMS-1529-P).................................................................. 994 Home Health Prospective Payment System Rate Update for Calendar Year 2008 (CMS-1541-P) 0938-AO32 995 Provider Nomination Provision (CMS-1331-P)............................................ 0938-AO33 996 Gynecological Cytology Proficiency Testing Requirements for Laboratories, Individuals, 0938-AO34 and Proficiency Testing Program Approvals (CMS-2252-P)................................ 997 Special Medicare GME Affillations for a Teaching Hospital Affected by a Disaster (CMS- 0938-AO35 1531-IFC)............................................................................. 998 State Children's Health Insurance Program (SCHIP) Redistribution of Unexpended SCHIP 0938-AO38 Funds From the Appropriation for Fiscal Year 2003 (CMS-2235-NC)....................... 999 Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year 0938-AO40 Beginning July 1, 2007 (FY 2008) (CMS-1479-P)......................................... 1000 Notification Procedures for Hospital Discharges (CMS-4105-F).......................... 0938-AO41 1001 State Option To Establish Non-Emergency Medical Transportation Program (CMS-2234-P)... 0938-AO45 1002 High Risk Pools (CMS-2260-P).......................................................... 0938-AO46 1003 Cost Sharing Options (CMS-2244-P)..................................................... 0938-AO47 1004 Benchmark Benefit Package (CMS-2232-P)................................................ 0938-AO48 1005 Improved Enforcement of Documentation Requirements (CMS-2257-P)....................... 0938-AO51 1006 Self-Directed Personal Assistance Services State Plan Option (CMS-2229-P)............. 0938-AO52 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1007 Requirements for Providers and Suppliers To Establish and Maintain Medicare Enrollment 0938-AH73 (CMS-6002-F).......................................................................... 1008 Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610 0938-AJ29 Review)............................................................................... 1009 Use of Restraints and Seclusion in Residential Treatment Facilities Providing 0938-AJ96 Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)............... 1010 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67 Relationships (CMS-1810-F)............................................................ 1011 Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F)............................. 0938-AN09 1012 Nondiscrimination in Health Coverage in the Group Market (CMS-4081-F)................. 0938-AN29 1013 Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)................... 0938-AN30 1014 National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-NC) 0938-AN71 1015 Payment Error Rate Measurement (PERM) Program (CMS-6026-IFC2)......................... 0938-AN77 1016 Inpatient Psychiatric Facility Prospective Payment System--Update for RY 2006 (CMS- 0938-AN82 1306-F)............................................................................... 1017 Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F). 0938-AN83 1018 Prospective Payment System for Long-Term Care Hospitals RY 2007: Annual Payment Rate 0938-AO06 Updates (CMS-1485-F).................................................................. 1019 Part A Premiums for Calendar Year 2007 for the Uninsured Aged and for Certain Disabled 0938-AO18 Individuals Who Have Exhausted Other Entitlement (CMS-8028-N)......................... 1020 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AO19 Amounts for Calendar Year 2007 (CMS-8029-N)........................................... 1021 Fiscal Year 2007 SCHIP Allotments (CMS-2251-N)........................................ 0938-AO21 1022 Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2007 (CMS-8030-N) 0938-AO23 1023 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AO25 Update for FY 2007 (CMS-1530-N)....................................................... 1024 Hospice Wage Index for FY 2007 (CMS-1535-N)........................................... 0938-AO26 1025 State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: 0938-AO31 Fiscal Year 2006 (CMS-2231-IFC)....................................................... 1026 State Health Insurance Assistance Program (SHIP) (CMS-4005-F)......................... 0938-AO37 1027 Fee Schedule for Payment of Ambulance Services--Update for CY 2007 (CMS-1532-N)....... 0938-AO39 1028 Adoption of Standards for the E-Prescribing and the Medicare Prescription Drug Program 0938-AO42 (CMS-0018-N).......................................................................... 1029 Group Health Plans and Health Insurance Issues Under the Newborns and Mothers Health 0938-AO43 Protection Act (CMS-4116-F)........................................................... 1030 Targeted Case Management (CMS-2237-IFC)............................................... 0938-AO50 [[Page 22546]] 1031 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-IFC)............. 0938-AO53 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1032 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610 0938-AG82 Review)............................................................................... 1033 Hospital Conditions of Participation: Requirements for Approval and Reapproval of 0938-AH17 Transplant Centers To Perform Organ Transplants (CMS-3835-F).......................... 1034 Hospice Care Conditions of Participation (CMS-3844-F) (Section 610 Review)............ 0938-AH27 1035 Electronic Claims Attachments Standards (CMS-0050-F).................................. 0938-AK62 1036 Organ Procurement Organization Conditions for Coverage and Recertification (CMS-3064- 0938-AK81 F) (Section 610 Review)............................................................... 1037 Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................ 0938-AL54 1038 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family 0938-AL88 and Medical Leave Act (CMS-2158-F).................................................... 1039 Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........ 0938-AM73 1040 Hospital Conditions of Participation: Requirements for History and Physical 0938-AM88 Examinations; Authentication of Verbal Orders; Securing Medications; and Post- Anesthesia Evaluations (CMS-3122-F)................................................... 1041 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM98 (CMS-6146-F).......................................................................... 1042 Prior Determination Process for Certain Items and Services (CMS-6024-F)............... 0938-AN10 1043 Medicare Secondary Payer Amendments (CMS-6272-F)...................................... 0938-AN27 1044 Random Prepayment Review (CMS-6022-F)................................................. 0938-AN31 1045 Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand 0938-AN36 Sanitizer Amendment (CMS-3145-F)...................................................... 1046 Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325- 0938-AN58 F).................................................................................... 1047 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AN69 Relationships; E-Prescribing Exceptions (CMS-1303-F).................................. 1048 Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of 0938-AN72 Interest Requirements (CMS-6030-F).................................................... 1049 Health Care Infrastructure Improvement Program; Loan Program for Qualifying Hospitals 0938-AO03 Engaged in Cancer-Related Health Care (CMS-1287-F).................................... 1050 Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS- 0938-AO36 4094-F4).............................................................................. ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1051 Standard Unique National Health Plan Identifier (CMS-6017-P).......................... 0938-AH87 1052 Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements 0938-AJ10 (CMS-3006-F).......................................................................... 1053 Hospice Care Amendments (CMS-1022-F).................................................. 0938-AJ36 1054 Electronic Medicare Claims Submission (CMS-0008-F).................................... 0938-AM22 1055 Requirements for Long-Term Care Facilities; Nursing Services; Posting of Nurse 0938-AM55 Staffing Information (CMS-3121-F)..................................................... 1056 Conditions for Coverage for Payment of Power Mobility Devices, Including Powered 0938-AM74 Wheelchairs and Power-Operated Vehicles (CMS-3017-F).................................. 1057 Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate 0938-AN02 (CMS-1167-F).......................................................................... 1058 Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS- 0938-AN23 1478-F)............................................................................... 1059 Payment for Clinical Laboratory Tests (CMS-1494-P).................................... 0938-AN26 1060 Federal Enforcement in Group and Individual Health Insurance Markets (CMS-4091-F)..... 0938-AN35 1061 Home Health Prospective Payment System Rate Update for Calendar Year 2006 (CMS-1301-F) 0938-AN44 1062 Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 0938-AN46 Payment Rates (CMS-1501-FC)........................................................... 1063 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AN48 (CMS-6019-F).......................................................................... 1064 Electronic Prescribing Standards (CMS-0011-F)......................................... 0938-AN49 [[Page 22547]] 1065 Group Market Health Insurance Reform: Guaranteed Availability, Guaranteed 0938-AN60 Renewability, Disclosures to Small Employers (CMS-4102-F)............................. 1066 Individual Market Health Insurance Reform: Portability From Group to Individual 0938-AN61 Coverage; Federal Rules for Access in the Individual Market; State Alternative Mechanisms to Federal Rules (CMS-4103-F).............................................. 1067 All Provider Bad Debt Payment (CMS-1126-F)............................................ 0938-AN75 1068 Application of Inherent Reasonableness to All Medicare Part B Services (Other Than 0938-AN81 Physician Services) (CMS-1908-F)...................................................... 1069 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 0938-AN84 (CMS-1502-FC)......................................................................... 1070 Electronic Submission of Cost Reports (CMS-1199-F).................................... 0938-AN87 1071 Loan Forgiveness Criteria for the Health Care Infrastructure Loan Program (CMS-1320-F) 0938-AN93 1072 Fee Schedule for Payment of Ambulance Services--Update for CY 2006 (CMS-1294-N)....... 0938-AN99 1073 State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals 0938-AO04 (CMS-2210-F).......................................................................... 1074 Federal Government's Adoption of Twenty (20) Healthcare Messaging and Vocabulary 0938-AO05 Standards Recommended by the Consolidated Health Informatics Initiative (CMS-0015-N).. 1075 Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs) 0938-AO13 Effective January 1, 2008 (CMS-1517-P)................................................ 1076 Fire Safety Requirements for Religious Non-Medical Health Care Institutions: 0938-AO14 Correction to Add Written Fire Control Plans & Maintenance of Documentation (CMS-3183- IFC).................................................................................. ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1077 Developmental Disabilities and Bill of Rights Act..................................... 0970-AC07 1078 Administrative Cost Sharing Under TANF................................................ 0970-AC15 1079 Care and Placement of Unaccompanied Alien Children.................................... 0970-AC20 1080 Chafee National Youth in Transition Database.......................................... 0970-AC21 1081 Medical Support....................................................................... 0970-AC22 1082 Adoption and Foster Care Analysis and Reporting System................................ 0970-AC23 1083 Child Support Provisions of the Deficit Reduction Act................................. 0970-AC24 1084 Privatizing Functions................................................................. 0970-AC25 1085 Head Start Transportation............................................................. 0970-AC26 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1086 Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) 0970-AC01 Information........................................................................... 1087 Child Care and Development Fund State Match Provisions................................ 0970-AC18 1088 Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders.... 0970-AC19 1089 TANF Work Provisions of the Deficit Reduction Act..................................... 0970-AC27 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1090 Administrative Costs for Children in Title IV-E Foster Care........................... 0970-AC14 1091 Head Start Transportation............................................................. 0970-AC16 ---------------------------------------------------------------------------------------------------------------- [[Page 22548]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 833. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE CIVIL MONEY PENALTIES AND ASSESSMENTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b; 42 USC 1396u-2 CFR Citation: 42 CFR 1003 Legal Deadline: None Abstract: This proposed rule would revise part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments, by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; modify the current definition for the term ``claim;'' update various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e-mail communications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 NPRM Comment Period End 11/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB03 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 834. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104- 191, sec 216(b) CFR Citation: 42 CFR 1001 Legal Deadline: Final, Statutory, January 1, 1997. Abstract: This final rule establishes a new statutory exception for risk-sharing arrangements under the Federal health care programs' anti- kickback provisions. The rule sets forth an exception from liability for remuneration between an eligible organization and an individual or entity providing items or services in accordance with a written agreement between these parties. The rule allows remuneration between an organization and an individual or entity if a written agreement places the individual or entity at ``substantial financial risk'' for the cost or utilization of the items or services that the individual or entity is obligated to provide. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 05/23/97 62 FR 28410 ANPRM Comment Period End 06/09/97 Interim Final Rule 11/19/99 64 FR 63504 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 Related RIN: Related to 0991-AB06 RIN: 0991-AA91 _______________________________________________________________________ 835. SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND DEDUCTIBLE AMOUNTS FOR A MEDICARE SELECT POLICY Priority: Substantive, Nonsignificant Legal Authority: PL 100-93, sec 14(a) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This final rule will expand the existing safe harbor for certain waivers of beneficiary coinsurance and deductible amounts to benefit the policyholders of Medicare SELECT supplemental insurance. Specifically, the amended safe harbor will protect waivers of coinsurance and deductible amounts under part A or part B of the Medicare program owed by beneficiaries covered by a Medicare SELECT policy issued in accordance with section 1882(t)(1) of the Social Security Act, if the waiver is in accordance with a price reduction agreement covering such policyholders between the Medicare SELECT issuer and the provider or supplier offering the waiver. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/25/02 67 FR 60202 NPRM Comment Period End 10/25/02 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB16 _______________________________________________________________________ 836. CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES Priority: Substantive, Nonsignificant Legal Authority: Social Security Act, sec 112B(6); Social Security Act, sec 112B(6)(A) CFR Citation: 42 CFR 1001 Legal Deadline: None [[Page 22549]] Abstract: This rule would amend the Office of Inspector General's exclusion regulations at 42 CFR 1001.701, addressing excessive claims, by including definitions for the terms ``substantially in excess'' and ``usual charges,'' and by clarifying the ``good cause'' exception set forth in this section. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/15/03 68 FR 53939 NPRM Comment Period End 11/14/03 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB23 _______________________________________________________________________ 837. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE HARBOR FOR FEDERALLY QUALIFIED HEALTH CENTERS UNDER THE ANTI-KICKBACK STATUTE Priority: Other Significant Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 431 CFR Citation: 42 CFR 1001 Legal Deadline: Final, Statutory, December 8, 2004. Abstract: This rule will set forth standards for the new anti-kickback safe harbor addressing remuneration between federally qualified health centers and certain providers where significant community benefit exits. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/01/05 70 FR 38081 Interim Final Rule Comment Period End 08/01/05 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 Related RIN: Related to 0991-AB06, Related to 0991-AA91 RIN: 0991-AB38 _______________________________________________________________________ 838. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE HARBOR FOR CERTAIN ELECTRONIC PRESCRIBING ARRANGEMENTS UNDER THE ANTI- KICKBACK STATUTE Priority: Other Significant Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 101(a)(4)(D)(6) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This rule will establish a safe harbor with respect to the provision of nonmonetary remuneration--in the form of hardware, software, or information technology and training services--necessary and used solely to receive and transmit electronic prescription information in accordance with section 1860-D of the Social Security Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/11/05 70 FR 59015 NPRM Comment Period End 12/12/05 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB39 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of the Secretary (OS) _______________________________________________________________________ 839. DEBT COLLECTION Priority: Substantive, Nonsignificant Legal Authority: 31 USC 3711; 31 CFR 900 to 904 CFR Citation: 45 CFR 30 Legal Deadline: None Abstract: The Department will amend part 30 of title 45 of the Code of Federal Regulations (CFR) to reflect the amendments to the Federal Claims Collection Act made by the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, as implemented by the Department of the Treasury at 31 CFR 900-904. The proposed rule will prescribe the standards and procedures for the Department's use in the administrative collection, offset, compromise, and suspension or termination of debts owed to the Department. The proposed rule is required in order to bring the Department's claims collection provisions in compliance with the Department of the Treasury regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/13/04 69 FR 42010 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department of Health and Human Services, Office of the Secretary, HHS Cohen Building, [[Page 22550]] Room 4760, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB18 _______________________________________________________________________ 840. SALARY OFFSET Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: 5 USC 5514 CFR Citation: 5 CFR 550; 45 CFR 33 Legal Deadline: None Abstract: The Department will add a new part 33 to title 45 of the Code of Federal Regulations (CFR) to implement the salary offset provisions of the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104- 134, 110 Stat. 1321 to 1358, codified at 5 U.S.C. 5514, as implemented by the Office of Personnel Management at 5 CFR part 550, subpart K. The proposed rule is required in order to bring the Department's salary offset provisions in compliance with Governmentwide regulations published by the Office of Personnel Management. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/13/04 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department of Health and Human Services, Office of the Secretary, HHS Cohen Building, Room 4760, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB19 _______________________________________________________________________ 841. REVISIONS TO THE WAIVER PROVISIONS OF THE OFFICE OF INSPECTOR GENERAL'S (OIG) EXCLUSION AUTHORITIES Priority: Substantive, Nonsignificant Legal Authority: PL 108-173, sec 949; PL 105-33, sec 4331; Social Security Act, sec 1128(c)(3)(b) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: In accordance with section 949 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, this rule would revise the OIG's exclusion authority to permit any Federal health care program to request a waiver of an OIG exclusion imposed under sections 1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB33 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Office of the Secretary (OS) _______________________________________________________________________ 842. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT Priority: Other Significant CFR Citation: 45 CFR 160, subparts C to E Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 02/16/06 71 FR 8390 Final Action Effective 03/16/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Carol Conrad Phone: 202 690-1840 RIN: 0991-AB29 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 843. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-310 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, April 2001. 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 09/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Paolo Del Vecchio, Department of Health and Human Services, Substance Abuse and Mental [[Page 22551]] 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 Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 844. MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING PROGRAM Priority: Other Significant Legal Authority: PL 100-71; 5 USC 7301 CFR Citation: None Legal Deadline: NPRM, Statutory, December 2003. Abstract: HHS is proposing to establish scientific and technical guidelines for the testing of hair, sweat, and oral fluid specimens in addition to urine specimens; scientific and technical guidelines for using on-site tests to test urine and oral fluids at the collection site; requirements for the certification of instrumented initial test facilities; and added standards for collectors, on-site testers, and medical review officers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 04/13/04 69 FR 19673 Final Action 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-7017 Fax: 301 443-1450 Email: jfaha@samhsa.gov RIN: 0930-AA12 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 845. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF CDC ANIMAL IMPORTATION REGULATIONS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Centers for Disease Control and Prevention (CDC) is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to begin the process of revising the regulations for importation of dogs, cats and other animals into the United States (42 CFR 71.51 and 71.56). The input received from stakeholders via the ANPRM with the aim of improving CDC's ability to prevent importation of communicable diseases. The scope of this ANPRM does not include the nonhuman primate regulations (42 CFR 71.53). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 05/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jennifer Brooks, Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Infectious Diseases, 1600 Clifton Road NE., NE E-03, Atlanta, GA 30333 Phone: 404 639-7048 RIN: 0920-AA14 _______________________________________________________________________ 846. AMENDMENTS TO POWERED AIR-PURIFYING RESPIRATOR REQUIREMENTS FOR APPROVAL OF RESPIRATORY PROTECTION DEVICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 28 USC 651; 30 USC 3; 30 USC 7; 30 USC 11; 30 USC 842; 30 USC 844 CFR Citation: 42 CFR 84 Legal Deadline: None Abstract: NIOSH plans to modify sections of 42 CFR Part 84 concerning performance testing and other specifications for the certification of powered air-purifying respirators. These respirators are used in a variety of workplace applications, including emergency response activities. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 03/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Federalism: Undetermined Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards Branch, HHS, CDC, NIOSH, Department of Health and Human Services, Centers for Disease Control and Prevention, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA16 _______________________________________________________________________ 847. AMENDMENTS TO PERFORMANCE REQUIREMENTS FOR CHEMICAL BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR (CBRN) APPROVAL OF RESPIRATORY PROTECTION DEVICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 29 USC 651; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 11; 30 USC 842l; 30 USC 844 CFR Citation: 42 CFR 84 Legal Deadline: None [[Page 22552]] Abstract: NIOSH plans to modify sections of 42 CFR Part 84 concerning performance testing and other specifications for the certification of closed-circuit, self-contained breathing apparatus, supplied air respirators, and combination (supplied air and air purifying capable) respirators against CBRN respiratory hazards. These respirators are used in emergency response situations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 03/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards Branch, HHS, CDC, NIOSH, Department of Health and Human Services, Centers for Disease Control and Prevention, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA17 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 848. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION FOR APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842(h); 30 USC 844 CFR Citation: 42 CFR 84 Legal Deadline: None Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices. Areas for potential modification in this module are: 1) Upgrade of quality assurance requirements; 2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; 3) revised approval label requirements; 4) updated and restructured fee schedule; and 5) fee retention in the respirator program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards Branch, HHS, CDC, NIOSH, Department of Health and Human Services, Centers for Disease Control and Prevention, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA04 _______________________________________________________________________ 849. AMENDMENTS TO SELF-CONTAINED BREATHING APPARATUS REQUIREMENTS FOR APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Priority: Other Significant Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842; 30 USC 844 CFR Citation: 42 CFR 84 Legal Deadline: None Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning performance testing and other specifications for the certification of closed-circuit, self-contained breathing apparatus. These respiratory protective devices are used in emergencies for the protection of miners and workers in other industries. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards Branch, HHS, CDC, NIOSH, Department of Health and Human Services, Centers for Disease Control and Prevention, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA10 _______________________________________________________________________ 850. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: Not Yet Determined CFR Citation: 42 CFR 70; 42 CFR 71 Legal Deadline: None Abstract: By statute, the Secretary of Health and Human Services (HHS) 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. Interstate authority is split between CDC and the Food and Drug Administration (FDA), with CDC delegated interstate authority as it pertains to humans. CDC maintains quarantine stations at eight major airports with quarantine inspectors who respond to reports of diseases from carriers. According to the statutory scheme, the President of the United States 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, and Severe Acute Respiratory Syndrome (SARS) and influenza caused by novel or reemergent influenza virus that are [[Page 22553]] causing, or have the potential to cause, a pandemic. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ram Koppaka M.D., Ph.D, Department of Health and Human Services, Centers for Disease Control and Prevention, MS-E-03, 1600 Clifton Road, Atlanta, GA 30333 Phone: 404 498-2308 RIN: 0920-AA12 _______________________________________________________________________ 851. AMENDMENTS TO REQUIREMENTS FOR COAL MINE DUST PERSONAL SAMPLER UNITS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None Abstract: NIOSH and MSHA jointly plan to modify 30 CFR part 74, which provides requirements for the approval by NIOSH and MSHA or coal mine dust personal sampler units that are worn by miners to determine the concentrations of respirable dust in coal mine atmospheres. The existing requirements are design-specific for a particular monitoring technology that has been available since the 1970's. The amendments would establish requirements that would promote the development and govern the testing and approval of new coal mine dust sampler designs and technology for use in coal mines. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: John Breslin, Director, Science, Pittsburgh Research Laboratory, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-6873 RIN: 0920-AA18 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 852. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000; AMENDMENTS Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: HHS is amending its procedures to consider designating classes of employees to be added to the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000 (``EEOICPA''), 42 U.S.C. sections 7384-7385. HHS must change these procedures to implement amendments to EEOICPA enacted on October 28, 2004, as part of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Public Law No. 108-375 (codified as amended in scattered sections of 42 U.S.C.). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/22/05 70 FR 75949 Interim Final Rule Comment Period End 02/21/06 Next Action Undetermined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Larry Elliott, Director, Office of Compensation Analysis and Support, Department of Health and Human Services, Centers for Disease Control and Prevention, 4676 Columbia Pkwy, MS C-46, Cincinnati, OH 45226 Phone: 513 533-6825 RIN: 0920-AA13 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 853. CONTROL OF COMMUNICABLE DISEASES Priority: Other Significant Legal Authority: 25 USC 198, 231, and 1661; 42 U.S.C. 243, 248, 249, 264-272, and 2001 CFR Citation: 42 CFR 70 and 71 Legal Deadline: None Abstract: CDC is committed to protecting the health and safety of the American public by preventing the introduction of communicable disease into the United States. Having updated regulations in place is an important measure to ensure swift response to public health threats. CDC proposes to update existing regulations related to preventing the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. and from one State or possession into another. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 11/30/05 70 FR 71892 Regulatory Flexibility Analysis Required: No [[Page 22554]] Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Jennifer Brooks, Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Infectious Diseases, 1600 Clifton Road NE., NE E-03, Atlanta, GA 30333 Phone: 404 639-7048 RIN: 0920-AA15 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 854. MEDICAL DEVICES; CURRENT GOOD MANUFACTURING PRACTICE (CGMP) FINAL RULE; QUALITY SYSTEMS REGULATIONS (SECTION 610 REVIEW) Priority: Routine and Frequent Legal Authority: 5 USC 610 CFR Citation: 21 CFR 808; 21 CFR 812; 21 CFR 820 Legal Deadline: None Abstract: FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 820. The purpose of this review is to determine if any of the regulations in part 820 should be continued without change, or should be amended or rescinded, to minimize adverse economic impacts on small entities. FDA will consider and solicit comments on the following: 1) The continued need for a regulation in part 820; 2) the nature of complaints or comments received concerning a regulation in part 820; 3) the complexity of a regulation in part 820; 4) the extent to which a regulation in part 820 overlaps, duplicates, or conflicts with other Federal, State, or local government rules; and 5) the degree to which technology, economic conditions or other factors have changed in the area affected by a regulation in part 820. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 04/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined 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-AF71 _______________________________________________________________________ 855. PACKAGE SIZE LIMITATION FOR SODIUM PHOSPHATES ORAL SOLUTION AND WARNING AND DIRECTION STATEMENTS FOR ORAL AND RECTAL SODIUM PHOSPHATES FOR OVER-THE-COUNTER LAXATIVE USE (SECTION 610 REVIEW) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 610 CFR Citation: 21 CFR 201.307 Legal Deadline: None Abstract: Section 201.307 (21 CFR section 201.307) describes a final rule to limit the container size for sodium phosphates oral solution (dibasic sodium phosphate/monobasic sodium phosphate oral solution) to not greater than 90 milliliters (mL) (3 ounces (oz)) when used as an over-the-counter (OTC) laxative drug product. FDA limited the container size due to reports of deaths associated with an overdosage of sodium phosphates when packaged in a larger size container and a larger than intended dose was ingested inadvertently. In addition, this final rule required warning and direction statements to inform consumers that exceeding the recommended dose of oral and rectal sodium phosphates products in a 24 hour period could be harmful. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 201.307. The purpose of this review is to determine whether the regulation in section 201.307 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 201.307; (2) the nature of the complaints or comments received concerning the regulation in section 201.307; (3) the complexity of the regulation in section 201.307; (4) the extent to which the regulation in section 201.307 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 package size and labeling regulation in section 201.307. The section 610 review will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the Agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 06/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF73 [[Page 22555]] _______________________________________________________________________ 856. OVER-THE-COUNTER DRUG PRODUCTS CONTAINING ANALGESIC/ANTIPYRETIC ACTIVE INGREDIENTS FOR INTERNAL USE: REQUIRED ALCOHOL WARNING (SECTION 610 REVIEW) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 610 CFR Citation: 21 CFR 201.322 Legal Deadline: None Abstract: Section 201.322 describes a regulation which requires an alcohol warning for all over-the-counter (OTC) drug products, labeled for adult use, containing internal analgesic/antipyretic active ingredients. The required warning statements advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. FDA issued the final rule after considering comments on the Agency's proposed regulation for OTC internal analgesic, antipyretic, and antirheumatic drug products: a proposed regulation to establish an alcohol warning; recommendations from its Nonprescription Drugs Advisory Committee (NDAC) and Arthritis Drugs Advisory Committee (ADAC); and data submitted to the agency. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 201.322. The purpose of this review is to determine whether the regulation in section 201.322 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 201.322; (2) the nature of the complaints or comments received concerning the regulation in section 201.322; (3) the complexity of the regulation in section 201.322; (4) the extent to which the regulation in section 201.322 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 labeling regulation in section 201.322. The section 610 review will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the Agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 06/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF74 _______________________________________________________________________ 857. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND III ACTIVE INGREDIENTS (SECTION 610 REVIEW) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 610 CFR Citation: 21 CFR 310.545 Legal Deadline: None Abstract: Section 310.545 (21 CFR 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 products would result in that product not being generally recognized as safe and effective and would result in misbranding. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 310.545. The purpose of this review is 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 will consider, and is soliciting 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 will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the Agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 06/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State [[Page 22556]] Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF75 _______________________________________________________________________ 858. MEDICAL DEVICES: CLASSIFICATION/ RECLASSIFICATION; RESTRICTED DEVICES; ANALYTE SPECIFIC REAGENTS (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j CFR Citation: 21 CFR 809.10; 21 CFR 809.30 Legal Deadline: None Abstract: FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 809. The purpose of this review is to determine if any of the regulations in part 809 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities. FDA will consider and solicit comments on the following: 1) The continued need for a regulation in part 809; 2) the nature of complaints or comments received concerning a regulation in part 809; 3) the complexity of a regulation in part 809; 4) the extent to which a regulation in part 809 overlaps, duplicates, or conflicts with other Federal, State, or Government rules; and 5) the degree to which technology economic conditions or other factors have changed in the area affected by a regulation in part 809. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 04/00/06 End Review of Current Regulation11/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None 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 _______________________________________________________________________ 859. AMENDED ECONOMIC IMPACT ANALYSIS OF FINAL RULE ON USER LABELING ON NATURAL RUBBER-CONTAINING MEDICAL DEVICE (SECTION 610 REVIEW) Priority: Other Significant. Major status under 5 USC 801 is undetermined. 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 CFR Citation: 21 CFR 801.437 Legal Deadline: Other, Statutory, September 30, 2007, Planned Section 610 Review. Abstract: FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 801. The purpose of this review is to determine if any of the regulations in part 801 should be continued without change, or should be amended or rescinded, consistent with stated objectives and applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider and solicit comments on the following: 1) The continued need for a regulation in part 801; 2) the nature of complaints or comments received concerning a regulation in part 801; 3) the complexity of a regulation in part 801; 4) the extent to which a regulation in part 801 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 a regulation in part 801. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/30/97 62 FR 51021 Final Action Effective 09/30/98 End Review of Current Regulation12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None 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 _______________________________________________________________________ 860. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (SECTION 610 REVIEW) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21 USC 360c - 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 CFR Citation: 21 CFR Part 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64; 21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR 314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21 CFR 807.87; 21 CFR 807.100; 21 CFR 812.43; 21 CFR 812.110; 21 CFR 812.140; 21 CFR 814.20; 21 CFR 814.42; 21 CFR 814.112; 21 CFR 860.123 Legal Deadline: Other, Statutory, February 2, 2006, Planned Section 610 Review. Abstract: FDA is undertaking a review of 21 CFR sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 should be continued without change, or whether they should be amended or rescinded, [[Page 22557]] consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (2) the nature of complaints or comments received concerning the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (3) the complexity of the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (4) the extent to which the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 overlap, duplicate, or conflict with other regulations 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 regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 04/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None 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, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: howard.mullerjr@fda.hhs.gov Stephen M. Ripley, Consumer Safety Officer, 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 Fax: 301 827-9434 Elisa D. Harvey, Director, Office of Device Evaluation, Department of Health and Human Services, Food and Drug Administration, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 594-1190 Fax: 301 594-3076 Email: elisa.harvey@fda.hhs.gov RIN: 0910-AF79 _______________________________________________________________________ 861. BEVERAGES: BOTTLED WATER (SECTION 610 REVIEW) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined 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 CFR Citation: 21 CFR 165.110 Legal Deadline: Other, Statutory, November 13, 2005, Planned Section 610 Review. Abstract: Section 165.110 (21 CFR 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, and is soliciting comments on, 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 03/00/07 End Review 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Richard A. Williams, Director, Division of Market Studies, OSAS, CFSAN, Department of Health and Human Services, Food and Drug Administration, HFS-725, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1989 Fax: 301 436-2626 Email: richard.williams@fda.hhs.gov RIN: 0910-AF80 _______________________________________________________________________ 862. 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 (SECTION 610 REVIEW) Priority: Other Significant. Major status under 5 USC 801 is undetermined. 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 CFR Citation: 21 CFR 101.54; 21 CFR 101.60 Legal Deadline: Other, Statutory, September 23, 2007, Deadline for 610(c) Review. Abstract: Section 101.54 (21 CFR 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 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 is undertaking a review of sections 101.54 and 101.60 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine [[Page 22558]] 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 will consider, and is soliciting 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 04/00/06 End Review 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Richard A. Williams, Director, Division of Market Studies, OSAS, CFSAN, Department of Health and Human Services, Food and Drug Administration, HFS-725, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1989 Fax: 301 436-2626 Email: richard.williams@fda.hhs.gov RIN: 0910-AF83 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 863. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 330; 21 CFR 514; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271 Legal Deadline: None Abstract: The proposed rule would reorganize, consolidate, clarify, and modify current regulations at 21 CFR part 207 concerning who must register establishments and list human drugs, certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted for initial registration and listing and for changes to registration and listing. The proposed rule would require that this information be submitted via the Internet into the FDA registration and listing database, instead of the current requirement to submit the information to FDA on paper forms. The proposed rule would also require that the NDC number appear on certain drug labels. In addition, FDA would assign the NDC number to newly listed drugs and take other steps to minimize the use of inaccurate NDC numbers on drug labels. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None 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, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: howard.mullerjr@fda.hhs.gov RIN: 0910-AA49 _______________________________________________________________________ 864. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN Priority: Routine and Frequent Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c; 21 USC 360i; 21 USC 371 CFR Citation: 21 CFR 868.2700 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to reclassify pressure regulators for use with medical oxygen from class I to class II and to establish a special control for oxygen pressure regulators to address problems of fire and explosion associated with use of these devices. The special control will be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the special control will be exempt from the premarket notification requirements of the Act. The Agency believes it is taking a least burdensome approach for industry. This proposed rule will phase-in a compliance approach that will minimize the cost. FDA seeks to reclassify these devices under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined 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 [[Page 22559]] Email: myrna.hanna@fda.hhs.gov RIN: 0910-AC30 _______________________________________________________________________ 865. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which study 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 the use of standardized data structure, terminology, and code sets to allow for more efficient and comprehensive data review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301-827-5562 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AC52 _______________________________________________________________________ 866. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 CFR Citation: 21 CFR 201.161(a); 21 CFR 211.94; 21 CFR 211.125 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes, and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high- pressure medical gas cylinders that have resulted in death and injuries to patients. These proposed amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas mixups, do not occur in the future. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/10/06 71 FR 18039 NPRM Comment Period End 07/10/06 Final Action 04/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Elaine H. Tseng, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC53 _______________________________________________________________________ 867. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 341 to 343; 21 USC 348; 21 USC 349; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360c; 21 USC 360e; 21 USC 360i to 360k; 21 USC 361; 21 USC 371; 21 USC 379e; 42 USC 262 CFR Citation: 21 CFR 58.11; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 101.70; 21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 511.1; 21 CFR 812.46 Legal Deadline: None Abstract: The proposed rule would require sponsors to promptly report any information indicating that any person has or may have engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov Related RIN: Previously reported as 0910-AC02 RIN: 0910-AC59 _______________________________________________________________________ 868. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Priority: Other Significant 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; [[Page 22560]] 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 CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80 Legal Deadline: None Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR 201.56, 201.57, and 201.80). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF11 _______________________________________________________________________ 869. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Priority: Other Significant Legal Authority: 21 USC 379e(b) CFR Citation: 21 CFR 73.100(d); 21 CFR 73.2087(c); 21 CFR 101.22(k) Legal Deadline: None Abstract: The purpose of this proposed rule is to protect consumers who have allergies to the color additives carmine and cochineal extract by requiring label declaration on products under FDA jurisdiction. This action responds to adverse event reports received by FDA and to a citizen petition submitted to FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/30/06 71 FR 4839 NPRM Comment Period End 05/01/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None 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 _______________________________________________________________________ 870. CHARGING FOR INVESTIGATIONAL DRUGS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.7; 21 CFR 312.8 Legal Deadline: None Abstract: The proposed rule would amend FDA's investigational new drug regulation concerning charging for investigational drugs. The proposed rule would 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 to be described in the Agency's proposed rule on expanded access to investigational drugs for treatment use, and clarify what costs can be recovered for an investigational drug. The proposed 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 08/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF13 _______________________________________________________________________ 871. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE Priority: Other Significant Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.42; 21 CFR 312.300; 21 CFR 312.305; 21 CFR 312.310; 21 CFR 312.315; 21 CFR 312.320 Legal Deadline: None Abstract: To amend the regulations governing investigational new drugs 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 IND. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: None Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF14 _______________________________________________________________________ 872. DISTRIBUTION OF BLOOD DERIVATIVES BY REGISTERED BLOOD ESTABLISHMENTS THAT QUALIFY AS HEALTH CARE ENTITIES; PDMA OF 1987; PDA OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES Priority: Substantive, Nonsignificant Legal Authority: 21 USC 351 to 353; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 203.3(q); 21 CFR 203.22(h); 21 CFR 205.3(h) Legal Deadline: None Abstract: FDA is proposing to amend certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act [[Page 22561]] (PDMA) of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999, (64 FR 67720), do not allow a registered blood establishment that provides health care services to concurrently distribute blood derivatives. The effective date of those provisions of that rule is December 1, 2006, as published on February 23, 2004, (69 FR 8105). FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services related to its activities as a blood establishment to also distribute blood derivatives. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/01/06 71 FR 5200 NPRM Comment Period End 05/02/06 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Additional Information: Delayed effective date of portion of rule to 12/01/06, effective date of non-stayed portion of final rule, 64 FR 67720, December 3, 1999 Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, 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 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF16 _______________________________________________________________________ 873. BLOOD INITIATIVE--REQUIREMENTS FOR HUMAN BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360e; 21 USC 360h to 360j; 21 USC 360l; 21 USC 371 ; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 383; 42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 820; 21 CFR 1270 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend the biologics regulations, particularly those related to blood donor eligibility, by removing, revising, or updating specific regulations applicable to blood, blood components, source plasma, and source leukocytes to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, and on public comments. These actions are intended to help ensure the continued safety of the Nation's blood supply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Email: paula.mckeever@fda.hhs.gov Related RIN: Split from 0910-AB26 RIN: 0910-AF25 _______________________________________________________________________ 874. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 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 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 labeling intended to better inform consumers of potential risks associated with these products. 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 products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The Stevens Johnson and Cardiovascular Warnings Documents address new proposed product warnings. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Required Warnings and Other Labeling) 06/00/06 NPRM (Amendment) (Pediatric) 08/00/06 NPRM (Amendment) (Combinations with Sodium Bicarbonate) 10/00/06 NPRM (Amendment) (Overindulgence/ Hangover) 05/00/07 NPRM (Amendment) (Stevens Johnson Warnings) 06/00/06 NPRM (Amendment) (Cardiovascular Warnings) 06/00/06 Final Action (Internal Analgesics) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of [[Page 22562]] Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF36 _______________________________________________________________________ 875. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371; 21 USC 358; 21 USC 360gg to 360ss; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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) 06/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF37 _______________________________________________________________________ 876. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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) 01/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF39 _______________________________________________________________________ 877. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 sunscreen formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, and the other action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (UVA/UVB) 05/00/06 ANPRM (Sunscreen and Insect Repellent) 10/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF43 [[Page 22563]] _______________________________________________________________________ 878. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl propanolamine) 12/22/05 70 FR 75988 NPRM (Benzocaine) 08/00/06 Final Action (Phenyl propanolamine) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF45 _______________________________________________________________________ 879. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 05/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF53 _______________________________________________________________________ 880. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS Priority: Routine and Frequent 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 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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) 06/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF56 _______________________________________________________________________ 881. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Priority: Other Significant Legal Authority: 15 USC 1453 to 1455 ; 21 USC 321; 21 USC 343; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 CFR Citation: 21 CFR 1.98 Legal Deadline: None 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 [[Page 22564]] 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 02/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined 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), 5600 Fishers Lane, Room 14C-17, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AF61 _______________________________________________________________________ 882. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. 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 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov Related RIN: Related to 0910-AC82 RIN: 0910-AF63 _______________________________________________________________________ 883. BLOOD VESSELS RECOVERED WITH ORGANS AND INTENDED FOR USE IN ORGAN TRANSPLANTATION Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42 USC 271; 42 USC 273 to 274d; 42 USC 1302; 42 USC 1306 CFR Citation: 21 CFR 1271; 42 CFR 121 Legal Deadline: None Abstract: FDA and Health Resources and Services Administration (HRSA) are issuing a direct final rule and companion proposed rule to amend the regulations to consider as part of an organ (and regulated by HRSA) those blood vessels recovered with vascularized human organs that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (regulated by FDA). We are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs. We believe this change will eliminate unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA requirements with respect to vascular tissue (FDA jurisdiction) and organs (HRSA jurisdiction). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM - Companion to Direct Final Rule 06/00/06 Direct Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Email: paula.mckeever@fda.hhs.gov RIN: 0910-AF65 _______________________________________________________________________ 884. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES Priority: Other Significant Legal Authority: 21 USC 360 ccc-1 CFR Citation: 21 CFR 516 Legal Deadline: NPRM, Statutory, February 2, 2006. Final, Statutory, August 2, 2007. Abstract: This proposed rule is being issued in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed rule implements section 572 of the MUMS Act which provides for a public index listing of legally-marketed unapproved new animal drugs for minor species of animals (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). The drugs in this index will only be indicated for use in non-food minor species or for use in early non- food life stages to food-producing minor species. This proposed rule, will, among other things, specify the procedures for requesting eligibility for indexing and for requesting addition to the index as well as the reporting requirements for index holders. This rule will also describe the criteria requestors will use for assembling a qualified expert panel to evaluate for FDA the target animal safety and effectiveness of a new animal drug proposed for indexing. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/06 [[Page 22565]] NPRM Comment Period End 08/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and Minor Species Animal Drug Development, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, Room 180, HFV-50, MPN-4, Rockville, MD 20855 Phone: 240 276-9090 Fax: 240-276-9001 Email: andrew.beaulieu@fda.hhs.gov RIN: 0910-AF67 _______________________________________________________________________ 885. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address the consumer healthcare, food handlers and healthcare antiseptic products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Consumer Products) 12/00/06 NPRM (Food Handlers) 12/00/06 NPRM (Healthcare Antiseptics) 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF69 _______________________________________________________________________ 886. IMPORT TOLERANCES FOR ANIMAL DRUGS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 360b(a)(6) CFR Citation: Not Yet Determined Legal Deadline: None Abstract: FDA plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish drug residue tolerances (import tolerances) for imported food products of animal origin for drugs that are used in other countries, but that are unapproved new animal drugs in the United States. Food products of animal origin that are in compliance with the import tolerances will not be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) and may be imported into the U.S. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: George Kenneth Haibel, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, 7519 Standish Place, Rm. 169, MPN-4, HFV-6, Rockville, MD 20855 Phone: 240 276-9019 Fax: 240 276-9101 Email: george.haibel@fda.hhs.gov RIN: 0910-AF78 _______________________________________________________________________ 887. CURRENT GOOD MANUFACTURING PRACTICE FOR COMBINATION PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. 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 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The proposed rule would clarify and streamline the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule would provide a flexible quality management regulatory framework that recognizes that, in most instances, for combination products, a properly implemented quality system program under one set of medical product cGMP regulations will meet the requirements of another set (e.g., application of cGMPs for finished pharmaceuticals in 21 CFR 210/211 will generally meet the requirements of the device quality system regulations in 21 CFR 820). It would allow manufacturers the flexibility to select either the cGMP or quality system regulation to apply for the manufacture of their combination product, provided that their system incorporates select, key provisions from the regulations pertaining to the other part of their combination product. It would avoid the necessity to fully implement both sets of cGMP regulations when manufacturing combination products. The proposed rule is intended to ensure consistency and appropriateness in the regulation of combination products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: James S. Cohen, Senior Counsel, Department of Health and Human Services, Food and Drug [[Page 22566]] Administration, Office of Combination Products, 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 20855 Phone: 301 427-1934 Fax: 301 427-1935 Email: james.cohen@fda.hhs.gov RIN: 0910-AF81 _______________________________________________________________________ 888. POSTMARKET SAFETY REPORTING FOR COMBINATION PRODUCTS Priority: Other Significant 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 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The proposed rule would clarify the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule would provide a framework for the reporting of adverse events for combination products and specify sponsors' reporting requirements for each type of combination product. The proposed rule would clarify the circumstances in which following one set of postmarket safety reporting regulations generally would meet the requirements of another set, and the circumstances in which these requirements would be supplemented with specific reporting provisions applicable to the other constituent part of the combination product. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while avoiding the need for duplicative reporting requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Leigh Hayes, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Office of Combination Products, 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 20855 Phone: 301 427-1934 Fax: 301 427-1935 Email: leigh.hayes@fda.hhs.gov RIN: 0910-AF82 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 889. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined 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 CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 600; 21 CFR 601; 21 CFR 606 Legal Deadline: None Abstract: This regulation is 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 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 Comment Review End 10/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AA97 _______________________________________________________________________ 890. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e CFR Citation: 21 CFR 312; 21 CFR 314 Legal Deadline: None Abstract: The rule would amend the regulations on marketing approval of new drugs to discontinue the use of approvable and not approvable letters when taking action on a marketing application and instead use complete response letters. The rule would also amend the regulations on extension of the review clock because of amendments to applications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/20/04 69 FR 43357 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No [[Page 22567]] Government Levels Affected: None Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov RIN: 0910-AB34 _______________________________________________________________________ 891. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK) Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263 to 42 USC 263a; 42 USC 264; 21 USC 372; 21 USC 381 CFR Citation: 21 CFR 606; 21 CFR 610 Legal Deadline: None Abstract: This rulemaking is one of a number of actions being taken to amend the biologics regulations to remove, revise, or update the regulations applicable to blood, blood components, and blood derivatives. These actions are based on FDA's comprehensive review of the biologics regulations and on reports by the U.S. House of Representatives Committee on Government Reform and Oversight's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. In this rulemaking, FDA will amend the biologics regulations to require that blood establishments prepare and follow written procedures for appropriate action when it is determined that blood and blood components pose an increased risk for transmitting hepatitis C virus (HCV) infection because they have been collected from a donor who, at a later date, tested reactive for evidence of HCV. The HIV lookback regulations will be amended for consistency. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/16/00 65 FR 69377 NPRM Comment Period End 02/14/01 Final Action 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Email: paula.mckeever@fda.hhs.gov Related RIN: Related to 0910-AB26 RIN: 0910-AB76 _______________________________________________________________________ 892. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. 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 CFR Citation: 21 CFR 111 Legal Deadline: None Abstract: The Food and Drug Administration proposed in the Federal Register of March 13, 2003 (68 FR 12158), current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, they do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. FDA also proposed to require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule also responds to concerns that such regulations are necessary to ensure that consumers are provided with dietary supplement products which have not been adulterated as a result of manufacturing, packing, or holding, e.g., which have the identity and provide the quantity of dietary ingredients declared in labeling. 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 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Linda Kahl, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-024, College Park, MD 20740 Phone: 301 436-1209 Fax: 301 436-2964 Email: linda.kahl@fda.hhs.gov RIN: 0910-AB88 _______________________________________________________________________ 893. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF FDA-REGULATED PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to 263n CFR Citation: 21 CFR 50; 21 CFR 56 Legal Deadline: None Abstract: The final rule will finalize the interim rule that published in April 2001, providing additional protections for children involved as subjects in clinical investigations of FDA-regulated [[Page 22568]] products, as required by the Children's Health Act of 2000. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Rule 04/24/01 66 FR 20589 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC07 _______________________________________________________________________ 894. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. 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; . . . CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118 Legal Deadline: None Abstract: 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. This proposal would reduce SE prevalence in the egg production environment and consequently in the eggs themselves. Most SE contamination of eggs is a result of SE infection in the laying hen's reproductive tract, called transovarian contamination. The proposed measures are designed to reduce the likelihood of this transovarian contamination and include: (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 5-log destruction of SE. The proposed rule is one 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 Final Action 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: John Sheehan, Supervisory Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-032), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1488 Fax: 301 436-2632 Email: john.sheehan@fda.hhs.gov RIN: 0910-AC14 _______________________________________________________________________ 895. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS Priority: Info./Admin./Other Legal Authority: 21 USC 321; 21 USC 346 to 21 USC 346a; 21 USC 348; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n CFR Citation: 21 CFR 56.106 Legal Deadline: None Abstract: The final rule would require institutional review boards (IRB) to register with the Department of Health and Human Services. The registration information would include the name of the IRB, the name of the institution operating the IRB, and names, addresses, phone numbers, facsimile (fax) numbers, and electronic mail (e-mail) addresses of the senior officer of the institution and IRB chair or contact, the number of active protocols involving FDA-regulated products reviewed in the previous calendar year, and a description of the types of FDA-regulated products reviewed. The final rule would make it easier for FDA to inspect IRBs and to convey information to IRBs. [[Page 22569]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/06/04 69 FR 40556 Final Action 01/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None 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), 5600 Fishers Lane, Room 14C-17, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AC17 _______________________________________________________________________ 896. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST FOR COMMENTS AND INFORMATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381 CFR Citation: 21 CFR 50.23 Legal Deadline: None Abstract: This interim final rule will add an exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Catherine Lorraine, Director, Policy Development and Coordination Group, Office of Policy and Planning, Department of Health and Human Services, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-3360 Fax: 301 594-6777 RIN: 0910-AC25 _______________________________________________________________________ 897. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; ADULTERATION Priority: Routine and Frequent Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 800.20 Legal Deadline: None Abstract: The final rule amends the sampling plans, test method, and acceptable quality levels in 21 CFR 800.20. As prescribed by this regulation, FDA samples patient examination and surgeons' gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet specified quality levels. This rule would clarify sampling plans and the scoring of defects, lower acceptance rates for leaking gloves, raise rejection rates for leaking gloves, and add tightened inspection schemes for reexamined glove lots. The rule is intended to facilitate industry compliance and enhance the safety and effectiveness of gloves. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/31/03 68 FR 15404 NPRM Comment Period End 06/30/03 Final Action 06/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined 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-AC32 _______________________________________________________________________ 898. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN DRUGS Priority: Other Significant Legal Authority: 21 USC 355b CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209 Legal Deadline: Final, Statutory, January 4, 2003. Abstract: To require the 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 Final Action 10/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC35 _______________________________________________________________________ 899. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Other Significant. Major under 5 USC 801. Legal Authority: PL 107-188, sec 307 CFR Citation: 21 CFR 1.276 et seq Legal Deadline: Final, Statutory, December 12, 2003. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notice requirements for all imported food by December 12, 2003. If FDA fails to issue final regulations by this date, [[Page 22570]] the statute is self-executing on this date, and requires FDA to receive prior notice of not less than eight hours, nor more than five days until final regulations are issued. Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), requires notification to FDA prior to the entry of imported food. The required prior notice would provide the identity of the article of food; the manufacturer; the shipper; the grower, if known at the time of notification; the originating country; the shipping country; and the anticipated port of entry. The regulation identifies the parties responsible for providing the notice and explains the information that the prior notice is required to contain, the method of submission of the notice, and the minimum and maximum period of advance notice required. Section 307 also states that if FDA does not receive prior notice or receives inadequate prior notice, the imported food shall be refused admission and held at the port of entry until proper notice is provided. Section 307 authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. FDA and CBP issued an interim final rule (IFR) on October 10, 2003 (68 FR 58974). The IFR originally provided a 75-day comment period to ensure that those that comment on the IFR have the benefit of our outreach and educational efforts and have the experience with the systems, timeframes, and data elements. We reopened the comment period for an additional 90 days in April through July 2004 to allow for additional comment on the industry's experience with the prior notice system, and comment on the Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes. The final rule currently is under development, and it will confirm or amend the IFR, as appropriate. This final rule is not expected to have a significant impact on a substantial number of small entities. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/03/03 68 FR 5428 Interim Final Rule 10/10/03 68 FR 58974 Interim Final Rule Comment Period Reopened 04/14/04 69 FR 19763 Interim Final Rule Comment Period Reopened End 07/13/04 Final Rule 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1722 Fax: 301 436-2637 Email: may.nelson@fda.hhs.gov RIN: 0910-AC41 _______________________________________________________________________ 900. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Priority: Other Significant Legal Authority: PL 105-115, sec 121 CFR Citation: 21 CFR 212 Legal Deadline: Final, Statutory, November 21, 1999. 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 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Federal, State URL For More Information: www.fda.gov/cder/regulatory/pet Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov Related RIN: Previously reported as 0910-AB63 RIN: 0910-AC55 _______________________________________________________________________ 901. HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC 262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l) CFR Citation: 21 CFR 312.120 Legal Deadline: None Abstract: This final rule follows a proposed rule, which proposed to update the standards for the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We proposed to replace the requirement in 21 CFR 312.120 that non-IND foreign clinical studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki or with the laws and regulations of the country that is the research site, whichever provide greater protection to subjects. We would replace that with a requirement that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The proposed GCP standard is consistent with the standard of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for GCP and is sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research and obtain the informed consent of patients. [[Page 22571]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/10/04 69 FR 32467 Final Action 11/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov RIN: 0910-AF15 _______________________________________________________________________ 902. REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS; GROUP A STREPTOCOCCUS Priority: Info./Admin./Other Legal Authority: 42 USC 262 CFR Citation: 21 CFR 610.19 Legal Deadline: None Abstract: FDA issued a direct final rule and companion proposed rule to revoke 21 CFR 610.19, Status of specific products; Group A streptococcus. The products had been licensed by the National Institutes of Health prior to 1972, when regulatory authority over these products was transferred to FDA. The regulation prohibits the use of Group A streptococcus organisms and derivatives of Group A streptococcus as ingredients in Bacterial Vaccines and Bacterial Antigens with ``No U.S. Standard of Potency.'' The regulation was written to apply to a group of products that are no longer on the market, namely, streptococcus vaccines and antigens with ``No U.S. Standard of Potency'' that were not purified. The regulation was never intended to refer to purified streptococcus vaccines, which were not developed at that time. Therefore, the regulation is being revoked. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM - Companion to Direct Final Rule 12/02/05 70 FR 72257 Direct Final Rule 12/02/05 70 FR 72197 Final Action 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Valerie Butler, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF20 _______________________________________________________________________ 903. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT Priority: Other Significant Legal Authority: 21 USC 360c CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310 Legal Deadline: None Abstract: The classification regulations for male condoms would be amended to specify a labeling guidance document as a special control for condoms made from natural rubber latex. The new special control guidance document would identify issues presented by these devices, and would provide detailed recommendations for labeling to address these issues. FDA believes that compliance with the recommendations in the guidance, or with some equivalent means of addressing the identified issues together with the general controls, will provide a reasonable assurance of the safety and effectiveness of these devices. These labeling recommendations are also consistent with the labeling requirements of 21 CFR 801. The rule will demonstrate how the Agency is moving forward to meet the congressional directive of Public Law 106- 554 that FDA review condom labeling to assure that the information regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases is medically accurate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/14/05 70 FR 69102 Final Action 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None 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-AF21 _______________________________________________________________________ 904. BLOOD INITIATIVE--REVISIONS TO LABELING REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA; AND TECHNICAL AMENDMENT Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 360j; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa to 25; 21 USC 331; 21 USC 310 CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is amending the regulations regarding container labels and instruction circulars for certain human blood and blood components, including source plasma to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. This action is intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/30/03 68 FR 44678 NPRM Comment Period End 10/28/03 Final Action 12/00/06 [[Page 22572]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Brenda R. Friend, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-17, 1410 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF26 _______________________________________________________________________ 905. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . CFR Citation: 21 CFR 106; 21 CFR 107 Legal Deadline: None Abstract: The Agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, and records and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment period was extended on June 27, 2003, to end on August 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/09/96 61 FR 36154 NPRM Comment Period End 12/06/96 NPRM Comment Period Reopened 04/28/03 68 FR 22341 NPRM Comment Period Extended 06/27/03 68 FR 38247 NPRM Comment Period End 08/26/03 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF27 _______________________________________________________________________ 906. INFANT FORMULA QUALITY FACTORS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . CFR Citation: 21 CFR 106; 21 CFR 107 Legal Deadline: None Abstract: The Agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, and records and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment period was extended on June 27, 2003, to end on August 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/09/96 61 FR 36154 NPRM Comment Period End 12/06/96 NPRM Comment Period Reopened 04/28/03 68 FR 22341 NPRM Comment Period Extended 06/27/03 68 FR 38247 NPRM Comment Period End 08/26/03 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF28 _______________________________________________________________________ 907. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 these products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40237 Final Action 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF32 [[Page 22573]] _______________________________________________________________________ 908. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 combination products containing an oral bronchodilator. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40232 Final Action 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF33 _______________________________________________________________________ 909. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 phenylephrine bitartrate, and the other 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 NPRM (Phenyl propanolamine) 12/22/05 70 FR 75988 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/00/06 Final Action (Phenyl propanolamine) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF34 _______________________________________________________________________ 910. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 psyllium laxative drug products in a granular dosage form. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Laxative Drug Products) 08/00/06 Final Action (Granular Psyllium)12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF38 _______________________________________________________________________ 911. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None [[Page 22574]] 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 labeling for products formulated and marketed as lip protectants. The second action addresses skin protectant products to protect and treat fever blisters and cold sores. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Technical Amendments) 06/00/06 Final Action (Fever Blisters/ Cold Sores) 10/00/06 Final Action (Diaper Rash) 12/00/06 NPRM (Amendment) (Diaper Rash Drug Product) 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF42 _______________________________________________________________________ 912. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 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 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 labeling warning statements for products containing Nonoxynol 9. The other action addresses vaginal contraceptive drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Warnings) 05/00/06 NPRM (Vaginal Contraceptive Drug Products) 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF44 _______________________________________________________________________ 913. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 371 CFR Citation: 21 CFR 589.2001 Legal Deadline: None 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 Action 07/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None 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 _______________________________________________________________________ 914. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Priority: Other Significant Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 CFR Citation: 21 CFR 189.5; 21 CFR 700.27 Legal Deadline: None Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) (Beef). Specified risk materials are the brain, skull, eyes, [[Page 22575]] trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. After reviewing comments received to the interim final rule, FDA intends to issue a final rule. On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/14/04 69 FR 42256 Interim Final Rule Comment Period End 10/12/04 Interim Final Rule (Ammendments)09/07/05 70 FR 53063 Final Action 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Morris E. Potter, Lead Scientist for Epidemiology, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., NE, Atlanta, GA 30309 Phone: 404 253-1225 Fax: 404-253-1218 Email: morris.potter@fda.hhs.gov RIN: 0910-AF47 _______________________________________________________________________ 915. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE Priority: Other Significant Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381 CFR Citation: 21 CFR 189.5; 21 CFR 700.27 Legal Deadline: None Abstract: On July 14, 2004, FDA proposed to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics.`` FDA intends to finalize this proposal after reviewing any comments received. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/14/04 69 FR 42275 NPRM Comment Period End 08/13/04 Final Action 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, College Park, MD 20740 Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@fda.hhs.gov RIN: 0910-AF48 _______________________________________________________________________ 916. OVER-THE-COUNTER (OTC) DRUG REVIEW--DANDRUFF, SEBORRHEIC DERMATITIS, AND PSORIASIS PRODUCTS Priority: Routine and Frequent 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 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 combinations containing coal tar solution and menthol in a shampoo product. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 12/09/05 70 FR 73178 Final Action 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF49 _______________________________________________________________________ 917. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally [[Page 22576]] 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 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF51 _______________________________________________________________________ 918. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 (Overindulgence Labeling) 08/00/06 Final Action (Sodium Bicarbonate Labeling) 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF52 _______________________________________________________________________ 919. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG APPLICATIONS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 356a CFR Citation: 21 CFR 25; 21 CFR 500; 21 CFR 514; 21 CFR 558 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of the Food and Drug Modernization Act of 1997. The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug. The final rule sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/01/99 64 FR 53281 Final Action 11/00/06 Final Action Effective 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Dennis Bensley Jr., Chemist, Department of Health and Human Services, Food and Drug Administration, 7500 Standish Place, MPN- 2, Room 320, HFV-140, Rockville, MD 20855 Phone: 301 827-6956 Email: dennis.bensley@fda.hhs.gov RIN: 0910-AF59 _______________________________________________________________________ 920. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USES OR MINOR SPECIES Priority: Other Significant Legal Authority: 21 USC 360ccc-2 CFR Citation: 21 CFR 516 Legal Deadline: NPRM, Statutory, August 2, 2005. Final, Statutory, August 2, 2006. Abstract: The proposed rule was published on September 27, 2005, in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed rule would implement section 573 of the MUMS Act which sets forth the requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. MUMS designation of a new animal drug allows drug sponsors to be granted seven years of exclusive marketing rights for these limited demand new animal drugs once the drugs are approved or conditionally approved. This regulation would define content and format requirements for designation, requests changing designation ownership, and annual reporting requirements. This rule would also describe the criteria CVM will use for granting or denying these requests. Specific sections of the rule [[Page 22577]] are dedicated to documentation of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation. FDA intends to finalize this proposal after reviewing any comments received. This is a voluntary program for animal drug sponsors. While we do not have estimates of the impact on the animal drug industry, we expect that this rule will have a net beneficial impact on the industry with those firms participating who hope to profit as a result of the market exclusivity provided by the MUMS Act. A large number of these drug companies are classified as small businesses. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/27/05 70 FR 56394 NPRM Comment Period End 12/12/05 Final Rule 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and Minor Species Animal Drug Development, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, Room 180, HFV-50, MPN-4, Rockville, MD 20855 Phone: 240 276-9090 Fax: 240-276-9001 Email: andrew.beaulieu@fda.hhs.gov RIN: 0910-AF60 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 921. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS DERIVED FROM EXPOSED ANIMAL POPULATIONS Priority: Other Significant Legal Authority: 42 USC 264; 21 USC 301 et seq CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to prohibit the use of cervids (deer, elk) for food, including dietary supplements, and cosmetics if the cervids have been exposed to chronic wasting disease (CWD). FDA is proposing this regulation because of potential risks to health. CWD is a type of transmissible spongiform encephalopathy (TSE), a group of fatal, neurodegenerative diseases that include bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep and goats, and Creutzfeldt-Jakob disease (CJD) in humans. The disease has been identified in wild and farmed elk and wild deer populations. CWD has been found in cervid populations in certain areas of Wisconsin, Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, New Mexico, Minnesota, and Canada. In 1999, the World Health Organization said there is no evidence that CWD transmits to humans. However, it also suggested any part of a deer or elk believed to be diseased should not be eaten. Results of some studies using in vitro techniques have suggested that transmission to humans could possibly occur. However, if it does occur, it is likely to be through a very inefficient process. Currently, there are no validated analytical tests to identify animals in the preclinical phase of CWD, or any other TSE. In addition, no test exists to ensure food safety. CWD typically exhibits a long incubation period, during which time animals appear normal but are potentially infectious. Therefore, DA is proposing to require that food or cosmetic products derived from animals exposed to CWD not enter into commerce. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, College Park, MD 20740 Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@fda.hhs.gov RIN: 0910-AC21 _______________________________________________________________________ 922. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA Priority: Substantive, Nonsignificant 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 CFR Citation: 21 CFR 314.96(a)(1); 21 CFR 314.94(a)(7); 21 CFR 320.21(b)(1) Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to 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. FDA is proposing to 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 Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug [[Page 22578]] Evaluation and Research, 5515 Security Lane, Suite 1101, Rockville, MD 20857 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC23 _______________________________________________________________________ 923. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: CONSUMER RESEARCH TO CONSIDER NUTRIENT CONTENT AND HEALTH CLAIMS AND POSSIBLE FOOTNOTE OR DISCLOSURE STATEMENTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101 Legal Deadline: None Abstract: The Food and Drug Administration issued an advance notice of proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit information and data that potentially could be used to establish new nutrient content claims about trans fatty acids; to establish qualifying criteria for trans fat in current nutrient content claims for saturated fat and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices. The Agency also requested comments on whether it should consider statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts panel or as a disclosure statement in conjunction with claims to enhance consumers' understanding about such cholesterol-raising lipids and how to use the information to make healthy food choices. Information and data obtained from comments and from consumer studies that will be conducted by FDA also may be used to help draft a proposed rule that would establish criteria for certain nutrient content or health claims or require the use of a footnote, or other labeling approach, about one or more cholesterol-raising lipids in the Nutrition Facts panel to assist consumers in maintaining healthy dietary practices. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 07/11/03 68 FR 41507 ANPRM Comment Period End 10/09/03 ANPRM Comment Period Reopened for 45 days 03/01/04 69 FR 9559 ANPRM Comment Period Extended for Additional 60 days 04/19/04 69 FR 20838 ANPRM Comment Period End 06/18/04 NPRM To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal Agency Contact: Julie Moss, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-830, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2373 Fax: 301 436-2639 Email: julie.moss@fda.hhs.gov Related RIN: Related to 0910-AB66 RIN: 0910-AC50 _______________________________________________________________________ 924. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 130.5 Legal Deadline: None Abstract: In 1995, the FDA and FSIS reviewed their regulatory procedures and requirements for food standards to determine whether any were still needed, and if so, which ones should be modified or streamlined. To request public comment to assist them in their review of the need for food standards, both Agencies published advance notices of proposed rulemaking (ANPRMs) on food standards in December 1995 (60 FR 47453 and 60 FR 67492). These ANPRMs discussed the Agencies' regulations and policy governing food standards, the history of food standards, and the possible need to revise the food standards. Several comments in response to the ANPRMs recommended that the Agencies establish general principles or a fundamental philosophy for reviewing food standards and revising them. The Agencies agreed with these comments and determined that it would be appropriate to develop general principles for reviewing and revising food standards regulations. The Agencies also agreed with the comments that stated that the Agencies should work in concert to develop consistent food standards regulations. FDA and FSIS proposed a set of general principles that define how modern food standards should be structured (70 FR 29214, May 20, 2005). If this proposed rule is adopted, FDA and FSIS will require that a citizen petition for establishing, revising, or eliminating a food standard in 21 CFR parts 130 to 169 and 9 CFR part 319 be submitted in accordance with the general principles. Conversely, the Agencies may find deficient a petition to establish, revise, or eliminate a food standard that does not follow these general principles. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 12/29/95 60 FR 67492 ANPRM Comment Period End 04/29/96 NPRM 05/20/05 70 FR 29214 NPRM Comment Period End 08/18/05 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2371 Fax: 301 436-2636 Email: ritu.nalubola@fda.hhs.gov Related RIN: Related to 0583-AC72 RIN: 0910-AC54 _______________________________________________________________________ 925. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING CONTROLS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined [[Page 22579]] Legal Authority: 21 USC 351 CFR Citation: 21 CFR 211.122 Legal Deadline: None Abstract: The proposed rule would amend the packaging and labeling control provisions of the current good manufacturing practice regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. The proposal would also permit the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/29/97 62 FR 40489 Final Action To Be Determined Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined 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, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: howard.mullerjr@fda.hhs.gov RIN: 0910-AF08 _______________________________________________________________________ 926. HEALTH CLAIMS Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: 21 USC 343; 21 USC 371 CFR Citation: Not Yet Determined Legal Deadline: None 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 signaled 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 11/25/03 68 FR 66040 ANPRM Comment Period Extended 01/27/04 69 FR 3868 ANPRM Comment Period End 02/25/04 NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Nancy Crane, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1456 Fax: 301 436-2636 Email: nancy.crane@fda.hhs.gov RIN: 0910-AF09 _______________________________________________________________________ 927. FOOD LABELING; PROMINENCE OF CALORIES Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101.9 Legal Deadline: None Abstract: In response to the Report of the Working Group on Obesity (OWG) that FDA issued on March 12, 2004, the Agency issued on April 4, 2005, an advance notice of proposed rulemaking (ANPRM) in its efforts to combat the Nation's obesity problem. The ANPRM requested comments on ways to give more prominence to ``calories'' on the food label. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 04/04/05 70 FR 17008 ANPRM Comment Period End 06/20/05 NPRM To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Jill Kevala, Chemist, Department of Health and Human Services, Food and Drug Administration, HFS-830, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1450 Fax: 301 436-2636 Email: jill.kevala@fda.hhs.gov RIN: 0910-AF22 _______________________________________________________________________ 928. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101.9; 21 CFR 101.12; 21 CFR 101.60(b) Legal Deadline: None Abstract: In response to the Report of the Working Group on Obesity that FDA issued on March 12, 2004, the Agency issued on April 4, 2005, an advance notice of proposed rulemaking (ANPRM) in its efforts to combat the Nation's obesity problem. The ANPRM requested comments on changes to the Agency's nutrition labeling regulations on serving size and comments on allowance of truthful, nonmisleading, and useful approaches for promoting consumption of smaller portion sizes. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 04/04/05 70 FR 17010 ANPRM Comment Period End 06/20/05 NPRM To Be Determined Regulatory Flexibility Analysis Required: Undetermined [[Page 22580]] Government Levels Affected: Undetermined Agency Contact: Lori LeGault, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-840, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1791 Fax: 301 436-2635 Email: lori.legault@fda.hhs.gov RIN: 0910-AF23 _______________________________________________________________________ 929. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 claims for the common cold. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Amendment) (Common Cold) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF31 _______________________________________________________________________ 930. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 external analgesic drug products. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF35 _______________________________________________________________________ 931. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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 ________________________________________________________________________ NPRM (Plaque Gingivitis) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF40 _______________________________________________________________________ 932. USE OF MATERIALS DERIVED FROM CATTLE IN MEDICAL PRODUCTS INTENDED FOR USE IN HUMANS AND DRUGS INTENDED FOR USE IN RUMINANTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360f; 21 USC 360i; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 262; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 211.116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500.200; 21 CFR 530; 21 CFR 600.16; 21 CFR 895.102; 21 CFR 1271.465; 21 CFR 1271.470 [[Page 22581]] Legal Deadline: None Abstract: The regulation would prohibit the use of certain cattle material in the manufacture of medical products for humans and drugs for ruminants, and would require recordkeeping for products containing or manufactured with cattle materials to enable monitoring and enforcement of the prohibitions. The rule would prohibit the same cattle material that is prohibited in the previous FDA IFR that applies to foods and cosmetics. These include certain high risk tissues (e.g., brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the vertebral column, and dorsal root ganglia) from cattle 30 months and older, tonsils and the distal ileum of cattle of any age, mechanically separated beef, material from nonambulatory disabled cattle, and material from cattle not inspected and passed for human consumption. The prohibitions would apply only to materials derived from animals slaughtered after the effective dates of the rules. The prohibitions would not apply to tallow that met a specified purity standard. The rule would provide criteria for deviations from the requirements based on a showing of safety or appropriate benefit to risk ratio. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Eric Flamm, Senior Policy Advisor, Office of Policy, Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 5600 Fishers Lane, Room 14C-17, HF-23, Rockville, MD 20857 Phone: 301 827-0591 Fax: 301 827-4774 Email: eric.flamm@fda.hhs.gov Related RIN: Merged with 0910-AF55 RIN: 0910-AF54 _______________________________________________________________________ 933. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT DRUG PRODUCTS Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (IPECAC) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF68 _______________________________________________________________________ 934. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. 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 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None 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) 08/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF70 [[Page 22582]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 935. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW DRUG PRODUCTS Priority: Other Significant CFR Citation: 21 CFR 312.110 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/23/05 70 FR 70720 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Philip L. Chao Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AA61 _______________________________________________________________________ 936. REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS Priority: Other Significant CFR Citation: 21 CFR 201 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 01/24/06 71 FR 3922 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Elizabeth J. Sadove Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AA94 _______________________________________________________________________ 937. BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; IMPLEMENTATION OF EFFICACY REVIEW Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 610.21 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/19/05 70 FR 75018 Final Order 12/19/05 70 FR 75180 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Astrid L. Szeto Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF62 _______________________________________________________________________ 938. LOWFAT AND SKIM MILK AND LOWFAT AND NONFAT YOGURT PRODUCTS, LOWFAT COTTAGE CHEESE: REV. OF STAND. OF IDENT.; FOOD LAB., NUTRIENT CONT. CLAIMS FOR FAT, FATTY ACIDS, AND CHOLESTEROL CONT. OF FOODS (SECTION 610 REVIEW) Priority: Other Significant CFR Citation: 21 CFR 101; 21 CFR 131; 21 CFR 133 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/27/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Richard A. Williams Phone: 301 436-1989 Fax: 301 436-2626 Email: richard.williams@fda.hhs.gov RIN: 0910-AF64 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 939. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH PROFESSIONAL SHORTAGE AREAS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 254b; 42 USC 254e CFR Citation: 42 CFR 5; 42 CFR 51c Legal Deadline: None Abstract: This rule would consolidate the process for designating areas of health professional shortage and medical underservice that apply in several Department programs, and would improve the criteria for designating medically underserved populations and Primary Care Health Professional Shortage Areas. This notice of proposed rulemaking (NPRM) will address issues raised by comments received in a previous NPRM, dated September 1, 1998. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/01/98 63 FR 46538 Second NPRM 06/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Andy Jordan, Chief, Shortage Designation Branch, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 8C-26, Rockville, MD 20857 Phone: 301 594-0197 Email: dsd@hrsa.gov RIN: 0906-AA44 _______________________________________________________________________ 940. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND NEGATIVE ACTIONS Priority: Other Significant Legal Authority: 42 USC 1396r-2 CFR Citation: 45 CFR 60 Legal Deadline: None Abstract: Public Law 100-93 amended section 1921 of the Social Security Act to require that each State have in effect a system of reporting disciplinary licensure actions taken against all licensed health care practitioners and entities. It also requires States to report any negative action or finding that a peer review organization, private accreditation entity, or a State has concluded against a health care practitioner or entity. Section 1921 directs the Secretary to provide for maximum appropriate coordination in the implementation of these reporting requirements with those of the Health [[Page 22583]] Care Quality Improvement Act of 1986 (title IV of Pub. L. 99-660). Section 1921 requirements will be incorporated into the National Practitioner Data Bank. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data Banks, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 8-103, Rockville, MD 20857 Phone: 301 443-2300 RIN: 0906-AA57 _______________________________________________________________________ 941. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF AVERAGE COST OF A HEALTH INSURANCE POLICY Priority: Info./Admin./Other Legal Authority: Section 2115 of the Public Health Service Act, 42 USC, 300aa-15 CFR Citation: 42 CFR 100, sec 100.2 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) is proposing to revise the current method for calculating the average cost of a health insurance policy, which is an amount deducted from the award of compensation in certain cases. According to the Final Rule published on June 24, 1992, which established the current calculation, ``lf, over time, the average cost of health insurance, as calculated by the method described above, significantly differs from subsequent HIAA survey results or other authoritative sources then available, the Secretary of HHS will consider appropriate revisions of this rule.`` 57 FR 28098 (June 24, 1992). When the latest average monthly cost of an individual health insurance policy was calculated based on the current methodology, it was significantly different from the Kaiser Family Foundation/Health Research and Educational Trust average monthly cost of an individual health insurance policy for the same time period. Therefore, the Secretary is proposing a new methodology to calculate the average cost of a health insurance policy. Subtitle 2 of title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended, governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary) provides that a proceeding for compensation for a vaccine- related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims. In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The elements of compensation that may be awarded to a successful petitioner are set out in section 2115 of the Public Service Act, 42 U.S.C. section 300aa-15. Subsection (a)(3)(B) specifically provides for compensation for lost earnings for a person who has sustained a vaccine-related injury at age 18 and beyond. The injured person would be eligible to receive compensation for loss of earnings, after the age of 18, which are calculated on the basis of the average gross weekly earnings of workers in the private, non-farm sector, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The wage data are taken from the Employment and Earnings survey done by the Department of Labor, Bureau of Labor Statistics. Subsection (a)(3)(A) specifically provides for payment of actual and anticipated lost earnings for individuals injured after reaching age 18 and does not include deductions for taxes and the cost of health insurance. This new methodology is expected to result in a more accurate reflection of the actual average cost of a health insurance policy as compared to the figure reached under the methodology that is currently used which results in a number that is too high. Because the amount of compensation for lost wages is reduced by this figure for some petitioners receiving compensation under the VICP, such petitioners are likely to receive a greater amount of compensation if the amendment is adopted. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Geoffrey S. Evans, Acting Director, Division of Vaccine Injury Compensation, Department of Health and Human Services, Health Resources and Services Administration, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-6593 Fax: 301 443-8196 Email: gevansr@hrsa.gov RIN: 0906-AA68 [[Page 22584]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 942. SMALLPOX EMERGENCY PERSONNEL PROTECTION PROGRAM: SMALLPOX (VACCINIA) VACCINE INJURY TABLE Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-20, 117 Stat 638 CFR Citation: 42 CFR 102 Legal Deadline: None Abstract: To establish a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of, or exposure to, the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 08/27/03 68 FR 51492 Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Mr. Paul T. Clark, Director, Smallpox Vaccine Injury Compensation Program, Department of Health and Human Services, Health Resources and Services Administration, 11th Floor, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-5255 Email: smallpox@hrsa.gov Related RIN: Related to 0906-AA61 RIN: 0906-AA60 _______________________________________________________________________ 943. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE IMPLEMENTATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-20, 117 Stat 638 CFR Citation: 42 CFR 102 Legal Deadline: None Abstract: To provide benefits to certain persons harmed as a result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a result of contracting vaccinia through accidental exposure to certain persons. The Secretary may also provide death benefits to certain survivors of people who died as a direct result of these injuries. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/16/03 68 FR 70080 Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Mr. Paul T. Clark, Director, Smallpox Vaccine Injury Compensation Program, Department of Health and Human Services, Health Resources and Services Administration, 11th Floor, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-5255 Email: smallpox@hrsa.gov Related RIN: Related to 0906-AA60 RIN: 0906-AA61 _______________________________________________________________________ 944. INTESTINES ADDED TO THE DEFINITION OF ORGANS COVERED BY THE RULES GOVERNING THE OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN) Priority: Other Significant Legal Authority: 42 USC 274e, sec 301; 42 USC 273 to 274d, sec 371 to 376; 42 USC 1320b-8, sec 1138 CFR Citation: 42 CFR 121 Legal Deadline: None Abstract: The Department of Health and Human Services proposes to add intestines to the definition of organs covered by the rules governing the operation of the OPTN. After a review of intestinal transplants, HHS believes that intestines should now be included within the definition. The notice of proposed rulemaking provides the history of intestinal transplants, the factors that have persuaded HHS of the advisability of including intestines within the scope of the regulations governing the operation of the OPTN, and the anticipated consequences of this proposal. As the field of intestinal transplantation evolves, it becomes more critical that intestinal organ allocation policies keep pace with the advances in the field; that policy development include performance indicators to assess how well the policies achieve the goals of an equitable transplant system; that those policies are enforceable; and that patients and physicians have timely access to accurate data that will assist them in making decisions regarding intestinal transplantation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/23/05 70 FR 70765--70768 NPRM Comment Period End 01/23/06 Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Laura St. Martin, Chief Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-04, Parklawn Bldg., Rockville, MD 20857 Phone: 301 443-4423 Email: lstmartin@hrsa.gov RIN: 0906-AA62 _______________________________________________________________________ 945. REQUIREMENTS ESTABLISHING A LIMITATION ON ADMINISTRATIVE EXPENSES; RYAN WHITE CARE ACT TITLE IV GRANTS FOR COORDINATED SERVICES AND ACCESS TO RESEARCH Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300ff-71 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule finalizes the determination to establish a limitation on administrative expenses for Ryan White Comprehensive AIDS Resources Emergency (CARE) Act title IV Grants for Coordinated Services and Access to Research for Women, Infants, Children, and Youth. The rule establishes the limitation on administrative expenses as a percentage of the grant award, provides guidance on the procedures and processes for implementation of the limitation on administrative expenses, and clarifies the individual expenses that shall be categorized as administrative. The rule specifies the date for implementation as grants funded using fiscal year 2005 grant dollars. [[Page 22585]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/12/03 68 FR 47923 NPRM Comment Period End 09/11/03 Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Rafael Morales, Acting Director, Division of Community Based Programs, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 7A-21, Rockville, MD 20857 Phone: 301 443-3650 Email: jmorales@hrsa.gov RIN: 0906-AA65 _______________________________________________________________________ 946. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM Priority: Other Significant Legal Authority: Social Security Act, title V, sec 501(a)(2); Social Security Act, title V, sec 502(a)(1); 42 USC 701 CFR Citation: 42 CFR 51(a) Legal Deadline: None Abstract: In this rule, the HTPC is proposing to formally add a cost participation component to its grant program. This would require the grantees to have non-Federal matching funds and/or in-kind resources that are equal to or greater than $100,000 in years 2 through 5 of the 5-year project period. For example, in years 2-5, a project awarded $50,000 (i.e. the maximum annual award) of HTPC funds yearly would be expected to have, at a minimum, $100,000 in non-Federal matching funds each funding year. In this example, the $100,000 must come from alternate non-Federal funds, including, but not limited to, individuals, corporations, foundations, in-kind resources, or State and local agencies. Documentation of matching funds would be required (i.e., specific sources, funding level, in-kind contributions). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/27/05 70 FR 76435--76436 NPRM Comment Period End 02/27/06 Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership for Children Program, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 18A-55, Rockville, MD 20857 Phone: 301 443-0757 Email: jbelardo@hrsa.gov RIN: 0906-AA70 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 947. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE PAYMENTS REPORTING REQUIREMENTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 11131 CFR Citation: 45 CFR 60.7 Legal Deadline: None Abstract: This notice of proposed rulemaking (NPRM) proposes to require that, in addition to reporting to the National Practitioner Data Bank, medical malpractice payments made where physicians or other health care practitioners are named in medical malpractice actions or claims, judgments, or settlements, payments be reported where they are made for the benefit of physicians or other health care practitioners not named in the judgments or settlements but who furnished or failed to furnish the health care services upon which the actions or claims were based. The purpose of this NPRM is to prevent the evasion of the medical malpractice payment reporting requirement of the Data Bank through the agreement of the parties to a lawsuit to use the corporate health care entity to ``shield'' practitioners. It would also require malpractice payers, in very limited circumstances, when it is impossible to identify the practitioner who furnished or failed to furnish the health care services upon which the actions or claims were based, to report why the practitioner could not be identified, and to provide the name of the corporate health care entity. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/98 63 FR 71255 Second NPRM To Be Determined Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data Banks, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 8-103, Rockville, MD 20857 Phone: 301 443-2300 RIN: 0906-AA41 _______________________________________________________________________ 948. OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 274e, sec 301, 1984; 42 USC 273 to 274d, sec 371 to 376; 42 USC 1320b-8, sec 1138 CFR Citation: 42 CFR 121 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) proposes to amend the final rule governing the operation of the OPTN. This notice of proposed rulemaking provides the legislative and regulatory history of the current rule, the factors that persuaded HHS of the advisability of amending the final rule governing the operation of the OPTN, and the [[Page 22586]] anticipated consequences of this proposal. As required rapid changes in response to better understanding of the clinical scientific issues have become evident, HHS has determined that the current process for approving and enforcing policies must be amended. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Hui-Hsing Wong, Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Mail Stop 16C-17, Parklawn Bldg., Rockville, MD 20857 Phone: 301 443-8104 Fax: 301 594-6095 Email: hwong@hrsa.gov RIN: 0906-AA63 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 949. PUBLIC HEALTH SERVICE (PHS) GRANT APPEALS PROCEDURE Priority: Other Significant CFR Citation: 42 CFR 50.402 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 12/23/05 70 FR 76174 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Gail Ellen Lipton Phone: 301 443-6509 Email: glipton@hrsa.gov RIN: 0906-AA69 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Indian Health Service (IHS) _______________________________________________________________________ 950. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY MEDICARE-PARTICIPATING INPATIENT HOSPITAL TO INDIANS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: MMA, sec 506; PL 108-173 CFR Citation: 42 CFR 135, subpart D; 42 CFR 489, subpart B Legal Deadline: None Abstract: This provision requires that as a condition of participation in the Medicare Program, providers accept payment at rates established by the Secretary in regulations as payment in full for services provided in an inpatient hospital to American Indians/Alaskan Natives (AI/AN) beneficiaries referred or authorized by the Indian Health Service, Tribes or Tribal organizations, or Urban Indian Organization (I/T/U). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/06 NPRM Comment Period End 06/00/06 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Betty Z. Gould, Regulations Officer, Department of Health and Human Services, Indian Health Service, 12300 Twinbrook Parkway, Suite 450, Rockville, MD 20852 Phone: 301 443-1116 Email: bgould@hqe.ihs.gov RIN: 0917-AA07 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 951. GRANTS FOR RESEARCH PROJECTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216 CFR Citation: 42 CFR 52 Legal Deadline: None Abstract: NIH proposes to amend the regulations governing grants for research projects by revising the definition of Principal Investigator to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of principal investigator to one single individual when that more accurately reflects the management needs of a research project. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 [[Page 22587]] Email: jm40z@nih.gov RIN: 0925-AA42 _______________________________________________________________________ 952. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAMS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-5a; 42 USC 287c-33; 42 USC 288- 6; 42 USC 288-1; 42 USC 288-3 42 USC 288-5; 42 USC 288-5a ; 42 USC 288- 6 CFR Citation: 42 CFR 68 Legal Deadline: None Abstract: NIH proposes to issue a single set of regulations to govern all of its loan repayment (LRP) authorities. This action will include rescinding the current regulations at 42 CFR 68a and at 42 CFR 68c replaced by the new consolidated set of LRP regulations. This action will also include withdrawing the previously announced planned actions concerning NIH LRP authorities. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA43 _______________________________________________________________________ 953. NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 286b-3 CFR Citation: 42 CFR 64 Legal Deadline: None Abstract: NIH proposes to amend the regulations governing National Library of Medicine training grants by revising the definition of Project Director to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of the project director to one single individual when that more accurately reflects the management needs of a research project. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA44 _______________________________________________________________________ 954. MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 216 42 USC 241(a) (3) CFR Citation: 42 CFR 52c Legal Deadline: None Abstract: NIH proposes to amend the regulations governing Minority Biomedical Research Support Program grants by revising the definition of Program Director to mean one or more individuals designated by the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the program, rather than limiting the role of the program director to one single individual when that more accurately reflects the management needs of a research program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA45 _______________________________________________________________________ 955. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 9660(a) CFR Citation: 42 CFR 65a Legal Deadline: None Abstract: NIH proposes to amend the regulations governing National Institute of Environmental Health Sciences Hazardous Substances Basic Research and Training grants by revising the definition of Program Director to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of the program director to one single individual when that more accurately reflects the management needs of a research project. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA46 _______________________________________________________________________ 956. ENDOWMENT PROGRAM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-31 CFR Citation: Not Yet Determined Legal Deadline: None [[Page 22588]] Abstract: The Director of the National Center for Minority Health and Disparities Research is authorized under section 485E(h)(1) of the Public Health Service Act to carry out a program to facilitate minority health disparities research and other health disparities research by providing for research endowments at centers of excellence under section 736(Public Health Service Act). NIH plans to issue implementing regulations to govern these research endowments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA47 _______________________________________________________________________ 957. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY THE NATIONAL INSTITUTES OF HEALTH Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 216; 42 USC 288-4 CFR Citation: 42 CFR 68b Legal Deadline: None Abstract: Section 487D of the Public Health Service Act, as added by NIH Revitalization Act of 1993, creates a program offering scholarships to individuals from disadvantaged backgrounds who are enrolled as full- time students at accredited institutions pursuing academic programs appropriate for careers in professions needed by NIH. For each year of scholarship support, the recipient agrees to service (employment) after graduation, at NIH, for one year. Additionally, the individual agrees to at least 10 consecutive weeks of service (employment) at NIH during which the individual is attending the educational institution and receiving the NIH scholarship. The proposed new regulations will govern this program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA48 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 958. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 285g-10 CFR Citation: 42 CFR 63a Legal Deadline: None Abstract: NIH proposes to amend the training grants regulations to implement the new authority under section 452G of the Public Health Service (PHS) Act. This action is necessitated by enactment of the Children's Health Act of 2000. Section 1002 of this Act adds a new section 452G to the PHS Act that authorizes the Director of the National Institute of Child Health and Human Development, in consultation with the Administrator of the Health Resources and Services Administration, to support activities to provide for an increase in the number and size of institutional training grants supporting pediatric training. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/28/05 70 FR 4080 Final Action 05/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA28 _______________________________________________________________________ 959. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM Priority: Other Significant Legal Authority: 42 USC 287a-3a CFR Citation: 42 CFR 9 Legal Deadline: NPRM, Statutory, June 18, 2001. Abstract: NIH proposes to establish standards for operating a national chimpanzee sanctuary system to provide for the retirement of federally- owned or supported chimpanzees no longer needed for research. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/11/05 70 FR 1843 Final Action 05/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA31 [[Page 22589]] _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 960. HUMAN SUBJECTS PROTECTION REGULATIONS: ADDITIONAL PROTECTIONS FOR ADULT INDIVIDUALS WITH IMPAIRED DECISIONMAKING CAPACITY Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: Through this advance notice of proposed rulemaking (ANPRM), the Office for Human Research Protections (OHRP), Office of Public Health and Science, and the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) are seeking comment on whether it is necessary to develop additional safeguards to help protect adult individuals with impaired decisionmaking capacity who are potential subjects in research, and if so, suggestions for appropriate safeguards. This ANPRM stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission entitled ``Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity'' (December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee. The goal of these efforts is to maximize the safety and welfare of adult subjects with impaired decisionmaking capacity who participate in research supported, conducted, or regulated by HHS. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Julie A. Kaneshiro, Department of Health and Human Services, Office of Public Health and Science, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 Phone: 240 452-6900 Fax: 301 402-2071 Email: jakaneshiro@ophs.dhhs.gov RIN: 0940-AA11 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 961. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS REGISTRATION REQUIREMENTS Priority: Substantive, Nonsignificant Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes to add subpart F to Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, to require registration of institutional review boards (IRBs) with HHS. The registration information would include contact information, approximate numbers of active protocols involving research conducted or supported by HHS, accreditation status, IRB membership, and staffing for the IRB. The proposed registration requirements will make it easier for the Office for Human Research Protections (OHRP) to convey information to IRBs, and will support the current IRB registration operated by OHRP. Under the current OHRP IRB registration system, the submission of certain registration information is required by human subjects protection regulations, and certain other information may be submitted voluntarily. This proposed information collection was submitted to the Office of Management and Budget under the Paperwork Reduction Act. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with IRB registration requirements of the Food and Drug Administration (FDA), and creating a single, HHS IRB Registration system. FDA simultaneously published a proposed rule regarding FDA IRB registration requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/04/04 69 FR 40584 NPRM Comment Period End 10/04/04 Final Action 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and Human Services, Office of Public Health and Science, The Tower Building, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 240 453-6900 Fax: 301 402-2071 RIN: 0940-AA06 [[Page 22590]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of Public Health and Science (OPHS) _______________________________________________________________________ 962. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH MISCONDUCT WHISTLEBLOWERS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b CFR Citation: 42 CFR 94 Legal Deadline: None Abstract: To implement section 493(e) of the Public Health Service Act (added by sec 163 of the National Institutes of Health Revitalization Act of 1993, Pub. L. 103-43), the Department is proposing to add a new part 94 to title 42 of the Code of Federal Regulations. Under this proposed regulation, covered institutions must follow certain requirements for preventing and responding to occurrences of retaliation against whistleblowers. The purpose of this part is to protect: 1) Persons who make a good faith allegation that a covered institution or member thereof engaged in, or failed to respond adequately to an allegation of research misconduct; and 2) persons who cooperate in good faith with an investigation of research misconduct. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/28/00 65 FR 70830 NPRM Comment Period End 01/29/01 Final Action 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Chris Pascal, Director, Office of Research Integrity, Department of Health and Human Services, Office of Public Health and Science, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 240 453-8200 Fax: 301 443-5351 Related RIN: Related to 0940-AA04 RIN: 0940-AA01 _______________________________________________________________________ 963. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND ED. REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes to add subpart E to the Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, and would require that institutions engaged in human subjects research covered by an assurance of compliance filed with the Office for Human Research Protections ensure that institutional officials, institutional review board (IRB) chairpersons, and human protection administrators receive appropriate training and education about the institution's assurance and that IRB chairpersons and members, IRB staff, investigators, and other personnel involved in the conduct or oversight of human subjects research receive appropriate training and education about relevant human subjects protection requirements. The proposed training and education requirements will help to ensure that responsible individuals at assured institutions understand and meet their regulatory responsibilities for human subjects protection. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael A. Carome MD, Department of Health and Human Services, Office of Public Health and Science, The Tower Building, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 240 453-6900 Fax: 301 402-2071 RIN: 0940-AA08 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Office of Public Health and Science (OPHS) _______________________________________________________________________ 964. FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS TECHNICAL AMENDMENT Priority: Substantive, Nonsignificant CFR Citation: 45 CFR 46 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Technical Amendment 06/23/05 70 FR 36325 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael A. Carome Phone: 240 453-6900 Fax: 301 402-2071 RIN: 0940-AA10 [[Page 22591]] _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 965. INNOVATIONS IN FEE-FOR-SERVICE PAYMENT SYSTEMS TO IMPROVE QUALITY AND OUTCOMES (CMS-1298-ANPR) Priority: Other Significant Legal Authority: None CFR Citation: None Legal Deadline: None Abstract: This advance notice of proposed rulemaking explores the concept of ``paying for performance'' as a means of promoting better quality of care in Medicare fee-for-service payment systems. It explains the concept in general and reports on a number of activities of the Center for Medicare and Medicaid Services measuring and reporting and possible ways these results could be used to create financial incentives for high quality care. The notice seeks public comments on these ideas. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 04/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Gay W. Burton, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-4564 Email: gay.burton@cms.hhs.gov Teresa Clark, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-1079 Email: teresa.clark@cms.hhs.gov RIN: 0938-AN91 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 966. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS- 3819-P) (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb CFR Citation: 42 CFR 484 Legal Deadline: None 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 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Scott Cooper, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-05-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9465 Email: scott.cooper@cms.hhs.gov Mercedes Benitez-McCray, 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.benitezmccra@cms.hhs.gov RIN: 0938-AG81 _______________________________________________________________________ 967. APPEALS OF CMS OR CONTRACTOR DETERMINATIONS WHEN A PROVIDER OR SUPPLIER FAILS TO MEET OR MAINTAIN THE REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-P2) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) CFR Citation: 42 CFR 405.874 Legal Deadline: None Abstract: This proposed rule would extend appeal rights to all suppliers whose enrollment applications for Medicare billing privileges are disallowed by a carrier or whose Medicare billing privileges are revoked, except for those suppliers covered under other existing appeals provisions of our regulations. In addition, certain appeal provisions are revised to correspond with the existing appeal provisions in those other sections of our regulations. The rule would also extend appeal rights to all suppliers not covered by existing regulations to ensure they have a full and fair opportunity to be heard. This rule would incorporate provisions from section 936 of the Medicare Modernization Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/25/99 64 FR 57431 Second NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: August Nemec, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0612 Email: august.nemec@cms.hhs.gov RIN: 0938-AI49 [[Page 22592]] _______________________________________________________________________ 968. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND IMPROVEMENT PROGRAM (CMS-1910-P2) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 405; 42 CFR 491 Legal Deadline: None Abstract: This rule proposes to amend the Medicare certification and payment requirements for rural health clinics (RHCs), as required by section 4205 of the Balanced Budget Act of 1997. It proposes to change the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establish criteria for identifying RHCs essential to delivery of primary care services that we can continue to approve as Medicare RHCs in areas no longer designated as medically underserved; and limit nonphysician practitioner staffing requirements. This rule proposes to impose payment limits on provider-based RHCs and prohibit the use of RHC space, professional staff, equipment, and other RHC resources by another Medicare entity. The rule also proposes to require RHCs to establish a quality assessment and performance improvement program. In light of the fact that section 902 of MMA of 2003 requires the Secretary to issue regulations within 3 years, CMS is republishing the provisions of the final RHC rule as a proposed rule to provide the public with an opportunity to formally comment on the new policies established under the December 24, 2003 rule. In addition, we are proposing new policy revisions to the RHC and FQHC program to improve and strengthen this rural safety net benefit. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74792 Second NPRM 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: David Worgo, Health Insurance Specialist, Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-15-18, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5919 Email: david.worgo@cms.hhs.gov RIN: 0938-AJ17 _______________________________________________________________________ 969. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE (CMS-2130-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act) CFR Citation: 42 CFR 101; 42 CFR 418; 42 CFR 482 to 483; 42 CFR 485 Legal Deadline: None Abstract: This proposed rule would implement provisions of the Children's Health Act of 2000 (CHA) related to the use of restraints or seclusion for individuals receiving services in health care facilities that receive Federal funding. The rule would establish common terminology and basic expectations for the use of restraints and seclusion for health care facilities that furnish inpatient or residential care and receive Medicare or Medicaid funding. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Carla McGregor, Health Insurance Specialist, Survey and Certification Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-11-27, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0663 Email: carla.mcgregor@cms.hhs.gov RIN: 0938-AL26 _______________________________________________________________________ 970. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL CENTERS (CMS-3887-P) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: This proposed rule would revise the ambulatory surgical center conditions for coverage to reflect current innovations in healthcare delivery, quality assessment, and performance improvement. The focus would be to improve outcomes of health care and satisfaction for Medicare beneficiaries, while streamlining structural and procedural requirements when possible. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Joan Brooks, 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: 410 786-5526 Email: joan.brooks@cms.hhs.gov Jacqueline Morgan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards and Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4282 Email: jacqueline.morgan@cms.hhs.gov RIN: 0938-AL80 _______________________________________________________________________ 971. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1171 to 1179 of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None [[Page 22593]] Abstract: This proposed rule would revise some of the electronic transactions and code set standards mandated by the Health Insurance Portability and Accountability Act of 1996. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E-Health Standards and Services, Mail Stop S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov RIN: 0938-AM50 _______________________________________________________________________ 972. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 42 USC 1395i-3; 42 USC 1396r CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: This proposed rule establishes requirements that hospice agencies and long-term care (LTC) facilities must meet 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 10/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anita Panicker, 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: 410 786-5646 Fax: 410 786-8532 Email: anita.panicker@cms.hhs.gov RIN: 0938-AM87 _______________________________________________________________________ 973. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT (DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 108-173, MMA; Deficit Reduction Act of 2005, PL 109-171, sec 5101 CFR Citation: 42 CFR 414.200; 42 CFR 405.502(g); 42 CFR 424.57; 42 CFR 410.38 Legal Deadline: Final, Statutory, December 31, 2007. Abstract: Section 302 of the Medicare Modernization Act establishes DME competitive bidding. National competitive bidding will provide a program for using market forces to set Medicare payment amounts. This will also create incentives for suppliers to provide quality items and services while at the same time providing Medicare with reasonable prices for payment. This rule also incorporates provisions from section 5105 of the DRA of 2005, which concerns beneficiary ownership of certain DMEs. (The statute requires competitive bidding be implemented by 2007). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, State Agency Contact: Michael Keane, Health Policy Analyst, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4495 Email: michael.keane@cms.hhs.gov RIN: 0938-AN14 _______________________________________________________________________ 974. REVISIONS TO HIPAA CODE SETS (CMS-0013-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: PL 104-191 CFR Citation: 45 CFR 162 Legal Deadline: None 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Energy Effects: Statement of Energy Effects planned as required by Executive Order 13211. Agency Contact: Gladys Wheeler, 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 21244-1850 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov RIN: 0938-AN25 _______________________________________________________________________ 975. LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Section 1893 (f) (2) of the Social Security Act added by Section 935 of the MMA [[Page 22594]] CFR Citation: 42 CFR 405 Legal Deadline: Final, Statutory, December 8, 2003. Abstract: This proposed rule would implement one provision of section 935 of the Medicare Modernization Act which added a new subsection to section 1893 of the Social Security Act. It would limit recoupment where a provider or supplier has appealed an overpayment determination until the reconsideration-level appeal is decided. The proposed rule also changes how interest is to be paid to a provider or supplier whose overpayment is reversed at the third or subsequent levels of administrative appeal or through judicial review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Nancy Braymer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-14-21, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4323 Email: nancy.braymer@cms.hhs.gov RIN: 0938-AN42 _______________________________________________________________________ 976. REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR ACCREDITING ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1864; Social Security Act, sec 1865; Social Security Act, sec 1875 CFR Citation: 42 CFR 488.1 to 488.9 Legal Deadline: None Abstract: This proposed rule would respond to the recommendations in the GAO Report, ``CMS Needs Additional Authority to Adequately Oversee Patient Safety in Hospitals'' (GAO-04-850). With respect to the oversight and validation of hospital accreditation programs, a rate of disparity calculation is specified in Federal regulations at 42 CFR 488.8. This rule proposes to consider additional alternative measures to assess the performance of the accreditation organizations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Amber L. Wolfe, Health Insurance Specialist, Center for Medicaid and State Operations, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Survey and Certification Group, Mailstop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6773 Email: amber.wolfe@cms.hhs.gov RIN: 0938-AN62 _______________________________________________________________________ 977. CHANGES TO THE DISCLOSURE OF INFORMATION REQUIREMENTS FOR QUALITY IMPROVEMENT ORGANIZATIONS (CMS-3156-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1154 to 1160 of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This proposed rule would add a provision to the existing Quality Improvement Organization (QIO) confidentiality regulations allowing the release of Medicare beneficiary-specific information, with patient consent, from the QIO to practitioners and providers in a treatment relationship with the beneficiary. This release may only be permitted after the beneficiary has consented to the release and has been provided notice of the release. The new provisions will also permit the release of Medicare beneficiary-specific information, with patient consent, from the QIO to other QIOs, subcontractors to QIOs, and CMS for educational and quality improvement purposes. Additionally, the rule would add provisions for the Medicare beneficiary complaint system that is required by the statute and administered by the QIOs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Captain Arnold C. Farley, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Improvement Group, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-1154 Email: arnold.farley@cms.hhs.gov RIN: 0938-AN73 _______________________________________________________________________ 978. HOME HEALTH PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2007 (CMS- 1304-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1895; Deficit Reduction Act of 2005, PL 109-171, sec 5101 to 5201 CFR Citation: 42 CFR 484 Legal Deadline: Final, Statutory, January 1, 2007, Effective Date. Abstract: This notice sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies, effective on January 1, 2007. This rule would also incorporate provisions from the Deficit Reduction Act of 2005, which affects Home Health payments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Randy Throndset, Technical Advisor,, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mailstop C5-07-28, 7500 Security Boulevard, Baltimore, MD 21244 [[Page 22595]] Phone: 410 786-0131 Email: randy.throndset@ cms.hhs.gov RIN: 0938-AN76 _______________________________________________________________________ 979. FIRE SAFETY REQUIREMENTS FOR LONG-TERM CARE FACILITIES: SPRINKLER SYSTEMS (CMS-3191-P) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: This proposed rule would require all long-term care facilities to be equipped with sprinkler systems. This proposed rule requests public comment, including comment on the duration of a phase- in period, to allow long-term care facilities to install such systems. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Danielle N. 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 Fax: 410 786-8532 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AN79 _______________________________________________________________________ 980. PAYMENTS FOR SERVICE PROVIDED WITHOUT CHARGE (CMS-2489-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The proposed rule would clarify that Federal Financial Participation (FFP) is not available to States on behalf of Medicaid beneficiaries for Medicaid-covered services provided without charge (that is, free care) to individuals receiving the services. Free care means a particular service is available without charge to an individual who receives the service or to any third party on behalf of the individual. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Ellen W. Blackwell, Disability & Elderly Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S2-26-12, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4498 Fax: 410 786-3262 Email: ellen.blackwell@cms.hhs.gov RIN: 0938-AO07 _______________________________________________________________________ 981. QUALITY STANDARDS FOR GENETIC TESTING (CMS-2121- P) Priority: Other Significant Legal Authority: Sec. 353 of Public Health Service Act (42 USC 263a) CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule would add to the Clinical Laboratory Improvement Amendment (CLIA) regulations a new specialty of genetic testing that will address recommendations by the Clinical Laboratory Improvement Advisory Committee (CLIAC) and the Secretary's advisory committee for genetic testing. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Federalism: Undetermined Agency Contact: Cecelia Hinkel, Health Insurance Specialist, Division of Laboratory Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3347 Email: cecelia.hinkel@cms.hhs.gov RIN: 0938-AO09 _______________________________________________________________________ 982. MEDICAL IMPROVEMENT ELIGIBILITY GROUP AND DEFINITION OF WORK (CMS- 2143-P) Priority: Other Significant Legal Authority: PL 105-33 sec 4733 Balanced Budget Act of 1997; PL 106-170 sec 201 Ticket to Work and Work Incentives Improvement Act of 1999 CFR Citation: 42 CFR 435. 238; 42 CFR 436.232 Legal Deadline: None Abstract: In order to provide health services to employed individuals whose medical conditions have improved to the point where they are no longer eligible for disability benefits, this proposed rule would provide a definition of ``medically determinable severe impairment'' under the Ticket to Work and Work Incentives Improvement Act of 1999 (Ticket to Work). Under this definition, States can determine eligibility standards for the Medical Improvement Group authorized under the Ticket to Work law, thereby permitting individuals to retain their Medicaid coverage. Additionally, this proposed rule would give States offering Medicaid buy-in programs for employed individuals with disabilities the option of selecting a minimum work standard for participation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Carey Appold, Technical Director, Disabled & Elderly Health Programs Group, Div. of Advocacy and Special Issues, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mailstop [[Page 22596]] S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2117 Fax: 410 786-9004 Email: carey.appold@cms.hhs.gov RIN: 0938-AO10 _______________________________________________________________________ 983. REVISIONS TO THE PAYMENT POLICIES OF AMBULANCE SERVICES UNDER THE FEE SCHEDULE FOR AMBULANCE SERVICES (CMS-1317-P) Priority: Substantive, Nonsignificant Legal Authority: Sections 1834(1), and 1861 (s) (7) of the Social Security Act (the Act). CFR Citation: 42 CFR 414.605; 42 CFR 412.64; 42 CFR 410.40; 42 CFR 410.12; 42 CFR 414.610; 42 CFR 414.615 Legal Deadline: None Abstract: This rule would revise the fee schedule for payment of ambulance services specifically with respect to the definition of Specialty Care Transport (SCT) and the Metropolitan Statistical Area (MSA) geographic breakdown in relation to payment of ambulance services under Medicare. In addition, this proposed rule discusses the conversion factor and the effect of low billers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anne Elizabeth Tayloe, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-06-28, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4546 Email: anne.tayloe@cms.hhs.gov RIN: 0938-AO11 _______________________________________________________________________ 984. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND FY 2007 RATES (CMS-1488-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Sec 1886(d) of the Social Security Act;; Deficit Reduction Act of 2005, (PL 109-171), sec 5001 and 5003 CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 413; 42 CFR 415; 42 CFR 419; 42 CFR 422; 42 CFR 485 Legal Deadline: NPRM, Statutory, April 1, 2006. Final, Statutory, August 1, 2006. Abstract: This 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. The Addendum to this proposed rule proposes changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These proposed changes would apply to discharges occurring on or after 10/1/06. It also proposes rate-of-increase limits as well as proposed policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. This rule also incorporates provisions from sections 5001 and 5003 of the Deficit Reduction Act of 2005, which allows for hospital quality improvement and improvement to the Medicare dependent hospital program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Tziv Hefter, Director, Division of Acute Care Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mailstop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4487 Email: tziv.hefter@cms.hhs.gov RIN: 0938-AO12 _______________________________________________________________________ 985. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND CALENDAR YEAR 2007 PAYMENT RATES (CMS-1506-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: BBA; BBRA; BIPA; MMA; Deficit Reduction Act of 2005; (PL 109-171), sec 5103 and 5105 CFR Citation: 42 CFR 419 to 485 Legal Deadline: Final, Statutory, November 1, 2006. Abstract: This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare 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. These changes would be applicable to services furnished on or after January 1, 2007. In addition, this rule would also propose additions to and deletions from the list of covered procedures for ASCs effective July 1, 2007. Further, this rule would also propose to revise the method by which Medicare sets payment rates for ASC facility services, and the list of covered ASC procedures effective January 1, 2008. This rule would incorporate provisions from the DRA of 2005, which limits payments for procedures in ASCs, and includes a 3-year phase-out of hold harmless for small rural hospitals under the prospective payment system for hospital outpatient department services. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Rebecca Kane, Health Insurance Specialist, Center for [[Page 22597]] Medicare Management, Hospital & Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division Group of Outpatient Care, Mailstop C5-01-28, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-1589 Email: rebecca.kane@cms.hhs.gov Related RIN: Related to 0938-AO13, Related to 0938-AN23 RIN: 0938-AO15 _______________________________________________________________________ 986. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2007 (CMS-1540-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Section 1866(l) of the Social Security Act ; PL 105- 33; PL 106-554; PL 106-113;; Deficit Reduction Act of 2005; (PL 109- 171), sec 5005 CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, August 1, 2006. Abstract: This proposed rule would update rates for the prospective payment system for inpatient rehabilitation facilities for FY 2007. This rule would also incorporate provisions from section 5055 of the Deficit Reduction Act of 2005, which extends the phase-in of the inpatient rehabilitation facility classification criteria. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Bill Ullman, Center for Medicare Management, Chronic Care Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-06-24, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO16 _______________________________________________________________________ 987. OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC SERVICES AMENDMENT (CMS-2213-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Section 1102 of the Social Security Act CFR Citation: 42 CFR 440.20 Legal Deadline: None Abstract: This rule would amend the definition of outpatient hospital services for the Medicaid program. The purpose of this amendment is to clarify the scope of services available for Federal financial participation (FFP) under the outpatient hospital services benefit category. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Jeremy Silanskis, Health Insurance Specialist, Center for Medicaid Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-1592 Fax: 410 786-8533 Email: jeremy.silanskis@cms.hhs.gov RIN: 0938-AO17 _______________________________________________________________________ 988. BEST PRICE REQUIREMENTS FOR AUTHORIZED GENERIC DRUGS (CMS-2238-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1396r.8; Deficit Reduction Act of 2005, PL 109- 171, sec 6001 to 6003 CFR Citation: 42 CFR 447.535 Legal Deadline: Final, Statutory, July 1, 2007. Abstract: This proposed rule would require manufacturers to include best price in the calculation of rebates for authorized generic drugs, when such drugs are transferred or sold to a subsidiary or another unit within a company or to another entity that has been authorized (cross- licensed) to market and/or distribute authorized generic drug products. The proposed rule would define authorized generics as drugs marketed under the brand manufacturer's new drug application (NDA) and transferred or sold to a subsidiary or another unit within the brand company or to another entity that has been authorized (cross-licensed) to market and/or distribute authorized generic drug products. In addition, the rule would provide guidance to manufacturers regarding the appropriate treatment of authorized generic drugs under the Medicaid Drug Rebate program and would clarify CMS' policy on the issue. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Yolanda Lashawn Reese, Health Insurance Specialist, Division of Benefits and Coverage Policy Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mailstop S2-06-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-9898 Fax: 410 786-5882 Email: yolanda.reese@cms.hhs.gov RIN: 0938-AO20 _______________________________________________________________________ 989. FIVE-YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE PHYSICIAN FEE SCHEDULE (CMS-1512-PN) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Social Security Act sec 1848 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, November 1, 2006, Comments to be addressed as part of final physician fee. Abstract: This notice discusses changes to work relative value units (RVUs) affecting payment for physician services. Comments on this notice will be addressed as part of the final [[Page 22598]] physician fee schedule rule required to be published by 11/01/06. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Diane Milstead, Health Insurance Specialist, Center of Medicare and Medicaid, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mailstop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov RIN: 0938-AO22 _______________________________________________________________________ 990. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 2007 (CMS-1321-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871; Deficit Reduction Act of 2005; (PL 109-171), sec 5102, 5104, 5106, 5107, 5112, 5113 CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426 Legal Deadline: Final, Statutory, November 1, 2006. Abstract: This rule would make changes affecting Medicare Part B payment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Diane Milstead, Health Insurance Specialist, Center for Medicare and Medicaid Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov Related RIN: Related to 0938-AN26, Related to 0938-AN05 RIN: 0938-AO24 _______________________________________________________________________ 991. USE OF REPAYMENT PLANS (CMS-6032-P) Priority: Other Significant Legal Authority: Section 1893(i)(1) of the Social Security Act as amended by sec 935(i)(1) of Medicare Modernization Act (MMA) CFR Citation: 42 CFR 401.601, 42 CFR 401.607 Legal Deadline: Final, Statutory, December 9, 2003. Abstract: This proposed rule would modify Medicare regulations to implement a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules). Under this provision, we propose to grant a provider or a supplier an extended repayment schedule under certain terms and conditions as defined in the statute. The proposed rule would establish criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.'' Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Thomas A. Noplock, Health Insurance Specialist, Division of Medicare Overpayments, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Financial Services Group, Mailstop C3-15-01, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3378 Fax: 410 786-7030 Email: thomas.noplock@cms.hhs.gov RIN: 0938-AO27 _______________________________________________________________________ 992. REDISTRIBUTION OF UNEXPENDED STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2004 (CMS-2241-NC) Priority: Other Significant Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) & (f) of the Social Security Act CFR Citation: 42 CFR 457.600-630 Legal Deadline: None Abstract: This notice announces the procedure for redistribution of States' unexpended FY 2004 allotments that remained at the end of FY 2004 to those States that fully expended the FY 2004 SCHIP allotment. These redistributed allotments will be available through the end of FY 2007. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Richard Strauss, Technical Director of Finance Systems & Budget Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid and State Operations, Mailstop, S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO28 _______________________________________________________________________ 993. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2008: ANNUAL PAYMENT RATE UPDATES (CMS-1529-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-113 sec 123 ; PL 106-554 sec 307(b) CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, Effective 07/01/2007. Abstract: This rule proposes the annual payment rate update for the 2008 [[Page 22599]] prospective payment system for Medicare long-term care hospitals and also presents proposed changes or revisions on LTCH PPS policy for public comment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Linda McKenna, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4537 Email: linda.mckenna@cms.hhs.gov RIN: 0938-AO30 _______________________________________________________________________ 994. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2008 (CMS-1541-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Social Security Act, sec 1895 CFR Citation: 42 CFR 484 Legal Deadline: Final, Statutory, January 1, 2008, Effective 01/01/08. Abstract: This proposed rule would update the 60-day national episode rate and the national per-visit rate amounts under the Medicare Prospective Payment System for home health agencies, effective 1/1/08. This rule would also propose the first major refinement to the HH PPS since its implementation on 10/1/01. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Randy L. Throndset, Technical Advisor; Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-02-03, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0131 Email: randy.throndset@cms.hhs.gov RIN: 0938-AO32 _______________________________________________________________________ 995. PROVIDER NOMINATION PROVISION (CMS-1331-P) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), sec 911(d)(2)(A) CFR Citation: 42 CFR 421.103 to 42 CFR 421.106 ; 42 CFR 421.114 Legal Deadline: None Abstract: This regulation will allow the provider to utilize an intermediary to process submitted claims and bills. Groups and associations of providers may nominate organizations or agencies to serve as the intermediary for their group. If the provider would like to submit claims to an intermediary outside of the provider's service area, the provider has the right to nominate this outside intermediary to act on their behalf. CMS must approve these nominations based on a set of standards. If CMS determines an assignment or reassignment of a provider's intermediary will result in a more effective and efficient administration of the Medicare program, CMS can assign any intermediary to any provider. Effective 9/30/05, the provider nomination provision contained under title XVIII of the Social Security Act, section 1816, will expired. These provisions have been amended by the MMA. Section 911 (d) (2) (A) of the MMA requires the Secretary to enter into new agreements under section 1816 without regard to the provider nomination provisions and contracts under section 1842 of the Social Security Act (42 U.S.C. 1395h, 139u). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Local Agency Contact: Scott Sturiale, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S1-14-17, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2565 Email: scott.sturiale@cms.hhs.gov RIN: 0938-AO33 _______________________________________________________________________ 996. GYNECOLOGICAL CYTOLOGY PROFICIENCY TESTING REQUIREMENTS FOR LABORATORIES, INDIVIDUALS, AND PROFICIENCY TESTING PROGRAM APPROVALS (CMS-2252-P) Priority: Other Significant Legal Authority: 42 USC 263a, Clinical Laboratory Improvement Amendments of 1988; 42 USC 1395x secs 1861s(15) through 1861s(17) CFR Citation: 42 CFR 493 Legal Deadline: None Abstract: This proposed rule would revise certain participation requirements for clinical laboratories offering cytology services and individuals examining gynecological cytology specimens; and CMS- approval requirements for programs offering proficiency testing for gynecologic cytology under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 program. Evaluating the competency of each individual who examines gynecologic cytology specimens (pap smears) is required by Federal law and regulations. The cytology community, through professional organizations, is lobbying Congress to request a change in the statute to eliminate proficiency testing of individuals (pathologists and cytotechnologists) who examine pap smears. Failure to publish this rule timely could result in the failure to identify individuals who cannot competently and accurately examine pap smears, or failure to demonstrate a need for continual education. Identifying these individuals is essential in providing quality patient care. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined [[Page 22600]] Agency Contact: Cheryl B Wiseman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare & Medicare Services, Mailstop, S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3340 Email: cheryl.wiseman@cms.hhs.gov RIN: 0938-AO34 _______________________________________________________________________ 997. SPECIAL MEDICARE GME AFFILLATIONS FOR A TEACHING HOSPITAL AFFECTED BY A DISASTER (CMS-1531-IFC) Priority: Other Significant Legal Authority: sec 1886(h)(d) of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule will amend the current closed program regulations and Medicare affiliation agreement regulations to ameliorate the disruption in residency training caused by Hurricane Katrina and future emergency situations. Amendments to current closed program and Medicare affiliation agreement regulations will allow hospitals in areas affected by Hurricane Katrina and those hospitals adopting displaced residents, greater flexibility in maintaining Medicare funding during emergency situations. The amended regulations would go into effect during emergency situations as defined by the section 1135 emergency waiver invoked by the Secretary. Without changes to current regulations, adopting hospitals may be financially incapable of accepting displaced residents, home hospitals may have increased difficulty reopening residency training programs, and residents may be unable to continue with their planned residency training. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tzvi Hefter, Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6014 Email: tzvi.hefter@cms.hhs.gov RIN: 0938-AO35 _______________________________________________________________________ 998. STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) REDISTRIBUTION OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2003 (CMS-2235-NC) Priority: Other Significant Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); 2104 (e) & (f) of the Social Security Act, sec 6101 of DRA CFR Citation: 42 CFR 457.600.630 Legal Deadline: None Abstract: This notice announces the procedure for redistribution of States, unexpended FY 2003 allotments that remained at the end of FY 2005 to those States that fully expended the FY 2003 SCHIP allotment. It also announces the implementation of the section 6101 of the Deficit Reduction Act of 2006, which provides for additional allotments to eliminate States. SCHIP funding shortfalls in FY 2006. These redistributed allotments will be available through the end of FY 2006 (September 30, 2006). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 05/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss, Senior Financial Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S3-13-07, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO38 _______________________________________________________________________ 999. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE FOR RATE YEAR BEGINNING JULY 1, 2007 (FY 2008) (CMS-1479-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: PL 106-113, sec 124 BBRA CFR Citation: 42 CFR 412.400 subpart N Legal Deadline: Final, Statutory, July 1, 2007, Effective 07/01/2007. Abstract: This proposed rule would update the Inpatient Psychiatric Facility Prospective Payment System for 2006. This rule would update and revise the market basket and the use of new market area definitions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Local Federalism: Undetermined Agency Contact: Janet Samen, Acting Director, Division of Technical Payment Policy, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-05-27, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-9161 Email: janet.samen@cms.hhs.gov RIN: 0938-AO40 _______________________________________________________________________ 1000. NOTIFICATION PROCEDURES FOR HOSPITAL DISCHARGES (CMS-4105-F) Priority: Other Significant Legal Authority: 42 USC 1396ff CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 422; 42 CFR 489 Legal Deadline: Final, Judicial, November 28, 2006, Based on language in settlement agreement. Abstract: This rule sets forth new requirements for hospital discharge notices under both original Medicare and the Medicare Advantage (MA) program. Notably, this rule requires hospitals to comply with a two- step notice process when discharging hospital inpatients that is similar to the notice requirements applicable to home health agencies (HHAs), skilled nursing facilities (SNFs), and comprehensive outpatient rehabilitation facilities (CORFs). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/05/06 71 FR 17052 [[Page 22601]] NPRM Comment Period End 06/05/06 Final Action 04/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Eileen Zerhusen, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Department of Health and Human Services, Mailstop S3-23-03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7803 Email: eileen.zerhusen@cms.hhs.gov Related RIN: Merged with 0938-AK48, Merged with 0938-AL67 RIN: 0938-AO41 _______________________________________________________________________ 1001. STATE OPTION TO ESTABLISH NON-EMERGENCY MEDICAL TRANSPORTATION PROGRAM (CMS-2234-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6083 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, February 8, 2006. Abstract: Enactment of section 6083 of the Deficit Reduction Act of 2005 (DRA amends section 1902(a)of the Social Security Act (the Act) by adding a new section 1902(a)(70) that provides States with the ability to establish, under the State plan, a non-emergency medical transportation (NEMT) brokerage program. Such a program may be managed through a contract with a broker(s), as a method of assuring NEMT services for beneficiaries who need access to medical care, but have no other means of transportation. A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, CMSO, CMS, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Services Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5647 Fax: 410-786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO45 _______________________________________________________________________ 1002. HIGH RISK POOLS (CMS-2260-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6202 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, March 31, 2006. Abstract: Section 6202 of the Deficit Reduction Act of 2005 extends the funding and authorizes (H.R. 4519) and appropriates for FY 2006 $75 million for grants to help fund existing qualified State high risk pools and $15 million for grants to assist States to create and initially fund qualified high risk pools. The bill also authorizes appropriations of $75 million for each year FY 2007 through 2010. The section 6202 provision amendment to section 2745 establishes: (1) Seed grants to States for the creation and initial operation of a qualified high-risk pool for those States that do not have one, (2) grants to States to reimburse them for a percentage of losses incurred based on a methodology that allocates funding by 40 percent among all states, 30 percent to states based on their number of uninsured residents and 30 percent based on the number of people in State risk pools operating as an existing qualified high-risk pools during specified years and (3) bonus grants for supplemental consumer benefits. A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C2-01--16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5647 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO46 _______________________________________________________________________ 1003. COST SHARING OPTIONS (CMS-2244-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005, PL 109-171 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, March 31, 2006, sec 6041 & 6042. Final, Statutory, January 1, 2007, sec 6043. Abstract: This rule would incorporate sections 6041, 6042, and 6043 of the Deficit Reduction Act of 2005 (DRA), which provides State Medicaid agencies with increased flexibility to implement premium and cost sharing requirements for certain Medicaid recipients. This authority is in addition to the current authority States already had under section 1916 of the Social Security Act to implement premiums and cost sharing. Sections 6041, 6042, and 6043 of the DRA provide States with additional State plan flexibility to implement alternative premiums for certain recipients and to implement alternative cost sharing for certain medical services, particularly non-preferred drugs and non-emergency care furnished in a hospital emergency department. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Childrens Health Programs Group, Department of Health and [[Page 22602]] Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Services Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5647 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO47 _______________________________________________________________________ 1004. BENCHMARK BENEFIT PACKAGE (CMS-2232-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005 ; sec 6044 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, March 31, 2006. Abstract: Enactment of section 6044 of the Deficit Reduction Act of 2005 (DRA) responds to State requests for additional flexibility by providing States with new options. For non-disabled, non-elderly persons who are eligible for Medicaid, the DRA allows States to follow the lead established by SCHIP and provide more flexible benefit packages that are more comparable to those in the private sector. Benchmark coverage is one four types of coverage: Blue Cross/Blue Shield standard FEHBP coverage; State employee coverage; coverage of the largest commercial HMO in the states; and Secretary approved coverage. Children under age 19 enrolled in a benchmark plan will continue to receive EPSDT benefits through wrap-around coverage. A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, MailStop S2-01-16, 7500 Security Boulevard, Balitimore, MD 21244 Phone: 410 786-5647 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO48 _______________________________________________________________________ 1005. IMPROVED ENFORCEMENT OF DOCUMENTATION REQUIREMENTS (CMS-2257-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6036 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, July 1, 2006. Abstract: Enactment of section 6036 of the Deficit Reduction Act of 2005 (DRA) requires that, effective July 1, 2006, all new applicants for Medicaid must, in addition to declaring that they are a citizen or national of the U.S. or an alien in a satisfactory immigration status, if claiming to be a citizen or national submit to the State evidence of citizenship. Since 1987, aliens claiming to be in a satisfactory immigration status have had to provide evidence of the claimed status and have that status verified with the Department of Homeland Security (previously the Immigration and Naturalization Service). A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid States Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5957 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO51 _______________________________________________________________________ 1006. SELF-DIRECTED PERSONAL ASSISTANCE SERVICES STATE PLAN OPTION (CMS-2229-P) Priority: Other Significant Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6087 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2007. Abstract: The regulation is in support of the Deficit Reduction Act. Section 6087 allows a State to offer self-directed personal assistance services as a State Plan option and is intended to offer guidance to States on implementing the statutory provision. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, State Agency Contact: Theresa Pratt, Director, Division of Integrated Health Systems, Disabled and Elderly Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO52 [[Page 22603]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1007. REQUIREMENTS FOR PROVIDERS AND SUPPLIERS TO ESTABLISH AND MAINTAIN MEDICARE ENROLLMENT (CMS-6002-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 424 Legal Deadline: Final, Statutory, April 25, 2006, MMA Sec 902. Abstract: This final rule requires that all providers and suppliers (other than physicians who have elected to ``opt-out'' of the Medicare program) complete an enrollment form and submit specific information to CMS. This rule will require that all providers and suppliers periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. In addition, this final rule will implement provisions in the Medicare statute that require CMS to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. These statutory provisions include requirements meant to protect beneficiaries and the Medicare Trust Funds by preventing unqualified, fraudulent, or excluded providers and suppliers from providing items or services to Medicare beneficiaries or billing the Medicare program or its beneficiaries. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/25/03 68 FR 22064 Final Action 04/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Michael Collett, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Program Integrity Group, Division of Provider/Supplier Enrollment, N3-22-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6121 RIN: 0938-AH73 _______________________________________________________________________ 1008. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS- 3014-IFC) (SECTION 610 REVIEW) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This interim final rule with comment period requires hospitals that transfuse blood and blood products to prepare and follow written procedures for appropriate action when it is determined that blood and blood products the hospital received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and maintain records for at least 10 years. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/16/00 65 FR 69416 Interim Final Rule With Comment 08/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Mary Collins, 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: 410 786-3189 Email: mary.collins@cms.hhs.gov RIN: 0938-AJ29 _______________________________________________________________________ 1009. USE OF RESTRAINTS AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 (CMS-2065-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1396d CFR Citation: 42 CFR 441, 42 CFR 442, and 42 CFR 483 Legal Deadline: None Abstract: This rule addresses standards of practice that residential treatment facilities providing inpatient psychiatric services for individuals under age 21 must meet with regard to the use of restraints (including psychoactive drugs) and seclusion. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/22/01 66 FR 7148 60-Day Delay of Effective Date To 05/22/2001 03/21/01 66 FR 15800 Interim Final Rule Comment Period End 03/23/01 Interim Final Rule Effective 03/23/01 Interim Final Rule Amendment with Clarification 05/22/01 66 FR 28110 Interim Final Rule Comment Period End 07/23/01 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Thomas Shenk, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Benefits & Coverage Policy, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3295 Email: thomas.shenk@cms.hhs.gov RIN: 0938-AJ96 _______________________________________________________________________ 1010. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS (CMS-1810-F) Priority: Other Significant Legal Authority: 42 USC 1877 CFR Citation: 42 CFR 411; 42 CFR 424 Legal Deadline: Final, Statutory, March 26, 2007, MMA sec. 902. Abstract: This final rule incorporates into regulation certain statutory provisions that preclude payment for services under Medicare if a physician makes a referral to a facility in which he or she has a financial interest. It addresses comments from the January 9, 1998, proposed rule concerning the ownership, investment, and compensation exceptions. It also [[Page 22604]] addresses comments from the January 4, 2001, final rule with comment period. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 03/26/04 69 FR 16054 Interim Final Rule Comment Period End 06/24/04 Correction Notice 04/06/04 69 FR 17933 Second Correction Notice 09/24/04 69 FR 57226 Final Action 03/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Linda P. Howard, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Chronic Care Policy Group, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5255 Email: linda.howard@cms.hhs.gov RIN: 0938-AK67 _______________________________________________________________________ 1011. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F) Priority: Other Significant Legal Authority: Section 1923(a)(2)(D)of the Social Security Act CFR Citation: 42 CFR 447; 42 CFR 455 Legal Deadline: Final, Statutory, December 8, 2003, Sec 1001(d) of MMA. Abstract: This rule implements section 1001(d) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 which requires States to report additional information about their disproportionate share hospital (DSH) programs in their annual report. This section also requires States to independently audit and submit these certified audits annually to the Secretary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/26/05 70 FR 50262 Final Action 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: James Frizzera, Director, National Institutional Payment Policy Center for Medicaid and State Operations, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3263 Email: james.frizzera@cms.hhs.gov RIN: 0938-AN09 _______________________________________________________________________ 1012. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS- 4081-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300gg CFR Citation: 45 CFR 146.121 Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902. Abstract: This final rule governs the provisions prohibiting discrimination based on a health factor for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974, and the Public Health Service Act enacted as part of the Health Insurance Portability and Accountability Act of 1996. It also addresses comments we received on the Bonafide Wellness Plan proposed rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/08/97 62 FR 16894 Interim Final Rule Comment Period End 07/17/97 Interim Final Rule Effective 07/17/97 Interim Final Rule 01/08/01 66 FR 1378 Interim Final Rule Effective 03/09/01 Interim Final Rule Comment Period End 04/09/01 Final Action 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Medicare Plan Policy Group, S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6851 Email: david.mlawsky@cms.hhs.gov Related RIN: Previously reported as 0938-AK19 RIN: 0938-AN29 _______________________________________________________________________ 1013. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018- F) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb CFR Citation: 42 CFR 482 Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902. Abstract: This final rule sets forth standards for the use of restraints and seclusion in Medicare- and Medicaid-participating hospitals as part of the Patients' Rights Condition of Participation (CoP) and finalizes other patients' rights afforded by that CoP. It finalizes six standards that ensure minimum protections of each patient's physical and emotional health and safety. These standards address each patient's right to: Notification of his or her rights; the exercise of his or her rights in regard to his or her care; privacy and safety; confidentiality of patient records; freedom from restraints used in the provision of acute medical and surgical care unless clinically necessary; and freedom from seclusion and restraint for behavior management unless clinically necessary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/02/99 64 FR 36069 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Patricia Chmielewski, Health Insurance Specialist, Department of Health and Human [[Page 22605]] Services, Centers for Medicare & Medicaid Services, Clinical Standards and Quality Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6899 Email: patricia.chmielewski@cms.hhs.gov RIN: 0938-AN30 _______________________________________________________________________ 1014. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA DISSEMINATION (CMS-6060-NC) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: HIPAA of 1996, secs 1171 to 1179 of the Social Security Act (42 USC 1329d to 1320d-8); NPI final rule (01/23/2004); NPS System of Records (07/28/1998) CFR Citation: 45 CFR 163 Legal Deadline: None Abstract: The National Provider Identifier final rule, published January 23, 2004, stated that CMS would publish a follow-up notice to describe the data dissemination processes and any applicable charges for data. This notice with comment period describes the data that would be available from the National Plan and Provider Enumeration System (NPPES), in compliance with the provisions of the Privacy Act, the Freedom of Information Act, the Electronic Freedom of Information Act (FOIA) Amendments of 1996, and other applicable regulations and authorities, and must be consistent with the National Provider System of Records Notice published on July 28, 1998. The notice describes the data dissemination strategy, processes, and any applicable charges for data. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 08/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Helen Dietrick, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Program Integrity Group, Mailstop C3- 02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7448 Email: helen.dietrick@cms.hhs.gov RIN: 0938-AN71 _______________________________________________________________________ 1015. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-IFC2) Priority: Other Significant Legal Authority: Improper Payment Information Act of 2002 CFR Citation: 42 CFR 431; 42 CFR 457 Legal Deadline: Final, Statutory, October 1, 2005. Abstract: This interim final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and SCHIP. The Improper Payments Information Act of 2002 (IPIA) requires heads of Federal agencies to annually estimate and report to the Congress these estimates of improper payments for the programs they oversee and submit a report on actions the Agency is taking to reduce erroneous payments. This interim final rule responds to the public comments on the October 5, 2005 interim final rule and sets forth State requirements for submitting claims and policies to the Federal contractor for purposes of conducting FFS and managed care reviews. This interim final rule also solicits comments on the State requirements for conducting eligibility reviews and estimating payment error rates due to errors in eligibility determinations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/27/04 69 FR 52620 Interim Final Rule 10/05/05 70 FR 58260 Interim Final Rule 08/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: State Agency Contact: Christine Jones, Division Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3722 Email: christine.jones@cms.hhs.gov Related RIN: Related to 0938-AM86 RIN: 0938-AN77 _______________________________________________________________________ 1016. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE FOR RY 2006 (CMS-1306-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 106-113, sec 124 BBRA CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, July 1, 2006. Abstract: This rule will update the Prospective Payment Rate for Medicare Inpatient Psychiatric Facilities for discharges occurring during the rate year beginning 7/1/06 to 6/30/07. This rule will update and revise the market basket and the use of new market area definitions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/23/06 71 FR 3616 Final Action 05/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Local Agency Contact: Janet Samen, Acting Director, Division of Technical Payment Policy, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-05-27, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9161 Email: janet.samen@cms.hhs.gov RIN: 0938-AN82 _______________________________________________________________________ 1017. PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM REVISIONS (CMS-1201-F) Priority: Other Significant Legal Authority: PL 108-173, sec 902 of MMA; BIPA, sec 903 CFR Citation: 42 CFR 460 Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902. Abstract: This rule finalizes two interim final rules with comment periods. The November 24, 1999 rule established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs and the October 1, 2002 rule implemented section 903 of BIPA. These are pre-paid, capitated [[Page 22606]] programs for beneficiaries who meet special eligibility requirements and who elect to enroll. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 11/24/99 64 FR 66234 Interim Final Rule 10/01/02 67 FR 61496 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Janet Harris, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Chronic Care Policy Group, Mailstop C5- 05-27, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3137 Email: janet.harris@cms.hhs.gov Related RIN: Previously reported as 0938-AL59 RIN: 0938-AN83 _______________________________________________________________________ 1018. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2007: ANNUAL PAYMENT RATE UPDATES (CMS-1485-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 123 PL 106-113; sec 307(b), PL 106-554 CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, Effective July 1, 2006. Abstract: This rule proposes the annual payment rate update for the RY 2007 prospective payment system for Medicare long-term care hospitals and also presents proposed changes or revisions in LTCH PPS policy for public comment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/27/06 71 FR 4647 Final Action 05/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Linda McKenna, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4537 Email: linda.mckenna@cms.hhs.gov RIN: 0938-AO06 _______________________________________________________________________ 1019. PART A PREMIUMS FOR CALENDAR YEAR 2007 FOR THE UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8028-N) Priority: Other Significant Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Social Security Act, sec 1818(d)(2); Social Security Act, sec 1818 A(d)(2) CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2006. Abstract: This notice announces the hospital insurance premium for calendar year 2007 under Medicare's Hospital Insurance program (Medicare Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of the Actuary, Mailstop N3- 26-00, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO18 _______________________________________________________________________ 1020. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2007 (CMS-8029-N) Priority: Other Significant Legal Authority: 42 USC 1395e-2(b)(2); Social Security Act, sec 1813 (b)(2) CFR Citation: None Legal Deadline: Final, Statutory, September 15, 2006. Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year 2007 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office the of the Actuary, Mailstop N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO19 _______________________________________________________________________ 1021. FISCAL YEAR 2007 SCHIP ALLOTMENTS (CMS-2251-N) Priority: Other Significant Legal Authority: Title XXI of the Social Security Act, sec 2104 CFR Citation: 42 CFR 457 Legal Deadline: Final, Statutory, September 30, 2006. Abstract: This notice sets forth the final State Children's Health Insurance Program (SCHIP) allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2007. [[Page 22607]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Notice 08/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss, Technical Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO21 _______________________________________________________________________ 1022. PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE BEGINNING JANUARY 1, 2007 (CMS-8030-N) Priority: Other Significant Legal Authority: 42 USC 1395r; Social Security Act, sec 1839; MMA, sec 629; MMA, sec 811; Deficit Reduction Act of 2005, PL 109-171, sec 5111 CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2006. Abstract: This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) enrollees in Part B of Medicare for 2007. It also announces the monthly Part B premium to be paid by all enrollees, and the Part B deductible, during 2007. This notice will also incorporate provisions from section 5111 of the Deficit Reduction Act of 2005, which affects implementation of income income-related change in part B premium subsidy. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Suzanne Codespote, Deputy Director, Medicare and Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of the Actuary, Mailstop N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7737 Email: suzanne.codespote@cms.hhs.gov RIN: 0938-AO23 _______________________________________________________________________ 1023. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2007 (CMS-1530-N) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1888(e) CFR Citation: 42 CFR 424 Legal Deadline: Other, Statutory, July 31, 2006, Notice must be published before 08/01/2006. Abstract: This notice updates the payment rates used under the SNF PPS beginning 10/1/06. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 07/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Bill Ullman, Health Insurance Specialist, Division of Institutional Post Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Chronic Care Policy Group, Mailstop C5-07-08, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO25 _______________________________________________________________________ 1024. HOSPICE WAGE INDEX FOR FY 2007 (CMS-1535-N) Priority: Other Significant Legal Authority: 1814(i) (1) of the Act; 1814(i) (2) CFR Citation: 42 CFR 418 Legal Deadline: Final, Statutory, September 1, 2006. Abstract: This notice announces the annual update to the hospice wage index for FY 2007. 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 8/8/97. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 08/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Terri Deutsch, Health Insurance Specialist, Division of Community Post Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Chronic Care Policy Group, Mailstop C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-9462 Email: terri.deutsch@cms.hhs.gov RIN: 0938-AO26 _______________________________________________________________________ 1025. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR QUALIFYING INDIVIDUALS: FISCAL YEAR 2006 (CMS-2231-IFC) Priority: Other Significant Legal Authority: QI, TMA, and Abstinence Programs Extension and Hurricane Katrina Unemployment Relief Act of 2005, sec 101 CFR Citation: 42 CFR 433.10 Legal Deadline: Final, Statutory, September 30, 2006. Abstract: On August 26, 2005 CMS published in the FR an interim final rule for determining the revised FY 2005 allotments, CMS-2210-IFC. When CMS published this in the FR, we did not reference the allotments for fiscal years after FY 2005, since the funding for the program ended with FY 2005. However, on October 20, 2005, Pub. L. 109-91 was enacted; section 101 of that law extended the QI program to FY 2006 and FY 2007. In particular, section 101 extended the qualifying individual program through September 30, 2007 with no change in funding; that is, under this legislation, $400 million per fiscal year is appropriated for each of FY 2006 and FY 2007. We are publishing this rule as an IFC [[Page 22608]] because of the need to notify individual States of the limitations on Federal funds for their Medicaid expenditures for payment of Medicare Part B premiums for QIs. Some States have experienced deficits in their current allotments that have caused them to deny benefits to eligible applicants, while other States project a surplus in their allotments. This rule permits redistribution of funds and will allow all eligible applicants to receive QI benefits during this calendar year. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 05/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Governmental Jurisdictions Government Levels Affected: State Agency Contact: Richard Strauss, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-22-25, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov Related RIN: Related to 0938-AO04 RIN: 0938-AO31 _______________________________________________________________________ 1026. STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (CMS-4005-F) Priority: Other Significant Legal Authority: sec 4360 of OBRA 1990 (PL 101-508) CFR Citation: 42 CFR 403 Legal Deadline: Final, Statutory, December 8, 2006, MMA Section 902. Abstract: This rule adopts as final the provisions in the interim final regulation that published June 1, 2000, which explain the terms and conditions that apply to State grants for counseling and assistance to Medicare beneficiaries, and makes several minor technical clarifications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Robert Adams, Director, Division of Community-Based Education and Assistance, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S1-20-21, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-8695 Fax: 410 786-8004 Email: robert.adams1 @ cms.hhs.gov Related RIN: Related to 0938-AJ67 RIN: 0938-AO37 _______________________________________________________________________ 1027. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2007 (CMS-1532-N) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Sec 1834(1) of the Social Security Act CFR Citation: 42 CFR 410 Legal Deadline: Final, Statutory, Effective 01/01/2007. Abstract: This notice updates the fee schedule for ambulance services under the Medicare program, implementing section 1834(1) of the Social Security Act (effective 1/1/07). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 10/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Anne Tayloe, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4546 Email: ann.tayloe@cms.hhs.gov RIN: 0938-AO39 _______________________________________________________________________ 1028. ADOPTION OF STANDARDS FOR THE E-PRESCRIBING AND THE MEDICARE PRESCRIPTION DRUG PROGRAM (CMS-0018-N) Priority: Info./Admin./Other Legal Authority: 42 USC 1395 CFR Citation: 42 CFR 423 Legal Deadline: None Abstract: This notice permits the use of Version 8.1 of the NCPDP SCRIPT standard for e-prescribing transactions. Use of the standard is voluntary at this time. Version 5.0 of the NCPDP SCRIPT was adopted as an e-prescribing foundation standard 11/7/05. Voluntary use of Version 8.1 will be pilot tested with other available e-prescribing standards during the 2006 e-prescribing pilot project. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Electronic Standards and Services, Mailstop S2-16-17, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov Related RIN: Related to 0938-AN49 RIN: 0938-AO42 _______________________________________________________________________ 1029. GROUP HEALTH PLANS AND HEALTH INSURANCE ISSUES UNDER THE NEWBORNS AND MOTHERS HEALTH PROTECTION ACT (CMS-4116-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 300gg to 300gg-63; 300gg-91 to 300gg-92 CFR Citation: 45 CFR 144; 45 CFR 146; 45 CFR 148 Legal Deadline: None Abstract: This final rule sets forth the post-childbirth hospitalization length of stay requirements for group health plans and health insurance issuers that cover such length of stays. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. [[Page 22609]] Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-16-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6851 Email: david.mlawsky@cms.hhs.gov Related RIN: Related to 0938-AI17 RIN: 0938-AO43 _______________________________________________________________________ 1030. TARGETED CASE MANAGEMENT (CMS-2237-IFC) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6052 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2006. Abstract: This regulation is required by the Deficit Reduction Act. Section 6052 clarifies what is reimbursable under the Medicaid case management and targeted case management benefit and is intended to offer guidance to States on implementing the statutory provision. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Theresa Pratt, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Secruity Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO50 _______________________________________________________________________ 1031. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-2249-IFC) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6086 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2007. Abstract: The regulation would offer guidance to States on implementing the statutory provisions of sec 6086 of the Deficit Reduction Act Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Theresa Pratt, Director, Division of Integrated Health Systems, Disabled and Elderly Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO53 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1032. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818- F) (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 42 USC 1395rr et al CFR Citation: 42 CFR 400, 42 CFR 405,; 42 CFR 410, 42 CFR 413, 42 CFR 414; 42 CFR 488 and CFR 494 Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902. Abstract: This final rule revises the requirements that end stage renal disease (ESRD) facilities must meet to be certified under the Medicare program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/04/05 70 FR 6184 Final Action 02/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Teresa Casey, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7215 Email: mary.casey@cms.hhs.gov Rebecca Donnay, 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: 410 786-1428 Email: rebecca.donnay@cms.hhs.gov RIN: 0938-AG82 _______________________________________________________________________ 1033. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS- 3835-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 405, ; 42 CFR 482, and 42 CFR 488 Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902. Abstract: This rule establishes conditions of participation for Medicare-covered transplant centers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/04/05 70 FR 6140 Final Action 02/00/08 Regulatory Flexibility Analysis Required: No [[Page 22610]] Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Eva Fung, 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: 410 786-7539 Email: eva.fung@cms.hhs.gov RIN: 0938-AH17 _______________________________________________________________________ 1034. HOSPICE CARE CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 418 Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902. 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: Undetermined Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: 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 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 21244-1850 Phone: 410 786-6051 Email: mary.rossicoajou@cms.hhs.gov RIN: 0938-AH27 _______________________________________________________________________ 1035. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-F) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments. Legal Authority: 42 USC 1320d-2(a)(2)(B) CFR Citation: 45 CFR 162 Legal Deadline: Final, Statutory, February 21, 1999. Abstract: This rule finalizes an electronic standard for health care claims attachments. The standard is required by the Health Insurance Portability and Accountability Act of 1996. It will be used to transmit clinical or administrative data, in addition to the data contained in the claims standard, to help establish medical necessity or policy compliance for coverage and payment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/23/05 70 FR 55989 Final Action 09/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Lorraine Doo, Health Insurance Specialist, Office of E- Health Standards and Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-25-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6597 Email: lorraine.doo@cms.hhs.gov RIN: 0938-AK62 _______________________________________________________________________ 1036. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE AND RECERTIFICATION (CMS-3064-F) (SECTION 610 REVIEW) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1302 et al CFR Citation: 42 CFR 413; 42 CFR 441; 42 CFR 486; 42 CFR 498 Legal Deadline: Final, Statutory, February 4, 2008, MMA sec 902. Abstract: This rule establishes conditions for coverage for organ procurement organizations (OPOs) to be certified by the Secretary to receive payment from Medicare and Medicaid for organ procurement costs, and to be designated by the Secretary for a specific geographic service area. The Organ Procurement Organization Certification Act of 2000 requires CMS to increase the certification cycle for OPOs from two years to four years and to promulgate new performance standards for OPOs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/28/01 66 FR 67109 NPRM 02/04/05 70 FR 6086 Final Rule 02/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tzvi Hefter, Director, Division of Acute Care Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare and Medicaid Services, Mailstop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4487 Email: tzvi.hefter@cms.hhs.gov RIN: 0938-AK81 _______________________________________________________________________ 1037. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-F) Priority: Substantive, Nonsignificant Legal Authority: Sec 1878 of the Social Security Act CFR Citation: 42 CFR 405 [[Page 22611]] Legal Deadline: Final, Statutory, June 25, 2007, MMA sec. 902. Abstract: This final rule redefines, clarifies, and updates the guidelines and procedures for Provider Reimbursement Review Board appeals, based on recent court decisions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/25/04 69 FR 35716 NPRM Comment Period End 08/24/04 Final Action 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Morton Marcus, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4477 RIN: 0938-AL54 _______________________________________________________________________ 1038. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-F) Priority: Other Significant Legal Authority: 42 USC 300gg; PL 104-191 CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.120; 45 CFR 146.145 Legal Deadline: None Abstract: This final rule will clarify certain portability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan. It also implements changes made to the Internal Revenue Code, the Employee Retirement Income Security Act, and the Public Health Service Act enacted as part of the Health Insurance Portability and Accountability Act of 1996. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/30/04 69 FR 78800 Final 12/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: Federal, Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Medicare Plan Policy Group, Mailstop S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6851 Email: david.mlawsky@cms.hhs.gov RIN: 0938-AL88 _______________________________________________________________________ 1039. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS (CMS-4064-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Sec 521 of BIPA CFR Citation: 42 CFR 401 and 405 Legal Deadline: Final, Statutory, August 26, 2008, MMA sec 902. Abstract: This final rule will revise the Medicare appeals process by adding five levels of review. It will remove the distinction between the processing of initial determinations and appeals under part A and part B required by section 521 of Benefits Improvement and Protection Act of 2000 (BIPA). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 03/08/05 70 FR 11419 Interim Final Rule 06/30/05 70 FR 37700 Interim Final Rule 08/26/05 70 FR 50214 Final Action 08/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Arrah Tabe-Bedward, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S1-05-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-7129 Email: arrah.tabe-bedward@cms.hhs.gov Related RIN: Related to 0938-AK69 RIN: 0938-AM73 _______________________________________________________________________ 1040. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-F) Priority: Other Significant Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb CFR Citation: 42 CFR 482 Legal Deadline: Final, Statutory, March 25, 2008, MMA sec. 902. Abstract: This rule will reduce the burden on hospitals and allow hospitals to conform to current standards of practice. Hospitals must meet these final requirements to participate in Medicare and Medicaid programs. They must establish and maintain policies and procedures that will ensure their hospital will meet these requirements by using standard practices for history and physical examinations, securing medications, authenticating verbal orders, and completing post- anesthesia evaluations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/25/05 70 FR 15266 Final Action 03/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: None Additional Information: Decreases burden for hospitals and clinicians. Agency Contact: Patricia Chmielewski, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards and Quality Group, Mailstop S3- 02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6899 Email: patricia.chmielewski@cms.hhs.gov RIN: 0938-AM88 [[Page 22612]] _______________________________________________________________________ 1041. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6146-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: 42 CFR 402 Legal Deadline: Final, Statutory, July 23, 2007, MMA sec. 902. Abstract: This final rule proposes revisions to the CMS civil money penalty authorities. These proposed revisions are intended to add the specific exclusion sanction authorities as established in the procedures for imposing civil money penalties, assessments, and exclusions for certain violations of the Medicare and Medicaid programs. This rule also finalizes an August 4, 2005, rule that outlines the process for health care providers to follow if they wish CMS to request a waiver of exclusion on their behalf. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/23/04 69 FR 43956 Final Action 07/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Joel Cohen, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, C3-04-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3349 Related RIN: Related to 0938-AN48 RIN: 0938-AM98 _______________________________________________________________________ 1042. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS- 6024-F) Priority: Other Significant Legal Authority: Sec 938 of the Medicare Modernization Act of 2003 CFR Citation: 42 CFR 410 Legal Deadline: Final, Statutory, June 8, 2005. Abstract: Section 938 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires the Secretary to establish a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This final rule establishes reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/30/05 70 FR 51321 Final Action 08/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Misty D. Whitaker, Health Insurance Specialist, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Program Integrity Group, Office of Financial Management, Mail Stop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3087 Email: misty.whitaker@cms.hhs.gov RIN: 0938-AN10 _______________________________________________________________________ 1043. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 301 of the Medicare Modernization Act of 2003 CFR Citation: 42 CFR 411; 42 CFR 489 Legal Deadline: Final, Statutory, December 8, 2003. Abstract: This final rule implements amendments to the Medicare Secondary Payer (MSP) provisions under Title III of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA amendments clarify the MSP provisions regarding the obligations of primary plans and primary payers, the nature of the insurance arrangements subject to the MSP rules, the circumstances under which Medicare may make conditional payments, and the obligations of primary payers to reimburse Medicare. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 02/24/06 71 FR 9466 Final Action 02/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Suzanne Ripley, Health Insurance Specialist, Centers for Medicaid Services Office, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-14-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0970 Fax: 410 786-7030 Email: suzanne.ripley@cms.hhs.gov RIN: 0938-AN27 _______________________________________________________________________ 1044. RANDOM PREPAYMENT REVIEW (CMS-6022-F) Priority: Other Significant Legal Authority: Sec 934 of the MMA CFR Citation: 42 CFR 421 Legal Deadline: Final, Statutory, October 7, 2008, MMA sec. 902. Abstract: This rule implements the statutory requirements regarding the termination of non-random prepayment review under section 934 of the Medicare Modernization Act beginning December 8, 2003. This rule provides guidelines for terminating a provider of services or supplier from non-random payment review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/07/05 70 FR 58649 Final Action 10/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Marie Casey, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office [[Page 22613]] of Financial Management, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7861 Email: marie.casey2@cms.hhs.gov RIN: 0938-AN31 _______________________________________________________________________ 1045. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-F) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 482 to 42 CFR 483; 42 CFR 485 Legal Deadline: Final, Statutory, March 25, 2008, MMA sec. 902. Abstract: This final rule amends the fire safety standards for religious nonmedical health care institutions, hospices, programs of all-inclusive care for the elderly, hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, and critical access hospitals that participate in Medicare and Medicaid. The rule adopts a change made to the 2000 edition of the Life Safety Code (LSC) published by the National Fire Protection Association (NFPA). The LSC change allows facilities to place alcohol-based hand rub dispensers in exit corridors under certain conditions. Additionally, this rule includes a requirement for placement of battery- operated smoke alarms in resident rooms in non-sprinkled SNFs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule With Comment 03/25/05 70 FR 15229 Final Action 03/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Additional Information: Providers requesting publication of this regulation. Agency Contact: 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-AN36 _______________________________________________________________________ 1046. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND BIOLOGICALS (CMS-1325-F) Priority: Other Significant Legal Authority: MMA of 2003, sec 303(d) CFR Citation: 42 CFR 414 Legal Deadline: Final, Statutory, July 1, 2006. Abstract: Section 303(d) of the Medicare Modernization Act requires the implementation of a competitive bidding program for Medicare Part B drugs not paid on a cost or prospective payment system basis. Beginning July 1, 2006, physicians will be given a choice between purchasing these drugs and being paid by Medicare under the average sales price (ASP) system, or obtaining these drugs from vendors selected in a competitive bidding process. If the physician elects to obtain drugs from a competitive vendor, the vendor will bill Medicare for the drug. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/04/05 70 FR 10745 Interim Final Rule 07/06/05 70 FR 39022 Final Action 07/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Edmund E. Kasaitis, Health Insurance Specialist, Hospital & Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0477 Email: edmund.kasaitis@cms.hhs.gov RIN: 0938-AN58 _______________________________________________________________________ 1047. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS; E-PRESCRIBING EXCEPTIONS (CMS-1303-F) Priority: Other Significant Legal Authority: 1827(b)(4)-(b)(5); 1860D-4(e)(6); 1860D-42(e)(8)(B) CFR Citation: 42 CFR 411.357 Legal Deadline: Final, Statutory, January 1, 2006. Abstract: This rule proposes an exception to the physician self- referral prohibition for certain nonmonetary remuneration related to electronic prescribing (section 1860D-4 of the Medicare Modernization Act). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/07/05 70 FR 59181 Final Action 10/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Linda Howard, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-13-08, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5255 Email: linda.howard@cms.hhs.gov RIN: 0938-AN69 _______________________________________________________________________ 1048. MEDICARE INTEGRITY PROGRAM, FISCAL INTERMEDIARY AND CARRIER FUNCTIONS, AND CONFLICT OF INTEREST REQUIREMENTS (CMS-6030-F) Priority: Other Significant Legal Authority: Sec 902 of the MMA CFR Citation: 42 CFR 400 and 421 Legal Deadline: Final, Statutory, June 17, 2008, MMA sec. 902. Abstract: This rule finalizes certain sections of the Medicare regulations concerning fiscal intermediaries and carriers and brings them into conformity with the Medicare statute. The rule would distinguish between those functions that the statute requires to be included in agreements with fiscal intermediaries and those that may be included in the agreements. It would also provide that some or all of the functions may be included in carrier contracts. Currently all these functions are mandatory for carrier contracts. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/17/05 70 FR 35204 Final Action 06/00/08 Regulatory Flexibility Analysis Required: No [[Page 22614]] Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gary D. Williams, Health Insurance Specialist, Centers for Medicare & Medicaid Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6433 Email: gary.williams4@cms.hhs.gov Related RIN: Related to 0938-AI09 RIN: 0938-AN72 _______________________________________________________________________ 1049. HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM; LOAN PROGRAM FOR QUALIFYING HOSPITALS ENGAGED IN CANCER-RELATED HEALTH CARE (CMS-1287-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 108-173 sec 1016 CFR Citation: 42 CFR 505 Legal Deadline: Final, Statutory, September 30, 2008, MMA sec 902. Abstract: This rule will establish a loan program to improve certain hospital infrastructure, including capital improvement. To receive assistance, the applicant will be required to: 1) Engage in cancer research; and 2) be designated by the National Cancer Institute (NCI) as a cancer center or by the State as the official cancer institute. This rule will also establish the conditions under which these loans may be forgiven. No later than 4 years after enactment, the Secretary must submit a report to the Congress summarizing the financial performance of the projects that have received assistance under the loan program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 09/30/05 70 FR 57368 Final Action 09/00/08 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Melinda Jones, Health Insurance Specialist, Quality Measurement & Health Assessment Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-7069 Email: melinda.jones@cms.hhs.gov Tzvi Hefter, Director of the Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-01-17, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4487 Email: tzvi.hefter@cms.hhs.gov Related RIN: Related to 0938-AN93 RIN: 0938-AO03 _______________________________________________________________________ 1050. EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON MENTAL HEALTH PARITY (CMS-4094-F4) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300gg to 300gg63; 300gg-91 to 300gg-92 CFR Citation: 45 CFR 146 Legal Deadline: None Abstract: This amendment extends the sunset date of the regulation to December 31, 2006, consistent with a recent extension of the sunset date of the statute this regulation implements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/22/05 70 FR 42276 Final Rule 07/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C3-16-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 877 267-2323 Email: david.mlawsky@cms.hhs.gov Related RIN: Related to 0938-AN80 RIN: 0938-AO36 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1051. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIER (CMS-6017-P) Priority: Other Significant. Major under 5 USC 801. CFR Citation: 45 CFR 160; 45 CFR 162 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/22/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Helen Dietrick Phone: 410 786-7448 RIN: 0938-AH87 _______________________________________________________________________ 1052. MEDICARE OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA REPORTING REQUIREMENTS (CMS-3006-F) Priority: Other Significant CFR Citation: 42 CFR 484.11; 42 CFR 484.20; 42 CFR 488.68 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 12/23/05 70 FR 76199 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Local, State, Tribal Agency Contact: Rebecca Donnay Phone: 410 786-1428 Email: rebecca.donnay@cms.hhs.gov RIN: 0938-AJ10 [[Page 22615]] _______________________________________________________________________ 1053. HOSPICE CARE AMENDMENTS (CMS-1022-F) Priority: Other Significant CFR Citation: 42 CFR 418 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/22/05 70 FR 70532 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Linda Smith Phone: 410 786-5650 Related RIN: Previously reported as 0938-AH73 RIN: 0938-AJ36 _______________________________________________________________________ 1054. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-F) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/25/05 70 FR 71008 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Stewart Streimer Phone: 410 786-9318 Email: stewart.streimer@cms.hhs.gov RIN: 0938-AM22 _______________________________________________________________________ 1055. REQUIREMENTS FOR LONG-TERM CARE FACILITIES; NURSING SERVICES; POSTING OF NURSE STAFFING INFORMATION (CMS-3121-F) Priority: Other Significant CFR Citation: 42 CFR 483 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 10/28/05 70 FR 62065 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Anita Panicker Phone: 410 786-5646 Fax: 410 786-8532 Email: anita.panicker@cms.hhs.gov RIN: 0938-AM55 _______________________________________________________________________ 1056. CONDITIONS FOR COVERAGE FOR PAYMENT OF POWER MOBILITY DEVICES, INCLUDING POWERED WHEELCHAIRS AND POWER-OPERATED VEHICLES (CMS-3017-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 410.38 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 04/05/06 71 FR 17021 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Karen Daily Phone: 410 786-0189 Email: karen.daily@cms.hhs.gov RIN: 0938-AM74 _______________________________________________________________________ 1057. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY AND A BACK-UP RATE (CMS-1167-F) Priority: Other Significant CFR Citation: 42 CFR 414.222(a)(1) Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 01/27/06 71 FR 4518 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joel Kaiser Phone: 410 786-4499 Email: joel.kaiser@cms.hhs.gov Related RIN: Related to 0938-AL27 RIN: 0938-AN02 _______________________________________________________________________ 1058. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL CENTERS FOR 2005 (CMS-1478-F) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/09/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dana Burley Phone: 410 786-4547 Email: dana.burley@cms.hhs.gov Related RIN: Merged with 0938-AO15 RIN: 0938-AN23 _______________________________________________________________________ 1059. PAYMENT FOR CLINICAL LABORATORY TESTS (CMS-1494-P) Priority: Substantive, Nonsignificant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/08/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anita Greenberg Phone: 410 786-4601 Email: anita.greenberg@cms.hhs.gov Related RIN: Merged with 0938-AO24 RIN: 0938-AN26 _______________________________________________________________________ 1060. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS (CMS-4091-F) Priority: Other Significant CFR Citation: 45 CFR 150.101 to 150.465 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/25/05 70 FR 71020 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: David Mlawsky Phone: 410 786-6851 Email: david.mlawsky@cms.hhs.gov RIN: 0938-AN35 _______________________________________________________________________ 1061. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2006 (CMS-1301-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 484 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/09/05 70 FR 68131 [[Page 22616]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Randy Throndset Phone: 410 786-0131 Email: randy.throndset@cms.hhs.gov RIN: 0938-AN44 _______________________________________________________________________ 1062. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND CALENDAR YEAR 2006 PAYMENT RATES (CMS-1501-FC) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 419; 42 CFR 485 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/10/05 70 FR 68515 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Rebecca Kane Phone: 410 786-1589 Email: rebecca.kane@cms.hhs.gov RIN: 0938-AN46 _______________________________________________________________________ 1063. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6019-F) Priority: Other Significant CFR Citation: 42 CFR 402.400 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/06/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Cohen Phone: 410 786-3349 Email: joel.cohen@cms.hhs.gov Related RIN: Merged with 0938-AM98 RIN: 0938-AN48 _______________________________________________________________________ 1064. ELECTRONIC PRESCRIBING STANDARDS (CMS-0011-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/07/05 70 FR 67567 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gladys Wheeler Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov RIN: 0938-AN49 _______________________________________________________________________ 1065. GROUP MARKET HEALTH INSURANCE REFORM: GUARANTEED AVAILABILITY, GUARANTEED RENEWABILITY, DISCLOSURES TO SMALL EMPLOYERS (CMS-4102-F) Priority: Other Significant CFR Citation: 45 CFR 146.150; 45 CFR 146.152; 45 CFR 146.160 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/08/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David R. Mlawsky Phone: 877 267-2323 Email: david.mlawsky@cms.hhs.gov Related RIN: Related to 0938-AI08 RIN: 0938-AN60 _______________________________________________________________________ 1066. INDIVIDUAL MARKET HEALTH INSURANCE REFORM: PORTABILITY FROM GROUP TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIVIDUAL MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES (CMS-4103-F) Priority: Other Significant. Major under 5 USC 801. CFR Citation: 42 CFR 148.11; 42 CFR 148.102; 42 CFR 148.103; 42 CFR 148.122; 42 CFR 148.1 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/08/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David R. Mlawsky Phone: 877 267-2323 Email: david.mlawsky@cms.hhs.gov Related RIN: Related to 0938-AI08 RIN: 0938-AN61 _______________________________________________________________________ 1067. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F) Priority: Other Significant CFR Citation: 42 CFR 412 to 413; 42 CFR 1902 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 02/10/06 71 FR 6991 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Jill Keplinger Phone: 410 786-4550 Email: jill.keplinger@cms.hhs.gov Related RIN: Related to 0938-AK02 RIN: 0938-AN75 _______________________________________________________________________ 1068. APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE PART B SERVICES (OTHER THAN PHYSICIAN SERVICES) (CMS-1908-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 405 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 12/13/05 70 FR 73623 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Bill Long Phone: 410 786-5655 Email: bill.long@cms.hhs.gov RIN: 0938-AN81 _______________________________________________________________________ 1069. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 2006 (CMS-1502-FC) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 410; 42 CFR 414 [[Page 22617]] Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/21/05 70 FR 70116 Comment Period End 01/03/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: Federal Agency Contact: Diane Milstead Phone: 410 786-3355 Related RIN: Related to 0938-AN04 RIN: 0938-AN84 _______________________________________________________________________ 1070. ELECTRONIC SUBMISSION OF COST REPORTS (CMS-1199-F) Priority: Substantive, Nonsignificant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/10/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Darryl E. Simms Phone: 410 786-4524 Email: darryl.simms@cms.hhs.gov Related RIN: Related to 0938-AL51 RIN: 0938-AN87 _______________________________________________________________________ 1071. LOAN FORGIVENESS CRITERIA FOR THE HEALTH CARE INFRASTRUCTURE LOAN PROGRAM (CMS-1320-F) Priority: Other Significant CFR Citation: 42 CFR 505 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/08/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tzvi Hefter Phone: 410 786-4487 Email: tzvi.hefter@cms.hhs.gov Related RIN: Merged with 0938-AO03 RIN: 0938-AN93 _______________________________________________________________________ 1072. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2006 (CMS-1294-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 410 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 11/25/05 70 FR 71163 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Anne Tayloe Phone: 410 786-4546 Email: anne.tayloe@cms.hhs.gov RIN: 0938-AN99 _______________________________________________________________________ 1073. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR QUALIFYING INDIVIDUALS (CMS-2210-F) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Comment Period End 10/25/05 Withdrawn 02/08/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov Related RIN: Related to 0938-AO31 RIN: 0938-AO04 _______________________________________________________________________ 1074. FEDERAL GOVERNMENT'S ADOPTION OF TWENTY (20) HEALTHCARE MESSAGING AND VOCABULARY STANDARDS RECOMMENDED BY THE CONSOLIDATED HEALTH INFORMATICS INITIATIVE (CMS-0015-N) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 12/23/05 70 FR 76287 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Cheryl Ford Phone: 410 786-7415 Email: cheryl.ford@cms.hhs.gov RIN: 0938-AO05 _______________________________________________________________________ 1075. REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-P) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 FR 416 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/10/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: Federal Agency Contact: Joan H. Sanow Phone: 410 786-9739 Fax: 410 786-4490 Email: joan.sanow@cms.hhs.gov Related RIN: Merged with 0938-AO15 RIN: 0938-AO13 _______________________________________________________________________ 1076. FIRE SAFETY REQUIREMENTS FOR RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS: CORRECTION TO ADD WRITTEN FIRE CONTROL PLANS & MAINTENANCE OF DOCUMENTATION (CMS-3183-IFC) Priority: Other Significant CFR Citation: 42 CFR 403 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/08/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Janice A. Graham Phone: 410 786-8020 Fax: 410 786-2532 Email: janice.graham@cms.hhs.gov Related RIN: Related to 0938-AM90 RIN: 0938-AO14 [[Page 22618]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1077. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT Priority: Substantive, Nonsignificant Legal Authority: PL 106-402; 42 USC 15001 et seq CFR Citation: 45 CFR 1385 to 1388 Legal Deadline: Final, Statutory, October 30, 2001. Abstract: A notice of proposed rulemaking to amend current regulations and to implement changes made by the Developmental Disabilities Assistance and Bill of Rights Act of 2000. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions, Organizations Government Levels Affected: Local, State, Tribal Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 690-5841 RIN: 0970-AC07 _______________________________________________________________________ 1078. ADMINISTRATIVE COST SHARING UNDER TANF Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 263; 45 CFR 263.14 Legal Deadline: None Abstract: This proposed rule will require States (including the District of Columbia) and territories to use the ``benefiting'' cost allocation methodology in allocating the common administrative costs of determining eligibility in the Temporary Assistance for Needy Families (TANF) program, the Medicaid program, and the Food Stamp programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Grant Collins, Deputy Director, Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-6953 Email: gcollins@acf.hhs.gov RIN: 0970-AC15 _______________________________________________________________________ 1079. CARE AND PLACEMENT OF UNACCOMPANIED ALIEN CHILDREN Priority: Other Significant Legal Authority: 6 USC 279 CFR Citation: 45 CFR 410 Legal Deadline: None Abstract: This rule concerns the placement of unaccompanied alien children in appropriate facilities and homes, the services provided for the children while they are in the care of the Office of Refugee Resettlement (ORR) and the criteria for release of these children from Federal custody to sponsors. The rule also implements ORR's role in Flores class-action settlement agreement. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Maureen Dunn, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-5523 Email: mdunn@acf.hhs.gov RIN: 0970-AC20 _______________________________________________________________________ 1080. CHAFEE NATIONAL YOUTH IN TRANSITION DATABASE Priority: Other Significant Legal Authority: 42 USC 677 CFR Citation: 45 CFR 1356 Legal Deadline: None Abstract: This rule would require States to collect and report data on youth who are receiving independent living services and the outcomes of certain youth who are in foster care or who age-out of foster care. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC21 _______________________________________________________________________ 1081. MEDICAL SUPPORT Priority: Other Significant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 302 to 305 Legal Deadline: None Abstract: These rules would require that all support orders in the IV-D program address medical support, redefine reasonable-cost health insurance, require health insurance to be accessible, and make conforming changes to audit and self-assessment requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning Division, Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-9386 Email: bmatheson@acf.hhs.gov RIN: 0970-AC22 [[Page 22619]] _______________________________________________________________________ 1082. ADOPTION AND FOSTER CARE ANALYSIS AND REPORTING SYSTEM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 679 CFR Citation: 45 CFR 1355 Legal Deadline: None Abstract: This NPRM amends the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations at 45 CFR 1355.40 and the appendices to part 1355 to modify the requirements for States to collect and report data to ACF on children in foster care and in subsidized adoption or guardianship arrangements with the State. The rule also implements the AFCARS penalty requirements of the Adoption Promotion Act of 2003 (Pub. L. 108-145). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC23 _______________________________________________________________________ 1083. CHILD SUPPORT PROVISIONS OF THE DEFICIT REDUCTION ACT Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The proposed rule would implement provisions of the Deficit Reduction Act of 2005 related to review and adjustment of child support orders, Federal financial participation in the program, and fees for program services. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning Division, Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-9386 Email: bmatheson@acf.hhs.gov RIN: 0970-AC24 _______________________________________________________________________ 1084. PRIVATIZING FUNCTIONS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 1355 to 1356 Legal Deadline: None Abstract: Proposed rule would address States' ability to delegate decision-making authority to private agencies performing administration functions and the availability of funding for training funds under the Foster Care program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: State Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC25 _______________________________________________________________________ 1085. HEAD START TRANSPORTATION Priority: Substantive, Nonsignificant Legal Authority: 42 USC 9801 et seq CFR Citation: 45 CFR 1310 Legal Deadline: None Abstract: This proposed rule will address waiver for Head Start grantees from certain transportation requirements related to child safety restraint systems and bus monitors. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Craig Turner, Department of Health and Human Services, Administration for Children and Families, P.O. Box 1182, Washington, DC 20013 Phone: 202 205-8236 Email: cturner@acf.hhs.gov RIN: 0970-AC26 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1086. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR SERVICES (FPLS) INFORMATION Priority: Other Significant Legal Authority: 42 USC 652 to 654A; 42 USC 663; 42 USC 1302 CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70 Legal Deadline: None Abstract: The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 made far-reaching amendments to title IV-D of the Social Security Act, which governs the child support enforcement program. The Balanced Budget Act of 1997, the Adoption and Safe Families Act of 1997, and the Child Support Performance and Incentive Act of 1998 further amended title IV-D. A significant result of this legislation is [[Page 22620]] an expansion in the scope of information available to State IV-D child support enforcement agencies. The legislation has rendered obsolete or inconsistent several regulations at 45 CFR chapter III, Office of Child Support Enforcement, including the regulations on the Federal Parent Locator Service, the State Parent Locator Services, the offset of Federal payments for purposes of collecting child support, and the safeguarding of information. This regulation would update various sections in 45 CFR chapter III to reflect the statutory changes. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/14/05 70 FR 60038 NPRM Comment Period End 12/13/05 Final Action 11/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State, Tribal Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning Division, Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-9386 Email: bmatheson@acf.hhs.gov RIN: 0970-AC01 _______________________________________________________________________ 1087. CHILD CARE AND DEVELOPMENT FUND STATE MATCH PROVISIONS Priority: Other Significant Legal Authority: 42 USC 9858C CFR Citation: 45 CFR 98.16 Legal Deadline: None Abstract: This proposed rule revises the Child Care and Development Fund (CCDF) regulations to permit States to designate multiple public and/or private entities as eligible to receive private donations that may be certified as child care expenditures for purposes of receiving Federal CCDF matching funds. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/09/04 69 FR 64881 Final Action 10/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Karen Tvedt, Policy Director, Child Care Bureau, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Room 2046, Washington, DC 20447 Phone: 202 401-5130 Email: ktvedt@acf.hhs.gov RIN: 0970-AC18 _______________________________________________________________________ 1088. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF CHILD SUPPORT ORDERS Priority: Other Significant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 303 Legal Deadline: None Abstract: This rule permits States to use reasonable quantitative standards in adjusting an existing child support award amount after conducting review of the order, regardless of the method of review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/28/04 69 FR 77659 Final Action 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning Division, Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, 370 L'Enfant Promenade SW, Washington, DC 20447 Phone: 202 401-9386 Email: bmatheson@acf.hhs.gov RIN: 0970-AC19 _______________________________________________________________________ 1089. TANF WORK PROVISIONS OF THE DEFICIT REDUCTION ACT Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: Not Yet Determined Legal Deadline: Other, Statutory, June 30, 2006, Interim Final Rule. Abstract: Interim final rule will be issued to address new work requirements associated with the Deficit Reduction Act of 2005, including what counts as work activities, reporting and verifying hours of work and who should be included in the work participation rate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State, Tribal Agency Contact: Robert Shelbourne, Director of Policy, OFA/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 901 D Street, S.W., Washington, DC 20447 Phone: 202 401-5150 Email: rshelbourne@acf.hhs.gov RIN: 0970-AC27 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Administration for Children and Families (ACF) _______________________________________________________________________ 1090. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE Priority: Other Significant CFR Citation: 45 CFR 1356.60(c) Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/17/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State [[Page 22621]] Agency Contact: Kathleen McHugh Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC14 _______________________________________________________________________ 1091. HEAD START TRANSPORTATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 45 CFR 1310 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/17/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Windy Hill Phone: 202 205-8573 Email: whill@acf.hhs.gov RIN: 0970-AC16 [FR Doc. 06-2942 Filed 04-21-06; 8:45 am] BILLING CODE 4150-24-S