[June 28, 2004 (Volume 69, Number 123)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [DOCID: f:ua040408.wais] [Page 37428-37501] Department of Health and Human Services ----------------------------------------------------------------------- Part VIII ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 37428]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) _______________________________________________________________________ DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual agenda. _______________________________________________________________________ SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual publication of an inventory of all rulemaking actions under development or review by Federal departments and agencies. 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. Anyone wishing to communicate to the Department their views on the potential rulemakings outlined below is invited to do so. When the Department publishes a regulatory proposal, information about it automatically becomes available to the public at www.regulations.gov, the Governmentwide Web site for submission of comments on proposed regulations. Citizens may submit comments by clicking the Submit a Comment on the Regulation link on this site, which will open a blank comment form that includes instructions on how to submit the comment and what information must be provided for the comment to be considered. Comments submitted via www.regulations.gov are transmitted to the Department daily, and, as legally required, all comments are reviewed and taken into account if a final regulation is developed. 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 reflects an effort to present 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. (Also included, in several Long-Term Action sections, are summaries of actions that we will probably not take any earlier than 12 months after publication of this agenda.) 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: June 9, 2004. Ann C. Agnew, Executive Secretary to the Department. Office of the Secretary--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 813 Safe Harbor for Arrangements Involving Federally Qualified Health Centers............. 0991-AB06 814 Claims Collection..................................................................... 0991-AB18 815 Salary Offset......................................................................... 0991-AB19 816 Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver 0991-AB33 Provisions of the OIG's Exclusion Authorities......................................... ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 817 Shared Risk Exception to the Safe Harbor Provisions................................... 0991-AA91 818 Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color, 0991-AB10 National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration Act of 1987............................................................................... 819 Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a 0991-AB16 Medicare SELECT Policy................................................................ 820 Clarification of Terms and Application of Program Exclusion Authority for Submitting 0991-AB23 Claims Containing Excessive Charges................................................... 821 Technical Revisions to HIPDB Data Collection Activities............................... 0991-AB31 ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 822 Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money 0991-AB03 Penalties and Assessments............................................................. 823 Health Insurance Portability and Accountability Act--Enforcement...................... 0991-AB29 ---------------------------------------------------------------------------------------------------------------- [[Page 37429]] Office of the Secretary--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 824 Tax Refund Offset..................................................................... 0991-AB17 825 Implementation of the Equal Access to Justice Act in Agency Proceedings............... 0991-AB22 826 OIG Civil Money Penalties Under the Medicare Prescription Drug Discount Card Program.. 0991-AB30 ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 827 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 ---------------------------------------------------------------------------------------------------------------- 828 Mandatory Guidelines for the Federal Workplace Drug Testing Program................... 0930-AA12 ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 829 Substance Abuse and Mental Health Services Administration (SAMHSA) Charitable Choice.. 0930-AA11 830 Mandatory Guidelines for Federal Workplace Drug Testing Programs; Specimen Validity 0930-AA13 Testing............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 831 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04 Respiratory Protective Devices........................................................ ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 832 Procedures for Designating Classes of Employees as Members of the Special Exposure 0920-AA07 Cohort Under the Energy Employee Occupational Illness Compensation Act of 2000........ ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 833 Safety Reporting Requirements for Human Drug and Biological Products.................. 0910-AA97 834 Food Labeling; Prominence of Calories................................................. 0910-AF22 835 Food Labeling; Serving Sizes.......................................................... 0910-AF23 836 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 ---------------------------------------------------------------------------------------------------------------- [[Page 37430]] Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 837 Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and 0910-AA49 Biologics............................................................................. 838 Applications for FDA Approval To Market a New Drug; Complete Response Letter; 0910-AB34 Amendments To Unapproved Applications................................................. 839 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14 840 Exception From General Requirements for Informed Consent; Request for Comments and 0910-AC25 Information........................................................................... 841 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure 0910-AC30 Regulators for Use With Medical Oxygen................................................ 842 Food Standards: General Principles and Food Standards Modernization................... 0910-AC54 843 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 844 Reporting Information Regarding Falsification of Data................................. 0910-AC59 845 Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security 0910-AF06 and Bioterrorism Preparedness and Response Act of 2002................................ 846 Health Claims......................................................................... 0910-AF09 847 Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water. 0910-AF10 848 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation.............................................. 849 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 850 Charging for Investigational Drugs.................................................... 0910-AF13 851 Treatment Use of Investigational Drugs................................................ 0910-AF14 852 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AF16 Policies, Requirements, and Administrative Procedures; Derivatives of Blood........... 853 Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol.... 0910-AF18 854 Revocation of the Status of Specific Products; Group A Streptococcus.................. 0910-AF20 855 Latex Condoms: Special Controls....................................................... 0910-AF21 856 Blood Initiative--Regulations for Human Blood and Blood Components Intended for 0910-AF25 Transfusion or for Further Manufacturing Use.......................................... 857 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 858 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 859 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 860 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 861 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 862 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 863 Investigational New Drugs: Export Requirements for Unapproved New Drug Products....... 0910-AA61 864 Labeling for Human Prescription Drugs; Revised Format................................. 0910-AA94 865 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based 0910-AB28 Product Establishments; Inspection and Enforcement.................................... 866 CGMP 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).................................................................. 867 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88 Ingredients and Dietary Supplements................................................... 868 Additional Safeguards for Children in Clinical Investigations of FDA-Regulated 0910-AC07 Products.............................................................................. 869 Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration............... 0910-AC32 870 Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major 0910-AC34 Components............................................................................ 871 Establishment and Maintenance of Records Pursuant to the Public Health Security and 0910-AC39 Bioterrorism Preparedness and Response Act of 2002.................................... 872 Registration of Food and Animal Feed Facilities....................................... 0910-AC40 873 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism 0910-AC41 Preparedness and Response Act of 2002................................................. 874 Presubmission Conferences............................................................. 0910-AC44 875 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an 0910-AF15 Investigational New Drug Application.................................................. 876 Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood 0910-AF26 Components, Including Source Plasma................................................... [[Page 37431]] 877 Over-the-Counter (OTC) Drug Review--Antiperspirant Products........................... 0910-AF30 878 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 879 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 880 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 881 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 882 Requirements Pertaining to Sampling Services and Private Laboratories Used in 0910-AB96 Connection With Imported Food......................................................... 883 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed 0910-AC21 Animal Populations.................................................................... 884 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 885 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs............. 0910-AC35 886 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..... 887 Submission of Standardized Electronic Study Data From Clinical Studies Evaluating 0910-AC52 Human Drugs and Biologics............................................................. 888 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 889 Food Labeling: Food Allergen Ingredient Labeling...................................... 0910-AF07 890 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding 0910-AF08 of Drugs; Revision of Certain Labeling Controls....................................... 891 Current Good Manufacutring Practices; Quality Control Procedures; Notification 0910-AF27 Requirements; Records and Reports..................................................... 892 Infant Formula Quality Factors........................................................ 0910-AF28 893 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 894 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 895 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 896 Over-the-Counter (OTC) Drug Review.................................................... 0910-AA01 897 Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality 0910-AA04 Control Procedures, Quality Factors, Notification Requirements, and Records and Reports............................................................................... 898 Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest 0910-AA89 of Recipients......................................................................... 899 Blood Initiative...................................................................... 0910-AB26 900 Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue- 0910-AB27 Based Products........................................................................ 901 Supplements and Other Changes to an Approved Application.............................. 0910-AB61 902 Current Good Manufacturing Practice for Medicated Feeds............................... 0910-AB70 903 Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in 0910-AB91 Electronic Format..................................................................... 904 Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products...... 0910-AC19 905 Bar Code Label Requirements for Human Drug Products and Blood......................... 0910-AC26 906 Administrative Detention of Food for Human or Animal Consumption Under the Public 0910-AC38 Health Security and Bioterrorism Preparedness and Response Act of 2002................ 907 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed................. 0910-AC43 908 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review 0910-AC56 909 Revision of the Requirements for Spore-Forming Microorganisms......................... 0910-AC57 910 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 0910-AC58 (Part 110) (Completion of a Section 610 Review)....................................... 911 Over-the-Counter (OTC) Drug Review--Antidiarrheal Products............................ 0910-AF29 ---------------------------------------------------------------------------------------------------------------- [[Page 37432]] Health Resources and Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 912 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA41 Care Practitioners: Medical Malpractice Payments Reporting Requirements............... 913 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44 Areas................................................................................. 914 Intestines Added to the Definition of Organs Covered by the Rules Governing the 0906-AA62 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 915 Notice of Proposed Rulemaking to Amend the Final Rule Governing the Operation of the 0906-AA63 Organ Procurement and Transplantation Network (OPTN).................................. 916 National Vaccine Injury Compensation Program; Revisions and Additions to the Vaccine 0906-AA66 Injury Table.......................................................................... 917 Liability Protection for Certain Free Clinic Health Professionals..................... 0906-AA67 918 National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health 0906-AA68 Insurance Policy...................................................................... ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 919 Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox 0906-AA60 (Vaccinia) Vaccine Injury Table....................................................... 920 Smallpox Vaccine Injury Compensation Program: Administrative Implementation........... 0906-AA61 921 Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act 0906-AA65 Title IV Grants for Coordinated Services and Access to Research....................... ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 922 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA57 Care Practitioners: Reporting Adverse and Negative Actions............................ ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 923 Undergraduate Scholarship Program Regarding Professions Needed by the National 0925-AA10 Institutes of Health (NIH)............................................................ 924 National Institutes of Health Training Grants......................................... 0925-AA28 925 Standards for a National Chimpanzee Sanctuary System.................................. 0925-AA31 926 National Institutes of Health AIDS Research Loan Repayment Program.................... 0925-AA32 927 National Institutes of Health Extramural Loan Repayment Program for Clinical 0925-AA33 Researchers........................................................................... 928 National Institutes of Health Pediatric Research Loan Repayment Program............... 0925-AA34 929 National Institutes of Health Loan Repayment Program for Health Disparities Research.. 0925-AA35 930 National Institutes of Health Clinical Research Loan Repayment Program for Individuals 0925-AA36 From Disadvantaged Backgrounds........................................................ 931 National Institute of Child Health and Human Development Contraception and Infertility 0925-AA41 Research Loan Repayment Program....................................................... ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 932 National Institutes of Health Loan Repayment Program for Research Generally........... 0925-AA18 933 National Institutes of Health Center Grants........................................... 0925-AA24 ---------------------------------------------------------------------------------------------------------------- [[Page 37433]] National Institutes of Health--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 934 Scientific Peer Review of Research Grant Applications and Research and Development 0925-AA20 Contract Projects..................................................................... ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 935 Human Subjects Protection Regulations: Additional Protections for Adult Individuals 0940-AA11 with Impaired Decisionmaking Capacity................................................. ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 936 Public Health Service Policies on Research Misconduct................................. 0940-AA04 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 937 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01 Whistleblowers........................................................................ 938 Human Subjects Protection Regulations: Institutional Review Boards Registration 0940-AA06 Requirements.......................................................................... 939 Federal Policy for the Protection of Human Subjects Technical Amendment............... 0940-AA10 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 940 Human Subjects Protection Regulations: Training and Education Requirements for 0940-AA08 Institutional Officials, Institutional Review Board Members and Staff, Human Protections Administrators, and Investigator.......................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 941 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P).............. 0938-AG81 942 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 0938-AG82 Review)............................................................................... 943 Hospital Conditions of Participation: Requirements for Approval and Reapproval of 0938-AH17 Transplant Centers To Perform Organ Transplants (CMS-3835-P).......................... 944 Hospice Care--Conditions of Participation (CMS-3844-P)................................ 0938-AH27 945 Standard Unique National Health Plan Identifiers (CMS-6017-P)......................... 0938-AH87 946 Appeals of Carrier Determination that a Supplier Fails to Meet the Requirements for 0938-AI49 Medicare Billing Privileges (CMS-6003-P2)............................................. 947 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AJ17 and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2)....... 948 Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS- 0938-AJ98 6010-P)............................................................................... 949 Health Insurance Reform: Claims Attachments Standards (CMS-0050-P).................... 0938-AK62 950 Organ Procurement Organization Conditions for Coverage (CMS-3064-P)................... 0938-AK81 951 Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That 0938-AL26 Provide Inpatient or Residential Care (CMS-2130-P).................................... [[Page 37434]] 952 Provider Reimbursement Determinations and Appeals (CMS-1727-P)........................ 0938-AL54 953 Health Coverage Portability's Request for Information on Benefit-Specific Waiting 0938-AL64 Periods (CMS-2150-NC)................................................................. 954 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..... 0938-AL80 955 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family 0938-AL88 and Medical Leave Act (CMS-2158-P).................................................... 956 Modifications to Electronic Transactions and Code Sets (CMS-0009-P)................... 0938-AM50 957 Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment 0938-AM75 Rates (CMS-1427-P).................................................................... 958 Ticket to Work: Defining Individuals with Potentially Severe Disabilities and 0938-AM79 Providing a Work Threshold (CMS-2172-P)............................................... 959 Payment Error Rate Measurement (PERM) Program (CMS-2186-P)............................ 0938-AM86 960 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)............. 0938-AM87 961 Hospital Conditions of Participation: Requirements For History and Physical 0938-AM88 Examinations; Authentication of Verbal Orders, Securing Medications and Post- Anesthesia Evaluations (CMS-3122-P)................................................... 962 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 0938-AM90 (CMS-1429-P).......................................................................... 963 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM98 (CMS-6146-P).......................................................................... 964 Physician Referral for Nuclear Medicine Services and Supplies (CMS-1261-P)............ 0938-AN04 965 Medicare Advantage Program Title II (CMS-4069-P)...................................... 0938-AN06 966 Special Rules for Employer-Sponsored Drug Programs: Subsidies to Encourage Retention 0938-AN07 (Title I) (CMS-2199-P)................................................................ 967 Medicare Drug Benefit Effective Calendar Year 2006 (Title I) (CMS-4068-P)............. 0938-AN08 968 Enhanced DSH Treatment for Certain Hospitals (CMS-2198-P)............................. 0938-AN09 969 Prior Determination Process (CMS-6024-P).............................................. 0938-AN10 970 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, 0938-AN14 Orthotics, and Supplies (CMS-1270-P).................................................. 971 Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS- 0938-AN23 1478-PN).............................................................................. 972 Revisions to HIPAA Code Sets (CMS-0013-P)............................................. 0938-AN25 973 Payment for Clinical Laboratory Tests (CMS-1494-P).................................... 0938-AN26 974 Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates 0938-AN28 and Policy Changes for 2006 (CMS-1483-P).............................................. ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 975 Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient 0938-AJ96 Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)......................... 976 Revisions to the Medicare Appeals Process (CMS-4004-FC)............................... 0938-AL67 977 Electronic Medicare Claims Submission (CMS-0008-F).................................... 0938-AM22 978 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AM46 Update for FY 2005 (CMS-1249-N)....................................................... 979 Title I: Non-Federal Governmental Plans Exempt From HIPAA (CMS-2033-F)................ 0938-AM71 980 Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-FC)....... 0938-AM73 981 Conditions for Coverage of Power Mobility Devices, including Powered Wheelchairs and 0938-AM74 Power-Operated Vehicles Scooter(CMS-3017-IFC)......................................... 982 Hospice Wage Index FY 2005 (CMS-1264-N)............................................... 0938-AM78 983 Changes to the Hospital Inpatient Prospective Payment System and FY 2005 Rates (CMS- 0938-AM80 1428-F)............................................................................... 984 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2005 (CMS- 0938-AM82 1360-N)............................................................................... 985 Home Health Prospective Payment System Rate Update FY 2005 (CMS-1265-P)............... 0938-AM93 986 Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar 0938-AM97 Year 2004--Correction Notice CMS-1372-IFC)............................................ 987 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AM99 Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F5)............. 988 Time Limitation on Record keeping Requirements Under the Drug Rebate Program (CMS-2188- 0938-AN01 P).................................................................................... 989 Extended Availability of Unexpended SCHIP Funds From the Appropriation for FYs 1998 0938-AN03 Through 2004; Authority To Use a Portion of SCHIP Funds for Medicaid Expenditures (CMS- 2187-N)............................................................................... 990 FY 2005 SCHIP Allotments (CMS-2201-N)................................................. 0938-AN11 991 Schedule for Publishing Medicare Final Regulations After a Proposed or Interim Final 0938-AN12 Regulation (CMS-9026-N)............................................................... 992 Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142- 0938-AN13 NC)................................................................................... [[Page 37435]] 993 Part A Premiums for Calendar Year 2005 for the Uninsured Aged and for Certain Disabled 0938-AN15 Individuals Who Have Exhausted Other Entitlement (CMS-8022-N)......................... 994 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AN16 Amounts for Calendar Year 2005 (CMS-8021-N)........................................... 995 Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2005 0938-AN18 (CMS-8020-N).......................................................................... 996 Fee Schedule for Payment of Ambulance Services-Update for Calendar Year 2005 (CMS-1267- 0938-AN20 N).................................................................................... 997 Procedure for Producing Guidance Documents Describing Medicare's Coverage Process (CMS- 0938-AN21 3141-N)............................................................................... 998 Amendment to the Interim Final Regulation for Mental Health Parity (CMS-2152-F2)...... 0938-AN22 999 Medicare Ambulance Fee Schedule Update (CMS-1492-IFC)................................. 0938-AN24 1000 Medicare Secondary Payer (MSP): Workmen's Compensation (CMS-1272-FC).................. 0938-AN27 1001 Random Prepayment Review (CMS-6022-IFC)............................................... 0938-AN31 1002 Additional Payments for Certain Medicare Part B Drugs (CMS-1280-FC)................... 0938-AN34 1003 Federal Enforcement in Group and Individual Health Insurance Markets (CMS-2019-F)..... 0938-AN35 1004 Fire Safety Requirements for Certain Health Care Facilities, Amendment (CMS-3047-F2).. 0938-AN36 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1005 Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F) 0938-AH73 1006 Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements 0938-AJ10 (CMS-3006-F).......................................................................... 1007 Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)................ 0938-AJ29 1008 Medicare Hospice Care Amendments (CMS-1022-F)......................................... 0938-AJ36 1009 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67 Relationships--Phase II (CMS-1810-IFC)................................................ 1010 Continuation of Medicare Entitlement When Disability Benefit Ends Because of 0938-AK94 Substantial Gainful Activity (CMS-4018-F)............................................. 1011 Medicare Program; Interest Calculation (CMS-6014-F)................................... 0938-AL14 1012 Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers 0938-AL43 (CMS-2151-F).......................................................................... 1013 Prospective Payment System for Inpatient Psychiatric Facilities FY 2004 (CMS-1213-F).. 0938-AL50 1014 DMERC Service Areas and Related Matters (CMS-1219-F).................................. 0938-AL76 1015 Procedures for Maintaining Code Lists in the Negotiated National Coverage 0938-AM36 Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-F)............... 1016 Hospital Patients' Rights CoP--Standard Safety Compliance Committees (CMS-3120-P)..... 0938-AM39 1017 Requirements for Nursing Homes To Identify the Number of Licensed and Unlicensed 0938-AM55 Nurses (CMS-3121-F)................................................................... 1018 Covered Outpatient Drugs Under the Medicaid Drug Rebate Program (CMS-2174-P).......... 0938-AM81 1019 Revisions to Cost Sharing Regulations (CMS-2144-P).................................... 0938-AM94 1020 Medicare Program; Hospital Outpatient Prospective Payment System Payment Reform for 0938-AM96 Calendar Year 2004 CMS-1371-IFC....................................................... 1021 Payment for Respiratory Assist Devices with Bi-level Capability and a Back-up Rate 0938-AN02 (CMS-1167-F).......................................................................... 1022 Manufacturers' Submission of Average Sales Price Data for Medicare Part B Drugs and 0938-AN05 Biologicals (CMS-1380-IFC)............................................................ 1023 Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities 0938-AN19 (CMS-1224-F).......................................................................... 1024 Nondiscrimination in Health Coverage and Bonafide Wellness Plans in the Group Market 0938-AN29 (CMS-2022-F).......................................................................... 1025 Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)................... 0938-AN30 ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1026 Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F). 0938-AH99 1027 Coverage of Religious Nonmedical Health Care Institutions (CMS-1909-F)................ 0938-AI93 1028 All Provider Bad Debt Payment (CMS-1126-F)............................................ 0938-AK02 1029 Review of National Coverage Determinations and Local Coverage Determinations (CMS-3063- 0938-AK60 F).................................................................................... 1030 Rate of Reimbursement of Photocopy Expenses for Quality Improvement Organizations (CMS- 0938-AK68 3055-F)............................................................................... [[Page 37436]] 1031 Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-F). 0938-AK79 1032 Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans (CMS- 0938-AL49 6016-F)............................................................................... 1033 Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 0938-AL91 Payment Rates (CMS-1471-F)............................................................ 1034 Criteria for Determining Whether a Drug is Considered Usually Self-Administered (CMS- 0938-AM13 1228-P)............................................................................... 1035 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AM31 Amounts for Calendar Year 2004 (CMS-8016-N)........................................... 1036 Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate 0938-AM32 Beginning January 1, 2004 (CMS-8017-N)................................................ 1037 Part A Premiums for Calendar Year 2004 for the Uninsured Aged and for Certain Disabled 0938-AM33 Individuals Who Have Exhausted Other Entitlement (CMS-8018-N)......................... 1038 Grants to States for Operation of Qualified High Risk Pools (CMS-2179-FC)............. 0938-AM42 1039 Fee Schedule for Payment of Ambulance Services Update for Calendar Year 2004 (CMS-1232- 0938-AM44 FCC).................................................................................. 1040 Exclusion of Medicare Benefits for Aliens Not Lawfully Present in the United States 0938-AM47 (CMS-1222-FC)......................................................................... 1041 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM54 (CMS-6146-P).......................................................................... 1042 Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility 0938-AM72 (CMS-1262-F).......................................................................... 1043 Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates 0938-AM84 and Policy Changes (Effective 7/1/04) (CMS-1263-F).................................... 1044 Disproportionate Share Hospital (DSH) Payments Institutions for Mental Disease (IMDs) 0938-AM89 (CMS-2062-N).......................................................................... 1045 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AM95 Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F4)............. 1046 Notice of One-Time Appeal Process for Hospital Wage Index Classification (CMS-1373-N). 0938-AN00 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1047 Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) 0970-AC01 Information........................................................................... 1048 Developmental Disabilities and Bill of Rights Act..................................... 0970-AC07 1049 Administrative Costs for Children in Title IV-E Foster Care........................... 0970-AC14 1050 Administrative Cost Sharing Under TANF................................................ 0970-AC15 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1051 Child Support Enforcement Program; Federal Tax Refund Offset.......................... 0970-AC09 1052 Head Start Transportation............................................................. 0970-AC16 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1053 Child Support Enforcement for Indian Tribes........................................... 0970-AB73 1054 Charitable Choice Provisions Applicable to the Temporary Assistance for Needy Families 0970-AC12 Program............................................................................... 1055 Community Services Block Grant Charitable Choice...................................... 0970-AC13 ---------------------------------------------------------------------------------------------------------------- [[Page 37437]] Administration on Aging--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1056 Grants for State and Community Programs on Aging, Training, Research, and 0985-AA00 Discretionary Programs; Vulnerable Elder Rights; Grants to Indians and Native Hawaiians............................................................................. ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 813. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH CENTERS Priority: Substantive, Nonsignificant Legal Authority: PL 100-93, sec 14(a) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This rule would set forth a new anti-kickback safe harbor addressing remuneration between federally qualified health centers and certain service providers where a significant community benefit exists. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 Related RIN: Related to 0991-AA91 RIN: 0991-AB06 _______________________________________________________________________ 814. CLAIMS COLLECTION Priority: Substantive, Nonsignificant Legal Authority: 31 USC 3711; 31 CFR 900 to 904 CFR Citation: 45 CFR 30 Legal Deadline: None Abstract: The Department will amend part 30 of title 45 of the Code of Federal Regulations (CFR) to reflect the amendments to the Federal Claims Collection Act made by the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, as implemented by the Department of the Treasury at 31 CFR 900-904. The proposed rule will prescribe the standards and procedures for the Department's use in the administrative collection, offset, compromise, and suspension or termination of debts owed to the Department. The proposed rule is required in order to bring the Department's claims collection provisions in compliance with the Department of the Treasury regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 NPRM Comment Period End 09/00/04 Final Rule 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Katherine M. Drews, Associate General Counsel, Department of Health and Human Services, Office of the Secretary, Office of the General Counsel, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB18 _______________________________________________________________________ 815. SALARY OFFSET Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: 5 USC 5514; 5 CFR 550 CFR Citation: 45 CFR 33 Legal Deadline: None Abstract: The Department will add a new part 33 to title 45 of the Code of Federal Regulations (CFR) to implement the salary offset provisions of the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104- 134, 110 Stat. 1321 to 1358, codified at 5 U.S.C. 5514, as implemented by the Office of Personnel Management at 5 CFR part 550, subpart K. The proposed rule is required in order to bring the Department's salary offset provisions in compliance with Governmentwide regulations published by the Office of Personnel Management. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 NPRM Comment Period End 09/00/04 Final Rule 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Katherine M. Drews, Associate General Counsel, Department of Health and Human Services, Office of the Secretary, Office of the General Counsel, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB19 _______________________________________________________________________ 816. [bullet][ls-thn-eq] MEDICARE AND FEDERAL HEALTH CARE PROGRAMS: FRAUD AND ABUSE; REVISIONS TO THE WAIVER PROVISIONS OF THE OIG'S EXCLUSION AUTHORITIES Priority: Substantive, Nonsignificant Legal Authority: Sec 949, PL 108-173; Sec 4331, PL 105-33; Sec 1128(c)(3)(b), Social Security Act CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: In accordance with section 949 of the Medicare Prescription Drug, Improvement, and Modernization Act [[Page 37438]] of 2003, this rule would revise the OIG's exclusion authority to permit any Federal healhcare program to request a waiver of an OIG exclusion imposed under sections 1128(a)(1), (a)(3), or (a)(4) of the Social Security Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/04 NPRM Comment Period End 11/00/04 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB33 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 817. 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 Rule 12/00/04 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 Related RIN: Related to 0991-AB06 RIN: 0991-AA91 _______________________________________________________________________ 818. AMENDING THE REGULATIONS GOVERNING NONDISCRIMINATION ON THE BASIS OF RACE, COLOR, NATIONAL ORIGIN, HANDICAP, SEX, AND AGE TO CONFORM TO THE CIVIL RIGHTS RESTORATION ACT OF 1987 Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 100-259, Civil Rights Restoration Act of 1987 CFR Citation: 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91 Legal Deadline: None Abstract: The Secretary proposes to amend the Department's regulations implementing title VI of the Civil Rights Act of 1964, as amended, section 504 of the Rehabilitation Act of 1973, as amended, title IX of the Education Amendments of 1972, and the Age Discrimination Act of 1975, as amended. The principal proposed conforming change is to amend the regulations to add the definitions of ``program or activity'' or ``program'' that correspond to the statutory definitions enacted under the Civil Rights Restoration Act of 1987. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/06/00 65 FR 76460 Final Action 07/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Robinsue Frohboese, Principal Deputy Director, Office for Civil Rights, Department of Health and Human Services, Office of the Secretary, 200 Independence Avenue SW., Washington, DC 20202 Phone: 202 619-0403 RIN: 0991-AB10 _______________________________________________________________________ 819. SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND DEDUCTIBLE AMOUNTS FOR A MEDICARE SELECT POLICY Priority: Substantive, Nonsignificant Legal Authority: PL 100-93, sec 14(a) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This final rule will expand the existing safe harbor for certain waivers of beneficiary coinsurance and deductible amounts to benefit the policyholders of Medicare SELECT supplemental insurance. Specifically, the amended safe harbor will protect waivers of coinsurance and deductible amounts under part A or part B of the Medicare program owed by beneficiaries covered by a Medicare SELECT policy issued in accordance with section 1882(t)(1) of the Social Security Act, if the waiver is in accordance with a price reduction agreement covering such policyholders between the Medicare SELECT issuer and the provider or supplier offering the waiver. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/25/02 67 FR 60202 NPRM Comment Period End 10/25/02 Final Rule 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No [[Page 37439]] 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB16 _______________________________________________________________________ 820. CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES Priority: Substantive, Nonsignificant Legal Authority: Sec 112B (6) (6)(A) of the Social Security Act CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This rule would amend the OIG exclusion regulations at 42 CFR 1001.701, addressing excessive claims, by including definitions for the terms ``substantially in excess'' and ``usual charges,'' and by clarifying the ``good cause'' exception set forth in this section. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/15/03 68 FR 53939 NPRM Comment Period End 11/14/03 Final Action 01/00/05 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB23 _______________________________________________________________________ 821. [bullet][ls-thn-eq] TECHNICAL REVISIONS TO HIPDB DATA COLLECTION ACTIVITIES Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 221(a), PL 104-91; Sec 1128E(b)(2), Social Security Act CFR Citation: 45 CFR 61 Legal Deadline: None Abstract: This rule makes technical changes to the Healthcare Integrity and Protection Data Bank data collection reporting requirements by clarifying the types of personal numeric identifiers that may be reported to the data bank in connection with adverse actions. The rule classifies that in lieu of a Social Security Number (SSN), an individual taxpayer identification number (ITIN) may be reported to the data bank when, in those limited situations, an individual does not have a SSN. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 10/00/04 Interim Final Rule Comment Period End 11/00/04 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB31 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of the Secretary (OS) _______________________________________________________________________ 822. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE CIVIL MONEY PENALTIES AND ASSESSMENTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b; 42 USC 1396u-2 CFR Citation: 42 CFR 1003 Legal Deadline: None Abstract: This proposed rule would revise part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments, by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; modify the current definition for the term ``claim;'' update various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e-mail communications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB03 _______________________________________________________________________ 823. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Subtitle F of title II of PL 104-191; 42 USC 1320d-5 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rulemaking would seek to establish a framework for enforcing compliance with the ``administrative simplification'' provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 -- subtitle F of title II of Public Law 104-191, through the imposition of civil money penalties. [[Page 37440]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Carol Conrad, Department of Health and Human Services, Room 5347, Office of the General Counsel, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 690-1840 RIN: 0991-AB29 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Office of the Secretary (OS) _______________________________________________________________________ 824. TAX REFUND OFFSET Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 45 CFR 31 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 12/18/03 68 FR 70444 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Katherine M. Drews Phone: 202 619-0150 RIN: 0991-AB17 _______________________________________________________________________ 825. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY PROCEEDINGS Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 45 CFR 13 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 01/21/04 69 FR 2843 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Katherine M. Drews Phone: 202 619-0150 Related RIN: Previously reported as 0990-AA02 RIN: 0991-AB22 _______________________________________________________________________ 826. [bullet][ls-thn-eq] OIG CIVIL MONEY PENALTIES UNDER THE MEDICARE PRESCRIPTION DRUG DISCOUNT CARD PROGRAM Priority: Substantive, Nonsignificant Legal Authority: Sec 101, PL 108-173; Sec 1860D-31, Social Security Act CFR Citation: 42 CFR 1003 Legal Deadline: None Abstract: This rule sets forth the OIG's new authority for imposing civil money penalties against endorsed sponsors under the medicare prescription drug discount card program that knowingly engage in false or misleading marketing practicies; overcharge program enrollees; or misuse transtional assistance funds. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 05/19/04 69 FR 28842 Interim Final Rule Comment Period End 07/19/04 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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB30 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 827. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-310 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, April 2001. Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 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, Rockville, MD 20857 Phone: 301 443-2619 RIN: 0930-AA10 [[Page 37441]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 828. 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 04/00/05 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, Room 12C-15, 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) Completed Actions Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 829. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA) CHARITABLE CHOICE Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 42 CFR 54, sec 54.1--13; 42 CFR 54a, sec 54a.1--14 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 09/30/03 68 FR 56429 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Winnie Mitchell Phone: 301 443-2324 Fax: 301 443-0247 RIN: 0930-AA11 _______________________________________________________________________ 830. [bullet][ls-thn-eq] MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG TESTING PROGRAMS; SPECIMEN VALIDITY TESTING Priority: Other Significant Legal Authority: PL 100-71, sec 503 CFR Citation: None Legal Deadline: None Abstract: HHS is establishing standards for determining the validity of urine specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. These standards ensure that specimen validity testing (SVT) and reporting procedures are uniformly applied to all Federal agency urine specimens when a validity test is conducted. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 04/13/04 69 FR 19644 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Local, State Agency Contact: Walter F. Vogel, CSAP, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, CSAP, Suite 815, Rockville II, Rockville, MD 20857 Phone: 301 443-6014 RIN: 0930-AA13 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 831. 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 10/00/04 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Roland Berry Ann, Acting Chief, Respirator Branch, National Personal Protection Technology Laboratory, Department of Health and Human Services, Centers for Disease Control and Prevention, NIOSH, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-4000 RIN: 0920-AA04 [[Page 37442]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 832. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEE OCCUPATIONAL ILLNESS COMPENSATION ACT OF 2000 Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 83 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 05/28/04 69 FR 30763 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Larry Elliott Phone: 513 841-4498 RIN: 0920-AA07 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 833. 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 proposed rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and propose other revisions to these regulations to enhance the quality of safety reports received by FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/14/03 68 FR 12406 NPRM Comment Period Extended 06/18/03 NPRM Comment Period End 07/14/03 NPRM Comment Period Extension End 10/14/03 Comment Review End 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Elizabeth J Sadove, Regulatory Counsel, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and ResearchAdministration, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AA97 _______________________________________________________________________ 834. [bullet][ls-thn-eq] FOOD LABELING; PROMINENCE OF CALORIES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined 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 will issue an advance notice of proposed rulemaking (ANPRM) in its efforts to combat the nation's obesity problem. The ANPRM will request comments on ways to give more prominence to ``calories'' on the food label. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 10/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Shellee Anderson, Team Leader, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1450 Fax: 301-436-2636 Email: shellee.anderson@hhs.fda.gov RIN: 0910-AF22 _______________________________________________________________________ 835. [bullet][ls-thn-eq] FOOD LABELING; SERVING SIZES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101.9(b) 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 will issue an advance notice of proposed rulemaking (ANPRM) in its efforts to combat the nation's obesity problem. The ANPRM will request 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 10/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined [[Page 37443]] Federalism: Undetermined Agency Contact: Lori LeGault, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-840, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1791 Fax: 301-436-2635 Email: llegault@cfsan.fda.gov RIN: 0910-AF23 _______________________________________________________________________ 836. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Sunscreen and Insect Repellent) 11/00/04 NPRM (UVA/UVB) 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF43 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 837. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING REQUIREMENTS FOR DRUGS AND BIOLOGICS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 330; 21 CFR 514; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations on the registration of producers of drugs and the listing of drugs in commercial distribution. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list drugs or biologics regulated as drugs. The proposal describes when, how, and where to register and list, and what information must be submitted for registration and listing. The proposed regulations would also revise the requirements for the National Drug Code number and would require the electronic submission of most registration and listing information. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: Yes 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, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: mullerh@cder.fda.gov RIN: 0910-AA49 _______________________________________________________________________ 838. 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. Unfunded Mandates: 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 proposed 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 proposed rule would also amend the regulations on extension of the review clock because of amendments to applications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: pendletonb@cder.fda.gov RIN: 0910-AB34 [[Page 37444]] _______________________________________________________________________ 839. 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. In accordance with discussions at the public meetings, FDA intends to publish a proposed rule to require that shell eggs be produced under a plan that is designed to prevent transovarian SE from contaminating eggs at the farm during production. FDA intends to discuss in its proposal certain provisions of the 1999 Food Code that are relevant to how eggs are handled, prepared, and served at certain retail establishments. In addition, the agency plans to consider whether it should require provisions for certain retail establishments that serve populations most at risk of egg-related illness (i.e., the elderly, children, and the immunocompromised). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-306, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@cfsan.fda.gov RIN: 0910-AC14 _______________________________________________________________________ 840. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST FOR COMMENTS AND INFORMATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381 CFR Citation: 21 CFR 50.23 Legal Deadline: None Abstract: FDA is proposing an amendment to the 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 ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Catherine Lorraine, Director, Policy Development and Coordination Group, Department of Health and Human Services, Food and Drug Administration, 14-101-11, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-3360 Fax: 301 827-6777 RIN: 0910-AC25 _______________________________________________________________________ 841. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN Priority: Substantive, Nonsignificant Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c(e)(1); 21 USC 371 CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to reclassify pressure regulators for use with medical oxygen from class I to class II and to establish a special control for oxygen pressure regulators to address problems of fire and explosion associated with use of these devices. The special control will be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the special control will be exempt from the premarket notification requirements of the act. The agency believes it is taking a least burdensome approach for industry. This proposed rule will phase-in a compliance approach that will minimize the cost. FDA seeks to reclassify these devices under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AC30 [[Page 37445]] _______________________________________________________________________ 842. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 130.5 Legal Deadline: None Abstract: In 1995, the FDA and FSIS reviewed their regulatory procedures and requirements for food standards to determine whether any were still needed, and if so, which ones should be modified or streamlined. To request public comment to assist them in their review of the need for food standards, both agencies published advance notices of proposed rulemaking (ANPRMs) on food standards in December, 1995 (60 FR 47453 and 60 FR 67492). These ANPRMs discussed the agencies' regulations and policy governing food standards, the history of food standards, and the possible need to revise the food standards. Several comments in response to the ANPRMs recommended that the agencies establish general principles or a fundamental philosophy for reviewing food standards and revising them. The agencies agreed with these comments and determined that it would be appropriate to develop general principles for reviewing and revising food standards regulations. The agencies also agreed with the comments that stated that the agencies should work in concert to develop consistent food standards regulations. FDA and FSIS are now proposing a set of general principles that define how modern food standards should be structured. 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 7 CFR part 410 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 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and Human Services, Food and Drug Administration, HFS-820, 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@cfsan.fda.gov RIN: 0910-AC54 _______________________________________________________________________ 843. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: PL 105-115, sec 121 CFR Citation: 21 CFR 220 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 01/00/05 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: Wayne H. Mitchell, Regulatory Counsel, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: mitchellw@cder.fda.gov Related RIN: Previously reported as 0910-AB63 RIN: 0910-AC55 _______________________________________________________________________ 844. 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 70.3; 21 CFR 71.1; 21 CFR 170.3; 21 CFR 171.1; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 510.3; 21 CFR 511.1; 21 CFR 812.46 Legal Deadline: None Abstract: The proposed rule would require sponsors to promptly report any information indicating that any person has or may have falsified data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 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, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: pendletonb@cder.fda.gov Related RIN: Previously reported as 0910-AC02 RIN: 0910-AC59 [[Page 37446]] _______________________________________________________________________ 845. DEFINITION OF ``SERIOUS ADVERSE HEALTH CONSEQUENCES'' UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 334(h)(1)(A); 21 USC 335a(b)(3); 21 USC 343(v); 21 USC 350c(a) and (b); 21 USC 371; 21 USC 374(a)(1); 21 USC 381(j)(1) and (m)(2)(B)(ii); 21 USC 398(a) CFR Citation: 21 CFR 1.3(c) Legal Deadline: None Abstract: The proposed rule would define the term ``serious adverse health consequences'' for purposes of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and any implementing regulations. The term is used to describe part of the standard that is the basis for FDA to exercise certain authorities provided in sections 303, 304, 306, 307, 308, and 310 of title III (Protecting Safety and Security of the Food and Drug Supply), subtitle A (Protection of Food Supply), of the Bioterrorism Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ms. Karen Carson, Deputy Director, Office of Plant and Dairy Foods and Beverages, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Rm 3 A-001, College Park, MD 20740 Phone: 301 436-1664 Fax: 301 436-2632 Email: karen.carson@cfsan.fda.gov John E. Kvenberg, Deputy Director, Office of Compliance (HFS-600), Department of Health and Human Services, Food and Drug Administration, HFS-10, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Rm 3B064, College Park, MD 20740 Phone: 301 436-2359 Fax: 301 436-2717 Email: john.kvenberg@cfsan.fda.gov RIN: 0910-AF06 _______________________________________________________________________ 846. 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 01/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Nancy Crane, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1456 Fax: 301 436-2636 Email: nancy.crane@cfsan.fda.gov RIN: 0910-AF09 _______________________________________________________________________ 847. QUALITY STANDARD REGULATION ESTABLISHING ALLOWABLE LEVEL FOR ARSENIC IN BOTTLED WATER Priority: Other Significant. Major status under 5 USC 801 is 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(b) Legal Deadline: Final, Statutory, July 27, 2005. Abstract: Under section 410 of the Federal Food, Drug, and Cosmetic Act (the Act), not later than 180 days before the effective date of a National Primary Drinking Water Regulation (NPDWR) issued by the Environmental Protection Agency (EPA) for a contaminant under section 1412 of the Safe Drinking Water Act, the Food and Drug Administration (FDA) is required to issue a standard of quality regulation for that contaminant in bottled water or make a finding that such a regulation is not necessary to protectthe public health because the contaminant is contained in water in public water systems but not in water used for bottled water. The effective date for any such standard of quality regulation is to be the same as the effective date of the NPDWR. On January 22, 2001, EPA published a final rule revising the existing 0.05 mg/L maximum contaminant level (MCL) for arsenic in public drinking water to 0.01 mg/L (10 ppb). The effective date for this rule was temporarily delayed for 60 days from March 23, 2001, to a new effective date of May 22, 2001, in accordance with the memorandum of January 20, 2001, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review Plan'' (66 FR 7701; January 24, 2001). On May 22, 2001, EPA announced that it would further delay the effective date for the rule until February 22, 2002, to allow time to complete a reassessment of the information on which the revised arsenic standard is based. On February 22, 2002, the arsenic MCL of 0.01 mg/L in public drinking water rule became effective and water systems must comply with the new standard for arsenic in public drinking water by January 23, 2006. In accordance with section 410 of the Act, FDA is required to issue a standard of quality regulation for arsenic in bottled drinking water by July 27, 2005, with an effective date of January 23, 2006, or make a finding [[Page 37447]] that such a regulation is not necessary to protect the public health. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/04 NPRM Comment Period End 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Dr. Henry Kim, Supervisory Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, HFS-306, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2023 Fax: 301-436-2651 Email: hkim@cfsan.fda.gov RIN: 0910-AF10 _______________________________________________________________________ 848. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360(b); 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 201.57 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations concerning the format and content of the ``Pregnancy,'' ``Labor and Delivery,'' and ``Nursing Mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drugs. The proposal would require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AF11 _______________________________________________________________________ 849. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 379e(b) CFR Citation: 21 CFR 73.100 (d); 21 CFR 73.1100 (c); 21 CFR 73.2087 (c); 21 CFR 101.22 (k); 21 CFR 701.3; 21 CFR 740.20 Legal Deadline: None Abstract: The purpose of this proposed rule is to protect consumers who have allergies to the color additives carmine and cochineal extract by requiring label declaration on products under FDA jurisdiction. This action responds to adverse event reports received by FDA and to a citizen petition submitted to FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 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: 202 418-0714 Fax: 202-418-3126 Email: mhonigfo@cfsan.fda.gov RIN: 0910-AF12 _______________________________________________________________________ 850. CHARGING FOR INVESTIGATIONAL DRUGS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.7; 21 CFR 312.8 Legal Deadline: None Abstract: The proposed rule would amend FDA's investigational new drug exemption regulations concerning charging for investigational drugs. The proposed rule describes the types of investigational uses for which a sponsor may be able to charge, including uses for which charging was not previously expressly permitted, and the criteria for allowing charging for the identified investigational uses. The proposed rule would also describe the types of costs that can be recovered when charging for an investigational drug. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AF13 _______________________________________________________________________ 851. TREATMENT USE OF INVESTIGATIONAL DRUGS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 353; 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.42; 21 CFR 312.400; 21 CFR 312.405; 21 CFR 312.410; 21 CFR 312.415; 21 CFR [[Page 37448]] 312.420; 21 CFR 312.425; 21 CFR 312.430; 21 CFR 312.435 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations governing investigational new drug exemptions (INDs) to describe the way patients may obtain investigational drugs for treatment use. Treatment use of investigational drugs would be available to: 1) individual patients, including in emergencies; 2) intermediate size patient; and 3) larger populations under a treatment protocol or IND. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AF14 _______________________________________________________________________ 852. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES; DERIVATIVES OF BLOOD Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. 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: Other, Statutory, April 1, 2004, Effective date of final rule, 64 FR 67720, December 3, 1999. Date final rule takes effect: ``Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures.''. Abstract: FDA is proposing to amend the implementing regulation of the Prescription Drug Marketing Act of 1987, as modified by the Prescription Drug Amendments of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999, (64 FR 67720), do not allow a registered blood establishment that provides health care services related to its activities as a blood establishment to concurrently distribute derivatives of blood. The effective date of those provisions of that rule is December 1, 2006, as published on February 3, 2004, (69 FR 8105). FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services to also distribute derivatives of blood. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 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, 1401 Rockville Pike Suite 200N, Rockville, MD 20852 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF16 _______________________________________________________________________ 853. USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE DESIGNATION; ALBUTEROL Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 343; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 USC 374; 42 USC 7671 et seq CFR Citation: 21 CFR 2.125 Legal Deadline: None Abstract: Under the Clean Air Act, the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services, in consultation with the Environmental Protection Agency, is required to determine whether an FDA-regulated product that releases an ozone- depleting substance (ODS) is essential. The two agencies have tentatively determined that the two currently marketed non-ODS metered- dose inhalers (MDIs) will be satisfactory alternatives to albuterol MDIs that contain ODS, and are proposing to remove the essential use designations for albuterol MDIs. If the essential use designation is removed, albuterol MDIs that contain an ODS could not be marketed after a suitable transition period. The proposed rule will specifically ask for comments on which phase-out period length will best ensure a smooth transition and minimize any adverse affects on the public health. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/16/04 69 FR 33602 NPRM Comment Period End 08/16/04 Final Action 03/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: mitchellw@cder.fda.gov RIN: 0910-AF18 _______________________________________________________________________ 854. [bullet][ls-thn-eq] REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS; GROUP A STREPTOCOCCUS Priority: Info./Admin./Other Legal Authority: 42 USC 262 CFR Citation: 21 CFR 610.19 Legal Deadline: None Abstract: FDA is issuing a direct final rule and companion proposed rule to revoke 21 CFR 610.19, Status of specific products; Group A streptococcus. The current regulation was based on the panel report for bacterial vaccines with ``No U.S. [[Page 37449]] Standard of Potency.'' The vaccines had been licensed by the National Institutes of Health prior to 1972, when regulatory authority over these vaccines was transferred to FDA. The regulation prohibits the use of Group A streptococcus organisms and derivatives of Group Astreptococcus as ingredients in Bacterial Vaccines and Bacterial Antigens with ``No U.S. Standard of Potency.'' The regulation was never intended to refer to purified streptococcus vaccines, which were not developed at that time. Therefore, the regulation is being revoked. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM - Companion to Direct Final Rule 04/00/05 Direct Final Rule 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Valerie Butler, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), HFM-17, 1401 Rockville Pike, Rockville, MD 20852 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF20 _______________________________________________________________________ 855. [bullet][ls-thn-eq] LATEX CONDOMS: SPECIAL CONTROLS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 351; 21 USC 352; 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 NR latex. The new special control guidance document would provide detailed recommendations for labeling meeting the requirements of 21 CFR 801, that together with the general controls, provides a resaonable assurance of the safety and effectiveness of these devices. The rule will demonstrate how the agency is moving forward to meet the congressionaldirective of Public Law 106-554 that FDA review condom labeling to assure that the information regarding sexually transmitted disease transmission is medically accurate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AF21 _______________________________________________________________________ 856. [bullet][ls-thn-eq] BLOOD INITIATIVE--REGULATIONS FOR HUMAN BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE Priority: Other Significant. 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 360; . . . CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 610; . . . Legal Deadline: None Abstract: In multiple rulemakings, the Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and blood-derivative products 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. The other remaining subject intended to be addressed in the rulemakings include: labeling of blood and blood components (0910-AF26). These actions are intended to help ensure the continued safety of the Nation's blood supply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF25 _______________________________________________________________________ 857. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of [[Page 37450]] Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF32 _______________________________________________________________________ 858. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF33 _______________________________________________________________________ 859. [bullet][ls-thn-eq] 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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenylephrine Bitartrate) 09/00/04 NPRM (Phenyl-propanolamine) 09/00/04 NPRM (Amendment) (Sinusitis Claim) 10/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF34 _______________________________________________________________________ 860. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Labeling) 08/00/04 NPRM (Amendment) (Pediatric) 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF36 _______________________________________________________________________ 861. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. [[Page 37451]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Convenience Sizes) 08/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF37 _______________________________________________________________________ 862. [bullet][ls-thn-eq] 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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl-propanolamine) 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF45 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 863. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW DRUG PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC 241; 42 USC 243; 42 USC 262; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371 CFR Citation: 21 CFR 312.110 Legal Deadline: None Abstract: The final rule would amend the regulations on the exportation of unapproved new drug products, including biological products, for investigational use. In general, the rule would provide four different routes for exporting an unapproved new drug product for investigational use. One route would permit exportation, if the drug is the subject of an investigational new drug application (IND) and is being exported for use in the investigation. A second route would permit exportation, without prior Food and Drug Administration (FDA) approval and without an IND, if the product is to be exported for use in a clinical investigation and has received marketing authorization in certain developed countries. The third route would permit exportation, without prior FDA approval and without an IND, if the product is to be exported for use in a clinical investigation in certain specified developed countries. The fourth route would permit exportation without an IND, to any country provided that the exporter sends a written certification to FDA at the time the drug is first exported. Drugs exported under any of the first three routes would, however, be subject to certain statutory requirements, such as not conflicting with the foreign country's laws and not being sold or offered for sale in the United States. Drugs exported under either the second or third routes would be subject to additional statutory requirements, such as being in substantial conformity with the current good manufacturing practices and certain labeling requirements. These provisions would implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/19/02 67 FR 41642 Final Action 09/00/04 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, Room 15-61 (HF-23), Office of Policy and Planning, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: pchao@oc.fda.gov RIN: 0910-AA61 _______________________________________________________________________ 864. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT Priority: Other Significant. 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 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 Legal Deadline: None Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The regulation would amend the regulations governing the format and content of professional labeling for human [[Page 37452]] prescription drug and biologic products, 21 C.F.R. 201.56 and 201.57. The regulation would require that professional labeling include a section containing highlights of prescribing information, and a section containing an index to prescribing information; reorder currently required information and make minor changes to its content, and establish minimum graphical requirements for professional labeling. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/22/00 65 FR 81082 NPRM Comment Period End 03/22/01 NPRM Comment Period Reopened 03/30/01 NPRM Comment Period Reopening End 06/22/01 Final Action 10/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AA94 _______________________________________________________________________ 865. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCT ESTABLISHMENTS; INSPECTION AND ENFORCEMENT Priority: Other Significant Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 1270; 21 CFR 1271 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based products (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, recordkeeping, and the establishment of a quality program. FDA is also issuing regulations pertaining to labeling, reporting, inspections, and enforcement. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/08/01 66 FR 1508 NPRM Comment Period End 05/08/01 Final Action 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AB28 _______________________________________________________________________ 866. CGMP 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: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264 CFR Citation: 21 CFR 606; 21 CFR 610 Legal Deadline: None Abstract: This rulemaking is one of a number of actions being taken to amend the biologics regulations to remove, revise, or update the regulations applicable to blood, blood components, and blood derivatives. These actions are based on FDA's comprehensive review of the biologics regulations and on reports by the U.S. House of Representatives Committee on Government Reform and Oversight's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute ofMedicine, 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 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Related to 0910-AB26 RIN: 0910-AB76 _______________________________________________________________________ 867. 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 [[Page 37453]] 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 of dietary supplements, they do so in a manner that will not adulterate and misbrand such dietary ingredientsor 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 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Linda Kahl, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-206, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 202 418-3101 Fax: 202 418-3131 Email: linda.kahl@hhs.fda.gov RIN: 0910-AB88 _______________________________________________________________________ 868. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF FDA-REGULATED PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to 263n CFR Citation: 21 CFR 50; 21 CFR 56 Legal Deadline: Final, Statutory, April 17, 2001. 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 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC07 _______________________________________________________________________ 869. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; ADULTERATION Priority: Substantive, Nonsignificant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 800.20 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend the sampling plans, test method, and acceptable quality levels in 21 CFR 800.20. As prescribed by this regulation, FDA samples patient examination and surgeons' gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet specified quality levels. This proposal would clarify sampling plans and the scoring of defects, lower acceptance rates for leaking gloves, raise rejection rates for leaking gloves, and add tightened inspection schemes for reexamined glove lots. The rule is intended to facilitate industry compliance and enhance the safety and effectiveness of gloves. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/31/03 68 FR 15404 NPRM Comment Period End 06/30/03 Final Rule 12/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AC32 _______________________________________________________________________ 870. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360e to 360j; 21 USC 360hh to 360ss; 21 USC 371; 21 USC 381 CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32 Legal Deadline: None Abstract: This rule amends the performance standard for diagnostic x- ray systems and their components in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33 to address the changes in technology and practice. [[Page 37454]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/10/02 67 FR 76056 Final Action 06/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AC34 _______________________________________________________________________ 871. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: PL 107-188, sec 306 CFR Citation: 21 CFR 1 Legal Deadline: None Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 414(b) of the Federal Food, Drug and Cosmetic Act (FFDCA), which was added by section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act), authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. The Act authorizes regulations that require the establishment and maintenance of records, for not longer than two years, that would allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging. The required records would be those that are needed by FDA in order to address credible threats of serious adverse health consequences or death to humans or animals. Specific covered entities are those that manufacture, process, pack, transport, distribute, receive, hold, or import food. Farms and restaurants are excluded. The Secretary is directed to take into account the size of a business in promulgating these regulations. Section 306 of the Act also added section 414(a) and amended section 704(a) of FFDCA to permit FDA to inspect these records and other information if the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/09/03 68 FR 25188 NPRM Comment Period End 07/08/03 Final Action 07/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None URL For More Information: www.fda.gov/oc/bioterrorism/bioact.html URL For Public Comments: www.fda.gov/ohrms/dockets/02n0277/02n0277.htm Agency Contact: Nega Beru, Supervisory Chemist, Office of Plant, Dairy Foods and Beverages, Department of Health and Human Services, Food and Drug Administration, HFS-305, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1400 Fax: 301 436-2651 Email: nberu@cfsan.fda.gov RIN: 0910-AC39 _______________________________________________________________________ 872. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: PL 107-188, sec 305 CFR Citation: 21 CFR 1 Legal Deadline: Final, Statutory, December 12, 2003. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 305, directs the Secretary, through FDA, to issue a final regulation establishing registration requirements by December 12, 2003. The statute is self-implementing on this date if FDA does not issue a final regulation that is effective by December 12, 2003. Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism and other foodborne illness emergencies. Section 415 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), directs the Secretary to require facilities engaged in manufacturing, processing, packing, or holding of food for consumption in theUnited States to be registered with the Secretary. Section 415 directs the Secretary, to promulgate final regulations implementing the requirements by December 12, 2003. The owner, operator, or agent in charge of the facility must submit the registration. Foreign facilities must include the name of the United States agent for the facility. The registration must include the name and address of each facility at which, and all trade names under which, the registrant conducts business. If the Secretary determines it is necessary through guidance, the registration must include the general food category (as identified under 21 CFR 170.3) of foods manufactured, processed, packed, or held at the facility. The registrant is required to notify the Secretary of changes to the information contained in the registration in a timely manner. Under the interim final rule (IFR) published on October 10, 2003 (68 FR 58894), upon receipt of the completed registration form, FDA will notify the registrant of receipt of the registration and assign a unique registration number to the facility. Section 415 requires the Secretary to compile and maintain an up-to-date list of registered facilities. This list and any registration documents submitted to the Secretary are not subject to disclosure under the Freedom of Information Act. For purposes of section 415, ``facility'' includes any factory, warehouse, or establishment engaged in the manufacturing, processing, packing, or holding of food. Exempt from the registration requirement are farms, restaurants, other retail food [[Page 37455]] establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, and fishing vessels (except those engaged in processing as defined in 21 CFR 123.3(k)). Foreign facilities required to register include only those from which food is exported to the United States without further processing or packaging outside the United States. The Bioterrorism Act provides that if food from an unregistered foreign facility is offered for import into the United States without having registered, the food will be held at the port of entry or at a secure facility, until the foreign facility has registered. On April 14, 2004, FDA issued a notice reopening for 30 days, on a limited range of issues, the comment period on the IFR. FDA took this action consistent with its statement in the IFR that it would reopen the comment period for 30 days in order to ensure that those commenting on the IFRhave had the benefit of FDA's outreach and educational efforts and have had experience with the systems, timeframes, and data elements of the registration system. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/03/03 68 FR 5377 Interim Final Rule 10/10/03 68 FR 58894 Interim Final Rule Comment Period Reopened 04/14/04 69 FR 19766 Interim Final Rule Comment Period Reopened End 05/14/04 Final Rule 03/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Leslye M. Fraser, Associate Director for Regulations, Office of Regulations and Policy, 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: 301 436-2378 Fax: 301 436-2637 Email: leslye.fraser@cfsan.fda.gov RIN: 0910-AC40 _______________________________________________________________________ 873. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 107-188, sec 307 CFR Citation: 21 CFR 1.276 et seq Legal Deadline: Final, Statutory, December 12, 2003. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notice requirements for all imported food by December 12, 2003. If FDA fails to issue final regulations by this date, the statute is self-executing on this date, and requires FDA to receive prior notice of not less than eight hours, nor more than five days until final regulations are issued. Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. Section 801(m) requires notification to FDA prior to the entry of imported food. The required priornotice would provide the identity of the article of food; the manufacturer; the shipper; the grower, if known at the time of notification; the originating country; the shipping country; and the anticipated port of entry. The regulation identifies the parties responsible for providing the notice and explains the information that the prior notice is required to contain, the method of submission of the notice, and the minimum and maximum period of advance notice required. Section 307 also states that if FDA does not receive prior notice or receives inadequate prior notice, the imported food shall be refused admission and held at the port of entry until proper notice is provided. 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 06/14/04 Final Rule 03/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Mary Ayling, Lead, Inspection and Compliance Team, Food Safety Staff, Department of Health and Human Services, Food and Drug Administration, HFS-32, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2131 Fax: 301 436-2605 Email: mary.ayling@cfsan.fda.gov RIN: 0910-AC41 _______________________________________________________________________ 874. PRESUBMISSION CONFERENCES Priority: Substantive, Nonsignificant Legal Authority: 21 USC 360b CFR Citation: 21 CFR 514 Legal Deadline: None Abstract: This rule will implement section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act (the Act). This section of the Act states that any person intending to file a new animal drug application or supplemental new animal drug application, or to investigate a new animal drug is entitled to one or more conferences with the agency prior to submission to reach an agreement establishing a submission or investigational requirement. This rule would describe how to request a presubmission conference anddescribe the procedures for the conduct of presubmission conferences. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/25/00 65 FR 51782 Final Action 08/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Federalism: Undetermined Agency Contact: Gail Schmerfeld, Special Assistant, Department of Health [[Page 37456]] and Human Services, Food and Drug Administration, HFV-100, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855 Phone: 301 827-0205 Related RIN: Previously reported as 0910-AB68 RIN: 0910-AC44 _______________________________________________________________________ 875. 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. Unfunded Mandates: 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: The proposed rule would 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 are proposing to replace the requirement in 21 CFR 312.120 that non-IND foreign clinical studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki. 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 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: pendletonb@cder.fda.gov RIN: 0910-AF15 _______________________________________________________________________ 876. [bullet][ls-thn-eq] BLOOD INITIATIVE--REVISIONS TO LABELING AND STORAGE REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA Priority: Other Significant. 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 360; . . . CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 610; . . . Legal Deadline: None Abstract: In multiple rulemakings, the Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and blood-derivative products 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. The other remaining subject intended to be addressed in the rulemakings include: donor eligibility requirements (0910-AF25). These actions are intended to help ensure the continued safety of the Nation's blood supply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Suite 400S (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Related RIN: Split from 0910-AB26 RIN: 0910-AF26 _______________________________________________________________________ 877. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW-- ANTIPERSPIRANT 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 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Partial Stay) 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF30 [[Page 37457]] _______________________________________________________________________ 878. [bullet][ls-thn-eq] 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 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Amendment) (Common Cold) 10/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF31 _______________________________________________________________________ 879. [bullet][ls-thn-eq] 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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Emergency First Aid Eyewashes) 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF39 _______________________________________________________________________ 880. [bullet][ls-thn-eq] 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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Technical Amendments) 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF42 _______________________________________________________________________ 881. [bullet][ls-thn-eq] 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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Warnings) 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF44 [[Page 37458]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 882. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD Priority: Routine and Frequent Legal Authority: 21 USC 331 to 334; 21 USC 335b; 21 USC 335c; 21 USC 341 to 344; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 59 Legal Deadline: None Abstract: The proposed rule would establish requirements for importers and other persons who use sampling services and private laboratories in connection with imported food. For example, the proposal would pertain to persons who use sample collection services and private laboratories, and would describe some responsibilities for such persons, sample collection services, and private laboratories. These responsibilities would include recordkeeping requirements to ensure that the correct sample is collectedand analyzed, and a notification requirement if a person intends to use a sampling service or a private laboratory in connection with imported food. The proposed rule is intended to help insure the integrity and scientific validity of data and results submitted to FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/29/04 69 FR 23460 Final Action To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Room 15-61 (HF-23), Office of Policy and Planning, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: pchao@oc.fda.gov RIN: 0910-AB96 _______________________________________________________________________ 883. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS DERIVED FROM EXPOSED ANIMAL POPULATIONS Priority: Other Significant Legal Authority: 42 USC 264; 21 USC 301 et seq CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to prohibit the use of cervids (deer, elk) for food, including dietary supplements, and cosmetics if the cervids have been exposed to chronic wasting disease (CWD). FDA is proposing this regulation because of potential risks to health. CWD is a type of transmissible spongiform encephalopathy (TSE), a group of fatal, neurodegenerative diseases that include bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep and goats, and Creutzfeldt-Jakob disease (CJD) in humans. The disease has been identified in wild and farmed elk and wild deer populations. CWD has been found in cervid populations in certain areas of Wisconsin, Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, New Mexico, Minnesota, and Canada. In 1999, the World Health Organization said there is no evidence that CWD transmits to humans. However, it also suggested any part of a deer or elk believed to be diseased should not be eaten. Results of some studies using in vitro techniques have suggested that transmission to humans could possibly occur. However, if it does occur, it is likely to be through a very inefficient process. Currently, there are no validated analytical tests to identify animals in the preclinical phase of CWD, or any other TSE. In addition, no test exists to ensure food safety. CWD typically exhibits a long incubation period, during which time animals appear normal but are potentially infectious. Therefore, DA is proposing to require that food or cosmetic products derived from animals exposed to CWD not enter into commerce. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-306, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@cfsan.fda.gov RIN: 0910-AC21 _______________________________________________________________________ 884. 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 Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses [[Page 37459]] Government Levels Affected: None Agency Contact: Aileen Ciampa, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFD-7, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20857 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC23 _______________________________________________________________________ 885. 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 Final Action To Be Determined 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, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC35 _______________________________________________________________________ 886. 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 noitce 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 NPRM To Be Determined Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Agency Contact: Julie Schrimpf, Department of Health and Human Services, Food and Drug Administration, (HFS-832), HFS-800, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2373 Fax: 301 436-2639 Email: julie.schrimpf@cfsan.fda.gov Related RIN: Related to 0910-AB66 RIN: 0910-AC50 _______________________________________________________________________ 887. SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM CLINICAL STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations governing the format in which clinical study data (CSD) 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 CSD submitted for NDAs, ANDAs, BLAs, and their supplements and amendments be provided in electronic format and require the use of standard data structure, terminology, and code sets. The proposal would improve the efficiency of the exchange of information from clinical studies through the adoption of standards for study data submitted in an electronic form that FDA can process, review, and archive. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of Health and Human Services, Food and [[Page 37460]] Drug Administration, Room 3037, (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 594-6197 Email: muellern@cder.fda.gov RIN: 0910-AC52 _______________________________________________________________________ 888. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 351; 21 USC 353 CFR Citation: 21 CFR 201.161(a); 21 CFR 210.3(b); 21 CFR 211.94 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 To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Elaine H. Tseng, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC53 _______________________________________________________________________ 889. FOOD LABELING: FOOD ALLERGEN INGREDIENT LABELING Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321 ; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101 Legal Deadline: None Abstract: The purpose of this rulemaking is to reduce mortality and morbidity by providing sensitive individuals with additional food allergen information to help them protect themselves from serious allergic reactions, including life-threatening anaphylactic shock. The eight most common food allergens are: 1) peanuts; 2) soybeans; 3) milk; 4) eggs; 5) fish; 6) crustacea (e.g., lobster, crab, shrimp); 7) tree nuts (e.g., almonds, chestnuts, macadamia nuts, pecans, walnuts, hazelnuts or filberts, cashews, brazil nuts, pistachios, pine nuts); and 8) wheat. The rule would propose to require that foods that contain ingredients derived from these eight allergens include information on the label in plain English terms that clearly identifies the allergenic source of these ingredients. The agency is also proposing to require individual label declaration of spices, flavors, noncertified colors and incidental additives. Currently, section 403(i) of the Federal Food, Drug, and Cosmetic Act allows spices, flavors and noncertified colors used as ingredients of foods to be declared collectively on the label without naming each one. Federal regulations at 21 C.F.R. 101.100(a)(3) exempt incidental additives from ingredient declaration on the label if they are present in the food at an insignificant level and do not have any technical or functional effect in the finished food. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Rhonda Rhoda Kane M.S., R.D., Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-820, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2371 Fax: 301 436-2636 Email: rkane2@cfsan.fda.gov RIN: 0910-AF07 _______________________________________________________________________ 890. 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 [[Page 37461]] Federalism: Undetermined Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: mullerh@cder.fda.gov RIN: 0910-AF08 _______________________________________________________________________ 891. CURRENT GOOD MANUFACUTRING 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 onAugust 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-800, HFS- 024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@cfsan.fda.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF27 _______________________________________________________________________ 892. INFANT FORMULA QUALITY FACTORS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . CFR Citation: 21 CFR 106; 21 CFR 107 Legal Deadline: None Abstract: The agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, and records and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment period was extended on June 27, 2003, to end onAugust 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-800, HFS- 024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@cfsan.fda.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF28 _______________________________________________________________________ 893. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF35 _______________________________________________________________________ 894. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for [[Page 37462]] Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF38 _______________________________________________________________________ 895. [bullet][ls-thn-eq] 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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 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. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF40 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 896. OVER-THE-COUNTER (OTC) DRUG REVIEW 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 360b; 21 USC 361; 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. SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Actions Will Continue Under Separate Rulemakings 06/08/04 Anorectal Products (0910-AC65) Final Action (Amendment) 08/26/03 (68 FR 51167) Antidiarrheal Products (0910-AC82) NPRM (Amendment) (Trav. Diar) 04/ 17/03 (68 FR 18915) Merged With 0910-AF29 06/08/04 Antiemetic Products (0910-AC71) Final Action (Amendment) (Warning) 12/ 06/02 (67 FR 72555) Antiperspirant Products (0910-AC89) Final Action 06/09/03 (68 FR 34273) Final Action (Partial Stay) Merged With 0910-AF30 06/08/04 Cough/Cold (Antihistamine) Products (0910-AD31) Merged With 0910-AF31 06/08/04 Cough/Cold (Antitussive) Products (0910-AD24) Final Action (Amendment) (Warning) 12/06/02 (67 FR 72555) Cough/Cold (Bronchodilator) Products (0910-AD33) Merged With 0910-AF32 06/08/04 Cough/Cold (Combination) Products (0910-AD25) Final Action 12/23/02 (67 FR 78158) NPRM (Amendment) Merged With 0910-AF33 06/08/04 Cough/Cold (Nasal Decongestant) Products (0910-AD43) Merged With 0910- AF34 06/08/04 External Analgesic Products (0910-AD06) Final Action (Amendment)(Warning) 12/06/02 (67 FR 72555) NPRM (Amendment)(Patches) 07/17/03 (68 FR 42324) Merged With 0910-AF35 06/08/04 Ingrown Toenail Relief Products (0910-AD21) NPRM 10/04/02 (67 FR 62218) Final Action 05/07/03 (68 FR 24347) Internal Analgesic Products (0910-AD07) NPRM (Amendment)(Ibuprofen) 08/21/02 (67 FR 54139) Merged With 0910-AF36 06/08/04 Labeling of Drug Products for OTC Human Use (0910-AD47) NPRM (Sodium Labeling) 03/24/04 (69 FR 13765) Final Action (Sodium Labeling) 03/24/ 04 (69 FR 13717) Final Action (Ca/Mg/K/Na) 03/24/04 (69 FR 13725) Laxative Drug Products (0910-AC85) NPRM (Amendment) (Psyllium Granular Dosage Form) 08/05/03 (68 FR 46133) Merged With 0910-AF38 06/08/04 Nighttime Sleep Aid Products (0910-AD11) Final Action (Amendment)(Warning) 12/06/02 (67 FR 72555) Ophthalmic Products (0910-AC72) NPRM (Emergency First Aid Eyewashes) 02/19/03 (68 FR 7951) Final Action (Technical Amendment) 02/19/03 (68 FR 7919) Final Action (Name Change) 06/03/03 (68 FR 32981) Final Action (Emerg. First Aid Eyewashes) Merged With 0910-AF39 06/08/04 Oral Health Care Products (0910-AC98) ANPRM (Plaque/Gingivitis) 05/29/ 03 (68 FR 32232) Merged With 0910-AF40 06/08/04 Pediculicide Products (0910-AC79) NPRM (Labeling Amendment) 05/10/02 (67 FR 31739) Final Action (Labeling Amendment) 12/31/03 (68 FR 75414) Salicylate (Reye's Syndrome) (0910-AD13) Final Action (Warning) 04/17/ 03 (68 FR 18861) [[Page 37463]] Skin Protectant Products (0910-AC96) Final Action 06/04/03 (68 FR 33362) NPRM (Astringent) 06/13/03 (68 FR 35346) Final Action (Astringent) 06/13/03 (68 FR 35290) Final Action (Astringent) (Confirm Effective Date) 10/09/03 (68 FR 58273) Final Action (Technical Amendment) 12/09/03 (68 FR 68509) Final Action (Technical Amendment) Merged With 0910-AF42 06/08/04 Sunscreen Products (0910-AC68) Final Action (Names) 06/20/02 (67 FR 41821) ANPRM (Bug and Insect Repellent) and NPRM (UVA/UVB) Merged With 0910-AF43 06/08/04 Vaginal Contraceptive Products (0910-AD19) NPRM (Amendment) 01/16/03 (68 FR 2254) Merged With 0910-AF44 06/08/04 Weight Control Products (0910-AC93) Merged With 0910-AF45 06/08/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov RIN: 0910-AA01 _______________________________________________________________________ 897. INFANT FORMULA: REQUIREMENTS PERTAINING TO GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND 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 onAugust 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Actions Will Continue Under Separate Rulemakings 06/04/04 Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors (0910-AD81) 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 Merged With 0910-AF27 06/04/04 Infant Form Cons Comp, Micro Test & Recd Retention Req (0910- AD80) NPRM 01/26/89 (54 FR 3783) NPRM Comment Period End 03/27/ 89 Final Rule 12/24/91 (56 FR 66566) Infant Formula Quality Factors (0910-AD77) 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 Merged With 0910-AF28 06/04/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-800, HFS- 024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@cfsan.fda.gov RIN: 0910-AA04 _______________________________________________________________________ 898. DETERMINATION THAT INFORMED CONSENT IS INFEASIBLE OR IS CONTRARY TO THE BEST INTEREST OF RECIPIENTS Priority: Other Significant CFR Citation: 21 CFR 50; 21 CFR 312 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 06/10/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Agency Contact: Philip L. Chao Phone: 301 827-0587 Fax: 301 827-4774 Email: pchao@oc.fda.gov RIN: 0910-AA89 _______________________________________________________________________ 899. BLOOD INITIATIVE Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264 CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 680 Legal Deadline: None Abstract: In multiple rulemakings, the Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and blood-derivative products 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. The remaining subjects intended to be addressed in the rulemakings include: labeling of blood and blood components and donor eligibility requirements. These actions are intended to help ensure the continued safety of the Nation's blood supply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Actions Will Continue Under Separate Rulemakings 06/04/04 Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin (Human); Revision of Requirements (0910-AE95) NPRM 05/14/99 (64 FR 26344) Direct Final Rule 05/14/99 (64 FR 26282) Direct Final Rule - Confirmation in Part and Technical Amendment 03/14/00 (65 FR 13678) Final Action 08/28/00 (65 FR 52016) [[Page 37464]] General Requirements for Blood, Blood Components, and Plasma Derivatives; Notification of Deferred Donors (0910-AE99) NPRM 08/19/99 (64 FR 45355) Final Action 06/11/01 (66 FR 31165) Plasma Derivatives and Similar Recombinant-Based Products; Requirements for Notification of Recalls and Withdrawals (0910-AF02) ANPRM 08/19/99 (64 FR 45383) Withdrawn 06/04/04 Regulations for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (0910-AF00) Merged With 0910-AF25 06/04/04 Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents (0910-AE98) NPRM 08/19/99 (64 FR 45340) Final Action 06/11/01 (66 FR 31146) Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma (0910-AE96) NPRM 07/30/03 (68 FR 44678) Correction Notice 10/27/03 (68 FR 61172) NPRM Comment Period End 10/30/03 Merged With 0910-AF26 06/04/04 Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma (0910-AE89) NPRM 08/19/99 (64 FR 45375) Direct Final Rule 08/19/99 (64 FR 45366) Direct Final Rule - Confirmation in Part and Technical Amendment 01/10/01 (66 FR 1834) Final Action 08/06/ 01 (66 FR 40886) Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Related to 0910-AB76 RIN: 0910-AB26 _______________________________________________________________________ 900. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Priority: Other Significant CFR Citation: 21 CFR 210.1(c); 21 CFR 210.2(a); 21 CFR 210.2(b); 21 CFR 211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 05/24/04 69 FR 29786 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Paula S. McKeever Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AB27 _______________________________________________________________________ 901. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION Priority: Other Significant CFR Citation: 21 CFR 314 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 04/08/04 69 FR 18728 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Howard P. Muller Phone: 301 594-2041 Fax: 301 827-5562 Email: mullerh@cder.fda.gov RIN: 0910-AB61 _______________________________________________________________________ 902. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 21 CFR 225 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 05/19/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: George Graber Phone: 301 827-6651 Email: ggraber@cvm.fda.gov RIN: 0910-AB70 _______________________________________________________________________ 903. REQUIREMENTS FOR SUBMISSION OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS IN ELECTRONIC FORMAT Priority: Other Significant CFR Citation: 21 CFR 314; 21 CFR 601 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/11/03 68 FR 69009 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Nicole K. Mueller Phone: 301 594-2041 Fax: 301 594-6197 Email: muellern@cder.fda.gov RIN: 0910-AB91 _______________________________________________________________________ 904. USE OF MATERIALS DERIVED FROM BOVINE AND OVINE ANIMALS IN FDA- REGULATED PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: Not Yet Determined Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 05/19/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rebecca Buckner Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@cfsan.fda.gov RIN: 0910-AC19 _______________________________________________________________________ 905. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS AND BLOOD Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 21 CFR 201.25; 21 CFR 601.67 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 02/26/04 69 FR 9119 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None [[Page 37465]] Agency Contact: Philip L. Chao Phone: 301 827-0587 Fax: 301 827-4774 Email: pchao@oc.fda.gov RIN: 0910-AC26 _______________________________________________________________________ 906. ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 21 CFR 1; 21 CFR 10.45(d); 21 CFR 16.1(b)(1) Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 06/04/04 69 FR 31660 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Kelli Giannattasio Phone: 301 436-1432 Fax: 301-436-2639 Email: kelli.giannattasio@cfsan.fda.gov RIN: 0910-AC38 _______________________________________________________________________ 907. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED FEED Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 558.5; 21 CFR 510.455 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 05/27/04 69 FR 30194 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Deaman Momailovic Phone: 301 827-6652 Fax: 301 594-4512 Related RIN: Previously reported as 0910-AB50 RIN: 0910-AC43 _______________________________________________________________________ 908. BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; IMPLEMENTATION OF EFFICACY REVIEW Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 201.59; 21 CFR 610.21 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 01/05/04 69 FR 255 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Astrid L. Szeto Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AC56 _______________________________________________________________________ 909. REVISION OF THE REQUIREMENTS FOR SPORE-FORMING MICROORGANISMS Priority: Other Significant CFR Citation: 21 CFR 600.10(c); 21 CFR 600.11(e) Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM-Companion to Direct Final Rule 12/30/03 68 FR 75179 Direct Final Rule 12/30/03 68 FR 75116 Confirmation of Effective Date 05/14/04 69 FR 26768 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Valerie Butler Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AC57 _______________________________________________________________________ 910. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD (PART 110) (COMPLETION OF A SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 21 USC 342; 21 USC 371; 21 USC 374; 42 USC 264 CFR Citation: 21 CFR 110 Legal Deadline: None Abstract: Part 110 (21 CFR part 110) describes regulations for current good manufacturing practice in manufacturing, packing, and holding human food. Part 110 contains regulations describing sanitary practices for personnel, buildings and facilities, and equipment. It also includes regulations on production and process controls for manufacturing practices and on defect action levels for natural or unavoidable defects in food for human use that present no health hazard. FDA is undertaking a review of part110 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in part 110 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) the continued need for the regulations in part 110; (2) the nature of complaints or comments received concerning the regulations in part 110; (3) the complexity of the regulations in part 110; (4) the extent to which the regulations in part 110 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 110. 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 princples set forth in the Executive order. The combined effect of the two reviews will be to determine if it is possible to redesign current good manufacturing practices in ways that will maintain or increase the effectiveness of preventive and sanitary controls, and, at the same time, reduce compliance and other costs associated with the regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 05/01/03 End Review 12/31/03 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Richard A. Williams, Director, Division of Market Studies, Department of Health and Human Services, Food and Drug Administration, HFS-725, Center for Food Safety and Applied Nutrition, [[Page 37466]] 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1989 Fax: 301 436-2626 Email: richard.williams@cfsan.fda.gov RIN: 0910-AC58 _______________________________________________________________________ 911. [bullet][ls-thn-eq] OVER-THE-COUNTER (OTC) DRUG REVIEW-- ANTIDIARRHEAL 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 360b; 21 USC 361; 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Amendment) (Trav. Diar) 05/12/04 69 FR 26301 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF29 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 912. 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 careservices 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 04/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: John M. Heyob, Director, Division of Practitioner Data Banks, Department of Health and Human Services, Health Resources and Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 20957 Phone: 301 443-2300 Fax: 301 443-6725 RIN: 0906-AA41 _______________________________________________________________________ 913. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH PROFESSIONAL SHORTAGE AREAS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 254b; 42 USC 254e CFR Citation: 42 CFR 5; 42 CFR 51c Legal Deadline: None Abstract: This rule would consolidate the process for designating areas of health professional shortage and medical underservice that apply in several department programs, and would improve the criteria for designating medically underserved populations and Primary Care Health Professional Shortage Areas. This notice of proposed rulemaking (NPRM) will address issues raised by comments received in a previous NPRM, dated September 1, 1998. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/01/98 63 FR 46538 Second NPRM 09/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Andy Jordan, Acting Chief, Shortage Designation Branch, Department of Health and Human Services, Health Resources and Services Administration, Room 8C26, National Center for Health Workforce Analysis, Bureau of Health Professions, Parklawn Building, Rockville, MD 20857 Phone: 301 594-0197 Email: dsd@hrsa.gov RIN: 0906-AA44 [[Page 37467]] _______________________________________________________________________ 914. [bullet][ls-thn-eq] 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. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 274e, sec 301; 42 USC 273 to 274d, sec 371 to 376; 42 USC 1320b-8, sec 1138 CFR Citation: 42 CFR 121 Legal Deadline: None Abstract: The Department of Health and Human Services proposes to add intestines to the definition of organs covered by the rules governing the operation of the OPTN. After a review of intestinal transplants, HHS believes that intestines should now be included within the definition. The notice of proposed rulemaking provides the history of intestinal transplants, the factors that have persuaded HHS of the advisability of including intestines within the scope of the regulations governing the operation ofthe OPTN, and the anticipated consequences of this proposal. As the field of intestinal transplantation evolves, it becomes more critical that intestinal organ allocation policies keep pace with the advances in the field; that policy development include performance indicators to assess how well the policies achieve the goals of an equitable transplant system; that those policies are enforceable; and that patients and physicians have timely access to accurate data that will assist them in making decisions regarding intestinal transplantation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Laura St. Martin, Chief Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Mail Stop 16C-17, Parklawn Bldg., Rockville, MD 20857 Phone: 202 690-8476 Email: lstmartin@hrsa.gov RIN: 0906-AA62 _______________________________________________________________________ 915. [bullet][ls-thn-eq] NOTICE OF PROPOSED RULEMAKING TO AMEND THE FINAL RULE GOVERNING THE 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Hui--Hsing Wong, Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Mail Stop 16C-17, Parklawn Bldg., Rockville, MD 20857 Phone: 301 443-8104 Fax: 301 594 6095 Email: hwong@hrsa.gov RIN: 0906-AA63 _______________________________________________________________________ 916. [bullet][ls-thn-eq] NATIONAL VACCINE INJURY COMPENSATION PROGRAM; REVISIONS AND ADDITIONS TO THE VACCINE INJURY TABLE Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300aa-14, sec 2114; PL 103-66, sec 13632(a) CFR Citation: 42 CFR 100 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) is proposing to revise and make additions to the Vaccine Injury Table (Table). Section 2114(e) (2) of the Public Health Service Act provides for the inclusion of additional vaccines in the National Vaccine Injury Compensation Program when they are recommended by the Centers for Disease Control and Prevention for routine administration to children. In compliance with the Omnibus Budget Reconciliation Act of 1993, which added a new section 2114(e)(3) to the Act, a vaccine added to the Table through Section 2114(e) will be included in the Table, effective when an excise tax to provide funds for the payment of compensation with respect to such vaccines takes effect. HHS has determined that there are no resources required to implement these changes. Section 2114 (c) permits the Secretary of HHS to modify the Table. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Geoffrey Evans, Medical Director, Division of Vaccine Injury Compensation, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 16C-17, Rockville, MD 20857 Phone: 301 443-4198 Fax: 301 443 8196 Email: gevansr@hrsa.gov RIN: 0906-AA66 _______________________________________________________________________ 917. [bullet][ls-thn-eq] LIABILITY PROTECTION FOR CERTAIN FREE CLINIC HEALTH PROFESSIONALS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 233(o); PL 108-199, title II CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This notice of proposed rulemaking (NPRM) provides information on the implementation of 42 U.S.C. 233(o), which makes [[Page 37468]] available medical malpractice liability protection for certain volunteer health professionals in free clinics. This is accomplished by deeming eligible volunteers to be employees of the Public Health Service and, thereby, protected by the Federal Tort Claims Act (FTCA). The NPRM provides information whereby en entity or person can determine when and the extent to which a volunteer health professional at a free clinic is deeemed to be a Public Health Service Employee and, therefore, afforded the protections of the FTCA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Dr. Felicia Collins, Branch Chief, Clinical Quality Systems Branch HRSA/BPHC/ Division of Clinical Quality, Department of Health and Human Services, Health Resources and Services Administration, 4350 East West Hwy, Bethesda, MD 20814 Phone: 301 594-0818 Fax: 301 594 5224 RIN: 0906-AA67 _______________________________________________________________________ 918. [bullet][ls-thn-eq] NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF AVERAGE COST OF A HEALTH INSURANCE POLICY Priority: Info./Admin./Other. Major status under 5 USC 801 is undetermined. Legal Authority: Not Yet Determined 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 an amount deducted from the award of compensation in certain cases. According to the Final Rule published on June 24, 1992, which established the current calculation, ``lf, over time, the average cost of health insurance, as calculated by the method described above, significantly differs from subsequent HIAA survey results or other authoritative sources then available, the Secretary of HHS will consider appropriate revisions of this rule.`` 57 FR 28098 (June 24, 1992). When the latest average monthly of an individual health insurance policy was calculated based on the current methodology, it was significantly different from that the Kaiser Family Foundation/Health Research and Educational Trust average monthly cost of an individual health insurance policy for the same time period. Therefore, the Secretary is proposing a new methodology to calculate the average cost of a health insurance policy. Subtitle 2 of title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended, (the Act) 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 (the Court). 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 Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Thom E. Balbier Jr., Director, Division of Vaccine Injury Compen., Department of Health and Human Services, Health Resources and Services Administration, Room 8A-46, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-6593 Fax: 301 443-8196 Email: tbalbier@hrsa.gov RIN: 0906-AA68 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 919. INTERIM FINAL RULE FOR THE SMALLPOX EMERGENCY PERSONNEL PROTECTION PROGRAM: SMALLPOX (VACCINIA) VACCINE INJURY TABLE Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-20, 117 Stat 638 CFR Citation: 42 CFR 102 Legal Deadline: None Abstract: To establish a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of, or exposure to, the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 08/27/03 68 FR 51492 Final Action 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Vito Caserta, Chief Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 10th Floor, 4350 East West Highway, Bethesda, MD 20814 Phone: 301 443-4956 Email: smallpox@hrsa.gov RIN: 0906-AA60 [[Page 37469]] _______________________________________________________________________ 920. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE IMPLEMENTATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-20, 117 Stat 638 CFR Citation: 42 CFR 102 Legal Deadline: None Abstract: To provide benefits to certain persons harmed as a result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a result of contracting vaccinia through accidental exposure to certain persons. The Secretary may also provide death benefits to certain survivors of people who died as a direct result of these injuries. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Paul T. Clark, Director, Smallpox Vaccine Injury Compensation Program, Department of Health and Human Services, Health Resources and Services Administration, 10th Floor HRSA/OSP, 4350 East West Highway, Bethesda, MD 20814 Phone: 888 496-0338 Email: small@hrsa.gov Related RIN: Related to 0906-AA60 RIN: 0906-AA61 _______________________________________________________________________ 921. [bullet][ls-thn-eq] 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 FY 2005 grant dollars. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/12/03 68 FR 47923 NPRM Comment Period End 09/11/03 Final Action 08/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Wayne E. Sauseda Mr., Director, Division of Community Based Programs, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Rm. 7A-30, Rockville, MD 20857 Phone: 301 443-0493 Fax: 301 443 1839 Email: wsauseda@hrsa.gov RIN: 0906-AA65 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 922. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND NEGATIVE ACTIONS Priority: Substantive, Nonsignificant 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 To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: John M. Heyob, Director, Division of Practitioner Data Banks, Department of Health and Human Services, Health Resources and Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 20957 Phone: 301 443-2300 Fax: 301 443-6725 RIN: 0906-AA57 [[Page 37470]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 923. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY THE NATIONAL INSTITUTES OF HEALTH (NIH) Priority: Substantive, Nonsignificant 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 the National Institutes of Health Revitalization Act of 1993, creates a program offering scholarships, in an amount not to exceed $20,000 per year of academic study, 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 cover this program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA10 _______________________________________________________________________ 924. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 285g-10 CFR Citation: 42 CFR 63a Legal Deadline: None Abstract: NIH proposes to amend the training grants regulations to implement the new authority under section 452G of the Public Health Service (PHS) Act. This action is necessitated by enactment of the Children's Act of 2000. Section 1002 of this Act adds a new section 452G to the PHS Act that authorizes the Director of the National Institute of Child Health and Human Development, in consultation with the Administrator of the Health Resources and Services Administration, to support activities to provide for an increase in the number and size of institutional training grants supporting pediatric training. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA28 _______________________________________________________________________ 925. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM Priority: Substantive, Nonsignificant 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 09/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA31 _______________________________________________________________________ 926. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: 42 USC 216; 42 USC 288-1 CFR Citation: 42 CFR 68 Legal Deadline: None Abstract: Section 487A of the Public Health Service Act creates a program through which appropriately qualified health professionals may obtain federally funded repayment of educational loans by conducting AIDS research as NIH employees. NIH is issuing regulations that will govern the program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA32 _______________________________________________________________________ 927. NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT PROGRAM FOR CLINICAL RESEARCHERS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-5a CFR Citation: 42 CFR 68g Legal Deadline: None Abstract: NIH proposes to establish implementing regulations for the [[Page 37471]] Extramural Loan Repayment Program for Clinical Researchers, authorized under section 487F of the Public Health Service Act. The program provides for the repayment of the existing educational loan debt of qualified health professionals who agree to conduct clinical research. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA33 _______________________________________________________________________ 928. NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-6 CFR Citation: 42 CFR 68e Legal Deadline: None Abstract: NIH proposes to establish implementing regulations for Pediatric Research Loan Repayment Program, authorized under section 487F of the Public Health Service Act. The program provides for the repayment of the existing educational loan debt of qualified health professionals who agree to conduct pediatric research. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA34 _______________________________________________________________________ 929. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR HEALTH DISPARITIES RESEARCH Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-33 CFR Citation: 42 CFR 68f Legal Deadline: None Abstract: NIH proposes to establish implementing regulations for the Loan Repayment Program for Health Disparities Research, authorized under section 485G of the Public Health Service Act. The program provides for the repayment of the existing educational loan debt of qualified health professionals who agree to conduct minority-health or other health-disparities research for a minimum of two years. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA35 _______________________________________________________________________ 930. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-5 CFR Citation: 42 CFR 68a Legal Deadline: None Abstract: NIH proposes to amend the regulations governing the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds to reflect the new maximum annual loan amount of $35,000 and a change in program eligibility to include qualified health professionals who are not NIH employees, as well as to amend the definition of ``disadvantaged.'' Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 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, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA36 _______________________________________________________________________ 931. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 216; 42 USC 288-2 CFR Citation: 42 CFR 68c Legal Deadline: None Abstract: NIH proposes to amend its current regulations governing the National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program to make the eligibility requirements of the Program consistent with the eligibility requirements of the other extramural loan repayment programs administered by NIH. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None [[Page 37472]] Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA41 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 932. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-3 CFR Citation: 42 CFR 68d Legal Deadline: None Abstract: Regulations will be issued to govern the awarding of educational loan repayments to qualified health professionals who agree to conduct research as employees of the National Institutes of Health. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/05/02 67 FR 50622 Final Action 07/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA18 _______________________________________________________________________ 933. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 284g; 42 USC 285a-6(c)(1)(E); 42 USC 285a-7(c)(1)(G); 42 USC 285b-4; 42 USC 285c-5; 42 USC 285c-8; 42 USC 285d-6; 42 USC 285e-2; 42 USC 285e-3; 42 USC 285e-10a; . . . CFR Citation: 42 CFR 52a Legal Deadline: None Abstract: NIH proposes to amend the current center grants regulations to reflect new authorities set forth in sections 409C, 445I, 452E, and 485F of the Public Health Service Act. Section 409C concerns centers of excellence regarding research on autism; section 445I concerns centers of excellence in Alzheimer's disease research and treatment; section 452E concerns centers regarding research on ``fragile X;'' and section 485F concerns centers of excellence for research education and training for individualswho are members of minority health disparity populations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/12/02 67 FR 68548 Final Action 07/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA24 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions National Institutes of Health (NIH) _______________________________________________________________________ 934. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH AND DEVELOPMENT CONTRACT PROJECTS Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 52h Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 01/05/04 69 FR 272 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Jerry Moore Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA20 [[Page 37473]] _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 935. [bullet][ls-thn-eq] 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 Nation Human Research Protections Advisory Committee. The goal of these efforts is to maximize the safety and welfare of adult subjects with impaired decisionmaking capacity who participate in research supported, conducted, or regulated by HHS. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 09/00/04 ANPRM Comment Period End 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Julie A. Kaneshiro, Policy Team Leader, Office for Human Research Protections, Department of Health and Human Services, Office of Public Health and Science, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-2071 Email: jakaneshiro@ophs.dhhs.gov RIN: 0940-AA11 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 936. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b CFR Citation: 42 CFR 93 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes substantial revisions to the existing regulations at 42 CFR part 50, subpart A, ``Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science,'' 54 FR 32449, August 8, 1989. The National Institutes of Health Revitalization Act of 1993 (NIH Act), Public Law 103-43, contains provisions that affect the current rule. For example, section 161 of the NIH Act established the Office of Research Integrity (ORI) as an independent entity reporting to the Secretary, and recent organizational changes have also affected the ORI's operations. In addition, the Office of Science and Technology Policy (OSTP) published a Governmentwide policy that applies to federally-funded research and proposals submitted to the Federal agencies for research funding, 65 FR 76260, December 6, 2000. The proposed revised regulation will implement this OSTP policy, which contains a definition of research misconduct and basicguidelines for the response of Federal agencies and research institutions to allegations of research misconduct. The current regulation, which implemented section 493(e) of the Public Health Service Act, would be deleted, and a new part 93, subparts A, B, C, D, and E would be added. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/04 NPRM Comment Period End 07/00/04 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, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 443-3400 Fax: 301 443-5351 Related RIN: Related to 0940-AA01 RIN: 0940-AA04 [[Page 37474]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 937. 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 section 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 01/00/05 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, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 443-3400 Fax: 301 443-5351 Related RIN: Related to 0940-AA04 RIN: 0940-AA01 _______________________________________________________________________ 938. 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 will simultaneously publish a proposed rule regarding FDA IRB registration requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/16/04 69 FR 20777 NPRM Comment Period End 06/15/04 Final Action 12/00/04 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, Suite 200, The Tower Building, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-0527 RIN: 0940-AA06 _______________________________________________________________________ 939. [bullet][ls-thn-eq] FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS TECHNICAL AMENDMENT Priority: Substantive, Nonsignificant Legal Authority: 5 USC 301; 42 USC 289; 42 USC 300v-1(b) CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This final rule amends the Department of Health and Human Services (HHS) regulations for the protection of human subjects by changing all references to the Office for Protection from Research Risks (OPRR) to the Office for Human Research Protections (OHRP) and revising the footnote at the end of 45 CFR 46.101(i) by deleting the references to research involving fetuses, pregnant women, or human in vitro fertilization and subpart B of 45 CFR part 46. This technical amendment is being made in conjunction with the other federal departments and agencies that have promulgated the Federal Policy for the Protection of Human Subjects. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael A. Carome MD, Department of Health and Human Services, Office of Public Health and Science, Suite 200, The Tower Building, Suite 200, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-0527 RIN: 0940-AA10 [[Page 37475]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of Public Health and Science (OPHS) _______________________________________________________________________ 940. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND EDUCATION REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATOR Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes to add subpart E to the Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, and would require that institutions engaged in human subjects research covered by an assurance of compliance filed with the Office for Human Research Protections ensure that institutional officials, institutional review board (IRB) chairpersons, and human protection administrators receive appropriate training and education about the institution's assurance and that IRB chairpersons and members, IRB staff, investigators, and other personnel involved in the conduct or oversight of human subjects research receive appropriate training and education about relevant human subjects protection requirements. The proposed training and education requirements will help to ensure that responsible individuals at assured institutions understand and meet their regulatory responsibilities for human subjects protection. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael A. Carome MD, Department of Health and Human Services, Office of Public Health and Science, Suite 200, The Tower Building, Suite 200, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-0527 RIN: 0940-AA08 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 941. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS- 3819-P) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb CFR Citation: 42 CFR 484 Legal Deadline: None Abstract: This proposed rule would revise the existing CoPs that 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 the Administration's 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 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Mercedes Benitex-McCray, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5716 Scott Cooper, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9465 RIN: 0938-AG81 _______________________________________________________________________ 942. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-P) (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 42 USC 1395rr CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 410; 42 CFR 412; 42 CFR 488; 42 CFR 489; 42 CFR 494; 42 CFR 413; 42 CFR 414 Legal Deadline: None Abstract: This proposed rule would revise the requirements that end stage renal disease (ESRD) facilities must meet to be certified under the Medicare program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Robert Miller, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6797 Teresa Casey, Health Insurance Specalist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-05-04, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7215 RIN: 0938-AG82 [[Page 37476]] _______________________________________________________________________ 943. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-3835- P) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This proposed rule would establish conditions of participation for Medicare-covered transplants. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Eva Fung, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-06-6, Office of Clinical Standards and Quality, S3-06-06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7539 Aucha Prachanronarong, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9614 RIN: 0938-AH17 _______________________________________________________________________ 944. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-P) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395x(dd); 42 USC 1395hh CFR Citation: 42 CFR 418 Legal Deadline: None Abstract: This proposed rule revises the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The proposed 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, allow hospices greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses, Organizations Government Levels Affected: None Federalism: Undetermined Agency Contact: Mary Rossi Coajou, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6051 Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6617 RIN: 0938-AH27 _______________________________________________________________________ 945. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIERS (CMS-6017-P) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments. Legal Authority: 42 USC 1320d to 1320d-8 CFR Citation: 45 CFR 160; 45 CFR 162 Legal Deadline: Final, Statutory, February 21, 1998. Abstract: This proposed rule would implement a standard identifier to identify health plans that process and pay certain electronic health care transactions. It would implement one of the requirements for administrative simplification that have a national scope beyond Medicare and Medicaid. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Helen Dietrick, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S1-07-17, Office of Information Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7448 RIN: 0938-AH87 _______________________________________________________________________ 946. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-P2) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) CFR Citation: 42 CFR 405.874 Legal Deadline: None Abstract: This rule extends 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 also extends appeal rights to all suppliers not covered by existing regulations to ensure they have a full and fair opportunity to be heard. Rule will incorporate provisions from section 936 of the MMA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/25/99 64 FR 57431 Second NPRM 01/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ralph Goldberg, Division of Provider and Supplier Enrollment, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4870 RIN: 0938-AI49 [[Page 37477]] _______________________________________________________________________ 947. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND IMPROVEMENT PROGRAM (CMS-1910-P2) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 405; 42 CFR 491 Legal Deadline: None Abstract: This rule amends the Medicare certification and payment requirements for rural health clinics (RHCs), as required by section 4205 of the Balanced Budget Act of 1997. It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes 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 limits nonphysician practitioner staffing requirements. This rule imposes payment limits on provider-based RHCs and prohibits the use of RHC space, professional staff, equipment, and other RHC resources by another Medicare entity. The rule also requires RHCs to establish a quality assessment and performance improvement program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74792 Second NPRM 05/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: David Worgo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-15-18, Center for Medicare Management, 7500 Security Boulevard, C4- 15-18, Baltimore, MD 21244 Phone: 410 786-5919 RIN: 0938-AJ17 _______________________________________________________________________ 948. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, AND HOME NUTRITION THERAPY (CMS-6010-P) Priority: Substantive, Nonsignificant Legal Authority: Not Yet Determined CFR Citation: 42 CFR 424.57 Legal Deadline: None Abstract: This proposed rule would implement certain provisions in the statute relating to suppliers of durable medical equipment, prosthetics, orthotics, and supplies and establish service standards for suppliers of home oxygen equipment and therapeutic shoes home nutrition therapy. Establishing these standards would ensure that suppliers are qualified to provide the appropriate health care services and help safeguard the Medicare program and its beneficiaries from any instances of fraudulent or abusive billing practices. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ralph Goldberg, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C3-02-16, Center for Medicaid and State Operations, 7500 Security Boulevard, C3-02-16, Baltimore, MD 21244 Phone: 410 786-4870 RIN: 0938-AJ98 _______________________________________________________________________ 949. HEALTH INSURANCE REFORM: CLAIMS ATTACHMENTS STANDARDS (CMS-0050-P) Priority: Other 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, August 21, 1998. Abstract: This rule proposes an electronic standard for claims attachments. The standard is required by the Health Insurance Portability and Accountability Act of 1996. It would be used to transmit clinical data, in addition to those data contained in the claims standard, to help establish medical necessity for coverage. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Lorraine Doo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Health Insurance Portability and Account Act Standards, S2- 26-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6597 RIN: 0938-AK62 _______________________________________________________________________ 950. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-P) Priority: Other Significant Legal Authority: 42 USC 1320b-8(b)(1)(A)(i); 42 USC 273(b)(2) CFR Citation: 42 CFR 486.301 Legal Deadline: Final, Statutory, January 1, 2002, Requires promulgation of new conditions. Abstract: This rule would establish conditions for coverage for organ procurement organizations (OPOs) to be certified by the Secretary to receive payment from Medicare and Medicaid for organ procurement costs, and to be designated by the Secretary for a specific geographic service area. The Organ Procurement Organization Certification Act of 2000 requires CMS to increase the certification cycle for OPOs from two years to four years and to promulgate new performance standards for OPOs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/28/01 66 FR 67109 NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Marcia Newton, Office of Clinical Standards and [[Page 37478]] Quality, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, 7500 Security Boulevard, S3-05-18, Baltimore, MD 21244-1850 Phone: 410 786-5265 RIN: 0938-AK81 _______________________________________________________________________ 951. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE (CMS-2130-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act) CFR Citation: 42 CFR 101; 42 CFR 418; 42 CFR 482; 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 04/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Carla McGregor, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S2-09-23, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7089 RIN: 0938-AL26 _______________________________________________________________________ 952. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-P) Priority: Substantive, Nonsignificant Legal Authority: Sec 1878 of the Social Security Act CFR Citation: 42 CFR 405 Legal Deadline: None Abstract: This proposed rule would redefine, clarify, and update the guidelines and procedures for Provider Reimbursement Review Board appeals, based on recent court decisions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Morton Marcus, Heal Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-25-02, Baltimore, MD 21244 Phone: 410 786-4477 RIN: 0938-AL54 _______________________________________________________________________ 953. HEALTH COVERAGE PORTABILITY'S REQUEST FOR INFORMATION ON BENEFIT- SPECIFIC WAITING PERIODS (CMS-2150-NC) Priority: Info./Admin./Other Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: This notice requests information on the use of benefit- specific waiting periods by group health plan and group health insurance issuers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AL64 _______________________________________________________________________ 954. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL CENTERS (CMS-3887-P) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Sec 1102 of the Social Security Act; Sec 1832 of the Social Security Act; Sec 1871 of the Social Security Act CFR Citation: 42 CFR 410; 42 CFR 424; 42 CFR 416; 42 CFR 488; 42 CFR 489 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 05/00/05 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, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5526 Jacqueline Morgan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4282 RIN: 0938-AL80 [[Page 37479]] _______________________________________________________________________ 955. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-P) 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 proposed rule would clarify certain portability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan. It would also implement 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 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: Federal, Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AL88 _______________________________________________________________________ 956. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1171 to 1179 of the Social Security Act CFR Citation: 42 CFR 162.1002; 42 CFR 162.1802 Legal Deadline: None Abstract: This proposed rule would revise the electronic transactions and code set standards mandated by the Health Insurance Portability and Accountability Act of 1966. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 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: Stanley B. Nachimson, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, N2-16-03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6153 RIN: 0938-AM50 _______________________________________________________________________ 957. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE SYSTEM AND CALENDAR YEAR 2005 PAYMENT RATES (CMS-1427-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395L; Balanced Budget Act of 1997; Medicare, Medicaid and SCHIP Balanced Budget Refinement Act of 1999; Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, January 1, 2004. Abstract: The proposed rule would revise the Medicare hospital outpatient prospective payment system beginning January 1, 2005. (The statute requires that this proposed rule and subsequent final rule be published by November 1, 2004.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Cindy Read, Division Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Mangement, 7500 Security Boulevard, C4-05-07, Baltimore, MD 21244 Phone: 410 786-1852 RIN: 0938-AM75 _______________________________________________________________________ 958. TICKET TO WORK: DEFINING INDIVIDUALS WITH POTENTIALLY SEVERE DISABILITIES AND PROVIDING A WORK THRESHOLD (CMS-2172-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Ticket to Work and Work Incentives Improvement Act of 1999 CFR Citation: None Legal Deadline: None Abstract: This proposed rule would provide a definition of ``medically determinable severe impairment'' under the Ticket to Work and Work Incentives Improvement Act of 1999. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carey Appold, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, S2- 14-26, Baltimore, MD 21224 Phone: 410 786-2117 RIN: 0938-AM79 _______________________________________________________________________ 959. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-2186-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1902 (a)(6) of the Social Security Act; Sec 2107 (b)(1) of the Social Security Act; Improper Payments Information Act of 2002 (IPIA) (PL 107-300) CFR Citation: None Legal Deadline: None [[Page 37480]] Abstract: Sections 1902(a)(6)and 2107(b)(1) of the Act, governing Medicaid and State Children's Health Insurance Program, respectively, require States to provide to the Secretary information to monitor program performance. This rule would require States under the current statutory provisions and the Improper Payments Information Act of 2002 and through this regulation to estimate improper payments using the CMS PERM methodolgy for the reporting year in the Medicaid and State Children's Health Insurance Program. The States are further required to submit payment error rates to CMS for the purpose of calculating a national level payment error rate as required by the Improper Payments Information Act of 2002. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Federalism: Undetermined Agency Contact: Wayne Alden Slaughter, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, S3-13-15, Baltimore, MD 21244 Phone: 410 786-0038 RIN: 0938-AM86 _______________________________________________________________________ 960. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 42 USC 1395i-3; 42 USC 1396r CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: This proposed rule would establish a Condition of Participation (CoP) for hospice services that long term care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. We are proposing this new CoP to ensure that quality hospice are is to eligible residents. This proposed rule is intended to assist in meeting the Administration's goals for broad-based improvements in the quality of health care furnished through the Medicare and Medicaid programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Anita Panicker, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Bloulevard, S3-04-26, Baltimore, MD 21244 Phone: 410 786-5646 RIN: 0938-AM87 _______________________________________________________________________ 961. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS, SECURING MEDICATIONS AND POST-ANESTHESIA EVALUATIONS (CMS-3122-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395 x; 42 USC 1396 d; 42 USC 1395 bb CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This proposed rule would revise four of the conditions of participation that hospitals must meet to participate in the Medicare and Medicaid programs to decrease the burden on hospitals to conform to current standards of practice. They must establish and maintain policies and procedures that ensure that the hospital meets these requirements by using standard practices related to history and physical examinations, and completion of the post-anesthesia evaluation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: None Agency Contact: Patricia Chmielewski, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6899 RIN: 0938-AM88 _______________________________________________________________________ 962. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 2005 (CMS-1429-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395W-4 CFR Citation: 42 CFR 410; 42 CFR 414 Legal Deadline: NPRM, Statutory, June 1, 2004, Revisions to Payment Policies. Abstract: This rule would make several changes affecting Medicare part B payment. (The statute requires that the final rule be published by November 1, 2004.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Latesha Walker, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1101 RIN: 0938-AM90 _______________________________________________________________________ 963. [bullet][ls-thn-eq] REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6146-P) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None [[Page 37481]] Abstract: This rule proposes revisions to the CMS civil money penalty authorities. These proposed revisions are intended to add the specific exclusion sanction authorities as established in the procedures for imposing civil money penalties, assessments, and exclusions for certain violations of the Medicare and Medicaid programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Joel Cohen, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C3-04-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3349 RIN: 0938-AM98 _______________________________________________________________________ 964. [bullet][ls-thn-eq] PHYSICIAN REFERRAL FOR NUCLEAR MEDICINE SERVICES AND SUPPLIES (CMS-1261-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1877 of the Social Security Act CFR Citation: 42 CFR 411.351 Legal Deadline: None Abstract: This proposed rule would amend the definitions of ``radiology and certain other imaging services'' and ``radiation therapy services and supplies'' to include diagnostic and therapeutic nuclear medicine services and supplies, respectively. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joanne Sinsheimer, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4620 Email: jsinsheimer@cms.hhs.gov RIN: 0938-AN04 _______________________________________________________________________ 965. [bullet][ls-thn-eq] MEDICARE ADVANTAGE PROGRAM TITLE II (CMS-4069-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: 42 CFR 417; 42 CFR 422 Legal Deadline: None Abstract: This proposed rule would implement title II of the Medicare Prescription Drug and Improvement Modernization Act establishing the Medicare Advantage program that would replace the existing Medicare+Choice program. Medicare Advantage offers improved managed care plans with coordinated care and competitive bidding, to promote greater efficiency and responsiveness to Medicare beneficiaries. (Rule needs to be published at least one year before January 1, 2006 implementation to award contracts.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jane Andrews, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-13-01, Baltimore, MD 21244-1850 Phone: 410 786-3133 Email: jandrews@cms.hhs.gov RIN: 0938-AN06 _______________________________________________________________________ 966. [bullet][ls-thn-eq] SPECIAL RULES FOR EMPLOYER-SPONSORED DRUG PROGRAMS: SUBSIDIES TO ENCOURAGE RETENTION (TITLE I) (CMS-2199-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: P.L. 108-173, 1860D-22 CFR Citation: 42 CFR 423 Legal Deadline: NPRM, Statutory, January 1, 2006. Statute requires that payments to sponsors begin in 2006. Abstract: Section 1860(D-22) of the Social Security Act (as added by the Medicare Prescription Drug Improvement and Modernization Act) establishes special rules for employer sponsored drug programs, beginning January 1, 2006, concerning payments to sponsors of retiree prescription drug plans. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: James Mayhew, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9344 Email: jmayhew@cms.hhs.gov RIN: 0938-AN07 _______________________________________________________________________ 967. [bullet][ls-thn-eq] MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 2006 (TITLE I) (CMS-4068-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: PL 108-173 (MMA) CFR Citation: 42 CFR 417; 42 CFR 423 Legal Deadline: None Abstract: This proposed rule would implement title I of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) that establishes a new voluntary outpatient prescription drug benefit under a new Medicare part D, beginning January 1, 2006. Options for coverage of the drug benefit include private prescription drug plans (PDPs) that offer drug only coverage; Medicare Advantage plans; or preferred provider plans (PPOs) that would offer prescription drug and nondrug coverage. Plans would offer a standard drug benefit but have the [[Page 37482]] flexibility to vary the drug benefit within actuarial equivalency parameters. Assistance with premiums and cost sharing would be provided to eligible low-income beneficiaries. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal, State, Tribal Federalism: Undetermined Agency Contact: Tracey McCutcheon, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6715 Email: tmccutcheon@cms.hhs.gov RIN: 0938-AN08 _______________________________________________________________________ 968. [bullet][ls-thn-eq] ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: Section 1923(i) of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This regulation will implement section 1923(i) of the Social Security Act (the Act). Section 1923(i) of the Act requires States to report DSH payment information (name of DSH providers and amount of payment they received) to CMS. Under the law, States must also furnish CMS with an independent audit that verifies DSH payment to hospitals. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: James Frizzera, Director, National Institutional Payment Policy, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3263 Email: jfrizzera@cms.hhs.gov RIN: 0938-AN09 _______________________________________________________________________ 969. [bullet][ls-thn-eq] PRIOR DETERMINATION PROCESS (CMS-6024-P) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Sec 938 of the Medicare Modernization Act of 2003 CFR Citation: Not Yet Determined 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. (The final rule must be published by March 25, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Misty D. Whitaker, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3087 Email: mwhitaker@cms.hhs.gov RIN: 0938-AN10 _______________________________________________________________________ 970. [bullet][ls-thn-eq] COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT (DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270- P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Public Law 108, MMA CFR Citation: 42 CFR 414.200; 42 CFR 405.502 (g); 42 CFR 424.57; 42 CFR 410.38 Legal Deadline: NPRM, Statutory, April 1, 2005. Final, Statutory, May 1, 2006. Abstract: Section 302 of the Medicare Modernization Act establishes DME competitive bidding. National competitive bidding will provide a program for using market forces to set Medicare payment amounts. This will also create incentives for suppliers to provide quality items and services while at the same time providing Medicare with reasonable prices for payment. (The statute requires competitive bidding be implemented by January 1, 2007. Proposed and final rules must be published six months prior to implementation.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, State Agency Contact: Michael Patrick, Health Policy Analyst, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4495 Email: mkeane@cms.hhs.gov RIN: 0938-AN14 _______________________________________________________________________ 971. [bullet][ls-thn-eq] UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL CENTERS FOR 2005 (CMS-1478-PN) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: NPRM, Statutory, July 1, 2005. Abstract: This proposed notice updates the list of Medicare-covered ASC procedures. (The subsequent final notice must be published by March 25, 2005, to be effective July 1, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Bob Cereghino, Health Insurance Specialist, Department of Health and Human [[Page 37483]] Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD Phone: 410 786-4645 Email: bcereghino@cms.hhs.gov RIN: 0938-AN23 _______________________________________________________________________ 972. [bullet][ls-thn-eq] 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 rule will propose revisions to the adopted transaction and code set standards detailed in regulations published by HHS on August 17, 2000, and February 20, 2003. The Secretary intends to propose any replacements for specific code sets. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 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: Maria A. Friedman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6333 Email: mfriedman@cms.hhs.gov RIN: 0938-AN25 _______________________________________________________________________ 973. [bullet][ls-thn-eq] PAYMENT FOR CLINICAL LABORATORY TESTS (CMS-1494- P) Priority: Substantive, Nonsignificant Legal Authority: Sec 1833(h)(8) of the MMA; Sec 416 of the MMA; PL 108- 173 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Medicare Modernization Act of 2003 (MMA), Public Law 108- 173, requires codification of the payment basis for determining Medicare payments for new clinical laboratory tests under the clinical laboratory fee schedule. Also, MMA's section 416 eliminates the application of the clinical laboratory fee schedule for hospital outpatient laboratory testing by a hospital with fewer than 50 beds in a qualified rural area for cost reporting periods beginning during the two-year period beginning on July 1, 2004. Section 1833(h) of the Act mandates payment for outpatient clinical laboratory tests under a clinical laboratory fee schedule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anita Greenberg, Health Insurance Specialist, CMS/CMM/ HAPG/DAS, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4601 Email: agreenberg@cms.hhs.gov RIN: 0938-AN26 _______________________________________________________________________ 974. [bullet][ls-thn-eq] PROSPECTIVE PAYMENT SYSTEM FOR LONG TERM CARE HOSPITALS: ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES FOR 2006 (CMS- 1483-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Sec 123, PL 106-113; Sec 307(b), PL 106-554 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule proposes the payment rate update for the 2006 prospective payment system for Medicare long-term care hospitals. The new rates will be based on cost reports from the first LTC PPS rate year. The proposed and final rules must be published by April 29, 2005, to be effective July 1, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Judy Richter, Health Insurance Specialist, CMS/CMM/ HAPG/DAC, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2590 Email: jrichter@cms.hhs.gov RIN: 0938-AN28 [[Page 37484]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 975. USE OF RESTRAINT 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 to 442; 42 CFR 483 Legal Deadline: None Abstract: This final rule addresses standards of practices that residential treatment facilities providing inpatient psychiatric services for individuals under age 21 must meet with regard to the use of restraints 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 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Larry Cutler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S2-14-26, Center for Medicaid and State Operations, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5903 RIN: 0938-AJ96 _______________________________________________________________________ 976. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-FC) Priority: Other Significant Legal Authority: Sec 521 of BIPA CFR Citation: 42 CFR 405 Legal Deadline: NPRM, Statutory, October 1, 2002, Statutory effective date October 1, 2002. Abstract: This final rule with comment period addresses one discrete aspect of the November 15, 2002, proposed rule, ``Changes to the Medicare Claims Appeal Procedures'' (67 FR 69312). As required by section 1869(b)(1)(F) of the Social Security Act, this rule establishes expedited determination and reconsideration procedures for beneficiaries who are informed by a provider that Medicare coverage of their services is about to end. This rule implements section 937 of the Medicare Modernization Act which requires a process for correction of minor errors and omissions without pursing the appeals process. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/15/02 67 FR 69312 Final Action 05/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Janet Miller, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, N2-14-26, S1-06-04, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1588 RIN: 0938-AL67 _______________________________________________________________________ 977. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-F) Priority: Other Significant Legal Authority: PL 107-105 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This final rule implements the requirements for electronic submission of Medicare claims, submitted on or after October 16, 2003. In addition, this rule also implements the conditions upon which a waiver could be granted for these requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 08/15/03 68 FR 48805 Interim Final Rule Comment Period End 10/16/03 Final Action 09/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Stewart Streimer, Director, Division of Operations Standards, Office of Program Administration, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 1-C-6 Meadows East Building, 6325 Security Boulevard, Baltimore, MD 21207 Phone: 410 786-9318 RIN: 0938-AM22 _______________________________________________________________________ 978. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2005 (CMS-1249-N) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Sec 1888(e) of the Social Security Act CFR Citation: 42 CFR 413.330 to 413.350 Legal Deadline: NPRM, Statutory, July 30, 2004, Statue requires the final rule to be published by August 1, 2004. Abstract: This annual notice updates the payment rates used under the skilled nursing facilities prospective payment system beginning October 1, 2004. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 07/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: William Ullman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-13-15, Center for Medicaid and State Operations, 7500 Security Boulevard, C5-07-08, Baltimore, MD 21244 Phone: 401 786-5667 RIN: 0938-AM46 _______________________________________________________________________ 979. TITLE I: NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HIPAA (CMS- 2033-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 2721(b)(2) of the Public Health Service Act [[Page 37485]] CFR Citation: 45 CFR 146.180 Legal Deadline: None Abstract: This final rule adopts as final the exemption election requirements that apply to self-funded non-Federal governmental plans. Since we received no public comments on the July 26, 2002, interim final with comment period, this rule finalizes the circumstances under which plan sponsors may exempt these plans from most of the requirements of title XXVII of the Public Health Service Act and provides guidance on the procedures, limitations, and documentation associated with exemption elections. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule With Comment Period 07/26/02 67 FR 48802 Final Action 08/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Dave Holstein, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Insurance Standards Team, S3-16-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1564 Related RIN: Related to 0938-AK00 RIN: 0938-AM71 _______________________________________________________________________ 980. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS (CMS-4064-FC) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 521 of BIPA CFR Citation: 42 CFR 40S Legal Deadline: None Abstract: This final rule will revise the Medicare appeals process by adding five-tiered (five levels) of review. It will remove the distinction between the processing of initial determination 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 ________________________________________________________________________ Final Action 05/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Agency Contact: Janet Miller, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, N2-14-26, S1-06-04, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1588 Related RIN: Related to 0938-AK69 RIN: 0938-AM73 _______________________________________________________________________ 981. CONDITIONS FOR COVERAGE OF POWER MOBILITY DEVICES, INCLUDING POWERED WHEELCHAIRS AND POWER-OPERATED VEHICLES SCOOTER(CMS-3017-IFC) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1102 of the Social Security Act; Sec 1871 of the Social Security Act CFR Citation: 42 CFR ch IV, sec 410, subpart B; 42 CFR 410.38 Legal Deadline: None Abstract: This rule will make the requirements to purchase power operated vehicles, functioning as wheelchairs, less stringent. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Lorrie Ballantine, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7543 RIN: 0938-AM74 _______________________________________________________________________ 982. HOSPICE WAGE INDEX FY 2005 (CMS-1264-N) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 1814(i)(A) CFR Citation: 42 CFR 418.306(d) Legal Deadline: Final, Statutory, October 1, 2004, effective date. Wage Index update is effective October 1, of each year. Abstract: This notice announces the annual update to the hospice wage index for FY 2005. The wage index is used to reflect local differences in wage levels. The hospice wage index methodology and values are based on the recommendations of a negotiated rulemaking advisory committee and were originally published on August 8, 1997. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 08/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Terri Deutseh, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-08-28, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-9462 RIN: 0938-AM78 _______________________________________________________________________ 983. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 2005 RATES (CMS-1428-F) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1886(d) of the Social Security Act CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 489 Legal Deadline: NPRM, Statutory, April 1, 2004. Final, Statutory, August 1, 2004. Abstract: This proposed rule would revise the Medicare acute hospital inpatient prospective payment system for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, the Addendum, [[Page 37486]] describes changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes apply to discharges on or after October 1, 2004. This proposed rule also setsforth proposed rate-of- increase limits as well as proposed policy changes for hospitals and hospital units excluded from the prospective payments systems. (The statute requires that this proposed and subsequent final rule be published by August 1, 2004.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/18/04 69 FR 28195 Final Action 08/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Tzvi Hefter, Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-07-07, Center for Medicare Management, 7500 Security Boulevard, C4-07-07, Baltimore, MD 21244 Phone: 410 786-4487 RIN: 0938-AM80 _______________________________________________________________________ 984. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2005 (CMS-1360-N) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1886(j) of the Social Security Act; PL 105-33; PL 106-554; PL 106-113 CFR Citation: None Legal Deadline: Final, Statutory, August 1, 2004, Rates for PPS. Abstract: This notice updates rates for the prospective payment system for inpatient rehabilitation facilities for FY 2005. (The statute requires that this notice be published by August 1, 2004.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 07/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Robert Kuhl, Division Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-11-06, Center for Medicare Management, 7500 Security Boulevard, C5-06-24, Baltimore, MD 21244 Phone: 410 786-4597 RIN: 0938-AM82 _______________________________________________________________________ 985. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FY 2005 (CMS- 1265-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1895 of the Social Security Act, ; Sec 421 of the MMA; Sec 701 of the MMA CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This 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 agencies. It also proposes to rebase and revise the home health market basket to reflect total cost and modify certain variables for some of the cost categories. It implements sections 421 (one-year increase in rural areas) and 701 (move to CY updates) of the Medicare Modernization Act (effective April 1, 2004). (The proposed and final rules must be published by September 30, 2004, to allow three months for systems changes.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/02/04 69 FR 31248 Final Action 10/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Randy Throndset, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0131 RIN: 0938-AM93 _______________________________________________________________________ 986. [bullet][ls-thn-eq] CHANGES TO MEDICARE PAYMENT FOR DRUGS AND PHYSICIAN FEE SCHEDULE PAYMENTS FOR CALENDAR YEAR 2004--CORRECTION NOTICE CMS-1372-IFC) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Medicare Prescription Drug, Improvement and Modernization Act of 2003 CFR Citation: 42 CFR 405; 42 CFR 414 Legal Deadline: Final, Statutory, January 1, 2004. Abstract: This final rule with comment implements section 602 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. Specifically, it revises the payment methodology under Medicare for Part B covered drugs and biologicals that are not paid on a cost or prospective payment basis; makes adjustments to payment for certain drug administration services under the physician fee schedule; makes revisions to the geographic practice expense cost indices used for determining payment under the physician fee schedule and announces a 1.5 percent increase in the calendar year 2004 physician fee schedule conversion factor. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/07/04 69 FR 1084 Interim Final Rule Comment Period End 03/08/04 Correction 03/26/04 69 FR 15703 Correction 06/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Marc Hartstein, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-4539 Email: mhartstein@cms.hhs.gov RIN: 0938-AM97 [[Page 37487]] _______________________________________________________________________ 987. [bullet][ls-thn-eq] PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS: EXTENSION OF PARTIAL DELAY OF EFFECTIVE DATE (CMS-1809-F5) Priority: Routine and Frequent Legal Authority: Sec 1877 of the Social Security Act CFR Citation: None Legal Deadline: None Abstract: This final rule delays for six months the effective date of the last sentence of 42 CFR 411.354(d)(1) of the physician self- referral rule published on January 4, 2001. This sentence defines compensation that is ``set in advance'' as it relates to percentage compensation methodologies. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 07/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Karen Raschke, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-0016 Email: kraschke@cms.hhs.gov Related RIN: Related to 0938-AL29, Related to 0938-AM21, Related to 0938-AM58, Related to 0938-AM95 RIN: 0938-AM99 _______________________________________________________________________ 988. [bullet][ls-thn-eq] TIME LIMITATION ON RECORD KEEPING REQUIREMENTS UNDER THE DRUG REBATE PROGRAM (CMS-2188-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: This proposed rule would establish ten-year record keeping requirements for drug manufacturers under the Medicaid drug rebate program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/06/04 69 FR 565 Final Action 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Marge Watchorn, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4361 Email: mwatchorn@cms.hhs.gov RIN: 0938-AN01 _______________________________________________________________________ 989. [bullet][ls-thn-eq] EXTENDED AVAILABILITY OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FYS 1998 THROUGH 2004; AUTHORITY TO USE A PORTION OF SCHIP FUNDS FOR MEDICAID EXPENDITURES (CMS-2187-N) Priority: Other Significant Legal Authority: 42 USC 1302 CFR Citation: None Legal Deadline: None Abstract: This notice extends availability of unexpended SCHIP funds from the appropriation for fiscal years 1998 through 2004 and provides the authority for qualifying States to use a portion of SCHIP funds for Medicaid expenditures. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 06/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: State Agency Contact: Richard Strauss, Division Director, Division of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2019 Email: rstrauss@cms.hhs.gov RIN: 0938-AN03 _______________________________________________________________________ 990. [bullet][ls-thn-eq] FY 2005 SCHIP ALLOTMENTS (CMS-2201-N) Priority: Economically Significant Legal Authority: Title XXI of the Social Security Act, sec 2104 CFR Citation: 42 CFR 457 Legal Deadline: None Abstract: This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2005. (The notice must be published as soon as possible so that the funds can be distributed to the States before September 30, 2004, as required by the statute.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 08/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss, Director, Division of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore , MD 21244 Phone: 410 786-2019 Email: rstrauss@cms.hhs.gov RIN: 0938-AN11 _______________________________________________________________________ 991. [bullet][ls-thn-eq] SCHEDULE FOR PUBLISHING MEDICARE FINAL REGULATIONS AFTER A PROPOSED OR INTERIM FINAL REGULATION (CMS-9026-N) Priority: Info./Admin./Other Legal Authority: Sec 902 of the Medicare Modernization Act of 2003 CFR Citation: None Legal Deadline: None Abstract: In accordance with Section 902 of the Medicare Modernization Act of 2003, this rule establishes a regular timeline for the publication of final regulations based on the previous publication of a proposed or interim final regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 09/00/04 Regulatory Flexibility Analysis Required: No [[Page 37488]] Small Entities Affected: No Government Levels Affected: None Agency Contact: Renee Swann, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4492 Email: rswann@cms.hhs.gov RIN: 0938-AN12 _______________________________________________________________________ 992. [bullet][ls-thn-eq] EVALUATION CRITERIA AND STANDARDS FOR QUALITY IMPROVEMENT PROGRAM CONTRACTS (CMS-3142-NC) Priority: Info./Admin./Other. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1153(h)(2) of the Social Security Act CFR Citation: None Legal Deadline: Final, Statutory, August 31, 2004. There is a 60 day comment period required for the evaluation criteria used in evaluating the Quality Improvement Organizations. Abstract: Section 1153(h)(2) of the Act requires the Secretary to publish in the Federal Register the general criteria and standards that will be used to evaluate the Quality Improvement Organizations (QIOs), and provide opportunity for public comment. This notice will describe the evaluation criteria CMS will use to evaluate the QIOs. There should be no additional costs associated with this requirement. The evaluation portion of the contract has already been factored into the award. (This notice with comment period must be published by May 28, 2004, to allow sufficient time for receipt and response to comments prior to the first round of QIO evaluations beginning November 2004. Delaying the first round of evaluations will delay the statutory requirement to notify QIOs of nonrenewal of their current contracts 90 days prior to their expiration, as well as extend the QIOs' work beyond the current contract period.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 09/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Maria L, Hammel, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1775 Email: mhammel@cms.hhs.gov RIN: 0938-AN13 _______________________________________________________________________ 993. [bullet][ls-thn-eq] PART A PREMIUMS FOR CALENDAR YEAR 2005 FOR THE UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8022-N) Priority: Other Significant Legal Authority: 42 USC 1395-2(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: NPRM, Statutory, January 1, 2005. Abstract: This notice announces the hospital insurance premium for Calendar Year 2005 under Medicare's Hospital Insurance Program (Medicare part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement. (CMS generally publishes this notice to coincide with the SSA Cola announcement.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 10/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland, Deputy Director, Medicare & Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6390 Email: cmcfarland@cms.hhs.gov RIN: 0938-AN15 _______________________________________________________________________ 994. [bullet][ls-thn-eq] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2005 (CMS- 8021-N) Priority: Other Significant Legal Authority: 42 USC 1395-2 (b) (2); Social Security Act section 1813 (b) (2) CFR Citation: None Legal Deadline: NPRM, Statutory, January 1, 2005. Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in Calendar Year 2005 under Medicare's Hospital Insurance program (Medicare part A). The Medicare statute specifies the formula used to determine these amounts. (CMS generally publishes this notice to coincide with the SSA Cola announcement.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 10/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland, Deputy Director, Medicare & Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6390 Email: cmcfarland@cms.hhs.gov RIN: 0938-AN16 _______________________________________________________________________ 995. [bullet][ls-thn-eq] MEDICARE PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE BEGINNING JANUARY 1, 2005 (CMS-8020-N) Priority: Other Significant Legal Authority: 42 USC 1395r; Social Security Act, sec 1839; MMA, sec 629; MMA, sec 811 CFR Citation: None Legal Deadline: NPRM, Statutory, September 30, 2004. Abstract: Section 629 of the Medicare Modernization Act requires indexing the part B deductible to inflation beginning January 1, 2005. This notice announces the monthly actuarial rates for aged (65 and over) and disabled [[Page 37489]] (under age 65) enrollees in part B of Medicare for 2005. It also announces the monthly Part B premium to be paid by all enrollees during 2005. (CMS generally publishes this notice to coincide with the SSA Cola announcement.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 10/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carter Warfield, Deputy Director, Medicare & Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6396 Email: cwarfield@cms.hhs.gov RIN: 0938-AN18 _______________________________________________________________________ 996. [bullet][ls-thn-eq] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES- UPDATE FOR CALENDAR YEAR 2005 (CMS-1267-N) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 1861(S)(7); 1834(I)(3)(B); 221 BIPA CFR Citation: 414.620(f) CFR; 414.610(c)(5) CFR; 414.615 CFR; 414.605 CFR Legal Deadline: Final, Statutory, January 1, 2004. Abstract: This notice updates the fee schedule for ambulance services under the Medicare program, implementing section 1834(1) of the Social Security Act. (This nonmajor rule must be published by December 1, 2004, to be effective January 1, 2005) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ann Tayloe, Health Insurance Specialist, CMS/CMM/HAPG/ DAS, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4546 Email: atayloe@cms.hhs.gov RIN: 0938-AN20 _______________________________________________________________________ 997. [bullet][ls-thn-eq] PROCEDURE FOR PRODUCING GUIDANCE DOCUMENTS DESCRIBING MEDICARE'S COVERAGE PROCESS (CMS-3141-N) Priority: Info./Admin./Other. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 731 of the MMA CFR Citation: None Legal Deadline: Other, Statutory, January 1, 2004, Required by Section 731 of the MMA. Abstract: Section 731 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) requires that the Secretary make available to the public the factors considered in making national coverage determinations of whether an item or service is reasonable and necessary. This notice describes a proposed method of developing and making public guidance documents consistent with these requirements and invites public comment on this process beginning January 1, 2005. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 08/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Vadim Lubarsky, Technical Adivsor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0840 Email: vlubarsky@cms.hhs.gov RIN: 0938-AN21 _______________________________________________________________________ 998. [bullet][ls-thn-eq] AMENDMENT TO THE INTERIM FINAL REGULATION FOR MENTAL HEALTH PARITY (CMS-2152-F2) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: 45 CFR 146.136 Legal Deadline: None Abstract: The amendment to the interim final rule changes the sunset date of regulations under the Mental Health Parity Act of 1996 (MHPA). The MHPA as initially enacted had a sunset date of September 30, 2001. The implementing regulations published in 1997 included a corresponding sunset date. Subsequent legislation enacted on January 10, 2002, extended the sunset date of the MHPA to December 31, 2002. Legislation enacted on December 2, 2002, extended the sunset date again, to December 31, 2003. Therefore, this amendment to the 1997 regulations extends the sunset date of the regulations to December 31, 2004, consistent with the MHPA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/27/03 68 FR 38206 Final Action 07/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AN22 _______________________________________________________________________ 999. [bullet][ls-thn-eq] MEDICARE AMBULANCE FEE SCHEDULE UPDATE (CMS- 1492-IFC) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1834(i) of the Social Security Act; Sec 414 of the MMA CFR Citation: 42 CFR 414, subpart H Legal Deadline: Final, Statutory, July 1, 2004, Interim final. Abstract: Section 414 of the Medicare Modernization Act provides for temporary increases to the Medicare ambulance fee schedule beginning July 7, 2004. It also increases mileage payments for certain long trips. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/00/04 [[Page 37490]] Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local Federalism: Undetermined Agency Contact: Robert Niemann, Health Insurance Specialist, CMS/CMM/ HAPG/DAS, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4596 Email: rnieman@cms.hhs.gov RIN: 0938-AN24 _______________________________________________________________________ 1000. [bullet][ls-thn-eq] MEDICARE SECONDARY PAYER (MSP): WORKMEN'S COMPENSATION (CMS-1272-FC) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 301 of the Medicare Prescripition Drug, Improvement, and Modernization Act of 2003 CFR Citation: 42 CFR 411 Legal Deadline: Final, Statutory, December 8, 2003. Abstract: Section 301 of the Medicare Modernization Act clarifies when CMS may make a conditional Medicare payment when other insurance cannot reasonably be expected to make a prompt payment (effective December 8, 2003). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 06/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Agency Contact: Suzanne Ripley, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0970 Email: sripley@cms.hhs.gov RIN: 0938-AN27 _______________________________________________________________________ 1001. [bullet][ls-thn-eq] RANDOM PREPAYMENT REVIEW (CMS-6022-IFC) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Sec 934 of the MMA CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, December 8, 2004. Abstract: Section 934 of the Medicare Modernization Act establishes requirements for prepayment medical review of a provider beginning December 8, 2004. This regulation will establish contractor standards relating to the initiation and termination of nonrandom prepayment reivew. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule With Comment Period 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Federalism: Undetermined Agency Contact: Ann Casey, Health Insurance Specialist, CMS/OFM/PIG, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore , MD 21244 Phone: 410 786-7861 Email: acasey@cms.hhs.gov RIN: 0938-AN31 _______________________________________________________________________ 1002. [bullet][ls-thn-eq] ADDITIONAL PAYMENTS FOR CERTAIN MEDICARE PART B DRUGS (CMS-1280-FC) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 303(e)(2) of the Medicare Modernization Act of 2003 CFR Citation: 42 CFR 414.1000 to 414.1002 Legal Deadline: None Abstract: This final rule with comment period continues the implementation of section 303(e)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 by establishing a separate billable fee to be paid to pharmacies for supplying certain Medicare part B drugs and biologicals. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Rule With Comment Period 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Angela Mason, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, C4- 05-17, Baltimore, MD 21244 Phone: 410 786-7452 Email: amason@cms.hhs.gov RIN: 0938-AN34 _______________________________________________________________________ 1003. [bullet][ls-thn-eq] FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS (CMS-2019-F) Priority: Other Significant Legal Authority: 42 USC 300gg-22; 42 USC 300gg-31 CFR Citation: 45 CFR 150.101 to 150.465 Legal Deadline: None Abstract: This rule finalizes, without any substantive changes, an interim final regulation (HCFA-2019-IFC) that sets forth the process by which CMS enforces the HIPAA title I requirements with regards to State and local governmental group health plans. It also finalizes the process by which CMS assumes direct enforcement responsibility in a State with regard to group and individual market health insurance issues. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 05/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AN35 [[Page 37491]] _______________________________________________________________________ 1004. [bullet][ls-thn-eq] FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES, AMENDMENT (CMS-3047-F2) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: This final rule amends the fire safety standard for religious nonmedical health care institutions, hospices, programs of all- inclusive care for the elderly, hospitals, long term care facilities, intermediate care facilities for the mentally retarded, and critical access hospitals that participate in Medicare and Medicaid. The rule would adopt a change made to the 2000 edition of the Life Safety Code (LSC) published by the National Fire Protection Association (NFPA). We adopted the 2000 edition of the LSC in January 2003. The LSC change will allow facilities to place alcohol-based hand sanitizer dispensers in exit corridors under certain conditions. These sanitizers have proven to be effective in increasing hand hygiene and have the potential to improve infection control practice. Adopting the LSC change would increase a provider's flexibility in meeting infection control goals while minimizing potential fire safety concerns. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 05/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6617 RIN: 0938-AN36 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1005. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING PRIVILEGES (CMS-6002-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 424 Legal Deadline: None Abstract: This final rule is needed as part of the Administration's anti-fraud and abuse efforts. It would give HHS the authority to enroll and re-enroll providers with time frames for re-enrollment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/25/03 68 FR 22064 Final Action 04/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Michael Collett, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, C3-02-06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6121 RIN: 0938-AH73 _______________________________________________________________________ 1006. MEDICARE OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA REPORTING REQUIREMENTS (CMS-3006-F) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments and the private sector. Legal Authority: 42 USC 1302; 42 USC 1395(hh) CFR Citation: 42 CFR 484.11; 42 CFR 484.20; 42 CFR 488.68 Legal Deadline: None Abstract: This final rule requires home health agencies to electronically report OASIS data as a condition of participation in the Medicare program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/25/99 64 FR 3748 Final Action 11/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: State, Local, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Aucha Prachanronarong, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9614 RIN: 0938-AJ10 _______________________________________________________________________ 1007. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS- 3014-F) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 482.27 Legal Deadline: None Abstract: This rule requires hospitals that transfuse blood and blood products to prepare and follow written procedures for appropriate action when it is determined that blood and blood products the hospital received and transfused are at increased risk for transmitting 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 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None [[Page 37492]] Agency Contact: Mary Collins, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, S3- 02-01, Baltimore, MD 21244 Phone: 410 786-3189 RIN: 0938-AJ29 _______________________________________________________________________ 1008. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-F) Priority: Substantive, Nonsignificant Legal Authority: PL 105-33, sec 1961(dd) ; PL 105-33, sec 1814(i); PL 105-33, sec 4441 to 4444; PL 105-33, sec 4448; PL 106-113, sec 131; PL 106-554, sec 321; PL 106-554, sec 322; PL 105-33, sec 4449 CFR Citation: 42 CFR 418 Legal Deadline: None Abstract: This final rule revises certain regulations governing coverage and payments for hospice care under the Medicare program as required by the Balanced Budget Act of 1997. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/22/02 67 FR 70363 Final Action 11/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Thomas Saltz, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-05-27, Centers for Medicare Management, 7500 Security Boulevard, C4- 05-27, Baltimore, MD 21244 Phone: 410 786-4480 Related RIN: Previously reported as 0938-AH73 RIN: 0938-AJ36 _______________________________________________________________________ 1009. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS--PHASE II (CMS-1810-IFC) Priority: Other Significant Legal Authority: 42 USC 1877 CFR Citation: 42 CFR 411 & 424 Legal Deadline: None Abstract: This intermin final rule with comment period incorporates into regulation certain statutory provisions that preclude payment for services under Medicare if a physician makes a referral to a facility in which he/she has a financial interest. It addresses comments from the January 9, 1998, proposed rule concerning the ownership, investment, and compensation exceptions. It also addresses comments from the January 4, 2001, final rule with comment period. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 03/26/04 69 FR 16054 Interim Final Rule Comment Period End 06/24/04 Final Action 03/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, C4- 25-02, Baltimore, MD 21244 Phone: 410 786-4620 RIN: 0938-AK67 _______________________________________________________________________ 1010. CONTINUATION OF MEDICARE ENTITLEMENT WHEN DISABILITY BENEFIT ENDS BECAUSE OF SUBSTANTIAL GAINFUL ACTIVITY (CMS-4018-F) Priority: Substantive, Nonsignificant Legal Authority: Sec 202 of the TWWIIA of 1999; PL 106-170 CFR Citation: 42 CFR 406.12 Legal Deadline: None Abstract: This final rule implements the Ticket to Work and Work Incentives Improvement Act of 1999. It provides working disabled individuals with continued Medicare entitlement for an additional 54 months beyond the current limit, for a total of 78 months of Medicare coverage following the 15th month of the extended period of eligibility. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/25/03 68 FR 43998 Final Action 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Denise Cox, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Health Insurance Specialist, 7500 Security Boulevard, S1-05-06, Baltimore, MD 21244 Phone: 410 786-3195 RIN: 0938-AK94 _______________________________________________________________________ 1011. MEDICARE PROGRAM; INTEREST CALCULATION (CMS-6014-F) Priority: Other Significant Legal Authority: Sec 1815(d) of the Social Security Act; Sec 1833 (j) of the Social Security Act CFR Citation: 42 CFR 405.378; 42 CFR 411.24 Legal Deadline: None Abstract: This final rule will change the formula for computing interest on provider and supplier overpayments and underpayments to make it consistent with the new CMS accounting system, Healthcare Integrated General Ledger Accounting System. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/25/03 68 FR 43995 Final Action 07/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Nancy Braymer, Financial Management Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C3-14-21, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4323 RIN: 0938-AL14 [[Page 37493]] _______________________________________________________________________ 1012. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE ISSUERS (CMS-2151-F) Priority: Other Significant. Major under 5 USC 801. Legal Authority: 42 USC 300gg; PL 104-191 CFR Citation: 45 CFR 144.103; 45 CFR 146.111; 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 146.120; 45 CFR 146.125; 45 CFR 146.143; . . . Legal Deadline: None Abstract: This final rule provides portability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan under the Health Insurance Portability and Accountability Act of 1996. This regulation addresses limitations or preexisting exclusion periods on requests for special enrollments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/08/97 62 FR 16894 Interim Final Rule Comment Period End 07/07/97 Interim Final Rule Effective 07/07/97 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AL43 _______________________________________________________________________ 1013. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES FY 2004 (CMS-1213-F) Priority: Other Significant Legal Authority: PL 106-113; Sec 124 of the BBRA ; Sec 1886 of the Social Security Act CFR Citation: 42 CFR 412, subpart N; 42 CFR 413; 42 CFR 424 Legal Deadline: NPRM, Statutory, October 1, 2002, Public Law 106-113, Sec 124. Abstract: This final rule sets forth a prospective payment system (PPS) for inpatient psychiatric facilities and psychiatric units. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/28/03 68 FR 66919 Final Action 11/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, Local, State Agency Contact: Lana Price, Director, Division of Chronic Care Management, Chronic Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-05-27, Center for Medicare Management, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4533 RIN: 0938-AL50 _______________________________________________________________________ 1014. DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-F) Priority: Substantive, Nonsignificant Legal Authority: Sec 1842 of the Social Security Act; Sec 1834(a)(12) of the Social Security Act; Sec 1834(h)(3) of the Social Security Act; Sec 1834(j)(1) of the Social Security Act CFR Citation: 42 CFR 421.210 Legal Deadline: None Abstract: This rule allows flexibility in making changes to the DMERC contractor structure. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/26/04 69 FR 15755 Final Action 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Kim Nyland, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S1-14-27, Center for Medicare Management, 7500 Security Boulevard, S1- 14-27, Baltimore, MD 21244 Phone: 410 786-2289 RIN: 0938-AL76 _______________________________________________________________________ 1015. PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED NATIONAL COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES (CMS-3119-F) Priority: Other Significant Legal Authority: 42 USC 1395h(a); 42 USC 1395e; 42 USC 1395u(a); 42 USC 1395x; 42 USC 1395y(a)(1)(A); 42 USC 1395y(a)(7) CFR Citation: None Legal Deadline: None Abstract: This final rule establishes the procedures to be used for maintaining the lists of codes that were included in the national coverage determinations (NCDs) that were announced in 66 FR 58788 on November 25, 2001. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74607 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Jacqueline Sheridan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, C1-09-06, Baltimore, MD 21244 Phone: 410 786-4635 RIN: 0938-AM36 _______________________________________________________________________ 1016. HOSPITAL PATIENTS' RIGHTS COP--STANDARD SAFETY COMPLIANCE COMMITTEES (CMS-3120-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1395bb; 42 USC 1395x; 42 USC 1396d CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This proposed rule would allow hospitals to waive the current requirement that a physician or licensed independent practitioner perform a one-hour face-to-face [[Page 37494]] evaluation of a patient in restraint or seclusion for the purpose of behavior management. Under this proposed rule, a hospital could choose to have the one-hour assessment performed by another practitioner, such as a registered nurse, if that hospital established a Protections Compliance Committee to oversee the use of restraint or seclusion Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rachael Weinstein, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6775 RIN: 0938-AM39 _______________________________________________________________________ 1017. REQUIREMENTS FOR NURSING HOMES TO IDENTIFY THE NUMBER OF LICENSED AND UNLICENSED NURSES (CMS-3121-F) Priority: Other Significant Legal Authority: Sec 1819(b) of the Social Security Act; 42 USC 1395i- 3(b) CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: This final rule implements section 941 of the Medicare, Medicaid, and SCHIP benefits Improvement and Protection Act and requires nursing homes to post daily, for each shift, the number of full-time equivalents (FTEs) of registered nurses, licensed practical nurses, licensed vocational nurses, and certified nurse aides who are directly responsible for resident care. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/27/04 69 FR 9282 NPRM Comment Period End 04/27/04 Final Action 02/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Anita Panicker, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-04-26, Office of Clinical Standards and Quality, 7500 Security Boulevard, S3-02-01, Baltimore, MD 21244 Phone: 410 786-5646 RIN: 0938-AM55 _______________________________________________________________________ 1018. COVERED OUTPATIENT DRUGS UNDER THE MEDICAID DRUG REBATE PROGRAM (CMS-2174-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1905 (a) (12) of the Social Security Act; Sec 1903 (a) of the Social Security Act ; Sec 1902 (a) (54) of the Social Security Act ; Sec 1903 (i) (10) of the Social Security Act ; Sec 1927 of the Social Security Act CFR Citation: 42 CFR 441 ; 42 CFR 447 Legal Deadline: None Abstract: This proposed rule will repropose and request public comments on numerous provisions related to the Medicaid drug rebate program. The agency published a proposed rule on September 19, 1995. However, in light of new issues, the agency seeks an opportunity to propose new provisions and seeks comments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Marge Watchorn, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, S2- 05-16, Baltimore, MD 21244 Phone: 410 786-4361 RIN: 0938-AM81 _______________________________________________________________________ 1019. REVISIONS TO COST SHARING REGULATIONS (CMS-2144-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1916 of the Social Security Act ; Sec 1902(a)(4) of the Social Security Act CFR Citation: 42 CFR 447.51 to 447.56 Legal Deadline: None Abstract: This proposed rule would revise the cost sharing requirements in our current regulation to allow for the imposition of higher levels of cost sharing and more flexibility in the way in which cost sharing is imposed and administered under current statutory requirements. (The cost sharing requirements have remained unchanged since 1974. States have requested that we update the cost sharing requirements.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Alissa Deboy, Special Assistant, Department of Health and Human Services, Centers for Medicare & Medicaid Services, CMSO, S2- 14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6041 RIN: 0938-AM94 _______________________________________________________________________ 1020. [bullet][ls-thn-eq] MEDICARE PROGRAM; HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM PAYMENT REFORM FOR CALENDAR YEAR 2004 CMS- 1371-IFC Priority: Other Significant. Major under 5 USC 801. Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2004. Abstract: This rule revises payment rates for drugs in 2004 and 2005. (Section 621 of MMA requires the rule to be implemented by January 1, 2004.) [[Page 37495]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/06/04 69 FR 820 Final Action 01/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Dana Buley, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltmore, MD 21244 Phone: 410 786-4547 Email: dbuley@cms.hhs.gov RIN: 0938-AM96 _______________________________________________________________________ 1021. [bullet][ls-thn-eq] PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI- LEVEL CAPABILITY AND A BACK-UP RATE (CMS-1167-F) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: 42 USC 1395(m)(3) CFR Citation: 42 CFR 414.222(a)(1) Legal Deadline: Final, Statutory, August 22, 2006, MMA Section 902. Abstract: This final rule clarifies that respirator assist devices with bi-level capability and a back-up rate must be classified as capped rental Durable Medical equipment (DME) in accordance with section 1834(a)(3) of the Social Security Act (42 USC 1395(m)(3)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joel Kaiser, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C5-07-26, Baltimore, MD 21244 Phone: 410 786-4499 Email: jkaiser@cms.hhs.gov Related RIN: Related to 0938-AL27 RIN: 0938-AN02 _______________________________________________________________________ 1022. [bullet][ls-thn-eq] MANUFACTURERS' SUBMISSION OF AVERAGE SALES PRICE DATA FOR MEDICARE PART B DRUGS AND BIOLOGICALS (CMS-1380-IFC) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: Sec 303(c) of the MMA 2003 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: Section 303(c) of the Medicare Prescription Drug Improvement and Modernization Act requires manufacturers to submit average sales price data on Medicare part B drugs. This regulation provides instruction to manufacturers on the data submission requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/06/04 69 FR 17935 Final Action 04/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal Agency Contact: Angela Mason, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, C4- 05-17, Baltimore, MD 21244 Phone: 410 786-7452 Email: amason@cms.hhs.gov RIN: 0938-AN05 _______________________________________________________________________ 1023. [bullet][ls-thn-eq] NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH AGENCIES AND OTHER ENTITIES (CMS-1224-F) Priority: Substantive, Nonsignificant Legal Authority: PL 105-33, sec 4321 of the BBA CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This final rule establishes a process for collecting and maintaining information about hospitals referring Medicare patients to home health agencies (HHAs) with which the hospitals have a financial interest. Collected information will be available to the public to enhance its understanding and awareness of the availability of Medicare-certified HHAs to serve the Medicare population. (This final rule must be published by November 22, 2005, to meet the three-year publication deadline.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/22/02 67 FR 70373 Final Action 11/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Elizabeth Carmody, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7533 Email: ecarmody@cms.hhs.gov RIN: 0938-AN19 _______________________________________________________________________ 1024. [bullet][ls-thn-eq] NONDISCRIMINATION IN HEALTH COVERAGE AND BONAFIDE WELLNESS PLANS IN THE GROUP MARKET (CMS-2022-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300gg CFR Citation: 45 CFR 146.121 Legal Deadline: None Abstract: This document contains final rules governing the provisions prohibiting discrimination based on a health factor for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974, and the Public Health Service Act enacted as part of the Health Insurance Portability and Accountability Act of 1966. It also addresses comments we received on the Bonafide Wellness Plan proposed rule (CMS-2078-P). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/08/97 62 FR 16894 Interim Final Rule Comment Period End 07/17/97 Interim Final Rule Effective 07/17/97 [[Page 37496]] Interim Final Rule 01/08/01 66 FR 1378 Interim Final Rule Effective 03/09/01 Interim Final Rule Comment Period End 04/09/01 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6851 Email: dmlawsky@cms.hhs.gov RIN: 0938-AN29 _______________________________________________________________________ 1025. [bullet][ls-thn-eq] HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018-F) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This final rule sets forth standards for the use of restraints and seclusion in Medicare- and Medicaid-participating hospitals as part of the Patients' Rights Condition of Participation (CoP) and finalizes other patients' rights afforded by that CoP. It finalizes six standards that ensure minimum protections of each patient's physical and emotional health and safety. These standards address each patient's right to: 1) notification of his or her rights; 2) the exercise of his or her rights in regard to his or her care; 3) privacy and safety; 4) confidentiality of patient records; 5) freedom from restraints used in the provision of acute medical and surgical care unless clinically necessary; and 6) freedom from seclusion and restraint for behavior management unless clinically necessary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Patricia Chmielewski, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6899 Email: pchmielewski@cms.hhs.gov RIN: 0938-AN30 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1026. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER IDENTIFIER (CMS-0045-F) Priority: Other Significant. Major under 5 USC 801. CFR Citation: 42 CFR 160; 42 CFR 162 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 01/23/04 69 FR 3434 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Patricia Peyton Phone: 410 786-1812 RIN: 0938-AH99 _______________________________________________________________________ 1027. COVERAGE OF RELIGIOUS NONMEDICAL HEALTH CARE INSTITUTIONS (CMS- 1909-F) Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 403.736; 42 CFR 403. 738; 42 CFR 489.102 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/28/03 68 FR 66710 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Jean Marie Moore Phone: 410 786-3508 RIN: 0938-AI93 _______________________________________________________________________ 1028. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F) Priority: Other Significant. Major under 5 USC 801. CFR Citation: 42 CFR 413.80; 42 CFR 413.178 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 06/02/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Katie Walker Phone: 410 786-7278 RIN: 0938-AK02 _______________________________________________________________________ 1029. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE DETERMINATIONS (CMS-3063-F) Priority: Other Significant CFR Citation: 42 CFR 405 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/07/03 68 FR 63691 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Vadim Lubarsky Phone: 410 786-0840 Email: vlubarsky@cms.hhs.gov RIN: 0938-AK60 _______________________________________________________________________ 1030. RATE OF REIMBURSEMENT OF PHOTOCOPY EXPENSES FOR QUALITY IMPROVEMENT ORGANIZATIONS (CMS-3055-F) Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 476.78 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/05/03 68 FR 67955 [[Page 37497]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Les Caplan Phone: 410 786-7223 RIN: 0938-AK68 _______________________________________________________________________ 1031. ELIMINATION OF STATEMENT OF INTENT PROCEDURES FOR FILING MEDICARE CLAIMS (CMS-1185-F) Priority: Other Significant CFR Citation: 42 CFR 424 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 04/23/04 69 FR 21963 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, State Agency Contact: David Walczak Phone: 410 786-4475 RIN: 0938-AK79 _______________________________________________________________________ 1032. PERMITTING PREMIUM REDUCTIONS AS ADDITIONAL BENEFITS UNDER MEDICARE+CHOICE PLANS (CMS-6016-F) Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 408 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/28/03 68 FR 66721 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, Local, State Agency Contact: Michele Sanders Phone: 410 786-0808 RIN: 0938-AL49 _______________________________________________________________________ 1033. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND CALENDAR YEAR 2004 PAYMENT RATES (CMS-1471-F) Priority: Other Significant. Major under 5 USC 801. CFR Citation: Not Yet Determined Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 11/07/03 68 FR 63398 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Cindy Read Phone: 410 786-1852 RIN: 0938-AL91 _______________________________________________________________________ 1034. CRITERIA FOR DETERMINING WHETHER A DRUG IS CONSIDERED USUALLY SELF-ADMINISTERED (CMS-1228-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. CFR Citation: Not Yet Determined Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 04/26/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Angela Mason Phone: 410 786-7452 Email: amason@cms.hhs.gov RIN: 0938-AM13 _______________________________________________________________________ 1035. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2004 (CMS-8016-N) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 10/24/03 68 FR 60995 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 RIN: 0938-AM31 _______________________________________________________________________ 1036. MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 2004 (CMS-8017-N) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 10/24/03 68 FR 60997 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carter S. Warfield Phone: 410 786-6396 RIN: 0938-AM32 _______________________________________________________________________ 1037. PART A PREMIUMS FOR CALENDAR YEAR 2004 FOR THE UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8018-N) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 10/24/03 68 FR 61002 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 RIN: 0938-AM33 _______________________________________________________________________ 1038. GRANTS TO STATES FOR OPERATION OF QUALIFIED HIGH RISK POOLS (CMS- 2179-FC) Priority: Other Significant CFR Citation: 45 CFR 148 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 03/26/04 69 FR 15695 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: James Mayhew Phone: 410 786-9244 RIN: 0938-AM42 [[Page 37498]] _______________________________________________________________________ 1039. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES UPDATE FOR CALENDAR YEAR 2004 (CMS-1232-FCC) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 12/05/03 68 FR 67960 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anne Tayloe Phone: 410 786-4546 RIN: 0938-AM44 _______________________________________________________________________ 1040. EXCLUSION OF MEDICARE BENEFITS FOR ALIENS NOT LAWFULLY PRESENT IN THE UNITED STATES (CMS-1222-FC) Priority: Other Significant CFR Citation: 42 CFR 411.11 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 11/28/03 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Frederick William Grabau Phone: 410 786-0206 RIN: 0938-AM47 _______________________________________________________________________ 1041. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6146-P) Priority: Other Significant CFR Citation: 42 CFR 402, subpart C & 402.3 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 05/11/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Cohen Phone: 410 786-3349 Related RIN: Duplicate of 0938-AM98 RIN: 0938-AM54 _______________________________________________________________________ 1042. CHANGES TO THE CRITERIA FOR BEING CLASSIFIED AS AN INPATIENT REHABILITATION FACILITY (CMS-1262-F) Priority: Economically Significant CFR Citation: 42 CFR 412 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 05/07/04 69 FR 25751 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Robert Kuhl Phone: 410 786-4597 Related RIN: Split from 0938-AL95 RIN: 0938-AM72 _______________________________________________________________________ 1043. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS: ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES (EFFECTIVE 7/1/04) (CMS-1263-F) Priority: Other Significant CFR Citation: 42 CFR 412 ; 42 CFR 413 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 01/30/04 69 FR 4754 Final Action 05/07/04 69 FR 25673 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tzvi Hefter Phone: 410 786-4487 RIN: 0938-AM84 _______________________________________________________________________ 1044. DISPROPORTIONATE SHARE HOSPITAL (DSH) PAYMENTS INSTITUTIONS FOR MENTAL DISEASE (IMDS) (CMS-2062-N) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 03/26/04 69 FR 15850 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jim Frizzera Phone: 410 786-9535 RIN: 0938-AM89 _______________________________________________________________________ 1045. [bullet][ls-thn-eq] PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS: EXTENSION OF PARTIAL DELAY OF EFFECTIVE DATE (CMS-1809-F4) Priority: Other Significant Legal Authority: None CFR Citation: None Legal Deadline: None Abstract: This final rule delays for six months the effective date of the last sentence of 42 CFR 411.354(d)(1) of the physician self- referral rule published on January 4, 2001. This sentence defines compensation that is ``set in advance'' as it relates to percentage compensation methodologies. (The rule will be published only if Stark II, Phase II (CMS-1810-FC) is not published by December 31, 2003.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/24/03 68 FR 74491 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Karen Raschke, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-0016 Email: kraschke@cms.hhs.gov Related RIN: Related to 0938-AL29, Related to 0938-AM58 RIN: 0938-AM95 _______________________________________________________________________ 1046. [bullet][ls-thn-eq] NOTICE OF ONE-TIME APPEAL PROCESS FOR HOSPITAL WAGE INDEX CLASSIFICATION (CMS-1373-N) Priority: Info./Admin./Other Legal Authority: Sec 508(a) of the Medicare Prescription Drug Improvement and Moderization Act of 2003 [[Page 37499]] CFR Citation: None Legal Deadline: None Abstract: This notice implements section 508(a) of Public Law 108-173. This section provides that, by January 1, 2004, the Secretary must establish by instruction or otherwise, a process under which a hospital may appeal the wage index classification otherwise applicable to the hospital. (Statute requires notice be implemented and announced by 1/1/ 04, and applications be received by 2/15/04.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 01/06/03 68 FR 661 Notice 02/13/04 69 FR 7340 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Stephen Phillips, Deputy Division Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4548 Email: sphillips@cms.hhs.gov Related RIN: Related to 0938-AN17 RIN: 0938-AN00 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1047. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR SERVICES (FPLS) INFORMATION Priority: Substantive, Nonsignificant 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 enforcementagencies. 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, offset of Federal payments for purposes of collecting child support, and 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 01/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: State, Local, Tribal Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, Department of Health and Human Services, Administration for Children and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5369 TDD Phone: 800 877-8339 Fax: 202 401-4054 Email: ebrooks@acf.hhs.gov RIN: 0970-AC01 _______________________________________________________________________ 1048. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT Priority: Substantive, Nonsignificant Legal Authority: PL 106-402; USC 15001 et seq CFR Citation: 45 CFR 1385 to 1388 Legal Deadline: Final, Statutory, October 30, 2001. Abstract: A notice of proposed rulemaking will be published in the Federal Register 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 01/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions, Organizations Government Levels Affected: State, Local, Tribal Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health and Human Services, Administration for Children and Families, ADD HHH- 300F, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 690-5841 RIN: 0970-AC07 _______________________________________________________________________ 1049. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE Priority: Substantive, Nonsignificant Legal Authority: 42 USC 672; 42 USC 674; 42 USC 1302 CFR Citation: 45 CFR 1356.60(c) Legal Deadline: None Abstract: This notice of proposed rulemaking implements the title IV-E foster care eligibility and administrative cost provisions in sections 472 and 474 of the Social Security Act. We propose to prohibit the reimbursement of administrative costs claimed on behalf of children in unlicensed foster family homes, with the exception of children in relative foster family homes while the State is in the process of licensing the home. We also propose to prohibit the reimbursement of administrative costs claimedon behalf of children in unallowable facilities, with the exception of the month prior to a child's transition into an allowable facility. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State [[Page 37500]] Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau Policy, Department of Health and Human Services, Administration for Children and Families, Room 2411, 330 C Street SW., Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC14 _______________________________________________________________________ 1050. ADMINISTRATIVE COST SHARING UNDER TANF Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 263; 45 CFR 263.14 Legal Deadline: None Abstract: This proposed rule will enable States (including the District of Columbia) and territories to use either the ``primary program'' cost allocation methodology previously allowed under the Aid to Families with Dependent Children (AFDC) program to allocate the common administrative costs of determining eligibility in the Temporary Assistance for Needy Families (TANF) program, the Medicaid program, and the Food Stamp programs or to continue to use a ``benefiting'' cost allocation methodology. Pursuant to a determination by Secretary Thompson, States and territories would be able to elect to use their Federal TANF funds to pay for costs that are common to the administration of the TANF, Medicaid, and Food Stamps Programs, in accordance with the primary program cost allocation methodology previously allowed under the former AFDC program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/05 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: April Kaplan, Deputy Director, Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5138 Email: akaplan@acf.hhs.gov RIN: 0970-AC15 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1051. CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND OFFSET Priority: Substantive, Nonsignificant Legal Authority: 42 USC 664; 42 USC 1302 CFR Citation: 45 CFR 303.72 Legal Deadline: None Abstract: This interim final rule will revise existing regulations on collecting child support arrears through the Federal Tax Refund Offset process. The revisions are needed to reflect changes in data processing protocols with the Department of the Treasury. We are also updating the regulation to reflect current business practices and requests from the state child support agencies. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/26/03 68 FR 37978 Final Action 01/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, Department of Health and Human Services, Administration for Children and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5369 TDD Phone: 800 877-8339 Fax: 202 401-4054 Email: ebrooks@acf.hhs.gov RIN: 0970-AC09 _______________________________________________________________________ 1052. [bullet][ls-thn-eq] HEAD START TRANSPORTATION Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Not Yet Determined CFR Citation: 45 CFR 1310 Legal Deadline: None Abstract: This interim final rule will extend for 150 days those parts of the Head Start transportation regulation that deal with the requirement that each vehicle used to transport children is equipped for use of child safety restraint systems and the requirement that each bus have a bus monitor. Additionally, these rules will provide Head Start grantees the opportunity to request further extension of the effective date when such an extension is in the best interest of the children they serve. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/16/04 69 FR 2513 Final Action 12/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Windy Hill, Associate Commisioner, Head Start Bureau, Department of Health and Human Services, 330 C Street SW., Washington, DC 20447 Phone: 202 205-8573 Email: whill@acf.hhs.gov RIN: 0970-AC16 [[Page 37501]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Administration for Children and Families (ACF) _______________________________________________________________________ 1053. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES Priority: Other Significant CFR Citation: 45 CFR 309 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 03/30/04 69 FR 16638 Regulatory Flexibility Analysis Required: No Government Levels Affected: State, Tribal Agency Contact: Paige Biava Phone: 202 401-9386 RIN: 0970-AB73 _______________________________________________________________________ 1054. CHARITABLE CHOICE PROVISIONS APPLICABLE TO THE TEMPORARY ASSISTANCE FOR NEEDY FAMILIES PROGRAM Priority: Other Significant CFR Citation: 45 CFR 260.30; 45 CFR 260.34 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 09/30/03 68 FR 56449 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: April Kaplan Phone: 202 401-5138 Email: akaplan@acf.hhs.gov RIN: 0970-AC12 _______________________________________________________________________ 1055. COMMUNITY SERVICES BLOCK GRANT CHARITABLE CHOICE Priority: Substantive, Nonsignificant CFR Citation: 45 CFR 1050 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 09/30/03 68 FR 56466 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Agency Contact: Clarence Carter Phone: 202 401-9333 Email: ccarter@acf.hhs.gov RIN: 0970-AC13 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration on Aging (AOA) _______________________________________________________________________ 1056. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, TRAINING, RESEARCH, AND DISCRETIONARY PROGRAMS; VULNERABLE ELDER RIGHTS; GRANTS TO INDIANS AND NATIVE HAWAIIANS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 3001 et seq CFR Citation: 45 CFR 1321; 45 CFR 1326; 45 CFR 1328 Legal Deadline: None Abstract: In response to the reauthorization of the Older Americans Act, Public Law 106-501, the Administration on Aging (AoA) proposes to issue a notice of proposed rulemaking by fall of 2004. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: State, Tribal Federalism: Undetermined Agency Contact: Edwin Walker, Deputy Assistant Secretary for Policy and Programs, Department of Health and Human Services, Administration on Aging, Washington, DC 20201 Phone: 202 401-4634 RIN: 0985-AA00 [FR Doc. 04-13453 Filed 06-25-04; 8:45 am] BILLING CODE 4150-24-S