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 Publications0991-AA83
815 Shared Risk Exception to the Safe Harbor Provisions0991-AA91
816 Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums for ESRD Beneficiaries0991-AB04
817 Safe Harbor for Ambulance Restocking0991-AB05
818 Revisions and Technical Corrections to 42 CFR Chapter V0991-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 19870991-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 Organizations0991-AB03
821 Safe Harbor for Arrangements Involving Federally Qualified Health Centers0991-AB06
822 Definition of Terms; Substantially in Excess and Usual Charges and Clarification of the Good Cause Exception0991-AB13

Office of the Secretary—Completed Actions
Sequence Number Title Regulation Identification Number
823 Standards for Privacy of Individually Indentifiable Health Information0991-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 Beyond0930-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 Monitoring0930-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 Devices0920-AA04
827 Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of Cancer for Energy Employees Occupational Illness Compensation Program0920-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 Agents0920-AA02
829 Control of Communicable Diseases0920-AA03

Departmental Management—Proposed Rule Stage
Sequence Number Title Regulation Identification Number
830 Implementation of the Equal Access to Justice Act in Agency Proceedings0990-AA02

Food and Drug Administration—Prerule Stage
Sequence Number Title Regulation Identification Number
831 Natural Rubber-Containing Drugs; User Labeling0910-AB56
832 Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 19960910-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 Review0910-AA01
835 Hearing Aids; Professional and Patient Labeling; Conditions for Sale0910-AA39
836 Establishment Registration and Product Listing for Drugs and Biologics0910-AA49
837 Investigational New Drugs: Export Requirements for Unapproved New Drug Products0910-AA61
838 Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs0910-AA86
839 Safety Reporting Requirements for Human Drug and Biological Products0910-AA97
840 Radioactive Drugs for Basic Research0910-AB00
841 Administrative Practices and Procedures; Advisory Opinions and Guidelines0910-AB14
842 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products0910-AB28
843 Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications0910-AB34
844 Expanded Access to Investigational Therapies0910-AB37
845 Electronic Submission of Adverse Drug Reaction Reports0910-AB42
846 Distinguishing Marks for Drug Products Containing Insulin0910-AB43
847 Pregnancy Labeling0910-AB44
848 Positron Emission Tomography Drugs; Current Good Manufacturing Practices0910-AB63
849 Current Good Manufacturing Practice for Medicated Feeds0910-AB70
850 Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use0910-AB79
851 Repackaging Approval Requirements0910-AB81
852 Stability Testing of Drugs0910-AB82
853 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements0910-AB88
854 Submission in Electronic Format of Certain Labeling Information0910-AB91
855 Fees Relating to Drugs; Waiver and Reduction of Fees0910-AB92
856 Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications0910-AB93
857 Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food0910-AB96
858 Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment0910-AB99
859 Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation0910-AC00
860 Reporting Information Regarding Potential Fabrication or Falsification of Data0910-AC02
861 Status Reports for Quantity Marketed Information for Animal Drug Products Used in Food-Producing Animals0910-AC04
862 Labeling Dietary Supplements for Women Who Are or May Become Pregnant0910-AC09
863 Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers0910-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 Retail0910-AC14
866 Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition0910-AC18
867 Use of Materials Derived from Ruminant Animals in FDA Regulated Products0910-AC19
868 Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources0910-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 Pharmaceuticals0910-AA45
871 Bioavailability and Bioequivalence Requirements0910-AA51
872 Labeling for Human Prescription Drugs; Revised Format0910-AA94
873 Current Good Manufacturing Practice; Revision of Certain Labeling Controls0910-AA98
874 Use of Ozone-Depleting Substances0910-AA99
875 Exports; Notification and Recordkeeping Requirements0910-AB16
876 Foreign Establishment Registration and Listing0910-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 Export0910-AB24
878 Blood Initiative0910-AB26
879 Antibiotic Drug Approval and Exclusivity0910-AB33
880 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs0910-AB39
881 Supplements and Other Changes to Approved New Animal Drug Applications0910-AB49
882 Revisions to the General Safety Requirements for Biological Products; Direct Final Rule0910-AB51
883 Discontinuation of a Lifesaving Product0910-AB60
884 Supplements and Other Changes to an Approved Application0910-AB61
885 Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims0910-AB66
886 Presubmission Conferences0910-AB68
887 Surgeon's and Patient Examination Gloves; Reclassification0910-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 Labeling0910-AB78
890 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications0910-AB80
891 Food Additives: Food Contact Substances Notification System0910-AB94
892 State Certification of Mammography Facilities0910-AB98
893 Examination of Administrative Record and Other Advisory Committee Records0910-AC03
894 Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical0910-AC05
895 Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products0910-AC07
896 Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity0910-AC11
897 Revocation of Conditions for Marketing Digoxin Products for Oral Use0910-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 Reports0910-AA04
899 Food Labeling Review0910-AA19
900 Medical Foods0910-AA20
901 Classification of Computer Software Programs That Are Medical Devices0910-AA41
902 Reinventing FDA Food Regulations0910-AA58
903 Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients0910-AA89
904 Direct-to-Consumer Promotion Regulations0910-AA90
905 Investigational Use New Animal Drug Regulations (Section 610 Review)0910-AB02
906 Suitability Determination for Donors of Human Cellular and Tissue-Based Products0910-AB27
907 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed0910-AB50
908 Bulk Drug Substances for Use in Pharmacy Compounding0910-AB57
909 Pharmacy and Physician Compounding of Drug Products0910-AB58
910 Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness0910-AB59
911 Mandatory HACCP Regulations for Manufacturers of Rendered Products0910-AB72
912 Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action0910-AB73
913 Substances Prohibited From Use in Animal Food or Feed0910-AB90
914 Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States0910-AB95
915 Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness0910-AC01
916 Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness0910-AC08
917 Premarket Notice Concerning Bioengineered Foods0910-AC15
918 Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures0910-AC16
919 Institutional Review Boards: Registration Requirements0910-AC17
920 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations0910-AC21

Food and Drug Administration—Completed Actions
Sequence Number Title Regulation Identification Number
921 Biological Products: Reporting of Biological Product Deviations in Manufacturing0910-AA12
922 Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices0910-AA43
923 Drugs Used for Treatment of Narcotic Addicts0910-AA52
924 Establishment Registration and Listing of Human Cells, Tissues, and Cellular and Tissue-Based Products0910-AB05
925 Veterinary Feed Directives0910-AB09
926 Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements0910-AB30
927 Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports0910-AB83
928 Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling Standards0910-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 Areas0906-AA44
930 National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table0906-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 Requirements0906-AA41
932 Compliance Alternatives for Provision of Uncompensated Services0906-AA52
933 Final Rule for the Health Professions, Nursing, Public Health, and Allied Health Training Grant Programs Under 42 CFR Parts 57 and 580906-AA53

Health Resources and Services Administration—Completed Actions
Sequence Number Title Regulation Identification Number
934 Ricky Ray Hemophilia Relief Fund Program0906-AA56

Indian Health Service—Proposed Rule Stage
Sequence Number Title Regulation Identification Number
935 Tribal Self-Governance Amendments0917-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 Character0917-AA02

Indian Health Service—Completed Actions
Sequence Number Title Regulation Identification Number
937 Contracts Under the Indian Self-Determination Act0917-AA04

National Institutes of Health—Proposed Rule Stage
Sequence Number Title Regulation Identification Number
938 National Institutes of Health AIDS Research Loan Repayment Program0925-AA02
939 Undergraduate Scholarship Program Regarding Professions Needed by the NIH0925-AA10
940 National Cancer Institute Clinical Cancer Education Program0925-AA17
941 National Institutes of Health Loan Repayment Program for Research0925-AA18
942 NIH Center Grants0925-AA24
943 National Institutes of Health Clinics Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds0925-AA25
944 NIH Loan Repayment Program for Minority Health Disparties Research0925-AA26
945 Pediatric Research Loan Repayment Program0925-AA27
946 NIH Training Grants0925-AA28

National Institutes of Health—Final Rule Stage
Sequence Number Title Regulation Identification Number
947 National Research Service Awards0925-AA16
948 National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program0925-AA19
949 Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects0925-AA20

National Institutes of Health—Completed Actions
Sequence Number Title Regulation Identification Number
950 Traineeships0925-AA11
951 Additional Protections for Pregnant Women and Human Fetuses Involved in Research, and Pertaining to Human In Vitro Fertilization0925-AA14
952 Federal Policy (Common Rule) for the Protection of Human Subjects0925-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 Whistleblowers0940-AA01
954 Federal Policy (Common Rule) for the Protection of Human Subjects0940-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 Fertilization0940-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 Retarded0938-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 Programs0970-AB99
1106 Safeguarding Child Support and Expanded FPLS Information0970-AC01
1107 Developmental Disabilities and Bill of Rights Act0970-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 Facilities0970-AB54
1109 Child Support Enforcement for Indian Tribes0970-AB73
1110 Child Support Enforcement Program Omnibus Conforming Regulation0970-AB81
1111 Family Child Care Program Option for Head Start Programs0970-AB90
1112 Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory Revisions0970-AC00
1113 High Performance Bonus Awards Under the TANF Program0970-AC06
1114 Individual Development Accounts0970-AC08

Administration for Children and Families—Completed Actions
Sequence Number Title Regulation Identification Number
1115 Standards for Safe Transportation0970-AB24
1116 Incentive Payments and Audit Penalties to States and Political Subdivisions0970-AB85
1117 State Self-Assessments To Determine Compliance With Federal Regulations0970-AB96
1118 National Medical Support Notice0970-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 Hawaiians0985-AA00
1120 Grants for State and Community Programs on Aging, Family Caregivers, American Indians, and Native Hawaiians (Section 610 Review)0985-AA01