[April 30, 2007 (Volume 72, Number 82)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [DOCID: f:ua070408.wais] [Page 22490-22572] Department of Health and Human Services ----------------------------------------------------------------------- Part VIII ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 22490]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) _______________________________________________________________________ DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS ACTION: Semiannual Regulatory Agenda _______________________________________________________________________ SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the following inventory of the 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 rulemakings 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 these planned rulemakings. 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 27, 2007. Ann C. Agnew, Executive Secretary to the Department. Office of the Secretary--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 774 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 ---------------------------------------------------------------------------------------------------------------- 775 Shared Risk Exception to the Safe Harbor Provisions................................... 0991-AA91 776 Safe Harbor for Waiver of Beneficiary Co-insurance and Deductible Amounts for a 0991-AB16 Medicare SELECT Policy................................................................ 777 Clarification of Terms and Application of Program Exclusion Authority for Submitting 0991-AB23 Claims Containing Excessive Charges................................................... 778 Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally 0991-AB38 Qualified Health Centers Under the Anti-Kickback Statute.............................. ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 779 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 ---------------------------------------------------------------------------------------------------------------- 780 Debt Collection....................................................................... 0991-AB18 781 Salary Offset......................................................................... 0991-AB19 ---------------------------------------------------------------------------------------------------------------- [[Page 22491]] Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 782 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 ---------------------------------------------------------------------------------------------------------------- 783 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 ---------------------------------------------------------------------------------------------------------------- 784 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation 0920-AA14 Regulations........................................................................... 785 Amendments to Powered Air-Purifying Respirator Requirements for Approval of 0920-AA16 Respiratory Protection Devices........................................................ ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 786 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04 Respiratory Protective Devices........................................................ 787 Amendments to Self-Contained Breathing Apparatus Requirements for Approval of 0920-AA10 Respiratory Protective Devices........................................................ 788 Amendments to Requirements for Coal Mine Dust Personal Sampler Units.................. 0920-AA18 789 Medical Examination of Aliens......................................................... 0920-AA20 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 790 Control of Communicable Diseases, Interstate and Foreign Quarantine................... 0920-AA12 791 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...................................................................... 792 Interstate Shipment of Etiologic Agents............................................... 0920-AA19 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 793 Amendments to Performance Requirements for Chemical, Biological, Radiological, and 0920-AA17 Nuclear (CBRN) Approval of Respiratory Protection Devices............................. ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 794 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality 0910-AF71 Systems Regulations (Section 610 Review).............................................. [[Page 22492]] 795 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).................................................................. 796 Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for 0910-AF74 Internal Use: Required Alcohol Warning (Section 610 Review)........................... 797 Status of Certain Additional Over-the-Counter Drug Category II and III Active 0910-AF75 Ingredients (Section 610 Review)...................................................... 798 Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific 0910-AF76 Reagents (Section 610 Review)......................................................... 799 Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber- 0910-AF77 Containing Medical Device (Section 610 Review)........................................ 800 Financial Disclosure by Clinical Investigators (Section 610 Review)................... 0910-AF79 801 Beverages: Bottled Water (Section 610 Review)......................................... 0910-AF80 802 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 ---------------------------------------------------------------------------------------------------------------- 803 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure 0910-AC30 Regulators for Use With Medical Oxygen and Separate Classification of Oxygen Conserving Devices.................................................................... 804 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics....... 0910-AC52 805 Reporting Information Regarding Falsification of Data................................. 0910-AC59 806 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling..................................... 807 Blood Initiative--Requirements for Human Blood and Blood Components Intended for 0910-AF25 Transfusion or for Further Manufacturing Use.......................................... 808 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 809 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 810 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 811 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 812 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61 813 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63 814 Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68 815 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 816 Import Tolerances for Unapproved New Animal Drugs..................................... 0910-AF78 817 Current Good Manufacturing Practice for Combination Products.......................... 0910-AF81 818 Postmarket Safety Reporting for Combination Products.................................. 0910-AF82 819 Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma 0910-AF84 820 Revision of the Requirements for Live Vaccine Processing.............................. 0910-AF85 821 Medical Device Reporting; Electronic Submission Requirements.......................... 0910-AF86 822 Laser Products; Amendment to Performance Standard..................................... 0910-AF87 823 Electronic Registration and Listing for Devices....................................... 0910-AF88 824 Regulations on Fixed-Combination Drug Products........................................ 0910-AF89 825 Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Epinephrine] 0910-AF92 826 Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Flunisolide, 0910-AF93 Triamcinolone, Metaproterenol, Pirbuterol, Albuterol and Ipratropium in Combination, Cromolyn, and Nedocromil]............................................................. 827 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients..... 0910-AF95 828 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic 0910-AF96 Submission Requirements............................................................... 829 Proposed Revisions to 21 CFR Parts 314 and 320 To Implement Portions of Title XI of 0910-AF97 the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes............................................................................... ---------------------------------------------------------------------------------------------------------------- [[Page 22493]] Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 830 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.......................................................................... 831 Safety Reporting Requirements for Human Drug and Biological Products.................. 0910-AA97 832 Applications for FDA Approval To Market a New Drug; Complete Response Letter; 0910-AB34 Amendments to Unapproved Applications................................................. 833 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).................................................................. 834 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88 Ingredients and Dietary Supplements................................................... 835 Additional Safeguards for Children in Clinical Investigations......................... 0910-AC07 836 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14 837 Institutional Review Boards: Registration Requirements................................ 0910-AC17 838 Exception From General Requirements for Informed Consent; Request for Comments and 0910-AC25 Information........................................................................... 839 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 840 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 841 Charging for Investigational Drugs.................................................... 0910-AF13 842 Expanded Access to Investigational Drugs for Treatment Use............................ 0910-AF14 843 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an 0910-AF15 Investigational New Drug Application.................................................. 844 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............................................................. 845 Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, 0910-AF26 Including Source Plasma; and Technical Amendment...................................... 846 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27 Notification Requirements; Records and Reports........................................ 847 Infant Formula Quality Factors........................................................ 0910-AF28 848 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 849 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 850 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 851 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 852 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 853 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 854 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 855 Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of 0910-AF46 Bovine Spongiform Encephalopathy...................................................... 856 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 857 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 858 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 859 Designation of New Animal Drugs for Minor Uses or Minor Species....................... 0910-AF60 860 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species............... 0910-AF67 861 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic 0910-AF90 National Stockpile.................................................................... 862 Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and 0910-AF98 Testing, and Related Labeling......................................................... 863 Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide.... 0910-AG00 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 864 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 865 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs............. 0910-AC35 866 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism 0910-AC41 Preparedness and Response Act of 2002................................................. 867 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..... 868 Food Standards: General Principles and Food Standards Modernization................... 0910-AC54 [[Page 22494]] 869 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding 0910-AF08 of Drugs; Revision of Certain Labeling Controls....................................... 870 Health Claims......................................................................... 0910-AF09 871 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 872 Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and 0910-AF21 Condoms With Spermicidal Lubricant.................................................... 873 Food Labeling; Prominence of Calories................................................. 0910-AF22 874 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.................................................... 875 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 876 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 877 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 878 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 879 Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans 0910-AF54 and Drugs Intended for Use in Ruminants............................................... 880 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 881 Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and 0910-AF99 Pectin (Section 610 Review)........................................................... ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 882 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed 0910-AC21 Animal Populations.................................................................... 883 Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and 0910-AC32 Acceptance Criteria................................................................... 884 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 885 Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis 0910-AF49 Products.............................................................................. 886 Supplements and Other Changes to Approved New Animal Drug Applications................ 0910-AF59 887 Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation..... 0910-AF65 888 Over-the-Counter (OTC) Drug Review--Multiple Drug Products............................ 0910-AG01 ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 889 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44 Areas................................................................................. ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 890 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA57 Care Practitioners: Reporting Adverse and Negative Actions............................ 891 Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act 0906-AA65 Title IV Grants for Coordinated Services and Access to Research....................... 892 National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health 0906-AA68 Insurance Policy...................................................................... ---------------------------------------------------------------------------------------------------------------- [[Page 22495]] Health Resources and Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 893 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA41 Care Practitioners: Medical Malpractice Payments Reporting Requirements............... 894 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 0906-AA63 ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 895 Intestines Added to the Definition of Organs Covered by the Rules Governing the 0906-AA62 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 896 Healthy Tomorrow's Partnership for Children (HTPC) Program............................ 0906-AA70 ---------------------------------------------------------------------------------------------------------------- Indian Health Service--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 897 Section 506--Limitation on Charges for Services Furnished by Medicare-Participating 0917-AA07 Inpatient Hospital to Indians......................................................... ---------------------------------------------------------------------------------------------------------------- Agency for Healthcare Research and Quality--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 898 Patient Safety and Quality Improvement Act of 2005 Rules.............................. 0919-AA01 ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 899 Grants for Research Projects.......................................................... 0925-AA42 900 National Institutes of Health Loan Repayment Programs................................. 0925-AA43 901 National Library of Medicine Training Grants.......................................... 0925-AA44 902 Minority Biomedical Research Support Program.......................................... 0925-AA45 903 National Institute of Environmental Health Sciences Hazardous Substances Basic 0925-AA46 Research and Training Grants.......................................................... 904 Endowment Program..................................................................... 0925-AA47 905 Undergraduate Scholarship Program Regarding Professions Needed by the National 0925-AA48 Institutes of Health.................................................................. 906 NIH Training Grants................................................................... 0925-AA49 907 NIH Center Grants..................................................................... 0925-AA50 ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 908 Standards for a National Chimpanzee Sanctuary System.................................. 0925-AA31 ---------------------------------------------------------------------------------------------------------------- [[Page 22496]] National Institutes of Health--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 909 NIH Construction Grant................................................................ 0925-AA51 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 910 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 ---------------------------------------------------------------------------------------------------------------- 911 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01 Whistleblowers........................................................................ 912 Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional 0940-AA08 Officials, Institutional Review Board Members and Staff, Human Protections Administrators, and Investigators..................................................... 913 Human Subjects Protection Regulations: Additional Protections for Adult Individuals 0940-AA11 With Impaired Decisionmaking Capacity................................................. ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 914 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 915 Appeals of CMS or Contractor Determinations When a Provider or Supplier Fails To Meet 0938-AI49 the Requirements for Medicare Billing (CMS-6003-P2)................................... 916 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AJ17 and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2)....... 917 Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That 0938-AL26 Provide Inpatient or Residential Care (CMS-2130-P).................................... 918 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..... 0938-AL80 919 Modifications to Electronic Transactions and Code Sets (CMS-0009-P)................... 0938-AM50 920 Revisions to HIPAA Code Sets (CMS-0013-P)............................................. 0938-AN25 921 National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-NC) 0938-AN71 922 Changes to the Disclosure of Information Requirements for Quality Improvement 0938-AN73 Organizations (CMS-3156-P)............................................................ 923 Payments for Service Provided Without Charge (CMS-2489-P)............................. 0938-AO07 924 Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P)............. 0938-AO10 925 Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P).. 0938-AO17 926 Redistribution of Unexpended State Children's Health Insurance Program (SCHIP) Funds 0938-AO28 From the Appropriation for Fiscal Year 2004 (CMS-2241-NC)............................. 927 Home Health Prospective Payment System Refinements and Rate Update for Calendar Year 0938-AO32 2008 (CMS-1541-P)..................................................................... 928 Gynecological Cytology Proficiency Testing Requirements for Laboratories, Individuals, 0938-AO34 and Proficiency Testing Program Approvals (CMS-2252-P)................................ 929 State Option To Establish Non-Emergency Medical Transportation Program (CMS-2234-P)... 0938-AO45 930 Premiums and Cost Sharing (CMS-2244-P)................................................ 0938-AO47 931 State Flexibility for Medicaid Benefit Packages (CMS-2232-P).......................... 0938-AO48 932 Self-Directed Personal Assistance Services State Plan Option (CMS-2229-P)............. 0938-AO52 933 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-P)............... 0938-AO53 934 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2008 (CMS- 0938-AO63 1551-P)............................................................................... 935 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AO64 Update for FY 2008 (CMS-1545-P)....................................................... 936 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to 0938-AO65 Payment Under Part B for CY 2008 (CMS-1385-P)......................................... 937 Standards for E-Prescribing Under Medicare Part D (CMS-0016-P)........................ 0938-AO66 [[Page 22497]] 938 Exemption of Privacy Act Disclosure of Certain Investigative Materials (CMS-0029-P)... 0938-AO69 939 Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates (CMS- 0938-AO70 1533-P)............................................................................... 940 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AO71 Center Payment System Calendar Year 2008 Payment Rates (CMS-1392-P)................... 941 Hospice Wage Index for FY 2008 (CMS-1539-P)........................................... 0938-AO72 942 Policy and Technical Changes to the Medicare Prescription Drug Benefit (CMS-4130-P)... 0938-AO74 943 Special Enrollment Period and Medicare Premium Changes (CMS-4129-P)................... 0938-AO77 944 Revisions to the Medicare Advantage and Part D Prescription Drug Contract 0938-AO78 Determinations, Appeals, and Intermediate Sanctions Processes (CMS-4124-P)............ 945 Rehabilitation Services: State Plan Option (CMS-2261-P)............................... 0938-AO81 946 Waiver of Disapproval of Nurse Aide Training Program in Certain Cases and Nurse Aide 0938-AO82 Petition for Removal of Information for Singular Finding of Neglect (CMS-2266-P)...... 947 Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, 0938-AO84 Orthotics, and Supplies (DMEPOS) (CMS-6006-P)......................................... 948 Children of State Employees: Premium Assistance (CMS-2148-P).......................... 0938-AO86 949 Application of Certain Part 405 Appeals Provisions to the Part 423 Medicare 0938-AO87 Prescription Drug Appeals Process (CMS-4127-P)........................................ 950 Limitation on Contractor Liability (CMS-2264-P)....................................... 0938-AO88 951 Health Insurance Reform: Remote Security Standards (CMS-0020-P)....................... 0938-AO89 952 Establishing Additional Provider and Supplier Requirements for Enrollment Standards 0938-AO90 and Related Issues (CMS-6036-P)....................................................... 953 Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers 0938-AO91 (CMS-3178-P).......................................................................... 954 Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year 0938-AO92 Beginning July 1, 2008 (RY 2009) (CMS-1401-P)......................................... 955 Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate 0938-AO94 Updates (CMS-1393-P).................................................................. ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 956 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610 0938-AG82 Review)............................................................................... 957 Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610 0938-AJ29 Review)............................................................................... 958 Use of Restraints and Seclusion in Residential Treatment Facilities Providing 0938-AJ96 Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)............... 959 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67 Relationships (CMS-1810-RCN).......................................................... 960 Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................ 0938-AL54 961 Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........ 0938-AM73 962 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM98 (CMS-6146-F).......................................................................... 963 Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F)............................. 0938-AN09 964 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, 0938-AN14 Orthotics, and Supplies (CMS-1270-F).................................................. 965 Medicaid Prescription Drugs--Average Manufacturer Price (CMS-2238-F).................. 0938-AO20 966 Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate 0938-AO30 Updates and Policy Changes(CMS-1529-F)................................................ 967 Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year 2008 0938-AO40 (CMS-1479-N).......................................................................... 968 Group Health Plans and Health Insurance Issues Under the Newborns and Mothers Health 0938-AO43 Protection Act (CMS-4116-F)........................................................... 969 High Risk Pools (CMS-2260-IFC)........................................................ 0938-AO46 970 Targeted Case Management (CMS-2237-IFC)............................................... 0938-AO50 971 Citizenship Documentation Requirements (CMS-2257-F)................................... 0938-AO51 972 Cost Limits for Governmentally-Operated Providers (CMS-2258-F) (Section 610 Review)... 0938-AO57 973 Inpatient Hospital Deductible and Hospital and Extended Care Services Co-insurance 0938-AO61 Amounts for CY 2008 (CMS-8032-N)...................................................... 974 Part A Premiums for CY 2008 for the Uninsured Aged and for Certain Disabled 0938-AO62 Individuals Who Have Exhausted Other Entitlement (CMS-8031-N)......................... 975 Part B Monthly Actuarial Rates and Premium Rates Beginning January 1, 2008 (CMS-8033- 0938-AO68 N).................................................................................... [[Page 22498]] 976 Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs) 0938-AO73 Effective January 1, 2008 (CMS-1517-F)................................................ 977 Fiscal Year 2008 SCHIP Allotments (CMS-2262-N)........................................ 0938-AO76 978 Health Care-Related Tax Revisions (CMS-2275-P)........................................ 0938-AO80 979 Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS- 0938-AO83 4094-F5).............................................................................. 980 Fee Schedule for Payment of Ambulance Services--Update for CY 2008 (CMS-1552-N)....... 0938-AO85 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 981 Hospice Care Conditions of Participation (CMS-3844-F) (Section 610 Review)............ 0938-AH27 982 Electronic Claims Attachments Standards (CMS-0050-F).................................. 0938-AK62 983 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family 0938-AL88 and Medical Leave Act (CMS-2158-F).................................................... 984 Prior Determination Process for Certain Items and Services (CMS-6024-F)............... 0938-AN10 985 Medicare Secondary Payer Amendments (CMS-6272-F)...................................... 0938-AN27 986 Termination of Non-Random Prepayment Review (CMS-6022-F).............................. 0938-AN31 987 Limitation on Recoupment of Provider and Supplier Overpayments (CMS-6025-F)........... 0938-AN42 988 Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325- 0938-AN58 F).................................................................................... 989 Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of 0938-AN72 Interest Requirements (CMS-6030-F).................................................... 990 Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................ 0938-AN77 991 Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-F) 0938-AN79 992 Use of Repayment Plans (CMS-6032-F)................................................... 0938-AO27 993 Identification of Backward Compatible Version of Adopted Standard for E-Prescribing 0938-AO42 and the Medicare Prescription Drug Program (Version 8.1) (CMS-0018-F)................. 994 Prohibition of Mid-Year Benefit Enhancements for Medicare Advantage Organizations 0938-AO54 Offering Plans in Calendar Year 2007 and Subsequent Calendar Years (CMS-4121-F)....... 995 Medicare Part D Data (CMS-4119-F)..................................................... 0938-AO58 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 996 Hospital Conditions of Participation: Requirements for Approval and Reapproval of 0938-AH17 Transplant Centers To Perform Organ Transplants (CMS-3835-F).......................... 997 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)............. 0938-AM87 998 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)................................................... 999 Nondiscrimination in Health Coverage in the Group Market (CMS-4081-F)................. 0938-AN29 1000 Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)................... 0938-AN30 1001 Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F). 0938-AN83 1002 Medicare Graduate Medical Education Affiliation Provisions for Teaching Hospitals in 0938-AO35 Certain Emergency Situations (CMS-1531-F2)............................................ 1003 Notification Procedures for Hospital Discharges (CMS-4105-F).......................... 0938-AO41 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1004 Developmental Disabilities and Bill of Rights Act..................................... 0970-AC07 1005 Care and Placement of Unaccompanied Alien Children.................................... 0970-AC20 [[Page 22499]] 1006 Adoption and Foster Care Analysis and Reporting System................................ 0970-AC23 1007 Privatizing Functions................................................................. 0970-AC25 1008 Limitation on Use of Funds Made Available To Monitor and Combat Trafficking in Persons 0970-AC28 1009 Child Care and Development Fund Error Rate Reporting.................................. 0970-AC29 1010 Abstinence Education.................................................................. 0970-AC30 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1011 Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) 0970-AC01 Information........................................................................... 1012 Cost Allocation Methodology Applicable to the Temporary Assistance for Needy Families 0970-AC15 Program............................................................................... 1013 Child Care and Development Fund State Match Provisions................................ 0970-AC18 1014 Chafee National Youth in Transition Database.......................................... 0970-AC21 1015 Medical Support....................................................................... 0970-AC22 1016 Child Support Provisions of the Deficit Reduction Act................................. 0970-AC24 1017 TANF Work Provisions of the Deficit Reduction Act..................................... 0970-AC27 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1018 Head Start Transportation............................................................. 0970-AC26 ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 774. 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''; date various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e-mail communications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/07 NPRM Comment Period End 12/00/07 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 [[Page 22500]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 775. 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 10/00/07 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 _______________________________________________________________________ 776. SAFE HARBOR FOR WAIVER OF BENEFICIARY CO-INSURANCE 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 10/00/07 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 _______________________________________________________________________ 777. 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 Abstract: This rule would amend the Office of Inspector General's exclusion regulations at 42 CFR part 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 10/00/07 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 _______________________________________________________________________ 778. 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 exists. 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 09/00/07 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 [[Page 22501]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of the Secretary (OS) _______________________________________________________________________ 779. 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 ________________________________________________________________________ Final Action 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) _______________________________________________________________________ 780. DEBT COLLECTION Priority: Other Significant CFR Citation: 45 CFR 30 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 03/08/07 72 FR 10404 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jeffrey S. Davis Phone: 202 619-0150 RIN: 0991-AB18 _______________________________________________________________________ 781. SALARY OFFSET Priority: Other Significant CFR Citation: 5 CFR 550; 45 CFR 33 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 03/08/07 72 FR 10419 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jeffrey S. Davis Phone: 202 619-0150 RIN: 0991-AB19 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 782. 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, 42 USC 290jj to 290jj-2 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 07/00/07 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 Health Services Administration, Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2619 RIN: 0930-AA10 [[Page 22502]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 783. 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 07/00/07 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) _______________________________________________________________________ 784. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/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: 42 CFR 71 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 parts 71.51 and 71.56). The input received from stakeholders via the ANPRM will guide CDC in drafting a rule proposal 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Federalism: Undetermined Agency Contact: Jennifer Brooks, Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Infectious Diseases (NE E-03), 1600 Clifton Road NE., Atlanta, GA 30333 Phone: 404 639-7048 RIN: 0920-AA14 _______________________________________________________________________ 785. 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 03/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Federalism: Undetermined Agency Contact: Frank Palya, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 Fax: 412 386-4089 Email: fpalya@cdc.gov Bill Hoffman, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 Fax: 412 386-4089 Email: whoffman@cdc.gov RIN: 0920-AA16 [[Page 22503]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 786. 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 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Bill Hoffman, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 Fax: 412 386-4089 Email: whoffman@cdc.gov RIN: 0920-AA04 _______________________________________________________________________ 787. 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 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tim Rehak, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 Fax: 412 386-4089 Email: trehak@cdc.gov RIN: 0920-AA10 _______________________________________________________________________ 788. 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 of 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 1970s. 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 09/00/07 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 _______________________________________________________________________ 789. [bull] MEDICAL EXAMINATION OF ALIENS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: 42 CFR 34 Legal Deadline: None Abstract: CDC is changing the definition of ``communicable disease of public health significance'' in 42 CFR part 34.2(b). We are taking this action to afford CDC the maximum flexibility it needs to identify and respond to newly emerging and reemerging diseases. The existing definition is outdated, and immediate changes are urgently needed to improve the U.S. Government's ability to prevent the importation of infectious diseases that are currently causing severe illness and death in regions of the world where large numbers of U.S.-bound immigrants and refugees reside. Annually, approximately 500,000 immigrants and refugees enter the United States to reside permanently. The majority arrive from Asia, Africa, and Central and South America, regions with recently reported outbreaks of emerging infectious diseases. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No 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 (NE E-03), 1600 Clifton Road NE., Atlanta, GA 30333 Phone: 404 639-7048 RIN: 0920-AA20 [[Page 22504]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 790. 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 to 71 Legal Deadline: None Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC maintains quarantine stations at eight major airports with quarantine inspectors who respond to reports of diseases from carriers. According to the statutory scheme, the President determines through Executive order which diseases may subject individuals to quarantine. The current disease list, which was last updated in April 2005, includes cholera, diphtheria, tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, and Severe Acute Respiratory Syndrome (SARS) and influenza caused by novel or reemergent influenza virus that are causing, or have the potential to cause, a pandemic. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/30/05 70 FR 71892 Final Action 07/00/07 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 _______________________________________________________________________ 791. 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 to 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 Final Action 07/00/07 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, MS C-46, 4676 Columbia Parkway, Cincinnati, OH 45226 Phone: 513 533-6825 RIN: 0920-AA13 _______________________________________________________________________ 792. INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: 42 CFR 72 Legal Deadline: None Abstract: HHS/CDC proposes to rescind part 72 of title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule will eliminate duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS/CDC replaced those sections of part 72 that deal with select biological agents and toxins with a new set of regulations found in part 73 of title 42. HHS/CDC anticipates that rescission of part 72 will alleviate confusion and reduce the regulatory burden with no adverse impact on public health and safety. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/02/07 72 FR 92 Interim Final Rule 07/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Janet K. Nicholson, Associate Director, Lab Science, Department of Health and Human Services, Centers for Disease Control and Prevention, Room 5131, Clifton Building 16, Atlanta, GA 30329-4018 Phone: 404 639-3945 RIN: 0920-AA19 [[Page 22505]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 793. 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 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 03/00/09 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Bill Hoffman, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 Fax: 412 386-4089 Email: whoffman@cdc.gov RIN: 0920-AA17 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 794. 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 is soliciting 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 04/00/07 End Review 12/00/07 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF71 _______________________________________________________________________ 795. 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 sec. 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 [[Page 22506]] 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 12/01/06 End Review 12/00/07 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF73 _______________________________________________________________________ 796. 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 that 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 proposed to remove section 201.322 in the Federal Register on December 26, 2006, (71 FR 77314). FDA will consider the comments received in response to that proposal and, in addition, 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 12/01/06 End Review 12/00/07 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF74 _______________________________________________________________________ 797. 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 part 310.545) codifies a final rule that was issued stating certain first aid antiseptic, vaginal contraceptive, and antimicrobial diaper rash ingredients in over-the- counter (OTC) drug products are not generally recognized as safe and effective and are misbranded. This rule took into consideration the reports and recommendations of various OTC drug advisory review panels and public comment on proposed Agency regulations. Based on the absence of substantive comments in opposition to the Agency's proposed nonmonograph status for various ingredients, as well as the failure of interested parties to submit new data or information to FDA, the Agency determined that the presence of the subject ingredients in an OTC drug product would result in that product not being generally recognized as safe and effective and would result in misbranding. FDA 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 [[Page 22507]] 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 12/01/06 End Review 12/00/07 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF75 _______________________________________________________________________ 798. 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 two regulations in part 809. The purpose of this review is to determine if 21 CFR part 809.10 and 809.30 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities. FDA is soliciting and will consider comments on the following: 1) The continued need for 21 CFR part 809.10 and 809.30; 2) the nature of complaints or comments received concerning 21 CFR part 809.10 and 809.30; 3) the complexity of 21 CFR part 809.10 and 809.30; 4) the extent to which 21 CFR part 809.10 and 809.30 overlap, duplicate, or conflict 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 21 CFR part 809.10 and 809.30. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 04/00/07 End Review 11/00/07 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF76 _______________________________________________________________________ 799. 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 of the regulations in part 801 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine, consistent with stated objectives and applicable statutes, whether the regulations in part 801 should be continued without change, amended, or rescinded in order 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 regulation; 2) the nature of complaints or comments received concerning the regulation; 3) the complexity of the regulation; 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 the regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/30/97 62 FR 51021 Final Action Effective 09/30/98 End Review of Current Regulation12/00/07 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 [[Page 22508]] Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF77 _______________________________________________________________________ 800. 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 360; 21 USC 360c to 360j; 21 USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 21 USC 379; 42 USC 262 CFR Citation: 21 CFR 54 Legal Deadline: Other, Statutory, February 2, 2006, Planned section 610 review. Abstract: FDA is undertaking a review of 21 CFR part 54, under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in part 54 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulations in part 54; (2) the nature of complaints or comments received concerning the regulations in part 54; (3) the complexity of the regulations in part 54, (4) the extent to which the regulations in part 54 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in part 54. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/01/06 End Review 12/00/07 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: howard.mullerjr@fda.hhs.gov Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, 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, Center for Devices and Radiological Health, Corp Room 130F (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 _______________________________________________________________________ 801. 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 part 165.110) describes requirements for identity and quality standards for bottled water. FDA is undertaking a review of section 165.110 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in section 165.110 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, 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 03/01/07 End Review 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Richard A. Williams, Director, Division of Social Sciences, ORP, CFSAN, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS- 725), 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 _______________________________________________________________________ 802. 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 part 101.54) describes the requirements for when the terms ``high potency'' and ``antioxidant'' may be used on the label or in the labeling of foods, including dietary supplements. Section 101.60 (21 CFR part 101.60) describes the requirements for when the terms ``low [[Page 22509]] 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 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 12/01/06 End Review 09/00/07 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 Social Sciences, ORP, CFSAN, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS- 725), 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) _______________________________________________________________________ 803. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN AND SEPARATE CLASSIFICATION OF OXYGEN CONSERVING DEVICES Priority: Routine and Frequent Legal Authority: 21 USC 351; 21 USC 360; 21 USC 360(c); 21 USC 360e; 21 USC 360j; 21 USC 371 CFR Citation: 21 CFR 868.2700; 21 CFR 868.2750; 21 CFR 868.5905; 21 CFR 5910 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, establish a separate classification for oxygen conserving devices, and establish a special control for these devices to address problems of fire and explosion associated with use of these devices. The special control would be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the standard identified in the special controls guidance document would be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the Act). The agency believes it is taking a least burdensome approach for industry. The requirements of the proposed rule would be phased-in to minimize the cost of complying with the special control. FDA seeks to reclassify these devices under section 513(e)(1) of the act (21 U.S.C. 360c(e)(1)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/27/07 72 FR 8643 NPRM Comment Period End 05/29/07 Final Action 01/00/09 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AC30 _______________________________________________________________________ 804. 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; 21 CFR 314.96 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. The proposal would also require that FDA periodically issue guidance on the use of standardized data structure, terminology, and code sets (e.g., the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Martha Nguyen, Regulatory Counsel, Department of [[Page 22510]] Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AC52 _______________________________________________________________________ 805. 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 16.1; 21 CFR 58.11; 21 CFR 58.12; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 101.70; 21 CFR 170.101; 21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.56; 21 CFR 511.1; 21 CFR 571.1; 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 04/00/07 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, Suite 1101 (HFD-7), 5515 Security Lane, 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 _______________________________________________________________________ 806. 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; 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 part 201.56, 201.57, and 201.80). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 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: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Suite 1101, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF11 _______________________________________________________________________ 807. 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 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Brenda Friend, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1410 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF25 _______________________________________________________________________ 808. 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; 21 USC 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 [[Page 22511]] 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) 12/26/06 71 FR 77314 NPRM Comment Period End 05/25/07 NPRM (Amendment) (Overindulgence/ Hangover) 10/00/07 NPRM (Amendment) (Pediatric) 12/00/07 NPRM (Amendment) (Combinations with Sodium Bicarbonate) 12/00/07 NPRM (Amendment) (Safety) 12/00/07 Final Action (Internal Analgesics) 06/00/08 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 809. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS Priority: Other Significant 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 ________________________________________________________________________ ANPRM (Sunscreen and Insect Repellent) 02/22/07 72 FR 7941 NPRM (Sunscreen and Insect Repellent) 04/00/07 NPRM (UVA/UVB) 04/00/07 ANPRM Comment Period End 05/23/07 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 810. 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 phenyl propanolamine, and the other action addresses the ingredient benzocaine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl propanolamine) 12/22/05 70 FR 75988 NPRM (Benzocaine) 12/00/07 Final Action (Phenyl propanolamine) 12/00/08 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 [[Page 22512]] Services, Food and Drug Administration, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 811. 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) 10/00/07 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 (HFD-560), 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF56 _______________________________________________________________________ 812. 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 342; 21 USC 343; 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 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 02/00/08 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), Room 14C-17, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AF61 _______________________________________________________________________ 813. 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 12/00/07 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov Related RIN: Related to 0910-AC82 RIN: 0910-AF63 _______________________________________________________________________ 814. 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 [[Page 22513]] 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) 12/00/07 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF68 _______________________________________________________________________ 815. 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 health care, food handlers, and health care antiseptic products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Food Handlers) 12/00/07 Final Action 12/00/08 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF69 _______________________________________________________________________ 816. IMPORT TOLERANCES FOR UNAPPROVED NEW ANIMAL DRUGS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 360b(a)(6); 21 USC 371 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: FDA plans to publish a proposed rule and a direct final 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 United States. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 Direct Final Rule 08/00/07 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, Rm. 169 (MPN-4, HFV-6), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9019 Fax: 240 276-9101 Email: george.haibel@fda.hhs.gov RIN: 0910-AF78 _______________________________________________________________________ 817. 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: 21 CFR 4, subchapter A 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 parts 210 and 211 will generally meet the requirements of the device quality system regulations in 21 CFR part 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 [[Page 22514]] ensure consistency and appropriateness in the regulation of combination products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/07 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 Administration, Office of Combination Products, Suite 200 (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 20855 Phone: 301 427-1934 Fax: 301 427-1935 Email: james.cohen@fda.hhs.gov RIN: 0910-AF81 _______________________________________________________________________ 818. 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: 21 CFR 4, subchapter B 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. 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 11/00/07 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, Suite 200 (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 20855 Phone: 301 427-1934 Fax: 301 427-1935 Email: leigh.hayes@fda.hhs.gov RIN: 0910-AF82 _______________________________________________________________________ 819. REVISIONS TO THE REQUIREMENTS APPLICABLE TO BLOOD, BLOOD COMPONENTS, AND SOURCE PLASMA Priority: Routine and Frequent 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; 21 USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 606.3; 21 CFR 607.65; 21 CFR 610.53; 21 CFR 640.4; 21 CFR 640.21; 21 CFR 640.22; 21 CFR 640.24; 21 CFR 640.25; 21 CFR 640.30; 21 CFR 640.32; 21 CFR 640.34; 21 CFR 640.64 Legal Deadline: None Abstract: FDA is issuing this rulemaking to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. Some examples of the amendments include revisions to the dating period for Platelets, Red Blood Cells Deglycerolized, and Red Blood Cells Frozen; storage temperatures for blood; and pooling and pH level of Platelets. FDA is also removing two obsolete provisions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM--Companion to Direct Final Rule 06/00/07 Direct Final Rule 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF84 _______________________________________________________________________ 820. REVISION OF THE REQUIREMENTS FOR LIVE VACCINE PROCESSING Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25 CFR Citation: 21 CFR 600.11 Legal Deadline: None Abstract: This rulemaking is being issued to provide options to the existing requirement for processing live vaccines. FDA is amending the regulations due to advances in facility, system, and equipment design, and in sterilization technologies that will allow live vaccine processing to be performed in multiproduct manufacturing areas. We are amending this regulation to permit manufacturers greater flexibility in the use of their buildings and equipment for processing live vaccines when appropriate controls exist and have been demonstrated to be effective in preventing cross contamination of other products and areas. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. [[Page 22515]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM--Companion to Direct Final Rule 08/00/07 Direct Final Rule 08/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Nathaniel L. Geary, Consumer Safety Officer, 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: nathaniel.geary@fda.hhs.gov RIN: 0910-AF85 _______________________________________________________________________ 821. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS Priority: Other Significant Legal Authority: 21 USC 352; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 803 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulations to require that reports submitted to the Agency by persons subject to mandatory reporting requirements be transmitted electronically in a form that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/07 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF86 _______________________________________________________________________ 822. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD Priority: Substantive, Nonsignificant Legal Authority: 21 USC 360hh-ss CFR Citation: 21 CFR 1010; 21 CFR 1040 Legal Deadline: None Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA's performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard (to achieve harmonization and reflect current science), include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/08 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF87 _______________________________________________________________________ 823. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES Priority: Other Significant Legal Authority: PL 107-188, sec 321; 21 USC 360(p) CFR Citation: 21 CFR 807 Legal Deadline: None Abstract: FDA is proposing to amend the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the new requirements in section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 510(p) of the Federal Food, Drug, and Cosmetic Act, which was added by section 207 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). This proposed rule would require domestic and foreign device establishments to submit registration and listing data electronically via the Internet using FDA's Unified Registration and Listing System. This proposed rule would convert the registration and listing process to a paperless process. For those companies that do not have access to the web, FDA would offer an avenue by which they can register, list, and update information with a paper submission. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/07 Regulatory Flexibility Analysis Required: No 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF88 _______________________________________________________________________ 824. REGULATIONS ON FIXED-COMBINATION DRUG PRODUCTS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 371 CFR Citation: 21 CFR 300.50 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations on fixed- combination prescription and OTC [[Page 22516]] drugs. The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects. The proposed rule would create a single set of regulations for prescription and OTC combination drugs and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met, and it would clarify application of FDA's combination policy to certain natural source drugs and certain synthetic drugs. The regulation would also establish circumstances under which the agency might waive the combination drug requirements for a particular drug. The proposed rule will also address the issue of co-packaging. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/08 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov RIN: 0910-AF89 _______________________________________________________________________ 825. USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE DESIGNATIONS [EPINEPHRINE] 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 331; 21 USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq CFR Citation: 21 CFR 1.25 (Revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 82.66 Legal Deadline: None Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR part 2.125 as ``essential uses.'' This proposed rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing epinephrine. Under the provisions of this proposed rule these MDIs would have to be removed from the market. This proposed rule is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances That Deplete the Ozone Layer. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: Undetermined 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, Suite 1101 (HFD- 7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AF92 _______________________________________________________________________ 826. USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE DESIGNATIONS [FLUNISOLIDE, TRIAMCINOLONE, METAPROTERENOL, PIRBUTEROL, ALBUTEROL AND IPRATROPIUM IN COMBINATION, CROMOLYN, AND NEDOCROMIL] 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 331; 21 USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq CFR Citation: 21 CFR 1.25 (Revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 82.66 Legal Deadline: None Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR part 2.125 as ``essential uses.'' This proposed rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Under the provisions of this proposed rule these MDIs would have to be removed from the market. This proposed rule is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances That Deplete the Ozone Layer. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: No 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, Suite 1101 (HFD- 7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AF93 _______________________________________________________________________ 827. [bull] STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II ACTIVE INGREDIENTS 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 Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This proposed rule is part of FDA's ongoing review of OTC drug products. [[Page 22517]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/07 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. Agency Contact: Walter Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF95 _______________________________________________________________________ 828. [bull] POSTMARKETING SAFETY REPORTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS: ELECTRONIC SUBMISSION REQUIREMENTS 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 355a; 21 USC 356; 21 USC 356a; 21 USC 356b; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 375 CFR Citation: 21 CFR 310.305; 21 CFR 314.80; 21 CFR 314.98; 21 CFR 600.80; 21 CFR 600.81 Legal Deadline: None Abstract: The proposed rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products (21 CFR part 310.305, 314.80, 314.98, 600.80, and 600.81) to require that safety reports submitted to the Agency by persons subject to mandatory reporting requirements be transmitted electronically in a form that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed rule creates a requirement for manufacturers to submit postmarketing safety reports electronically in a compatible format using either direct submission or a web-based form. The rule will allow the Agency to review safety reports more quickly, and to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The proposed amendments would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and ICH standards for the electronic submission of safety information. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 11/05/98 63 FR 59746 ANPRM Comment Period End 02/03/99 NPRM 11/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Federalism: Undetermined Agency Contact: Marguerita B. Sims, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101, (HFD-007), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: marguerita.sims@fda.hhs.gov RIN: 0910-AF96 _______________________________________________________________________ 829. [bull] PROPOSED REVISIONS TO 21 CFR PARTS 314 AND 320 TO IMPLEMENT PORTIONS OF TITLE XI OF THE MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION ACT OF 2003 AND OTHER CHANGES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-173, title XI; 21 USC 355; 21 USC 371 CFR Citation: 21 CFR 314.3; 21 CFR 314.50; 21 CFR 314.52; 21 CFR 314.53; 21 CFR 314.60; 21 CFR 314.70; 21 CFR 314.94; 21 CFR 314.95; 21 CFR 314.96; 21 CFR 314.97; 21 CFR 314.101; 21 CFR 314.105; 21 CFR 314.107; 21 CFR 314.108; 21 CFR 320.1; 21 CFR 320.23 Legal Deadline: None Abstract: Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) (MMA) amended provisions of the Federal Food, Drug, and Cosmetic Act (the act) that govern the approval of new drug applications (NDAs) described by section 505(b)(2) of the act (505(b)(2) applications) and abbreviated new drug applications (ANDAs) described by section 505(j) of the act. This proposed rule would implement portions of Title XI of the MMA. These provisions are those: 1) That require applicants to notify drug sponsors who have patents listed in the FDA' Orange Book of the application; 2) that apply to the period of delay (a 30-month stay) before approval of certain applications; 3) that control the submission of amendments and supplements to certain applications, and, 4) define the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Janice L. Weiner, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101 (HFD-007), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: janice.weiner@fda.hhs.gov RIN: 0910-AF97 [[Page 22518]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 830. 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 rule will 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 rule will 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 rule will also require that the NDC number appear on certain drug labels. In addition, FDA will 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 08/29/06 71 FR 51276 NPRM Comment Period End 02/26/07 72 FR 5944 Final Action 03/00/08 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: howard.mullerjr@fda.hhs.gov RIN: 0910-AA49 _______________________________________________________________________ 831. 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 to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/14/03 68 FR 12406 NPRM Comment Period Extended 06/18/03 NPRM Comment Period End 07/14/03 NPRM Comment Period Extension End 10/14/03 Comment Review End 04/00/07 Final Action 03/00/08 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AA97 _______________________________________________________________________ 832. 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 10/00/07 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov RIN: 0910-AB34 [[Page 22519]] _______________________________________________________________________ 833. 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 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, 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 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Related to 0910-AB26 RIN: 0910-AB76 _______________________________________________________________________ 834. 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 12/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1209 Fax: 301 436-2964 Email: linda.kahl@fda.hhs.gov RIN: 0910-AB88 _______________________________________________________________________ 835. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS 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 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 12/00/07 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 [[Page 22520]] Drug Administration, Center for Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC07 _______________________________________________________________________ 836. 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 five-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 12/00/07 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, Director, Department of Health and Human Services, Food and Drug Administration, Division of Dairy and Egg Safety (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 _______________________________________________________________________ 837. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS Priority: Info./Admin./Other Legal Authority: 21 USC 321; 21 USC 346 to 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/06/04 69 FR 40556 Final Action 03/00/08 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 [[Page 22521]] Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AC17 _______________________________________________________________________ 838. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST FOR COMMENTS AND INFORMATION Priority: Other Significant 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 352; 21 USC 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 50.23 Legal Deadline: None Abstract: This 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 06/07/06 71 FR 32827 Final Action 04/00/07 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 _______________________________________________________________________ 839. 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 01/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: quynh.h.nguyen@fda.hhs.gov RIN: 0910-AC53 _______________________________________________________________________ 840. 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 08/00/07 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, Suite 1101 (HFD-7), 5515 Security Lane, 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 _______________________________________________________________________ 841. CHARGING FOR INVESTIGATIONAL DRUGS Priority: Other Significant 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 rule will amend FDA's investigational new drug regulation [[Page 22522]] concerning charging for investigational drugs. The rule will clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, set forth criteria for charging for an investigational drug for the different types of treatment uses described in the Agency's rule on expanded access to investigational drugs for treatment use, and clarify what costs can be recovered for an investigational drug. The rule is intended to permit charging for a broader range of investigational uses than is explicitly permitted in current regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/14/06 71 FR 75168 NPRM Comment Period End 03/14/07 Final Action 03/00/08 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 Evaluation and Research, Suite 1101, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF13 _______________________________________________________________________ 842. 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 treatment IND. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/14/06 71 FR 75147 NPRM Comment Period End 03/14/07 Final Action 03/00/08 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, Suite 1101, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF14 _______________________________________________________________________ 843. 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 part 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/10/04 69 FR 32467 Final Action 07/00/07 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: brian.pendleton@fda.hhs.gov RIN: 0910-AF15 _______________________________________________________________________ 844. 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 amending certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act (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), would not allow registered blood establishments or hemophilia treatment centers that provide health care services to concurrently distribute drugs, including blood derivatives. The effective date of those provisions of that rule is delayed until December 1, 2008, [[Page 22523]] as published on November 13, 2006 (71 FR 66108)--final rule; the applicability date was delayed in order to consider comments on the proposed rule published in the Federal Register February 1, 2006 (71 FR 5200). FDA is amending the final rule to allow registered blood establishments that provide health care services related to their activities as blood establishments and certain hemophilia treatment centers to also distribute certain products, including blood derivatives. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/01/06 71 FR 5200 NPRM Comment Period End 05/02/06 Delay of Applicability 11/13/06 71 FR 66108 Final Action 03/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF16 _______________________________________________________________________ 845. 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 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264 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 10/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Brenda Friend, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1410 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF26 _______________________________________________________________________ 846. 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. On August 1, 2006, FDA reopened the comment period on selected topics. The comment period closed on September 15, 2006. 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 NPRM Comment Period Reopened 08/01/06 71 FR 43392 NPRM Comment Period End 09/15/06 Final Action 02/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1459 Email: benson.silverman@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF27 _______________________________________________________________________ 847. 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 [[Page 22524]] comment period was extended on June 27, 2003, to end on August 26, 2003. The comment period was reopened on August 1, 2006, to end on September 15, 2006. 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 NPRM Comment Period Reopened 08/01/06 71 FR 43392 NPRM Comment Period End 09/15/06 Final Action 02/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1459 Email: benson.silverman@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF28 _______________________________________________________________________ 848. 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; 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 combination products containing an oral bronchodilator. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40232 Final Action (Technical Amendment) 04/00/07 Final Action 06/00/07 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 849. 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 phenyl propanolamine. 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) 08/01/06 71 FR 83358 Final Action (Phenyl propanolamine) 12/00/07 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 850. 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; 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 external analgesic drug products. [[Page 22525]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/07 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 851. 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; 21 USC 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) 12/12/06 71 FR 74474 Final Action 12/00/07 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 852. 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; 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 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 (Granular Psyllium)03/29/07 72 FR 14669 Final Action (Laxative Drug Products) 12/00/07 NPRM (Professional Labeling) 06/00/08 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 853. 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 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) 12/00/07 Final Action (Fever Blisters/ Cold Sores) 06/00/07 Final Action (Diaper Rash) 12/00/07 Final Action (Aluminum Acetate) (Technical Amendment) 06/00/07 [[Page 22526]] 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 854. 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) 04/00/07 NPRM (Vaginal Contraceptive Drug Products) 12/00/07 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 855. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 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 03/00/08 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 _______________________________________________________________________ 856. 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 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 12/00/07 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 (HFD-560), [[Page 22527]] 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF51 _______________________________________________________________________ 857. 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) 12/00/07 Final Action (Sodium Bicarbonate Labeling) 12/00/07 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 (HFD-560), 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF52 _______________________________________________________________________ 858. 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 08/29/06 71 FR 51146 NPRM Comment Period End 12/27/06 Final Action 12/00/07 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 (HFD-560), 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF53 _______________________________________________________________________ 859. 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, 2008. Final, Statutory, August 2, 2009. 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 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 7 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 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 comments received. This is a voluntary program for animal drug sponsors. 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 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Bernadette Dunham, 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 (HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9000 [[Page 22528]] Fax: 240 276-9001 Email: bernadette.dunham@fda.hhs.gov RIN: 0910-AF60 _______________________________________________________________________ 860. 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, 2009. Final, Statutory, August 2, 2010. Abstract: This rule is being issued in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The 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 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 08/22/06 71 FR 48840 NPRM Comment Period Extended 10/02/06 71 FR 57892 NPRM Comment Period End 12/20/06 Final Action 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Bernadette Dunham, 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 (HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9000 Fax: 240 276-9001 Email: bernadette.dunham@fda.hhs.gov RIN: 0910-AF67 _______________________________________________________________________ 861. EXCEPTIONS OR ALTERNATIVES TO LABELING REQUIREMENTS FOR PRODUCTS HELD BY THE STRATEGIC NATIONAL STOCKPILE Priority: Other Significant Legal Authority: 15 USC 1451 to 1561; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 and 356; 21 USC 358; 21 USC 360; 21 USC 371 to 375; 21 USC 379; 21 USC 381 and 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 262 to 264; 42 USC 271 CFR Citation: 21 CFR 201; 21 CFR 312; 21 CFR 314; 21 CFR 601; 21 CFR 610; 21 CFR 801; 21 CFR 807; 21 CFR 809; 21 CFR 812; 21 CFR 814 Legal Deadline: None Abstract: FDA is issuing regulations to permit FDA Center Directors to grant an exception or alternative to certain regulatory labeling provisions applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with such requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 10/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF90 _______________________________________________________________________ 862. [bull] HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS; DONOR SCREENING AND TESTING, AND RELATED LABELING Priority: Other Significant Legal Authority: 42 USC 264 CFR Citation: 21 CFR 1271.55; 21 CFR 1271.80; 21 CFR 1271.90; 21 CFR 1271.290; 21 CFR 1271.370 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is issuing a final rule, after issuing an interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps); and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 05/25/05 70 FR 29949 Final Action 12/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Brenda Friend, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1410 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF98 [[Page 22529]] _______________________________________________________________________ 863. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--ACNE DRUG PRODUCTS CONTAINING BENZOYL PEROXIDE 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 will address acne drug products containing benzoyl peroxide. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/07 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. Agency Contact: Walter Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AG00 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 864. 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 Evaluation and Research, Suite 1101, 5515 Security Lane, Rockville, MD 20857 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC23 _______________________________________________________________________ 865. 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 06/00/08 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC35 _______________________________________________________________________ 866. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Other Significant 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 22530]] 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 (the act), 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 regulation 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 the Bureau of Customs and Border Protection (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 09/00/08 Regulatory Flexibility Analysis Required: No 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 _______________________________________________________________________ 867. 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, Center for Food Safety and Applied Nutrition (HFS-830), 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 _______________________________________________________________________ 868. 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, [[Page 22531]] 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 _______________________________________________________________________ 869. 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 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, Suite 1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: howard.mullerjr@fda.hhs.gov RIN: 0910-AF08 _______________________________________________________________________ 870. 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: Julie Moss, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2373 Fax: 301 436-2639 Email: julie.moss@fda.hhs.gov RIN: 0910-AF09 [[Page 22532]] _______________________________________________________________________ 871. 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 Agency published a proposed rule on January 30, 2006, to require the label declaration of all foods and cosmetics containing the color additives cochineal extract and carmine in order to protect consumers with allergies to these additives. This proposal was issued in response to adverse event reports received by FDA and to a citizen petition submitted to FDA. The comment period ended on May 1, 2006. FDA intends to issue a final rule after reviewing comments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/30/06 71 FR 4839 NPRM Comment Period End 05/01/06 Final Action To Be Determined 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 _______________________________________________________________________ 872. 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 part 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 NPRM Comment Period End 02/13/06 Final Action 01/00/09 Regulatory Flexibility Analysis Required: No 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), PI50 RM150F, 1350 Piccard Drive, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF21 _______________________________________________________________________ 873. 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 Federalism: Undetermined Agency Contact: Jill Kevala, Chemist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), 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 _______________________________________________________________________ 874. 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 [[Page 22533]] ANPRM Comment Period End 06/20/05 NPRM To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Mary Brandt, Supervisor Team Leader, Department of Health and Human Services, Food and Drug Administration, HFS-840, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1788 Fax: 301 436-2635 Email: mary.brandt@fda.hhs.gov RIN: 0910-AF23 _______________________________________________________________________ 875. 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) 06/00/08 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 (HFD-560), 5600 Fishers Lane, 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 _______________________________________________________________________ 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) 12/00/08 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 (HFD-560), 5600 Fishers Lane, 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--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) 06/00/08 Final Action 06/00/08 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 (HFD-560), 5600 Fishers Lane, 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 [[Page 22534]] _______________________________________________________________________ 878. 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 and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. 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 (Amendments) 09/07/05 70 FR 53063 Interim Final Rule (Amendments) Comment Period End 11/07/05 Final Action 04/00/08 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 _______________________________________________________________________ 879. 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 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 01/12/07 72 FR 1582 NPRM Comment Period End 03/13/07 NPRM Comment Period Reopened 03/30/07 Final Action 10/00/08 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, Room 14C-17, HF-23, 5600 Fishers Lane, 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 _______________________________________________________________________ 880. 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 [[Page 22535]] 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) 06/00/08 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 Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF70 _______________________________________________________________________ 881. [bull] FOOD LABELING; SERVING SIZES; REFERENCE AMOUNT FOR BAKING POWDER, BAKING SODA, AND PECTIN (SECTION 610 REVIEW) Priority: Routine and Frequent 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 Legal Deadline: Other, Statutory, March 16, 2009, Planned section 610 review. Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition labeling regulations for the reference amount customarily consumed per eating occasion for the food category ``Baking powder, baking soda, pectin.'' Section 101.12 (21 CFR part 101.12) includes 1/8 teaspoon (tsp) as an additional allowable household measure. FDA is undertaking a review of sections 101.9 and 101.12 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.9 and 101.12 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulations in sections 101.9 and 101.12; (2) the nature of complaints or comments received concerning the regulations in sections 101.9 and 101.12; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.9 and 101.12 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.9 and 101.12. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/00/08 End Review 03/00/09 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: David Zorn, Lead Economist, Department of Health and Human Services, Food and Drug Administration, HFS-020, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1825 Fax: 301 436-2505 Email: david.zorn@fda.hhs.gov RIN: 0910-AF99 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 882. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS DERIVED FROM EXPOSED ANIMAL POPULATIONS Priority: Other Significant CFR Citation: Not Yet Determined Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 03/23/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rebecca Buckner Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@fda.hhs.gov RIN: 0910-AC21 _______________________________________________________________________ 883. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; TEST PROCEDURES AND ACCEPTANCE CRITERIA Priority: Routine and Frequent CFR Citation: 21 CFR 800.20 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/19/06 71 FR 75865 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Myrna Hanna Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AC32 _______________________________________________________________________ 884. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) PRODUCTS Priority: Routine and Frequent CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action (Technical Amendment) 03/19/07 72 FR 12730 [[Page 22536]] 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 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF32 _______________________________________________________________________ 885. OVER-THE-COUNTER (OTC) DRUG REVIEW--DANDRUFF, SEBORRHEIC DERMATITIS, AND PSORIASIS PRODUCTS Priority: Routine and Frequent CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 03/06/07 72 FR 9849 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 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF49 _______________________________________________________________________ 886. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG APPLICATIONS Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 25; 21 CFR 500; 21 CFR 514; 21 CFR 558 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/13/06 71 FR 74766 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Dennis Bensley Phone: 301 827-6956 Email: dennis.bensley@fda.hhs.gov RIN: 0910-AF59 _______________________________________________________________________ 887. BLOOD VESSELS RECOVERED WITH ORGANS AND INTENDED FOR USE IN ORGAN TRANSPLANTATION Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 1271; 42 CFR 121 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 03/12/07 72 FR 10922 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Denise Sanchez Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF65 _______________________________________________________________________ 888. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--MULTIPLE 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: Amendments to the Federal Food, Drug, and Cosmetic Act (the act) necessitate several changes to the citations used in Food and Drug Administration (FDA) regulations regarding the prescription-exemption procedure and the list of new drugs that are exempted from the prescription-dispensing requirements. These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action-Technical Amendment03/30/07 72 FR 15043 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. Agency Contact: Walter Jefferson Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AG01 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 889. 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. [[Page 22537]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/01/98 63 FR 46538 NPRM 07/00/07 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, Room 8C-26, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 594-0197 Email: dsd@hrsa.gov RIN: 0906-AA44 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 890. 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 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 03/21/06 71 FR 14135 NPRM Comment Period End 05/22/06 Final Action 07/00/07 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, Room 8-103, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2300 RIN: 0906-AA57 _______________________________________________________________________ 891. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/12/03 68 FR 47923 NPRM Comment Period End 09/11/03 Final Rule 07/00/07 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, Room 7A-21, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-3650 Email: jmorales@hrsa.gov RIN: 0906-AA65 _______________________________________________________________________ 892. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF AVERAGE COST OF A HEALTH INSURANCE POLICY Priority: Other Significant Legal Authority: sec 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, ``If, 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 [[Page 22538]] 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 06/09/06 71 FR 33420 Final Action 07/00/07 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 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 893. 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, Room 8-103, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2300 RIN: 0906-AA41 _______________________________________________________________________ 894. 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 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. [[Page 22539]] 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, Mail Stop 16C-17, 5600 Fishers Lane, Parklawn Building, 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) _______________________________________________________________________ 895. 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 CFR Citation: 42 CFR 121 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 03/09/07 72 FR 10616 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Laura St. Martin Phone: 301 443-4423 Email: lstmartin@hrsa.gov RIN: 0906-AA62 _______________________________________________________________________ 896. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM Priority: Other Significant CFR Citation: 42 CFR 51(a) Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 01/24/07 72 FR 3079 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Belardo Phone: 301 443-0757 Email: jbelardo@hrsa.gov RIN: 0906-AA70 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Indian Health Service (IHS) _______________________________________________________________________ 897. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY MEDICARE-PARTICIPATING INPATIENT HOSPITAL TO INDIANS Priority: Other Significant 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 04/28/06 71 FR 25124 NPRM Comment Period End 06/27/06 Final Action 08/00/07 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, Suite 450, 12300 Twinbrook Parkway, 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 Agency for Healthcare Research and Quality (AHRQ) _______________________________________________________________________ 898. [bull] PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005 RULES Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USO 299b-12 to 299b-26; PL 109-41 CFR Citation: 42 CFR 3 Legal Deadline: None Abstract: The proposed rules to implement the Patient Safety and Quality Improvement Act of 2005 establish a framework in which hospitals, doctors, and other health care providers may voluntarily contract with Patient Safety Organizations (PSOs) to report and analyze health care errors. Providers contract with PSOs for expertise in the collection of patient safety event reports and analysis of the cause of adverse events. The proposed rules outline the requirements that entities must meet and certify to the Secretary for acceptance as a PSO. The [[Page 22540]] proposed rules establish legal boundaries of privilege and confidentiality within which reporting and analysis occurs, and sets forth procedures for the imposition of civil money penalties for the knowing or reckless disclosure of patient safety work product. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: William Munier, Department of Health and Human Services, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850 Phone: 301 427-1219 Fax: 301 443-0251 Email: william.munier@ahrq.hhs.gov RIN: 0919-AA01 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 899. GRANTS FOR RESEARCH PROJECTS Priority: Other Significant 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 06/00/07 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-AA42 _______________________________________________________________________ 900. 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 part 68a and at 42 CFR part 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 09/00/07 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 _______________________________________________________________________ 901. 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 08/00/07 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 [[Page 22541]] _______________________________________________________________________ 902. 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 08/00/07 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 _______________________________________________________________________ 903. 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 08/00/07 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 _______________________________________________________________________ 904. ENDOWMENT PROGRAM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-31 CFR Citation: Not Yet Determined Legal Deadline: None 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 09/00/07 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 _______________________________________________________________________ 905. 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 07/00/07 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 _______________________________________________________________________ 906. NIH TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 285q-1; 42 USC 287c-32 [[Page 22542]] CFR Citation: 42 CFR 63a Legal Deadline: None Abstract: NIH plans to amend the Agency's existing training grants regulations to (1) reflect their applicability to the training authorities set forth in PHS's ACT sections 464W and 485F, (2) reflect their applicability to the National Center on Minority Health and Health Disparities (NCMHD) and Fogarty International Center (FIC) Minority Health and Health Disparities International Research Training (MHIRT) awards, and (3) revise the definition of program director to mean one or more individuals named by the grantee in the grant application, and approved by the Secretary, who is responsible for the management and conduct of the training program, rather than limiting the role of program director to a single individual when that more accurately reflects the management needs of a training program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/07 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-AA49 _______________________________________________________________________ 907. NIH CENTER GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-21h; 42 USC 241 CFR Citation: 42 CFR 57a Legal Deadline: None Abstract: NIH plans to amend the Agency's existing center grant regulations by revising section 52a.1 to reflect the applicability of the regulations to (1) the program of research centers on complementary and alternative medicine administered by the National Center for Complementary and Alternative Medicine (NCCAM) and (2) the regional centers of excellence for biodefense and emerging infectious diseases research administered by the National Institute of Allergy and Infectious Diseases (NIAID). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/07 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-AA50 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 908. 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 08/00/07 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 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions National Institutes of Health (NIH) _______________________________________________________________________ 909. NIH CONSTRUCTION GRANT Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 52b Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 04/02/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA51 [[Page 22543]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 910. 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 03/00/08 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 Email: irene.stith-coleman@hhs.gov RIN: 0940-AA06 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of Public Health and Science (OPHS) _______________________________________________________________________ 911. 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 06/00/08 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 _______________________________________________________________________ 912. 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: Through this advance notice of proposed rulemaking (ANPRM), the Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services is seeking comment on whether it is necessary to require institutions engaged in human subjects research covered by Federalwide Assurance filed with OHRP to ensure that institutional officials and institutional review board (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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Elyse Summers, Department of Health and Human Services, Office of Public Health and [[Page 22544]] Science, The Tower Building, 1101 Wootten Parking, Rockville, MD 20852 Phone: 240 453-6900 Email: elyse.summers@hhs.gov RIN: 0940-AA08 _______________________________________________________________________ 913. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM To Be Determined 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, Suite 200, 1101 Wootton Parkway, Rockville, MD 20852 Phone: 240 452-6900 Fax: 301 402-2071 Email: julie.kaneshiro@hhs.gov RIN: 0940-AA11 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 914. 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 409, 42 CFR 418, 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 11/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Commander Mercedes Benitez-McCrary, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-05- 14, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5716 Email: mercedes.benitezmccrary@cms.hhs.gov RIN: 0938-AG81 _______________________________________________________________________ 915. APPEALS OF CMS OR CONTRACTOR DETERMINATIONS WHEN A PROVIDER OR SUPPLIER FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING (CMS-6003- P2) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) and 1395hh CFR Citation: 42 CFR 405.874; 42 CFR 424.525; 42 CFR 424.535; 42 CFR 424.545; 42 CFR 498.1; 42 CFR 498.2; 42 CFR 498.5; 42 CFR 498.22; 42 CFR 498.40; 42 CFR 498.44; 42 CFR 498.56; 42 CFR 498.78; 42 CFR 498.79; 42 CFR 498.86; 42 CFR 498.88; 42 CFR 405.802; 42 CFR 424.510; 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 03/02/07 72 FR 9479 [[Page 22545]] Second NPRM Comment Period End 05/02/07 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, Office of Financial Management, Program Integrity Group, Mailstop C3- 02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0612 Email: august.nemec@cms.hhs.gov RIN: 0938-AI49 _______________________________________________________________________ 916. 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; Deficit Reduction Act of 2005 (PL 109-171), sec 6083 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 which addresses section 5114 of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74792 Interim Final Rule 09/22/06 71 FR 55341 Interim Final Rule Comment Period End 11/21/06 Second NPRM 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: John Warren, Centers for Medicare Management,, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Ambulatory Services, Mailstop C4-01-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3633 Email: john.warren@cms.hhs.gov RIN: 0938-AJ17 _______________________________________________________________________ 917. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE (CMS-2130-P) Priority: Other Significant Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act) CFR Citation: 45 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 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 08/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Carla McGregor, Technical Director, Survey and Certification Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0663 Email: carla.mcgregor@cms.hhs.gov RIN: 0938-AL26 _______________________________________________________________________ 918. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL CENTERS (CMS-3887-P) Priority: Other Significant. Major under 5 USC 801. Legal Authority: sec 1102 and 1871 of the Social Security Act CFR Citation: 42 CFR 416 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 08/00/07 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 [[Page 22546]] Email: joan.brooks@cms.hhs.gov Commander 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 _______________________________________________________________________ 919. 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; Deficit Reduction Act of 2005, PL 109-171, sec 6035 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This proposed rule would adopt new versions of the X12 suite of HIPAA Transactions and allow the industry to use the most up-to-date versions of the HIPAA transactions for claims and remittance advice. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/07 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 _______________________________________________________________________ 920. 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 08/00/07 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 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov RIN: 0938-AN25 _______________________________________________________________________ 921. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA DISSEMINATION (CMS-6060-NC) Priority: Other Significant 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 (FOIA), 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 05/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Patrica Peyton, Technical Advisor, 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: 410 786-1812 Email: patrica.peyton@cms.hhs.gov RIN: 0938-AN71 _______________________________________________________________________ 922. 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 [[Page 22547]] 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 12/00/07 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, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1154 Email: arnold.farley@cms.hhs.gov RIN: 0938-AN73 _______________________________________________________________________ 923. PAYMENTS FOR SERVICE PROVIDED WITHOUT CHARGE (CMS-2489-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: None CFR Citation: 42 CFR 435 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 11/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Melissa L. Harris, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Disability and Elderly Health Programs Group, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3397 Email: melissa.harris@cms.hhs.gov RIN: 0938-AO07 _______________________________________________________________________ 924. 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: This proposed rule would establish, in regulations, certain provisions under the Balanced Budget Act of 1997 and the Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA). In addition, this proposed rule would allow States to provide health services to employed individuals with disabilities who lose eligibility for disability benefits due to improvement in medical conditions or because their income exceeds the income limitations. This proposed rule would also provide a definition for ``medically determinable severe impairment'' under the TWWIIA. Under this definition, States would determine eligibility standards for the Medical Improvement Group authorized under the TWWIIA legislation, thereby permitting eligible 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 applying a minimum work standard to two Medicaid buy-in groups. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Carey Appold, Technical Director, Disabled and 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 S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2117 Fax: 410 786-9004 Email: carey.appold@cms.hhs.gov RIN: 0938-AO10 _______________________________________________________________________ 925. OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC SERVICES AMENDMENT (CMS-2213-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 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 10/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Jeremy Silanskis, Health Insurance Specialist, 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 [[Page 22548]] Phone: 410 786-1592 Fax: 410 786-8533 Email: jeremy.silanskis@cms.hhs.gov RIN: 0938-AO17 _______________________________________________________________________ 926. 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) and (f) of the Social Security Act; National Institutes of Health Reform Act of 2006 (PL 109-432), sec 201(b) CFR Citation: 42 CFR 457.600 to 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 ________________________________________________________________________ Notice With Comment 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Richard Strauss, Technical Director, Finance Systems & Budget Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid and State Operations, Mailstop, C5-22-25, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO28 _______________________________________________________________________ 927. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE FOR CALENDAR YEAR 2008 (CMS-1541-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1102 and 1871; (42 USC 1302 and 1395 (hh)) CFR Citation: 42 CFR 484 Legal Deadline: Final, Statutory, January 1, 2008. Abstract: This major proposed rule would set 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 services, effective on January 1, 2008. As part of this proposed rule, we are also proposing to rebase and revise the home health market basket to ensure it continues to adequately reflect the price changes of efficiently providing home health services. In addition, we are proposing to revise the fixed dollar loss ratio, which is used in the calculation of outlier payments. This proposed rule also would set forth the refinements to the payment system. In addition, this proposed rule would establish new quality of care data collection requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Randy L. Throndset, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-02-03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0131 Email: randy.throndset@cms.hhs.gov RIN: 0938-AO32 _______________________________________________________________________ 928. 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); of the Social Security Act. CFR Citation: 42 CFR 493 Legal Deadline: None Abstract: This proposed rule would revise certain proficiency testing 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. Identifying these individuals is essential in providing quality patient care. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Cheryl B. Wiseman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop, S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3340 Email: cheryl.wiseman@cms.hhs.gov RIN: 0938-AO34 _______________________________________________________________________ 929. STATE OPTION TO ESTABLISH NON-EMERGENCY MEDICAL TRANSPORTATION PROGRAM (CMS-2234-P) Priority: Other Significant 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 [[Page 22549]] regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 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, Center for Medicaid State Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5647 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO45 _______________________________________________________________________ 930. PREMIUMS AND COST SHARING (CMS-2244-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; PL 109-171; secs 6041 to 6043; Tax Relief and Health Care Act of 2006; PL 109-432, sec 405(a) CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, March 31, 2006, secs 6041 and 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 provide 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 08/00/07 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 Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5647 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO47 _______________________________________________________________________ 931. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS-2232-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Deficit Reduction Act of 2005; sec 6044; sec 1102 of the Social Security Act CFR Citation: 42 CFR 440.300; 440.385 Legal Deadline: Final, Statutory, March 31, 2006. Abstract: This proposed rule would implement provisions of section 6044 of the Deficit Reduction Act of 2005, which amends the Social Security Act by adding a new section related to the coverage of medical assistance under approved State plans. Under this new section, States have increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid recipients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 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, Center for Medicaid State Operations, MailStop S2-01-16, 7500 Security Boulevard, Balitimore, MD 21244 Phone: 410 786-5647 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO48 _______________________________________________________________________ 932. 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 08/00/07 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, Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO52 _______________________________________________________________________ 933. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS- 2249-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086 CFR Citation: 42 CFR 431; 42 CFR 440; 42 CFR 441 [[Page 22550]] Legal Deadline: Final, Statutory, January 1, 2007. Abstract: This proposed rule would amend the Medicaid regulations to define and describe the home and community-based State plan services implementing new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None 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, Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO53 _______________________________________________________________________ 934. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2008 (CMS-1551-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: SSA, sec 1886(i); PL 105-33; PL 106-554; PL 106-113 CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, August 1, 2007. Abstract: This proposed rule would update rates for the prospective payment system for inpatient rehabilitation facilities for FY 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: William Ullman, Health Insurance Specialist, Centers for Medicare Management, 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 Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO63 _______________________________________________________________________ 935. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2008 (CMS-1545-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1888(e) CFR Citation: 42 CFR 424 Legal Deadline: Final, Statutory, July 31, 2007. Abstract: This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2008. In addition, this proposed rule would revise and rebase the SNF market basket. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: William Ullman, Health Insurance Specialist, Centers for Medicare Management, 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 Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO64 _______________________________________________________________________ 936. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND OTHER CHANGES TO PAYMENT UNDER PART B FOR CY 2008 (CMS-1385-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871; Social Security Act, sec 1848;; Tax Relief and Health Care Act of 2006 (Pub L 109-432), Sec 101(a), 102, 108, and 110 CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426 Legal Deadline: Final, Statutory, November 1, 2007. Abstract: This rule would make several changes affecting Medicare Part B payment to physicians and other Part B providers and suppliers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Diane S. Milstead, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Management, Mailstop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov RIN: 0938-AO65 _______________________________________________________________________ 937. STANDARDS FOR E-PRESCRIBING UNDER MEDICARE PART D (CMS-0016-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: This action may affect State, local or tribal governments and the private sector. Legal Authority: 42 USC 1395 CFR Citation: 42 CFR 423 Legal Deadline: Final, Statutory, April 1, 2008. Abstract: This rule proposes standards for electronic prescribing (e- prescribing) under Medicare Part D. This rule would require Medicare Part D and Medicare Advantage plans to support electronic transmission of basic prescription data to and from doctors and pharmacies and to adopt final standards for e-prescribing as required by section 101 of the MMA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 [[Page 22551]] Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Denise Buenning, Senior Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6711 Email: denise.buenning@cms.hhs.gov RIN: 0938-AO66 _______________________________________________________________________ 938. EXEMPTION OF PRIVACY ACT DISCLOSURE OF CERTAIN INVESTIGATIVE MATERIALS (CMS-0029-P) Priority: Info./Admin./Other Legal Authority: 5 USC 301; 5 USC 552a CFR Citation: 45 CFR 5b Legal Deadline: None Abstract: Unrestricted disclosure of confidential information in CMS files can impede ongoing investigations, invade the personal privacy of individuals, reveal the identities of confidential sources, or otherwise impair the ability of CMS to conduct investigations. For these reasons this rule proposes to exempt the ASPEN Complaint/Incident Tracking System (ACTS), Organ Procurement Organizations Systems (OPOS), Fraud Investigation Database (FID), and HIPAA Information Tracking System (HITS) from the notification, access, correction, and amendment provisions of the Privacy Act concerning records compiled for law enforcement purposes. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Katherine Marie Brewer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop N2-04-27, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7235 Fax: 410 786-5636 Email: katherine.brewer@cms.hhs.gov RIN: 0938-AO69 _______________________________________________________________________ 939. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND FY 2008 RATES (CMS-1533-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 1886(d) of the Social Security Act CFR Citation: 42 CFR 412; 413; 424; 485; 489 Legal Deadline: NPRM, Statutory, April 1, 2007. Final, Statutory, August 1, 2007. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Marc Hartstein, Deputy Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4548 Email: marc.hartstein@cms.hhs.gov Related RIN: Related to 0938-AO35 RIN: 0938-AO70 _______________________________________________________________________ 940. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM CALENDAR YEAR 2008 PAYMENT RATES (CMS-1392-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: BBA; BBRA; BIPA; MMA; DRA of 2005; 1833(i)(2)(D)(iii); CFR Citation: 42 CFR 410, 42 CFR 416, 42 CFR 419; 42 CFR 421, 42 CFR 485, 42 CFR 488 Legal Deadline: Final, Statutory, November 1, 2007. 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. The rule also proposes changes to the Ambulatory Surgical Center Payment System list and rates. These changes would be applicable to services furnished on or after January 1, 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-24-23, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1850 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AO71 _______________________________________________________________________ 941. HOSPICE WAGE INDEX FOR FY 2008 (CMS-1539-P) Priority: Other Significant Legal Authority: 42 USC 1814(i)(1) and 1814(i)(2) CFR Citation: 42 CFR 418 Legal Deadline: Final, Statutory, October 1, 2007. Abstract: This rule proposes the annual update to the hospice wage index for FY 2008. The wage index is used to reflect local differences in wage levels. [[Page 22552]] The hospice wage index methodology and values are based on recommendations of a negotiated rulemaking advisory committee and were originally published on August 8, 1997. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Terri Deutsch, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Community Post Acute Care, Hospital and Ambulatory Policy Group, Mailstop C5-08-18, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9462 Email: terri.deutsch@cms.hhs.cms RIN: 0938-AO72 _______________________________________________________________________ 942. [bull] POLICY AND TECHNICAL CHANGES TO THE MEDICARE PRESCRIPTION DRUG BENEFIT (CMS-4130-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1395w 101 through 1395w 152; 42 USC 1302 CFR Citation: 42 CFR 423.50; 42 CFR 423.56; 42 CFR 423.100; 42 CFR 423.120; 42 CFR 423.293; 42 CFR 423.308; 42 CFR 423.350 42 CFR 423.458; 42 CFR 423.464; 42 CFR 423.504; 42 CFR 423.505; 42 CFR 423.509; 42 CFR 423.560; 42 CFR 423.570; 42 CFR 423.584; 42 CFR 423.610; 42 CFR 423.780; 42 CFR 423.884; 42 CFR 423.902; 42 CFR 423.906; 42 CFR 423.910; Legal Deadline: None Abstract: This proposed rule both clarifies existing policy that is outlined in the final rule published in the Federal Register on January 28, 2005 entitled ``Medicare Program; Medicare Prescription Drug Benefit,'' as well as offers several proposed clarifications of policy for which we seek public comment. These proposed clarifications address our expectations of Part D sponsors in providing adequate access to home infusion pharmacies for infused covered Part D drugs and supplies associated with the ``inhalation of insulin``; the appropriate drug costs Part D sponsors should use as the basis for (1) Calculating beneficiary cost sharing, (2) reporting drug costs to CMS for the purposes of reconciliation and risk sharing, (3) developing bids submitted to CMS, and (4) retiree subsidy provisions related to the actuarial equivalence test. This proposed rule also addresses the exclusion from the definition of ''a Part D drug`` when used for the treatment of sexual or erectile dysfunction, in accordance with an October 26, 2005 statutory amendment to the Social Security Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Alissa M. Deboy, Acting Division Director, Center for Beneficiary Choices, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Drug Plan Policy and Analysis Division, Mailstop C1-26-16, 7500 Secruity Boulevard, Balitmore, MD 21244 Phone: 410 786-6041 Email: alissa.deboy@cms.hhs.gov Related RIN: Related to 0938-AN08 RIN: 0938-AO74 _______________________________________________________________________ 943. SPECIAL ENROLLMENT PERIOD AND MEDICARE PREMIUM CHANGES (CMS-4129-P) Priority: Other Significant. Major under 5 USC 801. Legal Authority: PL 109-171, sec 5115; PL 108-173, sec 811 CFR Citation: 42 CFR 406 to 408 Legal Deadline: Final, Statutory, January 1, 2007. Abstract: Section 5115 of the Deficit Reduction Act of 2005 (DRA) provides a special enrollment period for Medicare Part B/Part A and waiver of late enrollment penalty and for individuals who are serving as a volunteer outside the United States through a program that covers at least a 12-month period and who have health insurance while providing the voluntary service outside of the United States. Section 811 of the Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003 as amended by section 5111 of the DRA requires an additional amount be assessed to the Part B premium of individuals who have a modified adjusted gross income that reaches certain levels. The effective date for these provisions is January 1, 2007. Since SSA has the responsibility for calculating the additional premium amount, SSA will explain this statutory requirement in its part of the regulations (20 CFR part 418). CMS will include a reference to the SSA regulation in its change to 42 CFR part 408. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Sam DellaVecchia, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4481 Email: samuel.dellavecchia@cms.hhs.gov RIN: 0938-AO77 _______________________________________________________________________ 944. REVISIONS TO THE MEDICARE ADVANTAGE AND PART D PRESCRIPTION DRUG CONTRACT DETERMINATIONS, APPEALS, AND INTERMEDIATE SANCTIONS PROCESSES (CMS-4124-P) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395(hh); 42 USC 1395(w-101) to 1395(w-152) CFR Citation: 42 CFR 422, and 42 CFR 423 Legal Deadline: None Abstract: This proposed rule would clarify and modify the Medicare Advantage (MA) program provisions relating to disclosure of information, and contract determinations by MA organizations and Part D prescription drug plan sponsors. This proposed rule would also revise requirements [[Page 22553]] concerning the reconsideration of determinations and clarify the schedule for MA organizations and Part D plan sponsors to complete corrective action plans. In addition, it would clarify the intermediate sanction and civil money penalty (CMP) provisions relating to MA organizations and Medicare Part D prescription drug plan sponsors. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Christine Perenich, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-23-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2987 Email: christine.perenich@cms.hhs.gov RIN: 0938-AO78 _______________________________________________________________________ 945. [bull] REHABILITATION SERVICES: STATE PLAN OPTION (CMS-2261-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 1905 (a)(13) of the Social Security Act CFR Citation: 42 CFR 440.130(d) Legal Deadline: None Abstract: This proposed rule would amend the definition of Medicaid rehabilitative services in order to provide for important beneficiary protections such as a person-centered written rehabilitation plan and maintenance of case records. The proposed rule would also ensure the fiscal integrity of claimed Medicaid expenditures by clarifying the service definition and providing that Medicaid rehabilitative services must be coordinated with, but do not include services furnished by, other programs that are focused on social or educational development goals and are available as part of other services or programs. These services and programs include, but are not limited to, foster care, child welfare, education, child care, prevocational and vocational services, housing, parole and probation, juvenile justice, public guardianship, and any other non-Medicaid services from Federal, State, or local programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Linda Peltz, Director, Divison of Integrated Health Systems, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Disabled and Elderly Health Programs Group, Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3399 Fax: 410 786-3262 Email: linda.peltz@cms.hhs.gov RIN: 0938-AO81 _______________________________________________________________________ 946. [bull] WAIVER OF DISAPPROVAL OF NURSE AIDE TRAINING PROGRAM IN CERTAIN CASES AND NURSE AIDE PETITION FOR REMOVAL OF INFORMATION FOR SINGULAR FINDING OF NEGLECT (CMS-2266-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: sec 932 (c) (2) MMA; secs 1819(g)(1)(D) and 1919(g)(1)(D) of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This proposed rule will permit a waiver or nurse aide training disapproval for skilled nursing facilities and nursing facilities that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. The purpose of this regulation is to implement the legislative waiver provision enacted on December 8, 2003, in section 932(c)(2) of the MMA. The ability to make these waiver determinations could allow continued and consistent operation of a nursing home's nurse aide training program in facilities having non-quality of care deficiencies, which would ultimately benefit residents. This rule also codifies statutory provisions at sections 1819(g)(1)(D) and 1919(g)(1)(D) of the Social Security Act that would permit the State to establish a procedure to permit a nurse aide to petition the State to have a singular finding of neglect removed from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a singular occurrence. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Patricia Miller, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mailstop S2-19-14, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6780 Fax: 410 786-0194 Email: patricia.miller@cms.hhs.gov RIN: 0938-AO82 _______________________________________________________________________ 947. [bull] SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT, PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: sec 4312(a) of BBA of 1997 CFR Citation: 42 CFR 424.57 Legal Deadline: None Abstract: This proposed rule would implement section 4312(a) of the Balanced Budget Act of 1997, which requires a Medicare supplier of durable medical equipment (DME) to furnish CMS with a surety bond. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: August Nemec, Department of Health and Human Services, Centers for Medicare & [[Page 22554]] Medicaid Services, Mailstop C3-08-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0612 Email: august.nemec@cms.hhs.gov RIN: 0938-AO84 _______________________________________________________________________ 948. [bull] CHILDREN OF STATE EMPLOYEES: PREMIUM ASSISTANCE (CMS-2148-P) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: 42 CFR 457.1010; 42 CFR 457.310 Legal Deadline: None Abstract: This proposed rule would amend Medicaid regulations by revising the definition of ``optional targeted low-income child'' to exclude children eligible for health benefits coverage under a State health benefits plan on the basis of a family member's employment with a public agency, children who are inmates of a public institution, and children who are patients in an institution for mental diseases. This proposed rule also addresses the requirements for SCHIP family coverage through premium assistance. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Kathleen Farrell, Director, State Children's Health Insurance Program, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers of Medicaid State Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21224 Phone: 410 786-1236 Fax: 410786-5882 Email: kathleen.farrell@cms.hhs.gov RIN: 0938-AO86 _______________________________________________________________________ 949. [bull] APPLICATION OF CERTAIN PART 405 APPEALS PROVISIONS TO THE PART 423 MEDICARE PRESCRIPTION DRUG APPEALS PROCESS (CMS-4127-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: sec 1102, 1860D-1 to 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1395w-101 to 1395w-152, and 1395hh) CFR Citation: 42 CFR 560 to 638 Legal Deadline: None Abstract: The voluntary prescription drug benefit program was enacted into law by section 101 of title 1 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). The implementing regulations for the Part D program were published in a final rule on January 28, 2005, and became effective March 22, 2005. These regulations provide that the Medicare Advantage (MA) rules regarding appeals and reopenings will apply to the Part D appeals process to the extent they are appropriate. The MA regulations in turn apply the fee- for-service (FFS) appeals regulations (concerning the administrative review and hearing processes and representation of parties under titles II and XVIII of the Act) to the extent they are appropriate. Based on this regulatory framework, we noted in the January 28, 2005, rule that differences in the appeals procedures for Part D enrollees would be addressed in a future Part D rulemaking document. The purpose of the proposed rule is to provide additional guidance on the differences in appeals procedures for Part D enrollees by proposing more detailed regulations governing Part D appeals at the ALJ, MAC, and Federal district court levels and reopenings of determinations and decisions that follow the Part A and Part B procedures set forth in the part 405 rule, as appropriate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Federalism: Undetermined Agency Contact: Anthony Culotta, Director, Medicare Enrollment & Appeals Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C2-12-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4661 Email: anthony.culotta@cms.hhs.gov RIN: 0938-AO87 _______________________________________________________________________ 950. [bull] LIMITATION ON CONTRACTOR LIABILITY (CMS-2264-P) Priority: Other Significant Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6034; sec 1157 of the Social Security Act CFR Citation: 42 CFR 45 Legal Deadline: None Abstract: Section 6034 of the Deficit Reduction Act of 2005 established the Medicaid Integrity Program to promote the integrity of the Medicaid program by authorizing the Centers for Medicare and Medicaid Services (CMS) to enter into contracts with contractors that will (1) Review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; (2) audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; (3) identify overpayment of individuals or entities receiving Federal funds; and (4) educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This proposed rule would set forth limitations on a contractor's liability while performing these services under the Medicaid Integrity Program. This proposed rule would provide for limitation of a contractor's liability for actions taken to carry out a contract under the Medicaid Integrity Program. The proposed rule would, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 of the Social Security Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Barbara Rufo, Director, Division of Medicaid Integrity Contracts, Medicaid Integrity Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop B2-02-24, 7111 Security Boulevard, Baltimore, MD 21244 [[Page 22555]] Phone: 410 786-5589 Email: barbara.rufo@cms.hhs.gov RIN: 0938-AO88 _______________________________________________________________________ 951. [bull] HEALTH INSURANCE REFORM: REMOTE SECURITY STANDARDS (CMS- 0020-P) Priority: Other Significant Legal Authority: HIPAA CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This proposed rule would further address the existing compliance requirements of the HIPAA Security regulations specific to covered entities that allow offsite access to, or use of, electronic protected health information. The proposed rule is necessitated by several recent security incidents related to the use of laptops other portable and mobile devices and external handware that store, contain, or are used to access electronic protected health information. It is intended to provide a more prescriptive set of remote security requirements designed to reduce the likelihood of unauthorized uses and disclosures of sensitive health information. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Michael T. Phillips, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Electronic Health E-Standards & Services, Mailstop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21224 Phone: 410 786-6713 Email: michael.phillips@cms.hhs.gov RIN: 0938-AO89 _______________________________________________________________________ 952. [bull] ESTABLISHING ADDITIONAL PROVIDER AND SUPPLIER REQUIREMENTS FOR ENROLLMENT STANDARDS AND RELATED ISSUES (CMS-6036-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 numbers of providers and suppliers enrolling and maintaining enrollment within the Medicare Program are of such a large magnitude that CMS must be able to ensure that quality care is given to beneficiaries while at the same time guaranteeing the protection of the Medicare Trust Fund. This rule proposes new standards to help to maintain an acceptable level of care for the beneficiaries without adding increased risk of loss to the Medicare Trust Fund. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: August Rudolph Nemec III, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Mailstop C3-07-08, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0612 Fax: 410 786-7259 Email: august.nemec@cms.hhs.gov RIN: 0938-AO90 _______________________________________________________________________ 953. [bull] EMERGENCY PREPAREDNESS REQUIREMENTS FOR MEDICARE PARTICIPATING PROVIDERS AND SUPPLIERS (CMS-3178-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule proposes emergency preparedness requirements for a variety of Medicare providers and suppliers who participate in the Medicare and Medicaid programs. Medicare beneficiaries rely on health care facilities to safely and effectively plan for and execute appropriate evacuation procedures during times of disaster. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Monique S. Howard, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop S3-02 01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3869 Email: monique.howard@cms.hhs.gov RIN: 0938-AO91 _______________________________________________________________________ 954. [bull] INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM-- UPDATE FOR RATE YEAR BEGINNING JULY 1, 2008 (RY 2009) (CMS-1401-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 Legal Deadline: Final, Statutory, July 1, 2008. Abstract: This rule proposes updates to the Inpatient Psychiatric Facility Prospective Payment System for RY 2009. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/08 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: Undetermined Agency Contact: Janet Samen, Director, Division of Chronic Care Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-05-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4533 Email: janet.samen@cms.hhs.gov RIN: 0938-AO92 [[Page 22556]] _______________________________________________________________________ 955. [bull] PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2009: ANNUAL PAYMENT RATE UPDATES (CMS-1393-P) 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, July 1, 2008. Abstract: This rule proposes the payment rate update for the rate year 2009 prospective payment system (PPS) for Medicare long-term care hospitals (LTCH) and also presents proposed changes or revisions on LTCH PPS policy for public comment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Judith Richter, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-16-07, 7500 Security Boulevard, Baltimore Phone: 410 786-2590 Email: judith.richter@cms.hhs.gov RIN: 0938-AO94 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 956. 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 405; 42 CFR 410; 42 CFR 413 to 414; 42 CFR 488; 42 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 RIN: 0938-AG82 _______________________________________________________________________ 957. 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 components 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 07/00/07 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 _______________________________________________________________________ 958. 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 final 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 09/00/07 Regulatory Flexibility Analysis Required: No [[Page 22557]] 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 and Coverage Policy, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3295 Email: thomas.shenk@cms.hhs.gov RIN: 0938-AJ96 _______________________________________________________________________ 959. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS (CMS-1810-RCN) 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 rule finalizes certain statutory provisions that prevent payment for services and impose penalties when a physician makes a referral to an entity in which that physician has a financial interest, unless an exception applies. It also addresses comments received on the ``Phase II'' Stark regulation published in the Federal Register on March 26, 2004. 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 Notice 03/23/07 72 FR 13710 Final Action 03/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Lisa Ohrin, Deputy Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Chronic Care Policy Group, Divison of Technical Payment Policy, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4565 Email: lisa.ohrin@cms.hhs.gov RIN: 0938-AK67 _______________________________________________________________________ 960. 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, 413, and 417 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, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4477 Email: morton.marcus@cms.hhs.gov RIN: 0938-AL54 _______________________________________________________________________ 961. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS (CMS-4064-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 1869 (b) of the Act, as amended by sec 521 of BIPA CFR Citation: 42 CFR 401 and 405 Legal Deadline: Final, Statutory, March 8, 2008, MMA sec 902. Abstract: This final rule revises 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 Second Interim Final Rule 06/30/05 70 FR 37700 Third Interim Final Rule 08/26/05 70 FR 50214 Final Action 03/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Katherine L. Hosna, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C2-12-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4993 Email: katherine.hosna@cms.hhs.gov Related RIN: Related to 0938-AK69 RIN: 0938-AM73 _______________________________________________________________________ 962. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6146-F) Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: sec 1128a of the Social Security Act CFR Citation: 42 CFR 402 Legal Deadline: Final, Statutory, July 23, 2007, MMA sec. 902. Abstract: This final rule revises the CMS civil money penalty authorities. These 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 [[Page 22558]] 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, Program Integrity Group, Mailstop C3- 02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3349 Email: joel.cohen@cms.hhs.gov Related RIN: Related to 0938-AN48 RIN: 0938-AM98 _______________________________________________________________________ 963. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F) Priority: Other Significant Legal Authority: sec 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 11/00/07 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 _______________________________________________________________________ 964. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT (DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-F) 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 411; 42 CFR 414; 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 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/01/06 71 FR 25654 Notice 04/10/07 72 FR 16794 Final Action 03/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, State Agency Contact: Ralph Goldberg, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4870 Email: ralph.goldberg@cms.hhs.gov RIN: 0938-AN14 _______________________________________________________________________ 965. MEDICAID PRESCRIPTION DRUGS--AVERAGE MANUFACTURER PRICE (CMS-2238- F) Priority: Other Significant. Major under 5 USC 801. 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 final rule implements sections 6001, 6002, and 6003 of the Deficit Reduction Act of 2005. This rule sets the Federal upper reimbursement limit (FUL) as 250 percent of the average manufacturer price (AMP) for drugs on the FUL list, and will clarify the requirements and manner in which AMPs are determined for multiple- source drugs and other drug payment revisions. This rule also lists the physician administered multiple-source drugs that the Secretary determines have the highest dollar volume of dispensing in Medicaid and will require manufacturers to include authorized generics when they report their AMP and best price for covered outpatient drugs to the Secretary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/22/06 71 FR 77174 NPRM Comment Period End 02/20/07 Final Action 07/00/07 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 Phone: 410 786-9898 Fax: 410 786-5882 Email: yolanda.reese@cms.hhs.gov RIN: 0938-AO20 _______________________________________________________________________ 966. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2008: ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES(CMS-1529-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 106-113, sec 123 ; PL 106-554, sec 307(b) CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, July 1, 2007. [[Page 22559]] Abstract: This rule finalizes the annual payment rate update for the Rate Year (RY) 2008 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 02/01/07 72 FR 4776 NPRM Comment Period End 03/26/07 Final Action 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Judy Richter, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mail Stop C4-16-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2590 Email: judith.richter@cms.hhs.gov RIN: 0938-AO30 _______________________________________________________________________ 967. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE FOR RATE YEAR 2008 (CMS-1479-N) Priority: Other Significant. Major under 5 USC 801. Legal Authority: PL 106-113, sec 124 BBRA CFR Citation: 42 CFR 412.400, subpart N Legal Deadline: Final, Statutory, July 1, 2007. Abstract: This notice updates the Inpatient Psychiatric Facility Prospective Payment System for RY 2008. These changes are applicable for discharges occuring on or before July 1, 2007 through June 30, 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 05/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Local, State Agency Contact: Janet Samen, 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: 410 786-4533 Email: janet.samen@cms.hhs.gov RIN: 0938-AO40 _______________________________________________________________________ 968. 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 11/00/07 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. Agency Contact: Adam Shaw, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, Mailstop C5-14-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen B. Levin, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, Mailstop C5- 14-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov Related RIN: Related to 0938-AI17 RIN: 0938-AO43 _______________________________________________________________________ 969. HIGH RISK POOLS (CMS-2260-IFC) Priority: Other Significant. Major under 5 USC 801. 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 (HR 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 pool 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 ________________________________________________________________________ Interim Final Rule 09/00/07 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 Services Operations, Mailstop C2-01-16, 7500 Security Boulevard, Baltimore, MD 21244 [[Page 22560]] Phone: 410 786-5647 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO46 _______________________________________________________________________ 970. TARGETED CASE MANAGEMENT (CMS-2237-IFC) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6052 CFR Citation: 42 CFR 431, 42 CFR 440 to 441 Legal Deadline: Final, Statutory, January 1, 2006. Abstract: This interim final rule with comment period revises current Medicaid regulations to incorporate changes made by section 6052 of the Deficit Reduction Act of 2005. In addition, it incorporates provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985, the Omnibus Budget Reconciliation Act of 1986, the Tax Reform Act of 1986, the Omnibus Budget Reconciliation Act of 1987, and the Technical and Miscellaneous Revenue Act of 1988, concerning case managment and targeted case management services. This interim final rule with comment period will provide for optional coverage of case management services or targeted case management services furnished according to section 1905 (a)(19) and section 1915 (g) of the Social Security Act. This interim final rule with comment period clarifies the situations in which Medicaid will pay for case management activities and also clarifies when payment will not be consistent with proper and efficient operation of the Medicaid program, and is not available. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Theresa A. Pratt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5831 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO50 _______________________________________________________________________ 971. CITIZENSHIP DOCUMENTATION REQUIREMENTS (CMS-2257-F) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6036; sec 1102 of Social Security Act; Tax Relief and Health Care Act of 2006 (PL 109-432,) sec 405(c) CFR Citation: 42 CFR 435.403; 42 CFR 435.1009; 42 CFR 435.1010; 42 CFR 435.406 to 435.408; 42 CFR 435.1002; 42 CFR 435.1008; 42 CFR 435.1011; 42 CFR 436.406; 42 CFR 436.403; 42 CFR 436.407; 42 CFR 436.408; 42 CFR 436.1004; 42 CFR 436.1005; 42 CFR 440.2; 42 CFR 435.1009; 42 CFR 435.1010; 42 CFR 440.140; 42 CFR 440.180; 42 CFR 440.185; 42 CFR 441.13; 42 CFR 457.310; 42 CFR 483.5; 42 CFR 483.20; 42 CFR 483.102; 42 CFR 483.136; 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 United States 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 ________________________________________________________________________ Interim Final Rule Comment Period 07/12/06 71 FR 39214 Interim Final Rule Comment Period End 08/11/06 Final Action 05/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: 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 Phone: 410 786-5957 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO51 _______________________________________________________________________ 972. [bull] COST LIMITS FOR GOVERNMENTALLY-OPERATED PROVIDERS (CMS-2258- F) (SECTION 610 REVIEW) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments. Legal Authority: sec 1102 of the Social Security Act (42 U.S.C. 1302) CFR Citation: 42 CFR 447.321; 42 CFR 433.51; 42 CFR 447.271; 42 CFR 447.272; 42 CFR 447.34; 42 CFR 457.220; 42 CFR 457.628; 42 CFR 447.206, 447.207; Legal Deadline: None Abstract: The final rule will: (1) clarify that only units of government are able to participate in the financing of the non-Federal share; (2) establish minimum requirements for documenting cost when using a certified public expenditure; (3) limit providers operated by units of government to reimbursement that does not exceed the cost of providing covered services to eligible Medicaid recipients; and (4) establish a new regulatory provision explicitly requiring that provders receive and retain the total computable amount of their Medicaid payments Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/18/07 72 FR 2236 NPRM Comment Period End 03/19/07 Final Action 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal, Local, State Federalism: This action may have federalism implications as defined in EO 13132. [[Page 22561]] Agency Contact: Aaron Blight, Technical Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9560 Fax: 410786-1008 Email: aaron.blight@cms.hhs.gov RIN: 0938-AO57 _______________________________________________________________________ 973. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES CO-INSURANCE AMOUNTS FOR CY 2008 (CMS-8032-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, 2007. Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year 2008 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 ________________________________________________________________________ Final Action 09/00/07 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 Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO61 _______________________________________________________________________ 974. PART A PREMIUMS FOR CY 2008 FOR THE UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8031-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 1818A (d)(2) CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2007. Abstract: This notice announces the hospital insurance premium for calendar year 2008 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 ________________________________________________________________________ Final Action 09/00/07 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 Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO62 _______________________________________________________________________ 975. PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATES BEGINNING JANUARY 1, 2008 (CMS-8033-N) Priority: Other Significant Legal Authority: 42 USC 1395; Social Security Act, sec 1839; MMA, sec 629; MMA, sec 811; DRA, sec 5111 CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2007. 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 CY 2008. It also announces the monthly Part B premiums and the Part B deductible for CY 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/07 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-AO68 _______________________________________________________________________ 976. REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-F) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 42 USC 1833(i)(2)(D)(iii) CFR Citation: 42 CFR 416 Legal Deadline: Final, Statutory, January 1, 2008. Abstract: This rule revises the method by which Medicare sets payment rates for ASC facility services and includes illustrative new payment rates for ASC services in accordance with that methodology. This rule finalizes policies proposed as part of the August 23, 2006, CY 2007 Outpatient Prospective Payment System rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 11/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Joan Sanow, Deputy Director, Division of Outpatient Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 [[Page 22562]] Phone: 410 786-7802 Email: joan.sanow@cms.hhs.gov Related RIN: Split from 0938-AO15 RIN: 0938-AO73 _______________________________________________________________________ 977. FISCAL YEAR 2008 SCHIP ALLOTMENTS (CMS-2262-N) Priority: Other Significant Legal Authority: title XXI of the Social Security Act, sec 2104 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, September 30, 2007. 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 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 08/00/07 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, Centers for Medicaid State Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2019 Fax: 410 786-0025 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO76 _______________________________________________________________________ 978. [bull] HEALTH CARE-RELATED TAX REVISIONS (CMS-2275-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: President's 2007 Budget; PL 109-432, sec 403 CFR Citation: 42 CFR 433.66(1)(3)(i); 42 CFR 433.56(a)(4); 42 CFR 433.56(a)(8); 42 CFR 433.58; 42 CFR 433.60; Legal Deadline: None Abstract: This proposed rule would revise the threshold under the indirect guarantee hold harmless arrangement test to reflect the provisions of the Tax Relief and Health Care Act of 2006 by providing that, when determining whether there is an indirect guarantee under the two-prong test for any part of a fiscal year on or after January 1, 2008, through September 30, 2011, the allowable amount that can be collected from a health care-related tax is reduced from 6 to 5.5 percent of net patient revenues received by the taxpayers. This proposed rule would also clarify the standard for determining the existence of a hold harmless arrangement under the positive correlation test, Medicaid payment test, and the guarantee test (with conforming changes to parallel provisions concerning hold harmless arrangements with respect to provider-related donations); codify descriptions for two classes of health care services permissible under Federal statute for purposes of taxes on health care providers; and remove obsolete transition period regulatory language. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/23/07 72 FR 13726 Final Action 07/00/07 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. Energy Effects: Statement of Energy Effects planned as required by Executive Order 13211. Agency Contact: James Frizzera, Director, Division of Reimbursement and State Financing, 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 Phone: 410 786-9535 Fax: 410 786-1008 Email: james.frizzera@cms.hhs.gov RIN: 0938-AO80 _______________________________________________________________________ 979. [bull] EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON MENTAL HEALTH PARITY (CMS-4094-F5) Priority: Routine and Frequent Legal Authority: sec 2705 of the Public Health Service Act (as amended by the Mental Health Parity Act of 1996); sec 115(c) of the Tax Relief and Health Care Act of 2006 PL 109-432 CFR Citation: 45 CFR 146.136 Legal Deadline: Final, Statutory, December 31, 2007. Abstract: In section 115(c) of the Tax Relief and Health Care Act of 2006, legislation was enacted that extended the PHS Act provisions of the Mental Health Parity Act (MHPA) to services furnished through December 31, 2007. As a result of this most recently enacted legislation, it is now necessary to again publish conforming changes to the interim final regulation published June 27, 2003. These changes would conform the regulatory sunset date to the new statutory sunset date December 31, 2007, and would extend the duration of the increased cost exemption to be consistent with the new sunset date. The conforming changes would make absolutely no substantive changes to the existing regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Adam M. Shaw, Senior Technical Adviser, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Related RIN: Related to 0938-AO36 RIN: 0938-AO83 _______________________________________________________________________ 980. [bull] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2008 (CMS-1552-N) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 1834 (e) of the Social Security Act CFR Citation: 42 CFR 410 Legal Deadline: Final, Statutory, January 1, 2008. Abstract: This notice updates the fee schedule for ambulance services under the Medicare program, implementing [[Page 22563]] section 1834(e) of the Social Security Act (effective January 1, 2008). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 11/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Anne Tayloe, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4546 Email: anne.tayloe@cms.hhs.gov RIN: 0938-AO85 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 981. 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: Mary Rossi-Coajou, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6051 Email: mary.rossicoajou@cms.hhs.gov Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AH27 _______________________________________________________________________ 982. 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 for claims adjudication purposes. 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, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E-Health Standards and Services, Mailstop S2-25-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6597 Email: lorraine.doo@cms.hhs.gov RIN: 0938-AK62 _______________________________________________________________________ 983. 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 Action 08/00/08 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. [[Page 22564]] Agency Contact: Adam Shaw, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer and Policy Operations Group, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen Levin, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer and Policy Operations Group, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov RIN: 0938-AL88 _______________________________________________________________________ 984. 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 Modernization Act requires that physicians and beneficiaries be able to receive a prior determination regarding coverage of certain items and physicians' services beginning June 8, 2005. Full knowledge regarding financial liability for these services will be available to physicians and beneficiaries before expenses are incurred, although prior determination of coverage is not required for submission of a claim. 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: Debbie Skinner, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Program Integrity Goup, Office of Financial Management, Mailstop C3-02- 16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7480 Email: debbie.skinner@cms.hhs.gov RIN: 0938-AN10 _______________________________________________________________________ 985. 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, November 27, 2009, MMA sec. 902. 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, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-14-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0970 Fax: 410 786-7030 Email: suzanne.ripley@cms.hhs.gov RIN: 0938-AN27 _______________________________________________________________________ 986. TERMINATION OF NON-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 Prescription Drug Improvement and 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: Daniel Schwartz, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Program Intergrity Group, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4197 Email: daniel.schwartz@cms.hhs.gov RIN: 0938-AN31 _______________________________________________________________________ 987. LIMITATION ON RECOUPMENT OF PROVIDER AND SUPPLIER OVERPAYMENTS (CMS-6025-F) Priority: Other Significant Legal Authority: sec 1893 (f) (2) of the Social Security Act added by sec 935 of the MMA CFR Citation: 42 CFR 405 Legal Deadline: Final, Statutory, December 8, 2003. Abstract: This rule implements one provision of section 935 of the Medicare Prescription Drug Improvement and Modernization Act which added a new subsection to section 1893 of the Social Security Act. It adjusts Medicare's ability to recover an overpayment when the Qualified Independent Contractor (QIC) receives a valid appeal from the provider or supplier. This rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in Medicare's obligation to pay interest to a provider or supplier whose appeal is successful at levels above the QIC. [[Page 22565]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/22/06 71 FR 55404 NPRM Comment Period End 11/21/06 Final Action 09/00/09 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 _______________________________________________________________________ 988. 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 Second Interim Final Rule 09/06/05 70 FR 52930 Third Interim Final Rule 11/21/05 70 FR 70478 Fourth Interim Final Rule 08/18/06 71 FR 47870 Fourth Interim Final Rule Comment Period End 10/02/06 Final Action 07/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5620 Email: corinne.axelrod@cms.hhs.gov RIN: 0938-AN58 _______________________________________________________________________ 989. MEDICARE INTEGRITY PROGRAM, FISCAL INTERMEDIARY AND CARRIER FUNCTIONS, AND CONFLICT OF INTEREST REQUIREMENTS (CMS-6030-F) Priority: Other Significant Legal Authority: sec 1124, 1816, 1842, and 1893 of the Social Security Act CFR Citation: 42 CFR 400 and 42 CFR 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 distinguishes 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 Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gary D. Williams, 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- 1850 Phone: 410 786-6433 Email: gary.williams4@cms.hhs.gov Related RIN: Related to 0938-AI09 RIN: 0938-AN72 _______________________________________________________________________ 990. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-F) 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 rule sets forth the State requirements to provide information for purposes of estimating improper payments under Medicaid and SCHIP. The Improper Payments Information Act of 2002 (IPIA) requires heads of Federal agencies to annually estimate and report to 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 rule also responds to the public comments on the August 28, 2006, interim final rule and sets forth State requirements for submitting claims and policies to the Federal contractor for purposes of conducting fee-for-service and managed care reviews. This rule also responds to public 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 Second Interim Final Rule 08/28/06 71 FR 51049 Final Action 08/00/09 Regulatory Flexibility Analysis Required: No Government Levels Affected: State Agency Contact: Janet Reichert, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Program [[Page 22566]] Integrity Group, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4580 Email: janet.reichert@cms.hhs.gov Related RIN: Related to 0938-AM86 RIN: 0938-AN77 _______________________________________________________________________ 991. FIRE SAFETY REQUIREMENTS FOR LONG-TERM CARE FACILITIES: SPRINKLER SYSTEMS (CMS-3191-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: On July 16, 2004, the GAO published a report on Federal fire safety standards and procedures in nursing facilities. The GAO report cited automatic sprinkler systems in all nursing facilities. On October 27, 2006, CMS published a proposed rule that would require automatic sprinkler systems as the single most effective fire safety device in long-term care facilities and recommended that CMS explore requiring automatic sprinkler systems in all nursing facilities and request public comments on the length of a phase-in period to allow nursing facilities to comply with the new requirement. We received numerous public comments supporting the proposed rule and suggesting changes to it. This rule finalizes the content of the proposed rule and incorporates changes suggested by the public. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/27/06 71 FR 62957 NPRM Comment Period End 12/26/06 Final Action 10/00/09 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 _______________________________________________________________________ 992. USE OF REPAYMENT PLANS (CMS-6032-F) Priority: Other Significant Legal Authority: sec 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 rule modifies 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 will grant a provider or a supplier an extended repayment schedule under certain terms and conditions as defined in the statute. The final rule establishes criteria and procedures to apply this requirement and to define the concepts of ``hardship`` and ''extreme hardship.`` Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/27/06 71 FR 68519 NPRM Comment Period End 01/26/07 Final Action 11/00/09 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 Phone: 410 786-3378 Fax: 410 786-7030 Email: thomas.noplock@cms.hhs.gov RIN: 0938-AO27 _______________________________________________________________________ 993. IDENTIFICATION OF BACKWARD COMPATIBLE VERSION OF ADOPTED STANDARD FOR E-PRESCRIBING AND THE MEDICARE PRESCRIPTION DRUG PROGRAM (VERSION 8.1) (CMS-0018-F) Priority: Other Significant Legal Authority: 42 USC 1395 CFR Citation: 42 CFR 423 Legal Deadline: Final, Statutory, June 23, 2009, MMA sec. 902. Abstract: This final rule identifies version 8.1 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard as a backward compatible update of the adopted version 5.0. This rule also permits the voluntary use of version 8.1 of the NCPDP SCRIPT Standard for conducting certain e-prescribing transactions for the electronic prescription drug program under title I of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/23/06 71 FR 36020 Interim Final Rule Comment Period End 08/22/06 Final Action 06/00/09 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 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov Related RIN: Related to 0938-AN49 RIN: 0938-AO42 _______________________________________________________________________ 994. PROHIBITION OF MID-YEAR BENEFIT ENHANCEMENTS FOR MEDICARE ADVANTAGE ORGANIZATIONS OFFERING PLANS IN CALENDAR YEAR 2007 AND SUBSEQUENT CALENDAR YEARS (CMS-4121-F) Priority: Other Significant Legal Authority: 42 USC 1302, 1395hh [[Page 22567]] CFR Citation: 42 CFR 422.2; 42 CFR 422.254 Legal Deadline: None Abstract: This rule implements new policy to prohibit Medicare Advantage (MA) organizations from offering mid-year benefit enhancements (MYBEs). The policy is based on our experience during the first year of the new Medicare Advantage program and our belief that, in order to fully comply with the statute (MMA), we can no longer permit MYBEs as these threaten the integrity of the competitive bidding process established by the statute. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/01/06 71 FR 52014 Final Action 09/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Christopher McClintick, Health Insurance Specialist, Center for Beneficiary Choices, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Medicare Advantage Group, Division of Plan Policy, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4682 Email: christopher.mcclintick@cms.hhs.gov RIN: 0938-AO54 _______________________________________________________________________ 995. MEDICARE PART D DATA (CMS-4119-F) Priority: Other Significant Legal Authority: sec 1860 D-12 of the Social Security Act CFR Citation: 42 CFR 423 Legal Deadline: Final, Statutory, October 18, 2009, MMA sec. 902. Abstract: CMS is required by Congress to conduct a number of part D related research demonstration and evaluation studies that require part D claims data. We are finalizing a regulation that addresses use of part D claims information for other research, analysis, reporting, and public health functions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/18/06 71 FR 61445 NPRM Comment Period End 12/18/06 Final Action 10/00/09 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Organizations Government Levels Affected: None Agency Contact: Alissa M. Deboy, Acting Division Director, Center for Beneficiary Choices, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Drug Plan Policy and Analysis Division, Mailstop C1-26-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6041 Email: alissa.deboy@cms.hhs.gov RIN: 0938-AO58 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 996. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-3835- F) Priority: Other Significant CFR Citation: 42 CFR 405; 42 CFR 482; 42 CFR 488; 42 CFR 498 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 03/30/07 72 FR 15198 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Eva Fung Phone: 410 786-7539 Email: eva.fung@cms.hhs.gov RIN: 0938-AH17 _______________________________________________________________________ 997. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-P) Priority: Other Significant CFR Citation: 42 CFR 483 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 01/30/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anita Panicker Phone: 410 786-5646 Fax: 410 786-8532 Email: anita.panicker@cms.hhs.gov RIN: 0938-AM87 _______________________________________________________________________ 998. 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 CFR Citation: 42 CFR 482 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/27/06 71 FR 68672 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: None Agency Contact: Patricia Chmielewski Phone: 410 786-6899 Email: patricia.chmielewski@cms.hhs.gov RIN: 0938-AM88 [[Page 22568]] _______________________________________________________________________ 999. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS-4081- F) Priority: Other Significant CFR Citation: 45 CFR 146.121 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/13/06 71 FR 75014 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: Adam Shaw Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen Levin Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov Related RIN: Previously reported as 0938-AK19 RIN: 0938-AN29 _______________________________________________________________________ 1000. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018- F) Priority: Other Significant CFR Citation: 42 CFR 482 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/08/06 71 FR 71378 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Patricia Chmielewski Phone: 410 786-6899 Email: patricia.chmielewski@cms.hhs.gov RIN: 0938-AN30 _______________________________________________________________________ 1001. PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM REVISIONS (CMS-1201-F) Priority: Other Significant CFR Citation: 42 CFR 460 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/08/06 71 FR 71244 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Janet Harris Phone: 410 786-3137 Email: janet.harris@cms.hhs.gov Related RIN: Previously reported as 0938-AL59 RIN: 0938-AN83 _______________________________________________________________________ 1002. MEDICARE GRADUATE MEDICAL EDUCATION AFFILIATION PROVISIONS FOR TEACHING HOSPITALS IN CERTAIN EMERGENCY SITUATIONS (CMS-1531-F2) Priority: Other Significant CFR Citation: 42 CFR 413 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 02/05/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tzvi Hefter Phone: 410 786-6014 Email: tzvi.hefter@cms.hhs.gov Related RIN: Merged with 0938-AO70 RIN: 0938-AO35 _______________________________________________________________________ 1003. NOTIFICATION PROCEDURES FOR HOSPITAL DISCHARGES (CMS-4105-F) Priority: Other Significant CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 422; 42 CFR 489 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 11/27/06 71 FR 68708 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Eileen Zerhusen Phone: 410 786-7803 Email: eileen.zerhusen@cms.hhs.gov Related RIN: Merged with 0938-AK48, Merged with 0938-AL67 RIN: 0938-AO41 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1004. 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 09/00/07 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 _______________________________________________________________________ 1005. 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 [[Page 22569]] 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 09/00/07 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 _______________________________________________________________________ 1006. 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 part 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 12/00/07 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 _______________________________________________________________________ 1007. 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 decisionmaking 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 12/00/07 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 _______________________________________________________________________ 1008. LIMITATION ON USE OF FUNDS MADE AVAILABLE TO MONITOR AND COMBAT TRAFFICKING IN PERSONS Priority: Other Significant Legal Authority: 22 USC chapter 78 Trafficking Victims Protection Act CFR Citation: 45 CFR 404 Legal Deadline: None Abstract: This rule will implement provisions of the Trafficking Victims Protection Act which prohibit programs from using trafficking funds to promote, support, or advocate the legalization or practice of prostitution and make organizations ineligible to receive such funds that promotes, supports, or advocates the legalization or the practice of prostitution if the program operates a program that targets several forms of trafficking unless the organization provides services to individuals solely after they are no longer engaged in activities that resulted from such activities being trafficked. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Kenneth Tota, Chief of Operations--Office of Refugee Resettlement, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-4858 Email: ktota@acf.hhs.gov RIN: 0970-AC28 _______________________________________________________________________ 1009. CHILD CARE AND DEVELOPMENT FUND ERROR RATE REPORTING Priority: Other Significant Legal Authority: Improper Payments Information Act (PL 107-300) CFR Citation: 45 CFR 98 Legal Deadline: None Abstract: This rule will require States and selected territories to employ a case review process every 4 years in calculating a CCDF error rate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/02/07 72 FR 9491 NPRM Comment Period End 05/01/07 Final Action 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Local, State, Tribal Agency Contact: Jeffrey J. Polich, Child Care Program Specialist, Department of Health and Human Services, Administration for Children and Families, 8th Floor, 1250 Maryland Avenue SW., Washington, DC 20447 Phone: 202 205-8696 [[Page 22570]] Email: jeffrey.polich@acf.hhs.gov RIN: 0970-AC29 _______________________________________________________________________ 1010. ABSTINENCE EDUCATION Priority: Other Significant Unfunded Mandates: This action may affect State, local or tribal governments and the private sector. Legal Authority: sec 510 of the Social Security Act CFR Citation: 45 CFR 1352 Legal Deadline: None Abstract: This rule will provide guidance on the general requirements for abstinence education curricula, clarify the treatment of section 510(b)(2)(A) through (H), clarify appropriate target age groups for title V State Abstinence Education Grants, and clarify appropriate application of additional activities used by title V State Abstinence Education grantees. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Organizations Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: David Siegel, Family and Youth Services Bureau, Department of Health and Human Services, Administration for Children and Families, 8th Floor, 1250 Maryland Avenue SW., Washington, DC 20447 Phone: 202 401-9217 Email: dsiegel@acf.hhs.gov RIN: 0970-AC30 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1011. 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 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 06/00/07 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 _______________________________________________________________________ 1012. COST ALLOCATION METHODOLOGY APPLICABLE TO THE TEMPORARY ASSISTANCE FOR NEEDY FAMILIES PROGRAM Priority: Other Significant 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 09/27/06 71 FR 56440 NPRM Comment Period End 11/27/06 Final Action 03/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Robert Shelbourne, Deputy Director, Office of Family Assistance, Office of Policy, Department of Health and Human Services, Administration for Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5150 Email: rshelbourne@acf.hhs.gov RIN: 0970-AC15 _______________________________________________________________________ 1013. 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 rule revises the Child Care and Development Fund (CCDF) regulations to permit States to designate multiple public and/or private entities [[Page 22571]] 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 05/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Christine Calpin, Associate Director, Child Care-- Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 8th Floor, 1250 Maryland Avenue SW., Washington, DC 20447 Phone: 202 690-6782 Email: ccalpin@acf.hhs.gov RIN: 0970-AC18 _______________________________________________________________________ 1014. 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 07/14/06 71 FR 40345 Final Action 03/00/08 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 _______________________________________________________________________ 1015. 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 09/20/06 71 FR 54965 Final Action 09/00/07 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 _______________________________________________________________________ 1016. CHILD SUPPORT PROVISIONS OF THE DEFICIT REDUCTION ACT Priority: Economically Significant. Major under 5 USC 801. 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 01/24/07 72 FR 3093 Final Action 01/00/08 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 _______________________________________________________________________ 1017. TANF WORK PROVISIONS OF THE DEFICIT REDUCTION ACT Priority: Other Significant Legal Authority: 42 USC 1302 CFR Citation: 261, et seq Legal Deadline: Other, Statutory, June 30, 2006, Interim Final Rule. Abstract: This rule will 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 06/29/06 71 FR 37454 Final Action 12/00/07 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 SW., Washington, DC 20447 Phone: 202 401-5150 Email: rshelbourne@acf.hhs.gov RIN: 0970-AC27 [[Page 22572]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Administration for Children and Families (ACF) _______________________________________________________________________ 1018. HEAD START TRANSPORTATION Priority: Other Significant CFR Citation: 45 CFR 1310 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 10/04/06 71 FR 58533 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Craig Turner Phone: 202 205-8236 Email: cturner@acf.hhs.gov RIN: 0970-AC26 [FR Doc. 07-01618 Filed 04-27-07; 8:45 am] BILLING CODE 4150-24-S