Unified Agenda
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, Chs. II, III, and XIII
Unified Agenda of Federal Regulatory and Deregulatory Actions
AGENCY:
Office of the Secretary, HHS.
ACTION:
Semiannual regulatory agenda.
SUMMARY:
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual publication of an agenda outlining all current and projected rulemakings. The purpose of this exercise is to inform the public about regulatory actions under development within the Department, and to provide an opportunity for all concerned with the impact of these regulations to participate in their development at an early stage. The last such agenda was published on November 30, 2000.
FOR FURTHER INFORMATION CONTACT:
Ann Stallion, Department of Health and Human Services, Washington, DC 20201, (202) 690-6824, or the contact person for a specific component of the Department as listed below.
SUPPLEMENTARY INFORMATION:
The regulatory actions capsulized below do not necessarily reflect the new policy perspectives of the Bush administration and HHS Secretary Thompson. The statutorily dictated timing of the regulatory agenda caused the Department to begin its efforts to put together information required for the agenda well before the new Administration came into place. The following agenda thus simply reflects ongoing efforts by HHS to comply with many longstanding statutory obligations, and/or to effect improvements at the program-implementation level based on the Department's experience in administering existing programs. The timing of the October 2001 agenda will, obviously, provide the Department with an opportunity to set out a regulatory agenda that does reflect the policy directions that Secretary Thompson desires to take.
Public commentary is invited. Comments should be sent to the addresses listed below, depending on the specific agenda entry that is of interest. Comments may be sent to the Office of the Secretary if the responsible component of the Department is not apparent, or if a comment covers subjects crossing agency lines.
Administration on Children and Families: Madeline Mocko, Director, Division of Policy and Legislation, 7th Floor, 370 L' Enfant Promenade SW., Washington, DC 20447; Phone 202-401-9223.
Administration on Aging: Harry Posman, Executive Secretariat, Room 4753, 330 Independence Avenue SW., Washington, DC 20201; Phone 202-260-0669.
Agency for Health Care Policy and Research: Nancy Werbel, 2101 East Jefferson Street, Suite 603, Rockville, Maryland 20852; Phone 301-594-1455.
Centers for Disease Control: Thena Durham, Executive Secretariat, 1600 Clifton Road, Building 16, Atlanta, Georgia 30333; Phone 404-639-7120.
Food and Drug Administration: Ed Dutra, Director, Regulatory Policy and Management Staff, 5600 Fishers Lane, Rockville, Maryland 20857; Phone 301-443-3480.
Health Care Financing Administration: Anthony Mazzarella, Deputy Director, Operation Support Group, 7500 Security Boulevard, C4-26-05, Baltimore, Maryland 21244; Phone 410-786-7501.
Health Resource Services Administration: Dolores R. Etherith, 5600 Fishers Lane, Room 14-A-08, Rockville, Maryland 20857; Phone 301-443-1786.
Indian Health Service: Betty Gould, 12300 Twinbrook Parkway, Suite 450, Rockville, Maryland 20857; Phone 301-443-1116.
National Institutes of Health: Jerry Moore, 9000 Rockville Pike, Building 31, Room 1B25, Bethesda, Maryland 20205; Phone 301-496-4606.
Substance Abuse and Mental Health Services Administration: Joe Faha, 5600 Fishers Lane, Room 12-A-17, Rockville, Maryland 20857; Phone 301-443-4640.
Office of the Secretary: Ann C. Agnew, Executive Secretary to the Department, Room 603H, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
Dated:
March 14, 2001.
Ann C. Agnew,
Executive Secretary to the Department.
|
Office of the Secretary—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 813 | Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants) | 0991-AB12 |
|
Office of the Secretary—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 814 | Reproduction and Sale of Official Forms and Publications | 0991-AA83 |
| 815 | Shared Risk Exception to the Safe Harbor Provisions | 0991-AA91 |
| 816 | Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums for ESRD Beneficiaries | 0991-AB04 |
| 817 | Safe Harbor for Ambulance Restocking | 0991-AB05 |
| 818 | Revisions and Technical Corrections to 42 CFR Chapter V | 0991-AB09 |
| 819 | 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 | 0991-AB10 |
|
Office of the Secretary—Long-Term Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 820 | Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care Organizations | 0991-AB03 |
| 821 | Safe Harbor for Arrangements Involving Federally Qualified Health Centers | 0991-AB06 |
| 822 | Definition of Terms; Substantially in Excess and Usual Charges and Clarification of the Good Cause Exception | 0991-AB13 |
|
Office of the Secretary—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 823 | Standards for Privacy of Individually Indentifiable Health Information | 0991-AB08 |
|
Substance Abuse and Mental Health Services Administration—Long-Term Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 824 | Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change from March 31 to October 1 for FY 2001 and Beyond | 0930-AA04 |
|
Substance Abuse and Mental Health Services Administration—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 825 | Final and Delegation of Authority To Implement SAMHSA's Accreditation Based System for Opiod Treatment Program Monitoring | 0930-AA06 |
|
Centers for Disease Control and Prevention—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 826 | Amendments to Quality Assurance and Administrative Provision for Approval of Respiratory Protective Devices | 0920-AA04 |
| 827 | Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of Cancer for Energy Employees Occupational Illness Compensation Program | 0920-AA05 |
|
Centers for Disease Control and Prevention—Long-Term Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 828 | Packaging and Handling of Infectious Substances and Select Agents | 0920-AA02 |
| 829 | Control of Communicable Diseases | 0920-AA03 |
|
Departmental Management—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 830 | Implementation of the Equal Access to Justice Act in Agency Proceedings | 0990-AA02 |
|
Food and Drug Administration—Prerule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 831 | Natural Rubber-Containing Drugs; User Labeling | 0910-AB56 |
| 832 | Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 | 0910-AB71 |
| 833 | Part 600-Biological Products: General (Section 610 Review) | 0910-AC06 |
|
Food and Drug Administration—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 834 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 835 | Hearing Aids; Professional and Patient Labeling; Conditions for Sale | 0910-AA39 |
| 836 | Establishment Registration and Product Listing for Drugs and Biologics | 0910-AA49 |
| 837 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 838 | Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs | 0910-AA86 |
| 839 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 840 | Radioactive Drugs for Basic Research | 0910-AB00 |
| 841 | Administrative Practices and Procedures; Advisory Opinions and Guidelines | 0910-AB14 |
| 842 | Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products | 0910-AB28 |
| 843 | Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 844 | Expanded Access to Investigational Therapies | 0910-AB37 |
| 845 | Electronic Submission of Adverse Drug Reaction Reports | 0910-AB42 |
| 846 | Distinguishing Marks for Drug Products Containing Insulin | 0910-AB43 |
| 847 | Pregnancy Labeling | 0910-AB44 |
| 848 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AB63 |
| 849 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 850 | Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use | 0910-AB79 |
| 851 | Repackaging Approval Requirements | 0910-AB81 |
| 852 | Stability Testing of Drugs | 0910-AB82 |
| 853 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements | 0910-AB88 |
| 854 | Submission in Electronic Format of Certain Labeling Information | 0910-AB91 |
| 855 | Fees Relating to Drugs; Waiver and Reduction of Fees | 0910-AB92 |
| 856 | Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications | 0910-AB93 |
| 857 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food | 0910-AB96 |
| 858 | Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment | 0910-AB99 |
| 859 | Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation | 0910-AC00 |
| 860 | Reporting Information Regarding Potential Fabrication or Falsification of Data | 0910-AC02 |
| 861 | Status Reports for Quantity Marketed Information for Animal Drug Products Used in Food-Producing Animals | 0910-AC04 |
| 862 | Labeling Dietary Supplements for Women Who Are or May Become Pregnant | 0910-AC09 |
| 863 | Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers | 0910-AC10 |
| 864 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 0910-AC13 |
| 865 | Control of Salmonella Enteritidis in Shell Eggs During Production and Retail | 0910-AC14 |
| 866 | Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 867 | Use of Materials Derived from Ruminant Animals in FDA Regulated Products | 0910-AC19 |
| 868 | Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources | 0910-AC20 |
|
Food and Drug Administration—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 869 | New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) | 0910-AA02 |
| 870 | Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals | 0910-AA45 |
| 871 | Bioavailability and Bioequivalence Requirements | 0910-AA51 |
| 872 | Labeling for Human Prescription Drugs; Revised Format | 0910-AA94 |
| 873 | Current Good Manufacturing Practice; Revision of Certain Labeling Controls | 0910-AA98 |
| 874 | Use of Ozone-Depleting Substances | 0910-AA99 |
| 875 | Exports; Notification and Recordkeeping Requirements | 0910-AB16 |
| 876 | Foreign Establishment Registration and Listing | 0910-AB21 |
| 877 | FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export | 0910-AB24 |
| 878 | Blood Initiative | 0910-AB26 |
| 879 | Antibiotic Drug Approval and Exclusivity | 0910-AB33 |
| 880 | Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs | 0910-AB39 |
| 881 | Supplements and Other Changes to Approved New Animal Drug Applications | 0910-AB49 |
| 882 | Revisions to the General Safety Requirements for Biological Products; Direct Final Rule | 0910-AB51 |
| 883 | Discontinuation of a Lifesaving Product | 0910-AB60 |
| 884 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 885 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims | 0910-AB66 |
| 886 | Presubmission Conferences | 0910-AB68 |
| 887 | Surgeon's and Patient Examination Gloves; Reclassification | 0910-AB74 |
| 888 | CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) | 0910-AB76 |
| 889 | Antibiotic Resistance Labeling | 0910-AB78 |
| 890 | 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications | 0910-AB80 |
| 891 | Food Additives: Food Contact Substances Notification System | 0910-AB94 |
| 892 | State Certification of Mammography Facilities | 0910-AB98 |
| 893 | Examination of Administrative Record and Other Advisory Committee Records | 0910-AC03 |
| 894 | Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical | 0910-AC05 |
| 895 | Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products | 0910-AC07 |
| 896 | Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity | 0910-AC11 |
| 897 | Revocation of Conditions for Marketing Digoxin Products for Oral Use | 0910-AC12 |
|
Food and Drug Administration—Long-Term Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 898 | Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 899 | Food Labeling Review | 0910-AA19 |
| 900 | Medical Foods | 0910-AA20 |
| 901 | Classification of Computer Software Programs That Are Medical Devices | 0910-AA41 |
| 902 | Reinventing FDA Food Regulations | 0910-AA58 |
| 903 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 904 | Direct-to-Consumer Promotion Regulations | 0910-AA90 |
| 905 | Investigational Use New Animal Drug Regulations (Section 610 Review) | 0910-AB02 |
| 906 | Suitability Determination for Donors of Human Cellular and Tissue-Based Products | 0910-AB27 |
| 907 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AB50 |
| 908 | Bulk Drug Substances for Use in Pharmacy Compounding | 0910-AB57 |
| 909 | Pharmacy and Physician Compounding of Drug Products | 0910-AB58 |
| 910 | Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness | 0910-AB59 |
| 911 | Mandatory HACCP Regulations for Manufacturers of Rendered Products | 0910-AB72 |
| 912 | Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action | 0910-AB73 |
| 913 | Substances Prohibited From Use in Animal Food or Feed | 0910-AB90 |
| 914 | Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States | 0910-AB95 |
| 915 | Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness | 0910-AC01 |
| 916 | Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 0910-AC08 |
| 917 | Premarket Notice Concerning Bioengineered Foods | 0910-AC15 |
| 918 | Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures | 0910-AC16 |
| 919 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 920 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations | 0910-AC21 |
|
Food and Drug Administration—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 921 | Biological Products: Reporting of Biological Product Deviations in Manufacturing | 0910-AA12 |
| 922 | Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices | 0910-AA43 |
| 923 | Drugs Used for Treatment of Narcotic Addicts | 0910-AA52 |
| 924 | Establishment Registration and Listing of Human Cells, Tissues, and Cellular and Tissue-Based Products | 0910-AB05 |
| 925 | Veterinary Feed Directives | 0910-AB09 |
| 926 | Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements | 0910-AB30 |
| 927 | Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports | 0910-AB83 |
| 928 | Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling Standards | 0910-AB89 |
|
Health Resources and Services Administration—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 929 | Designation of Medically Underserved Populations and Health Professional Shortage Areas | 0906-AA44 |
| 930 | National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table | 0906-AA55 |
|
Health Resources and Services Administration—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 931 | National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Medical Malpractice Payments Reporting Requirements | 0906-AA41 |
| 932 | Compliance Alternatives for Provision of Uncompensated Services | 0906-AA52 |
| 933 | Final Rule for the Health Professions, Nursing, Public Health, and Allied Health Training Grant Programs Under 42 CFR Parts 57 and 58 | 0906-AA53 |
|
Health Resources and Services Administration—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 934 | Ricky Ray Hemophilia Relief Fund Program | 0906-AA56 |
|
Indian Health Service—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 935 | Tribal Self-Governance Amendments | 0917-AA05 |
|
Indian Health Service—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 936 | Indian Child Protection and Family Violence Prevention Act Minimum Standards of Character | 0917-AA02 |
|
Indian Health Service—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 937 | Contracts Under the Indian Self-Determination Act | 0917-AA04 |
|
National Institutes of Health—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 938 | National Institutes of Health AIDS Research Loan Repayment Program | 0925-AA02 |
| 939 | Undergraduate Scholarship Program Regarding Professions Needed by the NIH | 0925-AA10 |
| 940 | National Cancer Institute Clinical Cancer Education Program | 0925-AA17 |
| 941 | National Institutes of Health Loan Repayment Program for Research | 0925-AA18 |
| 942 | NIH Center Grants | 0925-AA24 |
| 943 | National Institutes of Health Clinics Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds | 0925-AA25 |
| 944 | NIH Loan Repayment Program for Minority Health Disparties Research | 0925-AA26 |
| 945 | Pediatric Research Loan Repayment Program | 0925-AA27 |
| 946 | NIH Training Grants | 0925-AA28 |
|
National Institutes of Health—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 947 | National Research Service Awards | 0925-AA16 |
| 948 | National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program | 0925-AA19 |
| 949 | Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects | 0925-AA20 |
|
National Institutes of Health—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 950 | Traineeships | 0925-AA11 |
| 951 | Additional Protections for Pregnant Women and Human Fetuses Involved in Research, and Pertaining to Human In Vitro Fertilization | 0925-AA14 |
| 952 | Federal Policy (Common Rule) for the Protection of Human Subjects | 0925-AA21 |
|
Office of Public Health and Science—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 953 | Public Health Service Standards for the Protection of Research Misconduct Whistleblowers | 0940-AA01 |
| 954 | Federal Policy (Common Rule) for the Protection of Human Subjects | 0940-AA03 |
|
Office of Public Health and Science—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 955 | Additional Protections for Pregnant Women and Human Fetuses Involved in Research, and Pertaining to Human In Vitro Fertilization | 0940-AA02 |
|
Health Care Financing Administration—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 956 | End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P) (Section 610 Review) | 0938-AG82 |
| 957 | Recognition of the American Osteopathic Association for Critical Access Hospitals (HCFA-2099-PN) | 0938-AK84 |
|
Health Care Financing Administration—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 958 | Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update (HCFA-1163-P) | 0938-AK47 |
|
Health Care Financing Administration—Long-Term Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 959 | "Without Fault" and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment Liability (HCFA-6007-F) | 0938-AD95 |
| 960 | Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC) | 0938-AF42 |
| 961 | Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F) | 0938-AG79 |
| 962 | Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F) | 0938-AG81 |
| 963 | Liability for Third Parties To Pay for Services (HCFA-2080-P) | 0938-AH01 |
| 964 | Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas and Intestinal Transplants (HCFA-3835-P) | 0938-AH17 |
| 965 | Hospice Care-Conditions of Participation (HCFA-3844-P) | 0938-AH27 |
| 966 | Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based Group Health Plans (HCFA-2047-F) | 0938-AH48 |
| 967 | Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC) | 0938-AH53 |
| 968 | Requirements for Establishing and Maintaining Medicare Billing Privileges (HCFA-6002-P) | 0938-AH73 |
| 969 | Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical Procedures for Ambulatory Surgical Centers (HCFA-1885-FC) | 0938-AH81 |
| 970 | Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P) | 0938-AH83 |
| 971 | National Standard for Identifiers of Health Plans (HCFA-4145-P) | 0938-AH87 |
| 972 | Standard Unique Health Care Provider Identifier (HCFA-0045-F) | 0938-AH99 |
| 973 | Medicaid: Medical Child Support (HCFA-2081-P) | 0938-AI21 |
| 974 | Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities, Rehabilitation Agencies (HCFA-6005-P) | 0938-AI48 |
| 975 | Appeals of Carrier Determination That a Physician or Other Supplier Fails To Meet the Requirements for Medicare Billing Privileges (HCFA-6003-F) | 0938-AI49 |
| 976 | Security Standards (HCFA-0049-F) | 0938-AI57 |
| 977 | National Standard Employer Identifier (HCFA-0047-F) | 0938-AI59 |
| 978 | Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan (HCFA-1777-P) | 0938-AI75 |
| 979 | Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA-3004-F) | 0938-AI89 |
| 980 | Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests (HCFA-3250-F) | 0938-AI92 |
| 981 | Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-F) | 0938-AI93 |
| 982 | External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-F) | 0938-AJ06 |
| 983 | Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the Conditions of Participation for Home Health Agencies (HCFA-3006-F) | 0938-AJ10 |
| 984 | Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-1910-F) | 0938-AJ17 |
| 985 | Hospital Conditions of Participation: Laboratory Services (HCFA-3014-F) | 0938-AJ29 |
| 986 | Medicare Hospice Care Amendments (HCFA-1022-P) | 0938-AJ36 |
| 987 | Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-P) | 0938-AJ39 |
| 988 | Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC) | 0938-AJ44 |
| 989 | Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital Services (HCFA-1069-F) | 0938-AJ55 |
| 990 | DME Surety Bonds (HCFA-6006-P) | 0938-AJ64 |
| 991 | State Health Insurance Assistance Program (SHIP) (HCFA-4005-F) | 0938-AJ67 |
| 992 | HHA Surety Bond (HCFA-6001-P) | 0938-AJ81 |
| 993 | Application of Inherent Reasonableness to All Part B Services Other Than Physician Services (HCFA-1908-F) | 0938-AJ97 |
| 994 | Supplier Standards Related to Training Requirements for Oxygen, Therapeutic Shoes (HCFA-6010-NPRM) | 0938-AJ98 |
| 995 | Non-Federal Governmental Plans Exempt From HIPAA (HCFA-2033-IFC) | 0938-AK00 |
| 996 | End Stage Renal Disease Bad Debt Payment (HCFA-1126-P) | 0938-AK02 |
| 997 | Practice Expense Data Collection (HCFA-1111-IFC) | 0938-AK14 |
| 998 | Payment for Clinical Psychology Training Programs (HCFA-1089-F) | 0938-AK15 |
| 999 | Provisions of the Balanced Budget and Refinement Act of 1999; Hospital Inpatient Payments and Rates and Costs of Graduate Medical Education (HCFA-1131-IFC) | 0938-AK20 |
| 1000 | Conditions of Participation of Intermediate Care Facilities for Persons With Mental Retardation (HCFA-3046-P) | 0938-AK23 |
| 1001 | Clinical Lab Requirements-Revisions to Regulations Implementing CLIA (HCFA-2226-F) | 0938-AK24 |
| 1002 | Prospective Fee Schedule for Ambulance Services (HCFA-1002-F) | 0938-AK30 |
| 1003 | Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term Care Facilities (HCFA-3047-P) | 0938-AK35 |
| 1004 | Medicare Provider and Supplier Hearing Procedures (HCFA-2093-P) | 0938-AK39 |
| 1005 | Hospital Conditions of Participation: Quality Assessment and Performance Improvements (HCFA-3050-F) | 0938-AK40 |
| 1006 | Requirements for the Recredentialing of Medicare+Choice Organizations Providers (HCFA-1160-F) | 0938-AK41 |
| 1007 | Supplementary Medical Insurance Premium Surcharge Agreements (HCFA-4007-P) | 0938-AK42 |
| 1008 | Medical Devices Coverage Decisions Related to Health Care Technology (HCFA-3059-P) | 0938-AK43 |
| 1009 | Medicaid Management Information System Revised Definition of "Mechanized Claims Processing and Information Retrieval System" (HCFA-2123-IFC) | 0938-AK44 |
| 1010 | Medicare Program; Reporting and Repayment of Overpayments (HCFA-6011-P) | 0938-AK45 |
| 1011 | Improvements to the Medicare+Choice Appeals and Grievance Procedures (HCFA-4024-F) | 0938-AK48 |
| 1012 | Civil Money Penalties, Assessments, and Revised Sanction Authorities (HCFA-6145-FC) | 0938-AK49 |
| 1013 | Payment for Upgraded Durable Medical Equipment (HCFA-1084-F) | 0938-AK50 |
| 1014 | Update to the Prospective Payment System for Home Health Agencies for FY 2002 (HCFA-1147-NC) | 0938-AK51 |
| 1015 | Recognition of the American Osteopathic Association for Ambulatory Surgical Center Programs (HCFA-2079-FN) | 0938-AK53 |
| 1016 | Prospective Payment System for Hospital Outpatient Services (HCFA-1159-P) | 0938-AK54 |
| 1017 | Medicare as Secondary Payer-Recovery of Conditional Payments (HCFA-6009-P) | 0938-AK55 |
| 1018 | Five Year Review of Work Relative Value Units Under the Physician Fee Schedule Proposed Notice (HCFA-1170-PN) | 0938-AK56 |
| 1019 | Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2002 (HCFA-1169-P) | 0938-AK57 |
| 1020 | Changes to National Coverage Determinations and Local Coverage Determinations (HCFA-4019-FC) | 0938-AK58 |
| 1021 | Revisions to the Prospective Payment System for Hospital Outpatient Services Mandated by BIPA (HCFA-1179-IFC) | 0938-AK59 |
| 1022 | Challenges to National Coverage Determinations and Local Coverage Determinations (HCFA-3063-P) | 0938-AK60 |
| 1023 | Revised Process for Making Medicare Coverage Decisions (HCFA-3062-N) | 0938-AK61 |
| 1024 | Claims Attachment Standard (HCFA-0050-P) | 0938-AK62 |
| 1025 | Standards for Electronic Signatures (HCFA-0051-F) | 0938-AK63 |
| 1026 | Health Insurance Reform: Modifications to Standards for Electronic Transaction (HCFA-0003-IFC) | 0938-AK64 |
| 1027 | Replacement of Reasonable Charge Methodology by Fee Schedule (HCFA-1010-F) | 0938-AK66 |
| 1028 | Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships-Phase II (HCFA-1810-FC) | 0938-AK67 |
| 1029 | Increase in the Rate of Reimbursement of Photocopy Expenses for Prospective Payment System Providers (HCFA-3055-P) | 0938-AK68 |
| 1030 | Long Term Care Prospective Payment System for FY 2003 (HCFA-1177-P) | 0938-AK69 |
| 1031 | Modifications to Managed Care Rules Based on Provisions of BIPA and Technical Corrections (HCFA-1180-P) | 0938-AK71 |
| 1032 | Changes to the Hospital Inpatients Prospective Payment System for Fiscal Year 2002 Rates (HCFA-1158-P) | 0938-AK73 |
| 1033 | Changes to Inpatient BIPA for Fiscal Year 2001 (HCFA-1178-IFC) | 0938-AK74 |
| 1034 | Medicare+Choice ESRD Rates (HCFA-1182-PN) | 0938-AK75 |
| 1035 | Revisions to Transaction and Code Set Standards for Electronic Transactions (HCFA-0005-IFC) | 0938-AK76 |
| 1036 | Medicare Inpatient Disproportionate Share Hospital Adjustment Calculation (HCFA-1171-IFC) | 0938-AK77 |
| 1037 | Statement of Intent (HCFA-1185-P) | 0938-AK79 |
| 1038 | Procedures for Public Consultations for Coding and Payment Determinations for New Laboratory Tests (HCFA-1186-N) | 0938-AK80 |
| 1039 | Organ Procurement Organization Condition for Coverage (HCFA-3064-P) | 0938-AK81 |
| 1040 | Qualification Requirements for Directors of Laboratories Performing High Complexity Testing (HCFA-2094-NPRM) | 0938-AK83 |
| 1041 | Protection and Promotion of Resident Rights (HCFA-3065-P) | 0938-AK85 |
| 1042 | Standards for Electronic Transactions-Elimination of NDC Coding Standards (HCFA-0006-P) | 0938-AK86 |
| 1043 | Hospital Reference Laboratory and Medicare Secondary Payer (HCFA-1187-P) | 0938-AK87 |
| 1044 | Portability in the Group Health Insurance Market (HCFA-2048-F) | 0938-AK88 |
|
Health Care Financing Administration—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 1045 | Changes to Peer Review Organization Regulations (HCFA-3135-F) | 0938-AD38 |
| 1046 | Protection of Income and Resources for Community Spouses of Institutionalized Individuals (HCFA-2023-P) | 0938-AE12 |
| 1047 | Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-F) | 0938-AE72 |
| 1048 | Payment for Nursing and Allied Health Science Education (HCFA-1685-F) | 0938-AE79 |
| 1049 | Coverage of Screening Pap Smears (HCFA-3705-F) | 0938-AE98 |
| 1050 | Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F) | 0938-AF68 |
| 1051 | Disclosure of Confidential PRO and ESRD Network Organization Information for Research Purposes (HCFA-3208-P) | 0938-AG33 |
| 1052 | Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, Underpayments and Overpayments (HCFA-2215-P) | 0938-AG59 |
| 1053 | Optional Coverage of Certain Tuberculosis to TB-Related Services, TB-Infected Individuals (HCFA-2082-P) | 0938-AG72 |
| 1054 | Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships-Expanded to Designated Health Services (HCFA-1809-FC) | 0938-AG80 |
| 1055 | Distinct Part Requirements for Nursing Homes and Prohibition on Financial Screening of Applicants for Nursing Home Admission (HCFA-3815-P) | 0938-AG84 |
| 1056 | CLIA Program: Categorization of Waived Tests (HCFA-2225-FC) | 0938-AG99 |
| 1057 | Additional Supplier Standards (HCFA-6004-FC) | 0938-AH19 |
| 1058 | State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P) | 0938-AH24 |
| 1059 | Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-1843-P) | 0938-AH37 |
| 1060 | Medicaid; Estate Recoveries (HCFA-2083-P) | 0938-AH63 |
| 1061 | Individual Market Health Insurance Reform: Portability From Group to Individual Coverage; Federal Rules for Access in the Individual Market; State Alternative Mechanisms to Federal Rules (HCFA-2882-F) | 0938-AH75 |
| 1062 | Disclosure of Peer Review Organization Information in Response to Beneficiary Complaints (HCFA-3241-P) | 0938-AH85 |
| 1063 | Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review Program (HCFA-2107-P) | 0938-AH89 |
| 1064 | Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC) | 0938-AH92 |
| 1065 | Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services (HCFA-2043-P) | 0938-AH95 |
| 1066 | Nondiscrimination in Health Coverage in the Group Market (HCFA-2022-F) | 0938-AI08 |
| 1067 | Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P) | 0938-AI11 |
| 1068 | Medicare Program; Adjustments to Cost Limits for Skilled Nursing Facility Inpatient Routine Service Costs (HCFA-1896-FN) | 0938-AI14 |
| 1069 | Medicare/Medicaid Program; User Fees for Information, Products, and Services (HCFA-6021-P) | 0938-AI46 |
| 1070 | Prospective Payment System for Hospital Outpatient Services (HCFA-1005-F) | 0938-AI56 |
| 1071 | State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P) | 0938-AI63 |
| 1072 | Medicaid Program; Home and Community-Based Services (HCFA-2010-FC) | 0938-AI67 |
| 1073 | Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions of the Balanced Budget Act of 1997 (HCFA-2001-F) | 0938-AI70 |
| 1074 | Prospective Fee Schedule for Ambulance Services (HCFA-1002-P) | 0938-AI72 |
| 1075 | Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and Elimination of Reclassifications (HCFA-1883-F) | 0938-AI80 |
| 1076 | Expanded Coverage for Diabetes Outpatient Self-Management Training Services (HCFA-3002-F) | 0938-AI96 |
| 1077 | Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance: Millennium Compliance (HCFA-4002-GNC) | 0938-AJ15 |
| 1078 | Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories in the State of California (HCFA-2245-N) | 0938-AJ47 |
| 1079 | Medicare Program: Criteria for Making National Coverage Decision (HCFA-3432-P) | 0938-AJ54 |
| 1080 | Medicare Program; Sustainable Growth Rate for Fiscal Year 2000 (HCFA-1110-N) | 0938-AJ60 |
| 1081 | Medicare and Medicaid Programs; Programs for All-Inclusive Care for the Elderly (PACE) (HCFA-1903-P) | 0938-AJ63 |
| 1082 | Clinical Social Worker Services (HCFA-1088-F) | 0938-AJ71 |
| 1083 | Medicaid Disproportionate Share Hospital Payments-Institutions for Mental Disease (HCFA-2062-N) | 0938-AJ74 |
| 1084 | The Children's Health Insurance Program: Implementing the Balanced Budget Act of 1997 (HCFA-2006-F) | 0938-AJ75 |
| 1085 | Medicare Program Update of Ambulatory Surgical Center Payment Rates Effective for Services On or After October 1, 1999 (HCFA-1085-N) | 0938-AJ86 |
| 1086 | Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update (HCFA-1112-F) | 0938-AJ93 |
| 1087 | Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Individuals Under Age 21 (HCFA-2065-F) | 0938-AJ96 |
| 1088 | Conditions of Participation for Intermediate Care Facilities for the Mentally Retarded | 0938-AJ99 |
| 1089 | Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and Intermediate Care Facilities for the Mentally Retarded (HCFA-2004-F) | 0938-AK04 |
| 1090 | Hospital Conditions of Participation; Anesthesia Services (HCFA-3049-F) | 0938-AK08 |
| 1091 | Changes to the Appeals Process for Beneficiaries Receiving Home Health Services in the Fee For Service Program (HCFA-4006-P) | 0938-AK10 |
| 1092 | Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2001 (HCFA-1120-F) | 0938-AK11 |
| 1093 | Revisions to Medicaid Upper Payment Limit Requirements for Hospital, Nursing Facility, Intermediate Care Facility Services for the Mentally Retarded and Clinic Services (HCFA-2071-F) | 0938-AK12 |
| 1094 | Hospice Wage Index (HCFA-1135-N) | 0938-AK13 |
| 1095 | HIPAA Program; Bona Fide Wellness Programs (HCFA-2078-F) | 0938-AK19 |
| 1096 | Application of Federal Financial Participation Limits (HCFA-2086-F) | 0938-AK22 |
| 1097 | Prospective Payment System for Hospital Outpatient Services: Exception to the Provider-Based Location Criteria for PPS-Exempt Facilities (HCFA-1143-F) | 0938-AK25 |
| 1098 | Criteria and Standards for Evaluating Intermediary and Carrier Performance During FY 2001 (HCFA-4010-GNC) | 0938-AK26 |
| 1099 | Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2001 (HCFA-8007-N) | 0938-AK27 |
| 1100 | Mandatory Transmission of OASIS for Non-Medicare/Medicaid Patients in Home Health Agencies and Continued Delay of Requirements for Patients Receiving Personal Care Services (HCFA-2070-N) | 0938-AK28 |
| 1101 | Removal of the Requirements for the Cardiac Pacemaker Registry (HCFA-3045-F) | 0938-AK29 |
| 1102 | Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships-Phase II (HCFA-1810-FC) | 0938-AK31 |
| 1103 | Elimination of Application of Federal Financial Participation Limits (HCFA-2086-P) | 0938-AK32 |
| 1104 | Conforming Regulations Changes and Statutory Revisions for Approval and Oversight of Accreditation Organizations (HCFA-2088-P) | 0938-AK36 |
|
Administration for Children and Families—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 1105 | Program Performance Standards for the Operation of Head Start Programs | 0970-AB99 |
| 1106 | Safeguarding Child Support and Expanded FPLS Information | 0970-AC01 |
| 1107 | Developmental Disabilities and Bill of Rights Act | 0970-AC07 |
|
Administration for Children and Families—Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 1108 | Construction and Major Renovation of Head Start and Early Head Start Facilities | 0970-AB54 |
| 1109 | Child Support Enforcement for Indian Tribes | 0970-AB73 |
| 1110 | Child Support Enforcement Program Omnibus Conforming Regulation | 0970-AB81 |
| 1111 | Family Child Care Program Option for Head Start Programs | 0970-AB90 |
| 1112 | Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory Revisions | 0970-AC00 |
| 1113 | High Performance Bonus Awards Under the TANF Program | 0970-AC06 |
| 1114 | Individual Development Accounts | 0970-AC08 |
|
Administration for Children and Families—Completed Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 1115 | Standards for Safe Transportation | 0970-AB24 |
| 1116 | Incentive Payments and Audit Penalties to States and Political Subdivisions | 0970-AB85 |
| 1117 | State Self-Assessments To Determine Compliance With Federal Regulations | 0970-AB96 |
| 1118 | National Medical Support Notice | 0970-AB97 |
|
Administration on Aging—Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 1119 | Grants for State and Community Programs on Aging, Intrastate Funding Formulas; Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to Indians and Native Hawaiians | 0985-AA00 |
| 1120 | Grants for State and Community Programs on Aging, Family Caregivers, American Indians, and Native Hawaiians (Section 610 Review) | 0985-AA01 |