[Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]



[[Page 21195]]



_______________________________________________________________________


Part VIII



Department of Health and Human Services



_______________________________________________________________________

Semiannual Regulatory Agenda

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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 President's Executive Order 12866 and the Regulatory 
Flexibility Act of 1980 require the semiannual publication of an agenda 
which summarizes all current, projected, and recently completed 
rulemakings. The agenda thus informs the public about regulatory 
actions under development within the Department, and it provides an 
opportunity for all concerned with the impact of the regulations to 
participate at an early stage. The last such agenda was published on 
November 9, 1998.

FOR FURTHER INFORMATION CONTACT: Ann White, 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 described below 
continue to reflect the Department's efforts to exemplify in its 
rulemaking practices the President's initiative to streamline the 
Federal regulatory system so that it helps bring important benefits to 
the American people while creating fewer burdens. These regulatory 
actions also are an indication of emerging policy mandates for HHS 
involving such national priorities as: Strengthening and modernizing 
the Medicare program; assuring the safety of the American food supply; 
establishing improved access to health services for children; shoring 
up recent advances in welfare reform and health-insurance reform; and 
eliminating waste, fraud, and abuse from the health care system. 
Underlying the Department's pursuit of its regulatory responsibilities 
in all of the above-mentioned programmatic areas, there endures the 
focus and discipline with which the principles of Executive Order 12866 
and the many subsequent regulatory reform initiatives of the Clinton 
Administration have energized the Department's regulatory functions. 
Public comments are invited to assist the Department in continuing 
these efforts.

    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.

    Health Care Financing Administration: Sue Brown, Director, 
Division of Regulations and Issuances, 7500 Security Boulevard, C5-
09-27, Baltimore, Maryland 21244; phone 410-786-4473.

    Food and Drug Administration: Ed Dutra, Director, Regulatory 
Policy and Management Staff, 5600 Fishers Lane, Rockville, Maryland 
20857; phone 301-443-3480.

    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: David Bunoski, 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.

    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 Penn, 12300 Twinbrook Parkway, 
Suite 450, Rockville, Maryland 20857; phone 301-443-1116.

    National Institutes of Health: Jerry Moore, 6011 Executive 
Boulevard, Room 601, MSC 7669, Rockville, Maryland 20852; 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: Jacquelyn Y. White, Deputy Executive 
Secretary to the Department, Office of the Executive Secretariat, 
Room 603H, Hubert H. Humphrey Building, 200 Independence Avenue 
SW., Washington, DC 20201.

Dated: March 22, 1999.

LaVarne Burton,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
905          Privacy Act Exempt Record System from the Healthcare Integrity and Protection Data       0991-AA99
            Bank..................................................................................
906          Revision of HHS Freedom of Information Act Regulations...............................    0991-AB01
907          Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care        0991-AB03
            Organizations.........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 21197]]


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
908          Clarification of the Initial OIG Safe Harbor Provisions and Establishment of             0991-AA66
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................
909          Reproduction and Sale of Official Forms and Publications.............................    0991-AA83
910          Revised OIG Civil Money Penalties Resulting From Public Law 104-191..................    0991-AA90
911          Shared Risk Exception to the Safe Harbor Provisions..................................    0991-AA91
912          Revised OIG Sanction Authorities Resulting From Public Law 105-33....................    0991-AA95
913          Block Grant Programs.................................................................    0991-AA97
914          Health Care Fraud and Abuse Data Collection Program..................................    0991-AA98
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
915          Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans..........    0991-AA45
916          Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental     0991-AA53
            Policies..............................................................................
917          Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community-        0991-AA79
            Based Health Care Center or Provider, of a Standard Survey............................
918          Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and       0991-AA80
            Rebate Agreements.....................................................................
919          Senior Biomedical Research Service...................................................    0991-AA82
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
920          Block Grants for Prevention and Treatment of Substance Abuse.........................    0930-AA01
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
921          Interstate Shipment of Biological Materials That Contain or May Contain Infectious       0920-AA02
            Substances............................................................................
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
922          Implementation of the Equal Access to Justice Act in Agency Proceedings..............    0990-AA02
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
923          Blood Initiative.....................................................................    0910-AB26
924          Pregnancy Labeling Revision..........................................................    0910-AB44
925          Natural Rubber-Containing Drugs; User Labeling.......................................    0910-AB56
----------------------------------------------------------------------------------------------------------------


[[Page 21198]]


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
926          Over-the-Counter (OTC) Drug Review...................................................    0910-AA01
927          Hearing Aids; Professional and Patient Labeling; Conditions for Sale.................    0910-AA39
928          Drugs Used for Treatment of Narcotic Addicts.........................................    0910-AA52
929          Investigational New Drugs: Export Requirements for Unapproved New Drug Products......    0910-AA61
930          Adverse Drug Reaction Reporting and Recordkeeping Requirements for Marketed OTC Drugs    0910-AA86
931          Informed Consent for Human Drugs and Biologics; Determination That Informed Consent      0910-AA89
            Is Not Feasible.......................................................................
932          Direct-to-Consumer Promotion Regulations.............................................    0910-AA90
933          Labeling for Human Prescription Drugs; Revised Format................................    0910-AA94
934          Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products..    0910-AA97
935          Use of Ozone-Depleting Substances....................................................    0910-AA99
936          Radioactive Drugs for Basic Research.................................................    0910-AB00
937          Veterinary Feed Directives...........................................................    0910-AB09
938          Administrative Practices and Procedures; Advisory Opinions and Guidelines............    0910-AB14
939          Exports; Reporting and Recordkeeping Requirements....................................    0910-AB16
940          Registration of Foreign Establishments and Product Listing...........................    0910-AB21
941          Suitability Determination for Donors of Human Cellular and Tissue-Based Products.....    0910-AB27
942          Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based        0910-AB28
            Products..............................................................................
943          Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration      0910-AB30
            Requirements..........................................................................
944          Antibiotic Drug Approval and Exclusivity.............................................    0910-AB33
945          Applications for FDA Approval To Market a New Drug or Antibiotic Drug; Complete          0910-AB34
            Response Letter; Amendments to Unapproved Applications................................
946          Expanded Access to Investigational Therapies.........................................    0910-AB37
947          Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs....    0910-AB39
948          Electronic Submission of Adverse Drug Reaction Reports...............................    0910-AB42
949          Distinguishing Marks for Drug Products Containing Insulin............................    0910-AB43
950          Progestational Drug Products for Human Use; Requirements for Labeling Directed to the    0910-AB45
            Patient...............................................................................
951          Supplemental Manufacturing Changes for New Animal Drugs..............................    0910-AB49
952          Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed................    0910-AB50
953          Pharmacy Compounding; General Regulations............................................    0910-AB58
954          Drug Products That Present Demonstrable Difficulties for Compounding Because of          0910-AB59
            Reasons of Safety or Effectiveness....................................................
955          Discontinuation of a Life-Saving Product.............................................    0910-AB60
956          Manufacturing Changes for Drugs......................................................    0910-AB61
957          Pediatric Studies of Drugs...........................................................    0910-AB62
958          Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............    0910-AB63
959          Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims...    0910-AB66
960          Designated Journals..................................................................    0910-AB67
961          Presubmission Conferences............................................................    0910-AB68
962          Classification of Sheep as a Minor Species for All Data Collection Purposes..........    0910-AB69
963          Current Good Manufacturing Practice for Medicated Feeds..............................    0910-AB70
964          Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act    0910-AB71
            of 1996 and the Safe Level Provisions of the Animal Medicinal Drug Clarification Act
            of 1994...............................................................................
965          Mandatory HACCP Regulations for Manufacturers of Rendered Products...................    0910-AB72
966          Surgeon's and Patient Examination Gloves; Reclassification...........................    0910-AB74
967          Current Good Manufacturing Practices for Blood and Blood Components: Notification of     0910-AB76
            Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HCV
            Infection.............................................................................
968          Antibiotic Resistance Labeling.......................................................    0910-AB78
969          Fixed-Combination Dosage Form Prescription Drugs for Human Use.......................    0910-AB79
970          180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications...............    0910-AB80
971          Repackaging Approval Requirements....................................................    0910-AB81
972          Stability Testing of Drug Substances and Drug Products...............................    0910-AB82
973          Postmarketing Studies for Human Drugs and Licensed Biological Products: Status           0910-AB83
            Reports...............................................................................
974          Amendment of Various Food Additive and Device Regulations to Reflect Current American    0910-AB84
            Society for Testing and Materials Citations...........................................
----------------------------------------------------------------------------------------------------------------


[[Page 21199]]


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
975          New Animal Drug Approval Process; Implementation of Title I of the Generic Animal        0910-AA02
            Drug and Patent Term Restoration Act (GADPTRA)........................................
976          Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and               0910-AA08
            Clarifications........................................................................
977          Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for        0910-AA43
            Juices................................................................................
978          Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished      0910-AA45
            Pharmaceuticals.......................................................................
979          Bioavailability and Bioequivalence Requirements......................................    0910-AA51
980          Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant;            0910-AA74
            Labeling Requirements; Warning Statement..............................................
981          New Drug Applications; Drug Master File..............................................    0910-AA78
982          Over-the-Counter Human Drugs; Labeling Requirements..................................    0910-AA79
983          Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening     0910-AA84
            Illnesses.............................................................................
984          Sterility Requirements for Inhalation Solution Products..............................    0910-AA88
985          Current Good Manufacturing Practice; Revision of Certain Labeling Controls...........    0910-AA98
986          Definition of Substantial Evidence...................................................    0910-AB08
987          New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification    0910-AB12
988          Medicated Feed Mill Licenses.........................................................    0910-AB18
989          Public Information; Communications With State and Foreign Government Officials.......    0910-AB22
990          FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping               0910-AB24
            Requirements for Unapproved or Violative Products Imported for Further Processing or
            Incorporation and Later Export........................................................
991          Biological Products Regulated Under Section 351 of the Public Health Service Act;        0910-AB29
            Implementation of Biologics License; Elimination of Establishment License and Product
            License...............................................................................
992          Revisions to the General Safety Requirements for Biological Products; Direct Final       0910-AB51
            Rule..................................................................................
993          Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring.......................    0910-AB52
994          Bulk Drug Substances for Use in Pharmacy Compounding.................................    0910-AB57
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
995          Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality         0910-AA04
            Factors, Notification Requirements, and Records and Reports...........................
996          Biological Products: Reporting of Errors and Accidents in Manufacturing..............    0910-AA12
997          Food Labeling Review.................................................................    0910-AA19
998          Medical Foods........................................................................    0910-AA20
999          Classification of Computer Software Programs That Are Medical Devices................    0910-AA41
1000         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution...    0910-AA49
1001         Reinventing FDA Food Regulations.....................................................    0910-AA58
1002         Dietary Supplement Regulations in Response to DSHEA..................................    0910-AA59
1003         Debarment Certification Regulations for Drug Applications............................    0910-AA76
1004         Investigational New Drug Applications; Request for Information and Comments..........    0910-AA83
1005         Investigational Use New Animal Drug Regulations......................................    0910-AB02
1006         Establishment Registration and Listing of Human Cellular and Tissue-Based Products...    0910-AB05
1007         Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless         0910-AB17
            Tobacco To Protect Children and Adolescents; Use of Nontobacco Trade or Brand Names...
1008         Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco             0910-AB19
            Requirements; Applications for Exemption Submitted by Various State Governments; Group
            1; Group 2............................................................................
1009         Citizen Petitions; Actions That Can Be Requested by Petition; Summary Denial; and        0910-AB73
            Referral for Other Administrative Action..............................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1010         Review of Warnings, Use Instructions, and Precautionary Information Under Section 314    0910-AA14
            of the National Childhood Vaccine Injury Act of 1986..................................

[[Page 21200]]


1011         Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products.......    0910-AA26
1012         Amalgam Ingredient Labeling..........................................................    0910-AA33
1013         Prescription Drug Product Labeling; Medication Guide.................................    0910-AA37
1014         Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent              0910-AA75
            Requirements..........................................................................
1015         Animal Drug Approvals for Minor Species and Minor Usage..............................    0910-AB07
1016         Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New        0910-AB20
            Drugs and Biological Products in Pediatric Patients...................................
1017         Dissemination of Treatment Information on Unapproved Uses for Marketed Drugs and         0910-AB23
            Devices...............................................................................
1018         Revocation of Antibiotic Certification Requirements; Conforming Revisions to             0910-AB32
            Regulations...........................................................................
1019         List of Drugs That Have Been Withdrawn or Removed From the Market for Reasons of         0910-AB40
            Safety and Effectiveness..............................................................
1020         Clinical Hold; Streamlining Clinical Research........................................    0910-AB41
1021         Medical Devices; IDE Modifications...................................................    0910-AB53
1022         Dispute Resolution...................................................................    0910-AB54
1023         Effective Date of Approval of an Abbreviated New Drug Application....................    0910-AB64
1024         Mutual Recog. of Pharmaceutical Good Manufacturing Inspection Rpts., Med. Device         0910-AB75
            Quality Sys. Audit Rpts., and Certain Medical Device Product Eval. Rpts.; the U.S. and
            the European Community................................................................
1025         Financial Disclosure by Clinical Investigators.......................................    0910-AB77
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1026         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA41
            Health Care Practitioners: Corporate Shield...........................................
1027         Designation of Medically Underserved Populations and Health Professional Shortage        0906-AA44
            Areas.................................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1028         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA42
            Health Care Practitioners: Charge for Self-Queries....................................
1029         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA43
            Health Care Practitioners: Reporting Adverse and Negative Actions.....................
1030         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA48
            Health Care Providers: Clarification and Modernization of Regulatory Terms............
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1031         Indian Child Protection and Family Violence Prevention Act Minimum Standards of          0917-AA02
            Character.............................................................................
----------------------------------------------------------------------------------------------------------------


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1032         Currently Effective Indian Health Service Eligibility Regulations....................    0917-AA03
----------------------------------------------------------------------------------------------------------------


[[Page 21201]]


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1033         National Institutes of Health AIDS Research Loan Repayment Program...................    0925-AA02
1034         Undergraduate Scholarship Program Regarding Professions Needed by the NIH............    0925-AA10
1035         National Research Service Awards.....................................................    0925-AA16
1036         Removal of National Cancer Institute Clinical Cancer Education Program...............    0925-AA17
1037         National Institutes of Health Loan Repayment Program for Research....................    0925-AA18
1038         National Institute of Child Health and Human Development Contraception and               0925-AA19
            Infertility Research Loan Repayment Program...........................................
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1039         National Institutes of Health Construction Grants....................................    0925-AA04
1040         Traineeships.........................................................................    0925-AA11
1041         Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects    0925-AA14
            in Research, and Pertaining to Human In Vitro Fertilization...........................
1042         Scientific Peer Review of Research Grant Applications and Research and Development       0925-AA20
            Contract Projects.....................................................................
1043         Federal Policy (Common Rule) for the Protection of Human Subjects....................    0925-AA21
1044         Service Fellowships..................................................................    0925-AA22
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1045         National Institutes of Health Clinical Research Loan Repayment Program for               0925-AA09
            Individuals From Disadvantaged Backgrounds............................................
----------------------------------------------------------------------------------------------------------------


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1046         Public Health Service Standards for the Protection of Research Misconduct                0940-AA01
            Whistleblowers........................................................................
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1047         Standards of Compliance for Abortion-Related Services in Family Planning Service         0940-AA00
            Projects..............................................................................
----------------------------------------------------------------------------------------------------------------


                           Office of Assistant Secretary for Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1048         Standards of Compliance for Abortion-Related Services in Family Planning Service         0937-AA00
            Projects..............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 21202]]


                                    Public Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1049         Public Health Service Standards for the Protection of Research Misconduct                0905-AE71
            Whistleblowers........................................................................
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1050         Medicare Coverage of Heart, Liver, and Lung Transplantation (HCFA-3835-PN)...........    0938-AH17
1051         Children's Health Insurance: Program Implementation; State Plan Approval; State          0938-AI28
            Payment; Coordination With State Medicaid Program (HCFA-2006-P).......................
1052         Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (HCFA-6003-P).............................................
1053         Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR).......................    0938-AI72
1054         Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests; Intent    0938-AI92
            To Form Negotiated Rulemaking Committee (HCFA-3250-NOI)...............................
1055         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--Third            0938-AJ37
            Quarter, 1998 (HCFA-9000-N)...........................................................
1056         Recognition of the Community Health Accreditation Program, Inc., (CHAP), (HCFA-2029-     0938-AJ42
            FN)...................................................................................
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1057         Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure     0938-AG44
            Breathing Machine Therapy (HCFA-3781-FN)..............................................
1058         Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F)...    0938-AG48
1059         CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)..........................    0938-AG99
1060         Additional Supplier Standards (HCFA-6004-F)..........................................    0938-AH19
1061         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-        0938-AH48
            Based Group Health Plans (HCFA-2047-FC)...............................................
1062         Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)...............    0938-AH53
1063         Utilization Control and Discontinued Review Activities; Medicaid (HCFA-2101-FC)......    0938-AH64
1064         Individual Market Health Ins. Reform Portability From Group to Indiv. Coverage;          0938-AH75
            Federal Rules for Access in the Indiv. Market; State Alternative Mechanisms to Federal
            Rules (HCFA-2882-F)...................................................................
1065         Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical        0938-AH81
            Procedures for Ambulatory Surgical Centers Effective for Calendar Year 1998 (HCFA-1885-
            F)....................................................................................
1066         Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)..................    0938-AH92
1067         Medicare+Choice Program (HCFA-1030-F)................................................    0938-AI29
1068         Medicare Program; Prospective Payment System and Consolidated Billing for Skilled        0938-AI47
            Nursing Facilities. (HCFA-1913-IFC)...................................................
1069         Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab.          0938-AI48
            Agencies, Community Mental Health Centers, and Independent Diagnostic Testing
            Facilities (HCFA-6005-P)..............................................................
1070         Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)...................    0938-AI67
1071         Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-F)................    0938-AI83
1072         Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-IFC)...........    0938-AI93
1073         Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the             0938-AJ10
            Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)..................
1074         Establishment of a Program To Collect Suggestions for Improving Medicare Program         0938-AJ30
            Efficiency and To Reward Suggestors (HCFA-4000-FC)....................................
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1075         Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F).......................    0938-AB50

[[Page 21203]]


1076         Changes to Peer Review Organization Regulations (HCFA-3135-F)........................    0938-AD38
1077         Omnibus Nursing Home Reform Requirements (HCFA-3488-F)...............................    0938-AD81
1078         ``Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare           0938-AD95
            Overpayment Liability (HCFA-1719-P)...................................................
1079         Protection of Income and Resources for Community Spouses of Institutionalized            0938-AE12
            Individuals (HCFA-2023-P).............................................................
1080         Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F).    0938-AE39
1081         Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-     0938-AE72
            F)....................................................................................
1082         Payment for Nursing and Allied Health Science Education (HCFA-1685-F)................    0938-AE79
1083         Coverage of Screening Pap Smears (HCFA-3705-F).......................................    0938-AE98
1084         Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC).................    0938-AF02
1085         Case Management (HCFA-2027-F)........................................................    0938-AF07
1086         Requirements for Certain Health Insuring Organizations and OBRA '90 Technical            0938-AF15
            Amendments (HCFA-1018-F)..............................................................
1087         Provider Reimbursement Determinations and Appeals (HCFA-1727-P)......................    0938-AF28
1088         Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)........................    0938-AF32
1089         Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC).    0938-AF42
1090         Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)....    0938-AF68
1091         Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,           0938-AF69
            Infants, and Children Under Age 19 (HCFA-2052-F)......................................
1092         Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)........    0938-AF87
1093         Revised Medicaid Management Information Systems (HCFA-2038-FN).......................    0938-AG10
1094         Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P)....................    0938-AG31
1095         Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth     0938-AG32
            Scope of Work Contracts (HCFA-3207-N).................................................
1096         Disclosure of Confidential PRO and ESRD Network Organization Information for Research    0938-AG33
            Purposes (HCFA-3208-P)................................................................
1097         Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,             0938-AG59
            Underpayments and Overpayments (HCFA-2215-P)..........................................
1098         Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With         0938-AG72
            Tuberculosis (HCFA-2082-P)............................................................
1099         Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F).....    0938-AG79
1100         Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AG80
            Relationships--Expanded to Designated Health Services (HCFA-1809-F)...................
1101         Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)...................    0938-AG81
1102         End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P).................    0938-AG82
1103         Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening      0938-AG84
            of Applicants for Nursing Home Admission (HCFA-3815-P)................................
1104         Liability for Third Parties To Pay for Care and Services (HCFA-2080-P)...............    0938-AH01
1105         Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F)....    0938-AH15
1106         Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical             0938-AH16
            Equipment (DME) and Home Health (HCFA-1834-P).........................................
1107         State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P).....................    0938-AH24
1108         Hospice Care--Conditions of Participation (HCFA-3844-P)..............................    0938-AH27
1109         CLIA Program; Cytology Proficiency Testing (HCFA-2233-N).............................    0938-AH35
1110         Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-    0938-AH37
            1843-P)...............................................................................
1111         Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)....    0938-AH49
1112         Limitations on Liability (HCFA-4859-FC)..............................................    0938-AH51
1113         Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P).................    0938-AH52
1114         Revision to Accrual Basis of Accounting Policy (HCFA-1876-F).........................    0938-AH61
1115         Medicaid; Estate Recoveries (HCFA-2083-P)............................................    0938-AH63
1116         Medicaid Hospice Care (HCFA-2016-P)..................................................    0938-AH65
1117         Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance    0938-AH66
            (HCFA-1848-P).........................................................................
1118         Medicare Technical Conforming Amendments (HCFA-1858-FC)..............................    0938-AH67
1119         Elimination of Certain Requirements for Peer Review Organizations in the Utilization     0938-AH68
            and Quality Review Process and a Change in the Length of Peer Review Organization
            Contracts (HCFA-3235-FC)..............................................................
1120         Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)......................    0938-AH69
1121         Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities            0938-AH72
            Participating in an Experiment (HCFA-2236-GNC)........................................
1122         Provider and Supplier Enrollment Periodic Renewal of Eligibility Requirements (HCFA-     0938-AH73
            6002-P)...............................................................................
1123         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)...    0938-AH83
1124         Disclosure of Peer Review Organization Information in Response to Beneficiary            0938-AH85
            Complaints (HCFA-3241-P)..............................................................

[[Page 21204]]


1125         National Standard for Identifiers of Health Plans (HCFA-4145-P)......................    0938-AH87
1126         Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review     0938-AH89
            Program (HCFA-2107-P).................................................................
1127         Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services    0938-AH95
            (HCFA-2043-P).........................................................................
1128         Revision to the Definition of an Unemployed Parent (HCFA-2106-FC)....................    0938-AH98
1129         National Standard Health Care Provider Identifier (HCFA-0045-F)......................    0938-AH99
1130         Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F).    0938-AI08
1131         Medicare Program; Medicare Integrity Program (HCFA-7020-F)...........................    0938-AI09
1132         Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries         0938-AI11
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).......................................
1133         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage      0938-AI13
            Decisions--Second Quarter, 1998 (HCFA-9002-N).........................................
1134         Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and    0938-AI16
            Sustainable Growth Rate for Fiscal Year 1998 (HCFA-1893-FN)...........................
1135         Medicaid: Medical Child Support (HCFA-2081-P)........................................    0938-AI21
1136         GME: Incentive Payments Under Plans for Voluntary Reduction in Number of Residents       0938-AI27
            (HCFA-1001-IFC).......................................................................
1137         Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F).    0938-AI38
1138         Medicare/Medicaid Program; User Fees (HCFA-6021-P)...................................    0938-AI46
1139         Security and Electronic Signature Standards (HCFA-0049-F)............................    0938-AI57
1140         Standards for Electronic Transactions (HCFA-0149-F)..................................    0938-AI58
1141         National Standard Employer Identifier (HCFA-0047-F)..................................    0938-AI59
1142         State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)........    0938-AI63
1143         Recognition of the Community Health Accreditation Program, Inc. (CHAP) and Joint         0938-AI69
            Commission for Accreditation of Healthcare Organizations (JCAHO) for Hospices (HCFA-
            2029-PN)..............................................................................
1144         Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions of    0938-AI70
            the Balanced Budget Act of 1997 (HCFA-2001-P).........................................
1145         Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC).    0938-AI73
1146         Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P)..........    0938-AI74
1147         Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan        0938-AI75
            (HCFA-1777-P).........................................................................
1148         Medicare Hospice Care (HCFA-1022-P)..................................................    0938-AI77
1149         Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and             0938-AI80
            Elimination of Reclassifications (HCFA-1883-P)........................................
1150         Medicare Program; Standardization of Medicare Coverage for Bone Mass Measurements        0938-AI89
            (HCFA-3004-IFC).......................................................................
1151         Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI).............    0938-AI91
1152         Peer Review Organization Contracts: Solicitation of Statements of Interest From In-      0938-AI99
            State Organizations (HCFA-3009-N).....................................................
1153         Replacement of Reasonable Charge Methodology by Fee Schedules (HCFA-1010-P)..........    0938-AJ00
1154         External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-P).........    0938-AJ06
1155         HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-2025-    0938-AJ07
            N)....................................................................................
1156         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--First Quarter    0938-AJ12
            1998 (HCFA-9879-N)....................................................................
1157         Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier         0938-AJ15
            Performance: Millennium Compliance (HCFA-4002-GNC)....................................
1158         Rural Health Clinics: Amendments to Participation Requirements and Payment               0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
            1910-P)...............................................................................
1159         Home Health Prospective Payment System (HCFA-1102-FC)................................    0938-AJ24
1160         Medicare Program State Allotments for Payments of Medicare Part B Premium for            0938-AJ28
            Qualifying Individuals: Federal Fiscal Year for 1999 (HCFA-2032-N)....................
1161         Hospital Conditions of Participation: Laboratory Services (HCFA-3 014-P).............    0938-AJ29
1162         Medicare Program; Procedures for Making Medical Services National Coverage Decisions     0938-AJ31
            (HCFA-3432-FNC).......................................................................
1163         Medicare Program; Special Payment Limits for Certain Durable Medical Equipment and       0938-AJ34
            Prosthetic Devices (HCFA-1050-PN).....................................................
1164         Medicaid Program; Civil Money Penalties for Nursing Homes (SNF/NF), Change in Notice     0938-AJ35
            Requirements, and Expansion of Discretionary Remedy (HCFA-2035-FC)....................
1165         Medicare Hospice Care (HCFA-1022-P)..................................................    0938-AJ36
1166         Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-FC)....................    0938-AJ39
1167         Recognition of the Joint Commission for Accreditation of Healthcare Organizations        0938-AJ41
            (JCAHO for Hospices) (HCFA-2039-FN)...................................................
1168         Decision on the Funding for the AIDS Healthcare Foundation START Program, (HCFA-2041-    0938-AJ43
            N)....................................................................................
1169         Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC).....    0938-AJ44

[[Page 21205]]


1170         Accelerated Payments to Providers Furnishing Services Under Medicare Part A and Part     0938-AJ45
            B and Advance Payments to Suppliers Furnishing Items or Services Under Medicare Part B
            (HCFA-1066-FC)........................................................................
1171         Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of       0938-AJ47
            1988 Exemption of Laboratories in the State of California (HCFA-2245-N)...............
1172         Federal Enforcement in Group and Individual Health Insurance Markets (HCFA-2019-FC)..    0938-AJ48
1173         Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2000        0938-AJ50
            Rates (HCFA-1053-P)...................................................................
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1174         Deduction of Incurred Medical Expenses (Spenddown) (HCFA-2020-F).....................    0938-AB07
1175         Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge        0938-AC58
            Rights Notice, and Hospital Responsibility for Emergency Care (HCFA-1393-IFC).........
1176         Criteria and Procedures for Developing Medical Services Coverage Policy (HCFA-3546-F)    0938-AD07
1177         Medicare Secondary Payer for Disabled Individuals (HCFA-1482-F)......................    0938-AD73
1178         Revisions to Regulations Implementing CLIA (HCFA-2226-F).............................    0938-AE47
1179         Medicare Coverage of, and Application of the Outpatient Mental Health Treatment          0938-AE99
            Limitation to, Clinical Psychologist and Clinical Social Worker Services (HCFA-3706-F)
1180         Revisions to Rules on Health Care Prepayment Plans (HCFA-1016-P).....................    0938-AF97
1181         Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and    0938-AF98
            Competitive Medical Plans (HCFA-1015-F)...............................................
1182         Payment for Preadmission Services (HCFA-1731-F)......................................    0938-AG00
1183         Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions    0938-AG05
            and Establishment of a Quality Assessment and Performance Improvement Program (HCFA-
            1910-P)...............................................................................
1184         Request for Assessment on the Salitron System for the Treatment of Xerostomia            0938-AG45
            Secondary to Sjogren's Syndrome (HCFA-3782-NC)........................................
1185         Clinical Laboratory Improvement Amendment (CLIA) Fee Schedule Revision (HCFA-3219-       0938-AG87
            GNC)..................................................................................
1186         Categorization and Certification Requirements for a New Subcategory of Moderate          0938-AG98
            Complexity Testing (HCFA-2222-F)......................................................
1187         Ambulance Services (HCFA-1813-F).....................................................    0938-AH13
1188         Criteria and Procedures for Extending Coverage to Certain Devices and Related            0938-AH21
            Services (HCFA-3841-F)................................................................
1189         Delegation of Civil Money Penalties (HCFA-6135-FC)...................................    0938-AH22
1190         Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating       0938-AH50
            Physicians (HCFA-1862-P)..............................................................
1191         Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998        0938-AH55
            Rates (HCFA-1878-F)...................................................................
1192         Conditions for Certification of Community Mental Health Centers and Coverage             0938-AH58
            Requirements for Partial Hospitalization Services (HCFA-1871-P).......................
1193         Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform         0938-AH76
            (HCFA-2105-IFC).......................................................................
1194         Medicare Program; Beneficiary Incentive Programs (HCFA-6144-FC)......................    0938-AH86
1195         Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB-    0938-AH90
            103-N)................................................................................
1196         Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal     0938-AH93
            Fiscal Year 1998 (HCFA-2110-N)........................................................
1197         Medicare Coverage of Certified Nurse-Midwife Services (HCFA-1496-P)..................    0938-AH96
1198         Health Insurance Reform: Parity in the Application of Certain Limits to Mental Health    0938-AI05
            Benefits (HCFA-2891-IFC)..............................................................
1199         Part A Premium for 1998 for the Uninsured Aged and for Certain Disabled Individuals      0938-AI10
            Who Have Exhausted Other Entitlement (HCFA-5056-N)....................................
1200         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AI12
            Amounts for 1998 (HCFA-5057-N)........................................................
1201         Health Insurance Portability: Newborns' and Mothers' Health Protection (HCFA-2892-       0938-AI17
            IFC)..................................................................................
1202         Medicaid Program: Charges for Vaccine Administration Under the Vaccines for Children     0938-AI20
            (VCF) Program (HCFA-2084-FNC).........................................................
1203         Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999       0938-AI22
            Rates (HCFA-1003-P)...................................................................
1204         Medicare Program; Notice for the Solicitation for Proposals for a Case Management        0938-AI26
            Demonstration Project Focused on Congestive Heart Failure or Diabetes Mellitus (HCFA-
            1104-N)...............................................................................
1205         Collection of User Fees From Medicare+Choice Plans and Risk-Sharing Contractors (HCFA-   0938-AI35
            1911-IFC).............................................................................
1206         Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for           0938-AI39
            Qualified Individuals: Federal Fiscal Year 1998 (HCFA-2005-NC)........................

[[Page 21206]]


1207         Medicare Program: Payments for Teleconsultations in Rural Health Professional            0938-AI44
            Shortage Areas (HCFA-1906-F)..........................................................
1208         Review and Payment for Claims Filed on Behalf of Medicare/Medicaid Dually Eligible       0938-AI50
            Beneficiaries (HCFA-2097-3)...........................................................
1209         Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for     0938-AI52
            Calendar Year 1999 (HCFA-1006-FC) (HCFA-1006-P).......................................
1210         Medicare Program; Prospective Payment System for Hospital Outpatient Services (HCFA-     0938-AI56
            1005-P)...............................................................................
1211         Medicare Program; Definition of Provider-Sponsored Organization and Related              0938-AI60
            Requirements (HCFA-1027-IFC)..........................................................
1212         Child Health Insurance Allotments FY 1999 (HCFA-2014-N)..............................    0938-AI64
1213         State Children's Health Insurance Program Allotments and Payments to States (HCFA-       0938-AI65
            2114-P)...............................................................................
1214         DSH Payments - Institution for Mental Disease (HCFA-2012-N)..........................    0938-AI66
1215         New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a)    0938-AI71
            of the Social Security Act July, August, September, October, and November 1997........
1216         Medicare Program; Advertising Costs (HCFA-1880-P)....................................    0938-AI76
1217         State Allotments for Additional Federal Funding of Emergency Health Services             0938-AI78
            Furnished to Undocumented Aliens: Federal Fiscal Years 1998 Through (HCFA-2000-N).....
1218         Medicaid Program; Extension of Waiver To Extend Medicaid Eligibility Timeframes (HCFA-   0938-AI79
            2009-N)...............................................................................
1219         Medicare and Medicaid Programs; Surety Bond Requirements for Home Health Agencies        0938-AI82
            (HCFA-1038-NC)........................................................................
1220         Schedule of Per-Beneficiary Limitations on Home Health Agency Costs for Cost             0938-AI84
            Reporting Periods Beginning On or After October 1, 1997 (HCFA-1905-FC)................
1221         Expanded Coverage of Blood Glucose Monitors and Test Strips (HCFA-3003-IFC)..........    0938-AI85
1222         Medicare Program; Hospice Wage Index (HCFA-1039-N)...................................    0938-AI87
1223         Recognition of the American Association for Accreditation of Ambulatory Surgery          0938-AI90
            Facilities, Inc. for Ambulatory Surgical Centers Program (HCFA-2008-PN)...............
1224         Medicaid, Medicare CLIA Program; Extension of Certain Effective Dates for Clinical       0938-AI94
            Laboratory Requirements Under CLIA (HCFA 2024-IFC)....................................
1225         Hospital Conditions of Participation, Identification of Potential Organ, Tissue, and     0938-AI95
            Eye Donor and Transplant Hospitals Provisions of Transplant Related Data (HCFA-3005-F)
1226         Expanded Coverage for Diabetes Outpatient Self-Management Training Services (HCFA-       0938-AI96
            3002-P)...............................................................................
1227         Medicare Program; Monthly Actuarial Rates and Monthly Supplementary Medical Insurance    0938-AI98
            Premium Rate Beginning January 1, 1999 (HCFA-8003-N)..................................
1228         Notice Announcing Revised Positron Emission Tomography (PET) Policy (HCFA-3008-NC)...    0938-AJ01
1229         Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care           0938-AJ02
            Services Coinsurance Amounts for 1999 (HCFA-8001-N)...................................
1230         Medicare Program; Part A Premium for 1999 for the Uninsured Aged and for Certain         0938-AJ03
            Disabled Individuals Who Have Exhausted Other Entitlement (HCFA-8000-N)...............
1231         Inpatient Psychiatric Services Benefit for Individuals Under Age 21 (HCFA-2060-F)....    0938-AJ05
1232         Physician Sustainable Growth Rate of Increase for FY 1999 (HCFA-1021-FN).............    0938-AJ09
1233         Comprehensive Assessment and Use of OASIS as Part of Conditions of Participation for     0938-AJ11
            Home Health Agencies (HCFA-3007-F)....................................................
1234         Request for Public Comments on Implementation of Risk Adjusted Payment for the           0938-AJ16
            Medicare+Choice Program and Notice of Public Meeting..................................
1235         Adjustments to Payment Amount for Erythropoietin/Epoietin for End-Stage Renal Disease    0938-AJ18
            Patients (HCFA-1098-PN)...............................................................
1236         Recognition of the Commission for Accreditation of Rehabilitation Facilities (HCFA-      0938-AJ25
            2036-NC)..............................................................................
1237         Medicare Program; Limited Additional Opportunity to Request Certain Hospital Wage        0938-AJ26
            Data Revisions for FY 1999 (HCFA-1049-FC).............................................
1238         Request for Nominations for Members for Practicing Physicians Advisory Council (HCFA-    0938-AJ27
            1048-N)...............................................................................
1239         Medicare and Medicaid Programs; Announcement of Additional Application From Hospitals    0938-AJ32
            Requesting Waivers for Organ Procurement Service Area (HCFA-1062-N)...................
1240         Medicare Program; January 6, 1999, Meeting of the Competitive Pricing Advisory           0938-AJ33
            Committee (HCFA-1061-N)...............................................................
1241         Medicare Program; March 15, 1999, Meeting of the Practicing Physician Advisory           0938-AJ38
            Council (HCFA-1064-N).................................................................
1242         March 9, April 8, and May 12, 1999 Meetings of the Kansas City Metropolitan Area,        0938-AJ46
            Competitive Pricing Demonstration Area Advisory Committee (HCFA-1068-N)...............
1243         Medicare Coordinated Care Demonstration Project and Request for Comments on Potential    0938-AJ49
            Best Practices of Coordinated Care (HCFA-1100-N)......................................
----------------------------------------------------------------------------------------------------------------


[[Page 21207]]


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1244         Construction of Head Start Facilities................................................    0970-AB54
1245         Bonus To Reward High Performance States Under the Temporary Assistance for Needy         0970-AB66
            Families Block Grant..................................................................
1246         Child Support Enforcement for Indian Tribes..........................................    0970-AB73
1247         Incentive Payments and Audit Penalties to States and Political Subdivisions..........    0970-AB85
1248         Family Child Care Program Option for Head Start Programs.............................    0970-AB90
1249         Implementation of AFCARS Corrective Action and Penalties and CAPTA Amendments........    0970-AB94
1250         State Self Assessments To Determine Compliance With Federal Regulations..............    0970-AB96
1251         Priority for Previously Selected Headstart Agencies..................................    0970-AB98
1252         Program Performance Standards for the Operation of Head Start Programs...............    0970-AB99
1253         Safeguarding Child Support and Expanded FPLS Information.............................    0970-AC01
1254         Assets for Independence Reserve Account..............................................    0970-AC02
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1255         Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan      0970-AA97
            Reviews, MEPA Implementation, and ASFA Implementation.................................
1256         Standards for Safe Transportation....................................................    0970-AB24
1257         Methodology for Determining Whether an Increase in a State's Child Poverty Rate Is       0970-AB65
            the Result of the TANF Program........................................................
1258         Temporary Assistance for Needy Families (TANF).......................................    0970-AB77
1259         Requirements for the Tribal Programs.................................................    0970-AB78
1260         Bonus to Reward Decrease in Illegitimacy Ratio.......................................    0970-AB79
1261         Child Support Enforcement Program Omnibus Conforming Regulation......................    0970-AB81
1262         Refugee Resettlement Program: Public/Private Partnership.............................    0970-AB83
1263         Head Start Appeal Timelines..........................................................    0970-AB87
1264         Welfare-to-Work Data Collection......................................................    0970-AB92
1265         National Medical Support Notice......................................................    0970-AB97
1266         Technical Revision of Head Start Regulations to Make Them Conform to Recent Statutory    0970-AC00
            Revisions.............................................................................
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1267         Standards for Purchase of Facilities.................................................    0970-AB31
1268         State Law Concerning Paternity Establishment.........................................    0970-AB69
1269         Grants to States for Access and Visitation Programs..................................    0970-AB72
1270         Case Closure.........................................................................    0970-AB82
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1271         Grants for State and Community Programs on Aging, Intrastate Funding Formulas;           0985-AA00
            Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to
            Indians & Native Hawaiians............................................................
----------------------------------------------------------------------------------------------------------------


[[Page 21208]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Office of the Secretary (OS)



_______________________________________________________________________




905.  PRIVACY ACT EXEMPT RECORD SYSTEM FROM THE HEALTHCARE 
INTEGRITY AND PROTECTION DATA BANK

Priority:  Substantive, Nonsignificant

Legal Authority:  5 USC 552a

CFR Citation:  45 CFR 56

Legal Deadline: None

Abstract: This proposed rule would exempt the new system of records for 
the Healthcare Integrity and Protection Data Bank (HIPDB) from certain 
provisions of the Privacy Act (5 U.S.C. 552a). The proposed exemption 
being set forth would apply to investigative materials compiled for law 
enforcement purposes in anticipation of civil, criminal or 
administrative proceedings.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99
NPRM Comment Period End         08/00/99

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 the 
Inspector General, OIG, 330 Independence Avenue SW., Washington, DC 
20201
Phone: 202 619-0089

RIN: 0991-AA99
_______________________________________________________________________




906.  REVISION OF HHS FREEDOM OF INFORMATION ACT REGULATIONS

Priority:  Other Significant

Legal Authority:  5 USC 552; 18 USC 1905; 42 USC 1306(C)

CFR Citation:  45 CFR 5

Legal Deadline: None

Abstract: This proposal responds to 1996 statutory amendments and it 
reflects organizational changes within HHS. Under the proposal, we will 
make records available in the form and format identified by the 
requester regardless of how the record already exists, when the 
requested record is ``readily reproducible'' in the requested form or 
format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/26/99                    64 FR 14668
NPRM Comment Period End         05/26/99
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Rosario Cirrincione, Director, Freedom of Information 
and Privacy, Acts Division, OASPA, Department of Health and Human 
Services, Office of the Secretary, 200 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 690-7453
Fax: 202 690-8320

RIN: 0991-AB01
_______________________________________________________________________




907.  CIVIL MONEY PENALTIES FOR MEDICARE+CHOICE ORGANIZATIONS 
AND MEDICAID MANAGED CARE ORGANIZATIONS

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 reflect OIG's authority to impose 
civil money penalties against health maintenance organizations and 
competitive medical plans that engage in certain abusive practices, 
including failure to provide medically necessary care and 
discriminatory enrollment procedures. This rule would specifically 
address the Medicare+Choice provisions set forth in Public Law 105-33 
(the Balanced Budget Act of 1997), and the Medicaid managed care 
provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99
NPRM Comment Period End         11/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulatory Officer, Department of 
Health and Human Services, Office of the Secretary, Office of the 
Inspector General, OIG, 330 Independence Avenue SW., Washington, DC 
20201
Phone: 202 619-0089

RIN: 0991-AB03
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


Office of the Secretary (OS)



_______________________________________________________________________




908. CLARIFICATION OF THE INITIAL OIG SAFE HARBOR PROVISIONS AND 
ESTABLISHMENT OF ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-
KICKBACK STATUTE

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  PL 100-93, sec 2; PL 100-93, sec 14

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This final rule serves both to clarify various aspects of the 
original safe harbor provisions and to add new safe harbors as 
authorized under section 14 of PL 100-93. Specifically, this rule 
modifies the original set of final safe harbor provisions (56 FR 35952, 
7/29/91) to give greater clarity to the rulemaking's original intent. 
In addition, this rule sets forth an expanded listing of safe harbor 
provisions designed to protect additional payment and business 
practices from criminal prosecution and civil sanctions under the anti-
kickback statute.

[[Page 21209]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/93                    58 FR 49008
NPRM Comment Period End         11/22/93
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: This final rule incorporates the safe harbor 
clarification provisions previously addressed in RIN 0991-AA74 and set 
forth in proposed rulemaking (59 FR 37202, July 21, 1994).

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-AA66
_______________________________________________________________________




909. REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS

Priority:  Info./Admin./Other

Legal Authority:  PL 103-296, sec 312 (42 USC 1320b-10)

CFR Citation:  45 CFR 101

Legal Deadline: None

Abstract: This interim final rule with comment period will establish 
procedures for implementation of section 312 of the Social Security 
Independence Act. That section amends existing prohibitions against 
``misuse of symbols, emblems, or names in reference to Social Security 
or Medicare.'' Section 312 prohibits the ``unauthorized reproduction, 
reprinting, or distribution for fee'' of a ``form, application, or 
other publication of the Social Security Administration or of the 
Department of Health and Human Services.'' It requires prior written 
authorization for any such activity in accordance with the Secretary's 
regulations. The Department plans to distinguish between forms and 
publications that potentially involve misuse in contrast to benign or 
desirable reproductions and distributions, and to provide pre-
authorization for the latter. The rule will be developed in 
consultation with the Social Security Administration.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michael Herrell, Office of the Assistant Secretary for 
Planning and Evaluation, Department of Health and Human Services, 
Office of the Secretary, 200 Independence Avenue SW., Washington, DC 
20201
Phone: 202 690-8291

RIN: 0991-AA83
_______________________________________________________________________




910. REVISED OIG CIVIL MONEY PENALTIES RESULTING FROM PUBLIC LAW 104-191

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-191, sec 231(a); PL 104-191, sec 231(b); PL 
104-191, sec 231(c); PL 104-191, sec 231(d); PL 104-191, sec 231(e); PL 
104-191, sec 231(h); PL 104-191, sec 232

CFR Citation:  42 CFR 1003; 42 CFR 1005; 42 CFR 1006

Legal Deadline: None

Abstract: This final rule will revise the OIG's civil money penalty 
provisions in conjunction with new and revised authorities set forth in 
the Health Insurance Portability and Accountability Act of 1996. Among 
other provisions, this final rulemaking would codify new civil money 
penalties for (1) excluded individuals retaining ownership or control 
interest in an entity; (2) upcoding and claims for medically 
unnecessary services; (3) offering inducements to beneficiaries; and 
(4) false certification of eligibility for home health services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/98                    63 FR 14393
NPRM Comment Period End         05/26/98
Final Action                    09/00/99

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-AA90
_______________________________________________________________________




911. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302, sec 216; 42 USC 1320a-7b; 42 USC 1395hh

CFR Citation:  41 CFR 1001

Legal Deadline:  Final, Statutory, January 1, 1997.

Abstract: This interim final rule will establish 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 would allow 
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 
which 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              07/00/99

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-AA91


_______________________________________________________________________



[[Page 21210]]

912. REVISED OIG SANCTION AUTHORITIES RESULTING FROM PUBLIC LAW 105-33

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 105-33, sec 4301; PL 105-33, sec 4303; PL 105-33, 
sec 4304; PL 105-33, sec 4331(c); PL 105-33, sec 4331(d)

CFR Citation:  42 CFR 1001; 42 CFR 1002; 42 CFR 1003

Legal Deadline: None

Abstract: This final rule will revise the OIG's exclusion and civil 
money penalty (CMP) authorities resulting from the Balanced Budget Act 
of 1997, Public Law 105-33. This rule will protect and strengthen 
Medicare and other Federal health care programs by increasing the OIG's 
anti-fraud and abuse authorities through new or revised exclusion and 
CMP provisions, including new CMPs (1) against institutional health 
care providers that employ, or enter into contracts for medical 
services with, excluded individuals; (2) for failure to report 
information to the Healthcare Integrity and Protection Data Bank; and 
(3) for health care providers who violate the anti-kickback statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/02/98                    63 FR 46736
NPRM Comment Period End         11/02/98
Final Action                    08/00/99

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, 330 Independence 
Avenue, OCIG, Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA95
_______________________________________________________________________




913. BLOCK GRANT PROGRAMS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 300w et seq; 42 USC 300x et seq; 42 USC 300y 
et seq; 42 USC 701 et seq; 42 USC 1243 et seq; 42 USC 1397 et seq; 42 
USC 8621 et seq; 42 USC 9901 et seq

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: The rule amends the regulations governing the administration 
on block grants. It updates current regulations to reflect current name 
and statutory petitions. It establishes submission and completion dates 
for funding applications from LIHEAP, CSBG and SSSBG. It clarifies that 
the department may specify the form of an application where this is 
authorized by statute. It requires to submit a obligation and 
expenditure for all block grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mike Herrell, Director, Division of Decision Systems, 
Department of Health and Human Services, Office of the Secretary, 200 
Independence Avenue SW., Room 447D, Washington, DC 20201
Phone: 202 690-8774
Fax: 202 690-8252

RIN: 0991-AA97
_______________________________________________________________________




914. HEALTH CARE FRAUD AND ABUSE DATA COLLECTION PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320a-7e

CFR Citation:  42 CFR 61 (New)

Legal Deadline:  Final, Statutory, January 1, 1997.

Abstract: This final rule would implement the requirements of section 
1128E of the Social Security Act, as added by section 221(a) of the 
Health Insurance Portability and Accountability Act of 1996. Section 
1128E of the Act directs the Department to establish a national health 
care fraud and abuse data collection program for the reporting and 
disclosure of certain final adverse actions taken against health care 
providers, suppliers and practitioners. The statute also requires the 
Department to implement the national health care fraud and abuse data 
collection program in such a manner as to avoid with reporting 
requirements established for the National Practitioner Data Bank under 
the Health Care Quality Improvement Act of 1986.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/30/98                    63 FR 58341
NPRM Comment Period End         01/11/99
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Additional Information: Was previously 0906-AA46.

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-AA98
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




915. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN 
INCENTIVE PLANS

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 1001; 42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer
Phone: 202 619-0089

RIN: 0991-AA45


_______________________________________________________________________



[[Page 21211]]

916. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO 
MEDICARE SUPPLEMENTAL POLICIES

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joel Jay Schaer
Phone: 202 619-0089

RIN: 0991-AA53
_______________________________________________________________________




917. CIVIL MONEY PENALTIES FOR NOTIFYING A HOME HEALTH AGENCY, OR A HOME 
OR COMMUNITY-BASED HEALTH CARE CENTER OR PROVIDER, OF A STANDARD SURVEY

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joel Jay Schaer
Phone: 202 619-0089

RIN: 0991-AA79
_______________________________________________________________________




918. CIVIL MONEY PENALTIES FOR FALSE INFORMATION ON DRUG MANUFACTURER 
PRICE SURVEYS AND REBATE AGREEMENTS

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joel Jay Schaer
Phone: 202 619-0089

RIN: 0991-AA80
_______________________________________________________________________




919. SENIOR BIOMEDICAL RESEARCH SERVICE

Priority:  Info./Admin./Other

CFR Citation:  42 CFR 24

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/12/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Rosemary Taylor
Phone: 202 690-7358
Fax: 202 690-6758

RIN: 0991-AA82
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




920. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

Priority:  Other Significant

CFR Citation:  45 CFR 96

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Agency Contact: Joseph D. Faha
Phone: 301 443-4640
Jim Sayers
Phone: 301 443-3820

RIN: 0930-AA01
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




921.  INTERSTATE SHIPMENT OF BIOLOGICAL MATERIALS THAT CONTAIN 
OR MAY CONTAIN INFECTIOUS SUBSTANCES

Priority:  Other Significant

Legal Authority:  42 USC 216; 42 USC 264; 42 USC 271; 42 USC 262 note; 
31 USC 9701; 18 USC 3559; 18 USC 3571

CFR Citation:  42 CFR 72.6 (Renumbered); 42 CFR 72.7 (Renumbered); 42 
CFR 72.1-5 (Revision); 42 CFR 72.1; 42 CFR 72.2

Legal Deadline: None

Abstract: The Centers for Disease Control and Prevention proposes to 
amend existing regulations located at 42 CFR Part 72 concerning the 
interstate shipment of infectious substances in order to clarify and 
expand the existing requirements for proper packaging and handling of 
these agents. One purpose of the proposed rule is to ensure that all 
biological materials that are known or suspected of containing an 
infectious substance are packaged for interstate shipment to minimize 
the potential for leakage of contents that could contaminate the 
environment or come into direct physical contact with persons handling 
such packages during transit. A second purpose is to insure receipt of 
certain infectious substances. This new regulation will harmonize CDC 
regulations with other Federal agencies' regulations and with 
international regulations. See ``A'' for additional information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

[[Page 21212]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: The purpose of this NPRM is to update 
regulations governing the packaging, labeling, and shipment of 
infectious agents. It is critical that infectious agents be transferred 
between labs for high priority diagnostic and research activities. 
Materials must be packaged in such a way as to prevent damage and 
leakage during transport in order to protect workers and the public 
from exposure. This NPRM is also a critical element of CDC's 
bioterrorism plan.

Agency Contact: Dr. Jonathan Richmond, Director, Office on Health and 
Safety, Department of Health and Human Services, Centers for Disease 
Control and Prevention, MS F05, 1600 Clifton Road NE., Atlanta, GA 
30333
Phone: 404 639-2453

RIN: 0920-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Departmental Management (HHSDM)



_______________________________________________________________________




922. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

Priority:  Substantive, Nonsignificant

Legal Authority:  5 USC 504(c)(1)

CFR Citation:  45 CFR 13

Legal Deadline: None

Abstract: The Equal Access to Justice Act requires agencies to pay fees 
to parties prevailing against the government in certain administrative 
proceedings. The Act has been amended several times since its 1980 
enactment, most recently by the Contract with America Advancement Act 
of 1996, which increased the amount of the hourly fees payable. The 
proposed rule revises 45 CFR Part 13 (HHS' regulation implementing the 
Equal Access to Justice Act) to conform with statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Second NPRM                     05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Timothy M. White, Associate General Counsel, Business 
and Administrative Law Division, Department of Health and Human 
Services, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 619-0150

RIN: 0990-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




923. BLOOD INITIATIVE

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 
USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

CFR Citation:  21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 640; 21 CFR 660; 21 CFR 680

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration is 
proposing to amend the biologics regulations by removing, revising, or 
updating specific regulations applicable to blood derivative products 
to be more consistent with current practices and to remove unnecessary 
or outdated requirements. This action is based on a comprehensive 
review of the regulations that has been performed by FDA. 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; the 
Institute of Medicine; as well as public comments. Some of the subjects 
intended to be addressed in the rulemakings include: ``Lookback'' 
requirements for hepatitis C virus; notification of consignees and end 
users of product safety information for plasma derivative products; and 
notification of permanently deferred donors; requirements for donor 
suitability and testing; viral inactivation. These actions are intended 
to help ensure the continued safety of the nation's blood supply.

Timetable:

Minor Changes to Reqs. for CGMP for Blood and Blood Components  Direct 
Final Rule 06/00/99

Notification of End Users of Plasma Derivative Products  ANPRM 06/00/99

Notification of Permanently Deferred Donors  NPRM 06/00/99

Reqs. Applicable to Albumin (Human), Plasma Protein Fraction  Direct 
Final Rule 06/00/99

Requirements for Donor Testing  NPRM 06/00/99

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM To Be 
Determined

Viral Inactivation  NPRM To Be Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Additional Information: See RIN 0910-AB76.

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Biologics Evaluation and Research (HFM-17), 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852

[[Page 21213]]

Phone: 301 827-6210

RIN: 0910-AB26
_______________________________________________________________________




924. PREGNANCY LABELING REVISION

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 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

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The advance notice of proposed rulemaking will announce that 
the Food and Drug Administration is considering ways to revise the 
regulatory requirements for the pregnancy labeling subsection of the 
labeling requirements for human drugs and biologics. The notice will 
make available preliminary proposals for changing the current 
requirements and will invite comments on all aspects of the notice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB44
_______________________________________________________________________




925. NATURAL RUBBER-CONTAINING DRUGS; USER LABELING

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; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 
USC 379; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The advance notice of proposed rulemaking requests comments 
on requirements under consideration for labeling statements on products 
regulated as drugs (including combination products regulated under drug 
labeling provisions) that contain natural rubber that contacts humans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/00/99
ANPRM Comment Period End        02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB56
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




926. OVER-THE-COUNTER (OTC) DRUG REVIEW

Priority:  Routine and Frequent

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 360a; 21 USC 371a

CFR Citation:  21 CFR 310; 21 CFR 330; 21 CFR 333; 21 CFR 334; 21 CFR 
335; 21 CFR 336; 21 CFR 337; 21 CFR 338; 21 CFR 339; 21 CFR 340; 21 CFR 
341; 21 CFR 342; 21 CFR 343; 21 CFR 344; 21 CFR 345; ...

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. NOTE: NPRM for 
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for 
``Emetic Products'' and reproposed as ``Poison Treatment Products.'' 
NPRM for ``Astringent (Wet Dressings) Products'' was included in the 
NPRM for ``Skin Protectant Products.'' NPRM for ``Diaper Rash 
Products'' was included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' 
``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Fever Blister/Cold Sore Products (External)'' was included in NPRMs 
for ``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Insect Bites and Stings (Relief) Products'' was included in NPRMs for 
``External Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/
Oak/Sumac Prevention'' was included in NPRMs for ``External Analgesic'' 
and ``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) 
Products'' was included in revised NPRM for ``Antimicrobial Products.'' 
NPRM for ``Alcohol (Topical) Products'' was included in revised NPRM 
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' 
was updated and split into two sections: First Aid Products and Health 
Care Antiseptic Products.
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.

[[Page 21214]]



Timetable:

Acne (Topical) Products  ANPRM 03/23/82 (47 FR 12430)  NPRM 01/15/85 
(50 FR 2172)  NPRM (Amendment) 08/07/91 (56 FR 37622)  Final Action 08/
16/91 (56 FR 41008)

Alcohol (Oral) in OTC Drug Products  NPRM 10/21/93 (58 FR 54466)  Final 
Action 03/13/95 (60 FR 13590)  NPRM (Amendment) 05/10/96 (61 FR 
21392)  Final Action (Amendment) 11/18/96 (61 FR 58629)

Anorectal Products  ANPRM 05/27/80 (45 FR 35576)  NPRM 08/15/88 (53 FR 
30756)  Final Action 08/03/90 (55 FR 31776)  Final Action (LYCD) 09/02/
93 (58 FR 46746)  Final Action (Witch Hazel) 06/03/94 (59 FR 28766)

Antacid Drug Products  ANPRM 04/05/73 (38 FR 8714)  NPRM 11/12/73 (38 
FR 31260)  Final Action 06/04/74 (39 FR 9862)  NPRM (Amendment) 
(Overindulgence) 12/24/91 (56 FR 66754)  Final Action (Amendment) 
(Warning) 08/26/93 (58 FR 45204)  NPRM (Amendment) (Testing) 09/23/93 
(58 FR 49826)  NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR 
5060)  Final Action (Technical Amendment) 11/25/94 (59 FR 60555)  Final 
Action (Amendment) (Testing) 02/08/96 (61 FR 4822)  Final Action 
(Amendment)(Sodium B.) 09/00/99

Anthelmintic Products  ANPRM 09/09/80 (45 FR 59541)  NPRM 08/24/82 (47 
FR 37062)  Final Action 08/01/86 (51 FR 27756)

Antibiotic First Aid Products  ANPRM 04/01/77 (42 FR 17642)  NPRM 07/
09/82 (47 FR 29986)  Final Action 12/11/87 (52 FR 47312)  NPRM 
(Amendment) 08/18/89 (54 FR 34188)  Final Action 03/15/90 (55 FR 
9721)  NPRM (Amendment) 05/11/90 (55 FR 19868)  NPRM (Amendment) 06/08/
90 (55 FR 23450)  Final Action (Amendment) 10/03/90 (55 FR 
40379)  Final Action (Amendment) 12/05/90 (55 FR 50171)  NPRM 
(Amendment) (Warning) 02/14/96 (61 FR 5918)  Final Action 
(Amendment)(Warning) 11/15/96 (61 FR 58471)

Anticaries Products  ANPRM 03/28/80 (45 FR 20666)  NPRM 09/30/85 (50 FR 
39854)  NPRM 06/15/88 (53 FR 22430)  Final Action 10/06/95 (60 FR 
52474)  Final Action (Technical Amendment) 10/07/96 (61 FR 52285)

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  NPRM (Amendment)(Trav. Diar.) 10/00/99  Final Action 10/00/
99

Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts)  ANPRM 
01/05/82 (47 FR 444)

Antiemetic Products  ANPRM 03/21/75 (40 FR 12934)  NPRM 07/13/79 (44 FR 
41064)  Final Action 04/30/87 (52 FR 15886)  NPRM (Amendment) 08/26/93 
(58 FR 45216)  Final Action 04/11/94 (59 FR 16981)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)

Antiflatulent Drug Products  NPRM 11/12/73 (38 FR 31260)  Final Action 
06/04/74 (39 FR 19877)  NPRM (Amendment) 01/29/88 (53 FR 2716)  Final 
Action (Amendment) 03/05/96 (61 FR 8836)

Antifungal (Topical) Products  ANPRM 03/23/82 (47 FR 12480)  NPRM 12/
12/89 (54 FR 51136)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25240)  Final Action (Amdt.)(Diaper Rash) 12/18/92 (57 FR 60430)  Final 
Action (Partial) 09/02/93 (58 FR 46744)  Final Action 09/23/93 (58 FR 
49890)

Antimicrobial Products  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25246)  Final 
Action (Diaper Rash) 03/00/04

Antiperspirant Products  ANPRM 10/10/78 (43 FR 46694)  NPRM 08/20/82 
(47 FR 36492)  Final Action 12/00/99

Aphrodisiac Products  ANPRM 10/01/82 (47 FR 43572)  NPRM 01/15/85 (50 
FR 2168)  Final Action 07/07/89 (54 FR 28780)

Aspirin (Heart Labeling Warning)  NPRM 10/20/93 (58 FR 54224)  Final 
Action 06/00/00

Aspirin (Heart Labeling)  Final Action 10/23/98 (63 FR 56802)

Astringent (Wet Dressings) Prdts (Merged w/other rulemkg)  ANPRM 09/07/
82 (47 FR 39436)

Benign Prostatic Hypertrophy Products  ANPRM 10/01/82 (47 FR 
43566)  NPRM 02/20/87 (52 FR 5406)  Final Action 02/27/90 (55 FR 6926)

Boil Ointments  ANPRM 06/29/82 (47 FR 28306)  NPRM 01/26/88 (53 FR 
2198)  Final Action 11/15/93 (58 FR 60332)

Camphorated Oil Drug Products  ANPRM 09/26/80 (45 FR 63869)  Final 
Action 09/21/82 (47 FR 41716)

Cholecystokinetic Products  ANPRM 02/12/80 (45 FR 9286)  NPRM 08/24/82 
(47 FR 37068)  Final Action 06/10/83 (48 FR 27004)  NPRM (Amendment) 
08/15/88 (53 FR 30786)  Final Action (Amendment) 02/28/89 (54 FR 8320)

Corn and Callus Remover Products  ANPRM 01/05/82 (47 FR 522)  NPRM 02/
20/87 (52 FR 5412)  Final Action 08/14/90 (55 FR 33258)

Cough/Cold (Anticholinergic) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 07/09/82 (47 FR 30002)  Final Action 11/08/85 (50 FR 
46582)

Cough/Cold (Antihistamine) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
01/15/85 (50 FR 2200)  NPRM (Amendment) 08/24/87 (52 FR 31892)  Final 
Action 12/09/92 (57 FR 58356)  Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)  NPRM (Amendment)(Diphenhydramine) 08/29/97 (62 FR 
45767)  Final Action 06/00/99

Cough/Cold (Antitussive) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
10/19/83 (48 FR 48576)  Final Action 08/12/87 (52 FR 30042)  NPRM 
(Amendment) 07/06/89 (54 FR 28442)  NPRM (Amendment) 10/02/89 (54 FR 
40412)  Final Action (Amendment) 07/06/90 (55 FR 27806)  Final Action 
(Amendment) 10/03/90 (55 FR 40381)  NPRM (Amendment)(Warning) 06/19/92 
(57 FR 27666)  NPRM (Amendment)(Ingredients) 12/09/92 (57 FR 
58378)  Final Action (Amendment)(Warning) 10/20/93 (58 FR 54232)  Final 
Action (Amdt.)(Ingredients) 06/03/94 (59 FR 29172)  NPRM 
(Amendment)(Diphenhydramine) 08/29/97 (62 FR 45767)  NPRM 
(Amendment)(Flammability) 07/20/98 (63 FR 38762)  Final Action 09/00/99

Cough/Cold (Bronchodilator) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 10/26/82 (47 FR 47520)  Final Action 10/02/86 (51 FR 
35326)  NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54238)  NPRM (Amendment)(MDI) 03/
09/95 (60 FR 13014)  NPRM (Amendment)(Ephedrine) 07/27/95 (60 FR 
38643)  Final Action (Amendment) (MDI) 05/20/96 (61 FR 25142)  NPRM 
(Amendment)(Ephedrine) 06/00/99

[[Page 21215]]

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/95 (60 
FR 10286)  Final Action (Theophylline) 07/27/95 (60 FR 38636)  Final 
Action (Ephedrine Combo) 06/00/99  Final Action 06/00/99

Cough/Cold (Diphenhydramine) Products  Final Action/Enforcement Policy 
04/09/96 (61 FR 15700)

Cough/Cold (Expectorant) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
07/09/82 (47 FR 30002)  Final Action 02/28/89 (54 FR 8494)  Final 
Action (Technical Changes) 06/30/92 (57 FR 29176)

Cough/Cold (Expectorant/Ipecac) Products  Final Action 09/14/92 (57 FR 
41857)

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 01/15/85 (50 FR 2220)  NPRM (Amendment) 06/19/92 (57 FR 
27658)  Final Action 08/23/94 (59 FR 43386)  Final Action; Partial Stay 
03/08/96 (61 FR 9570)  NPRM (Phenylpropanolamine) To Be Determined

Dandruff, Seborrheic Dermatitis and Psoriasis Control Products  ANPRM 
12/03/82 (47 FR 54646)  NPRM 07/30/86 (51 FR 27346)  Final Action 12/
04/91 (56 FR 63554)  NPRM (Amendment) 04/05/93 (58 FR 17554)  Final 
Action 01/28/94 (59 FR 4000)

Daytime Sedatives  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/78 (43 FR 
25544)  Final Action 06/22/79 (44 FR 36378)

Diaper Rash Products (Merged w/other rulemkg)  ANPRM 09/07/82 (47 FR 
39406)

Digestive Aid Products  ANPRM 01/05/82 (47 FR 454)  NPRM 01/29/88 (53 
FR 2706)  Final Action 10/21/93 (58 FR 54450)

Eligibility Criteria for Additional Conditions  ANPRM 10/03/96 (61 FR 
51625)  NPRM 05/00/99

Emetic Products  ANPRM 03/21/75 (40 FR 12939)  NPRM 09/05/78 (43 FR 
39544)  Final Action To Be Determined

Exocrine Pancreatic Insufficiency Products  ANPRM 12/21/79 (44 FR 
75666)  NPRM 11/08/85 (50 FR 46594)  NPRM (Reproposed) 07/15/91 (56 FR 
32282)  Final Action 04/24/95 (60 FR 20162)

External Analgesic Products  ANPRM 12/04/79 (44 FR 69768)  NPRM 02/08/
83 (48 FR 5852)  NPRM (Amendment) (Dandruff) 07/30/86 (51 FR 
27360)  NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592)  NPRM 
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818)  NPRM (Amendment) (Fvr 
Blister/Ext) 01/31/90 (55 FR 3370)  NPRM (Amendment) (1%Hydrocortisone) 
02/27/90 (55 FR 6932)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25234)  Final Action (Diaper Rash) 12/18/92 (57 FR 60426)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)  Final Action To Be 
Determined

Fever Blister Products (Internal)  ANPRM 01/05/82 (47 FR 502)  NPRM 06/
17/85 (50 FR 25156)  Final Action 06/30/92 (57 FR 29166)

First Aid Antiseptic  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Revised) 07/22/91 (56 FR 33644)  Final Action To Be 
Determined

Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other 
rulemkg)  ANPRM 09/07/82 (47 FR 39436)

Hair Grower and Hair Loss Prevention Products  ANPRM 11/07/80 (45 FR 
73955)  NPRM 01/15/85 (50 FR 2190)  Final Action 07/07/89 (54 FR 28772)

Healthcare Antiseptic Products  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/
06/78 (43 FR 1210)  NPRM (Revised) 06/17/94 (59 FR 31402)

Hormone (Topical) Products  ANPRM 01/05/82 (47 FR 430)  NPRM 10/02/89 
(54 FR 40618)  Final Action 09/09/93 (58 FR 57608)

Hypo/Hyperphosphatemia Products  ANPRM 12/09/80 (45 FR 81154)  NPRM 01/
15/85 (50 FR 2160)  Final Action 05/11/90 (55 FR 19852)

Ingrown Toenail Relief Products  ANPRM 10/17/80 (45 FR 69128)  NPRM 09/
03/82 (47 FR 39120)  Final Action 09/09/93 (58 FR 47602)

Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg)  ANPRM 09/
07/82 (47 FR 39412)

Insect Repellent Drug Products (Internal)  ANPRM 01/05/82 (47 FR 
424)  NPRM 06/10/83 (48 FR 26986)  Final Action 06/17/85 (50 FR 25170)

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068)  NPRM 
(Prof. Labeling)(Acute MI) 06/13/96 (61 FR 30002)  NPRM 
(Amendment)(Alcohol Warning) 11/14/97 (62 FR 61041)  Final Action 
(Alcohol Warning) 10/23/98 (63 FR 56789)  Final Action (Aspirin Prof 
Label) 10/23/98 (63 FR 56802)  Final Action (Sodium Bicarbonate) 09/00/
99  NPRM (Labeling-revised indications) 12/00/99  Final Action 
(Labeling-rev. ind.) 12/00/01

Internal Deodorant Products  ANPRM 01/05/82 (47 FR 512)  NPRM 06/17/85 
(50 FR 25162)  Final Action 05/11/90 (55 FR 19862)

Labeling of Drug Products for OTC Human Use  NPRM (Sodium Labeling) 04/
25/91 (56 FR 19222)  NPRM 04/05/93 (58 FR 17553)  Final Action 01/28/94 
(59 FR 3998)  NPRM (Do not mix drugs) 08/03/94 (59 FR 39499)  NPRM 
(Amendment) (Do not mix drugs) 10/04/95 (60 FR 52058)  NPRM (Unless a 
doctor tells you) 03/04/96 (61 FR 8450)  Final Action (Sodium Labeling) 
04/22/96 (61 FR 17798)  NPRM (Calcium/Magnesium/Potassium) 04/22/96 (61 
FR 17807)  NPRM (Unless a doc. tells you)(Wi.) 02/27/97 (62 FR 
9024)  Final Action (Format/Examples) 03/17/99 (64 FR 13254)  Final 
Action (Ca/Mg/K/Na) 08/00/99

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) (Directions/Bulk) 10/01/86 (51 FR 35136)  NPRM 
(Amendment) (Docusate Salts) 09/02/93 (58 FR 46589)  NPRM 
(Amendment)(Sodium Phosphates) 03/31/94 (59 FR 15139)  NPRM 
(Phenolphthalein) 09/02/97 (62 FR 46223)  Final Action (Sodium 
Phosphates) 05/21/98 (63 FR 27836)  NPRM (Amendment)(Phosphates Label) 
05/21/98 (63 FR 27886)  NPRM (Amendment)(Stim. Laxative) 06/19/98 (63 
FR 33592)  Final Action; stay (Na Phos. Enema) 12/07/98 (63 FR 
67399)  Part. With. (Na Phos. Prof. Lab.) 12/09/98 (63 FR 67817)  Final 
Action (Phenolphthalein) 01/29/99 (64 FR 4535)  Final Action 10/00/
99  Final Action (Stim. Laxative) 06/00/00

[[Page 21216]]

Leg Muscle Cramps (Nocturnal Relief) Products  ANPRM 10/01/82 (47 FR 
43562)  NPRM 11/08/85 (50 FR 46588)  Final Action 08/22/94 (59 FR 
43234)

Male Genital Desensitizer Products  ANPRM 09/07/82 (47 FR 39412)  NPRM 
10/02/85 (50 FR 40260)  Final Action 06/19/92 (57 FR 27654)

Menstrual Products  ANPRM 12/07/82 (47 FR 55075)  NPRM 11/16/88 (53 FR 
46194)  Final Action 12/00/01

Mercurial (Active/Inactive)  NPRM To Be Determined

Mercurial (Topical) Products (To be merged w/other rulemkg)  ANPRM 01/
05/82 (47 FR 436)

Nailbiting/Thumbsucking Deterrent Products  ANPRM 10/17/80 (45 FR 
69122)  NPRM 09/03/82 (47 FR 39096)  Final Action 09/02/93 (58 FR 
46749)

Nighttime Sleep Aid Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/
78 (43 FR 25544)  Final Action 02/14/89 (54 FR 6814)  NPRM (Amendment) 
08/26/93 (58 FR 45217)  Final Action (Amendment) 04/11/94 (59 FR 
16982)  NPRM (Amendment) (Warning) 08/29/97 (62 FR 45767)  Final Action 
To Be Determined

NDA Labeling Exclusivity  NPRM 11/09/93 (58 FR 59622)  Final Action To 
Be Determined

Ophthalmic Products  ANPRM 05/06/80 (45 FR 30002)  NPRM 06/28/83 (48 FR 
29788)  Final Action 03/04/88 (53 FR 7076)  Final Action (Anti-
infective) 12/18/92 (57 FR 60416)

Oral Discomfort (Relief) Products  ANPRM 05/25/82 (47 FR 22712)  NPRM 
09/24/91 (56 FR 48302)  Final Action 06/00/02

Oral Health Care Products  ANPRM 05/25/82 (47 FR 22760)  NPRM 01/27/88 
(53 FR 2436)  NPRM (Amendment) (Antimicrobials) 02/09/94 (59 FR 
6084)  ANPRM (Plaque/Gingivitis) 08/00/99  Final Action 12/00/00

Oral Wound Healing Products  ANPRM 11/02/79 (44 FR 63270)  NPRM 07/26/
83 (48 FR 33984)  Final Action 07/18/86 (51 FR 26112)

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) To Be 
Determined

Otic Products (Earwax)  NPRM 07/09/82 (47 FR 30012)  Final Action 08/
08/86 (51 FR 28656)

Otic Products (Swimmers Ear)  NPRM 07/30/86 (51 FR 27366)  Final Action 
02/15/95 (60 FR 8916)  Final Action Partial Stay 08/16/95 (60 FR 42435)

Overindulgence Remedies  ANPRM 10/01/82 (47 FR 43540)  NPRM 12/24/91 
(56 FR 66742)

Overindulgence Remedies/Prevention of Inebriation  ANPRM 10/01/82 (47 
FR 43540)  Final Action 07/19/83 (48 FR 32872)

Pediculicide Products  ANPRM 06/29/82 (47 FR 28312)  NPRM 04/03/89 (54 
FR 13480)  Final Action 12/14/93 (58 FR 65452)  NPRM (Labeling 
Amendment) 12/00/99

Phenylpropanolamine Products (Labeling)  NPRM 02/14/96 (61 FR 
3912)  Final Action To Be Determined

Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg)  ANPRM 09/07/
82 (47 FR 39412)

Poison Treatment Products  NPRM 01/15/85 (50 FR 2244)  NPRM (Amendment) 
04/00/99  Final Action 06/00/99

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 03/20/98 
(63 FR 13526)

Reporting of Adverse Reactions  NPRM 06/00/99

Salicylate (Reye Syndrome)  NPRM (Amendment)(Warning) 05/05/93 (58 FR 
26886)  ANPRM 10/20/93 (58 FR 54228)  Final Action (Warning) 10/00/99

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 12/00/99

Skin Protectant Products  ANPRM 08/04/78 (43 FR 34628)  NPRM 02/15/83 
(48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/89 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/90 (55 FR 25204)  Final Action (Astringent) 10/21/
93 (58 FR 54466)  Final Action (Witch Hazel) 06/03/94 (59 FR 
28767)  Final Action (Poison Ivy) 06/00/99  Final Action 06/00/99

Smoking Deterrent Products  ANPRM 01/05/82 (47 FR 490)  NPRM 07/03/85 
(50 FR 27552)  Final Action 06/01/93 (58 FR 31236)

Status of Certain Category II and III Ingredients  NPRM 05/16/90 (55 FR 
20434)  Final Action 11/07/90 (55 FR 46914)  NPRM 08/25/92 (57 FR 
38568)  Final Action 05/10/93 (58 FR 27636)  NPRM 04/22/98 (63 FR 
19799)

Stimulant (Overindulgence) Products  NPRM (Amendment) 12/24/91 (56 FR 
66758)

Stimulant Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/78 (43 FR 
25544)  Final Action 02/29/88 (53 FR 6100)

Stomach Acidifier Products  ANPRM 10/19/79 (44 FR 60316)  NPRM 01/15/85 
(50 FR 2184)  Final Action 08/17/88 (53 FR 31270)

Sunscreen Products  ANPRM 08/25/78 (43 FR 38206)  NPRM 05/12/93 (58 FR 
28194)  NPRM (Amendment) 06/08/94 (59 FR 29706)  NPRM 
(Amendment)(Avobenzone) 09/16/96 (61 FR 48645)  Final Action 
(Avobenzone Enf. Pol.) 04/30/97 (62 FR 23350)  Final Action 05/00/99

Sweet Spirits of Nitre  ANPRM 02/22/80 (45 FR 11846)  Final Action 06/
27/80 (45 FR 43400)

Topical Drug Products Containing Benzoyl Peroxide (Labeling)  NPRM 02/
17/95 (60 FR 9554)

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 02/
03/95 (60 FR 6892)  NPRM (Amendment) 12/00/99

Vaginal Drug Products  ANPRM 10/13/83 (48 FR 46694)  Withdrawal 02/03/
95 (60 FR 5226)  NPRM (Douches) 06/00/00

Vitamin/Mineral Products  ANPRM 03/16/79 (44 FR 16126)  Withdrawal 11/
27/81 (46 FR 57914)

Wart Remover Products  ANPRM 10/03/80 (45 FR 65609)  NPRM 09/03/82 (47 
FR 39102)  NPRM (Amendment) 03/27/87 (52 FR 9992)  Final Action 08/14/
90 (55 FR 33246)  NPRM (Amendment)(Directions) 01/28/94 (59 FR 
4015)  Final Action (Amdt.)(Directions) 11/23/94 (59 FR 60315)

Water Soluble Gums  NPRM 10/30/90 (55 FR 45782)  Final Action 08/26/93 
(58 FR 45194)

Weight Control Products  ANPRM 02/26/82 (47 FR 8466)  NPRM 10/30/90 (55 
FR 45788)  Final Action 08/08/91 (56 FR 37792)  NPRM (Amendment) To Be 
Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AA06.
NOTE: Reinventing government applies only to the Antacid Drug Products 
final action.

Agency Contact: Rosemary Cook, Supervisor, Project Management Staff, 
Office of Drug Evaluation V, Department of Health and Human Services, 
Food and Drug Administration, Center for Drug Evaluation and Research 
(HFD-105), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2222

RIN: 0910-AA01


_______________________________________________________________________



[[Page 21217]]

927. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 351; 21 USC 352; 21 USC 360d; 21 USC 371; 21 
USC 360j(e)

CFR Citation:  21 CFR 801.420; 21 CFR 801.421

Legal Deadline: None

Abstract: FDA is considering revising its present regulation governing 
the labeling and conditions for sale of hearing aids. The present rule 
requires an examination by a physician before purchase of a hearing 
aid, but permits an informed adult to waive that requirement. There is 
some evidence that this waiver provision is being misused.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/10/93                    58 FR 59695
ANPRM Comment Period End        01/10/94
NPRM                            10/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE46.

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 594-4765

RIN: 0910-AA39
_______________________________________________________________________




928. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 355; 21 USC 371; 21 USC 823; 42 USC 241; 42 
USC 257a; 42 USC 290; 42 USC 300

CFR Citation:  21 CFR 291

Legal Deadline: None

Abstract: The proposed rule will revise the regulations under part 291 
and title 42 to provide for the certification of narcotic treatment 
programs as a basis for fulfilling the Department's requirements of the 
Narcotic Addict Treatment Act of 1974. Certification will be based on 
accreditation by non-profit accrediting bodies. This new system will 
replace the current system which relies solely on direct FDA approval 
and inspection for determining whether narcotic treatment programs 
comply with Federal treatment standards. The proposed rule will provide 
for a transition period for programs operating under the existing 
regulatory system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nicholas Reuter, Associate Director for International 
and Domestic Drug Control, Department of Health and Human Services, 
Food and Drug Administration, Office of Health Affairs (HFY-20), 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-1696
Fax: 301 443-0232
Email: [email protected]

RIN: 0910-AA52
_______________________________________________________________________




929. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW 
DRUG PRODUCTS

Priority:  Routine and Frequent

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 21 USC 381; 21 
USC 382; 21 USC 393; 42 USC 241; 42 USC 243; 42 USC 262

CFR Citation:  21 CFR 312.110

Legal Deadline: None

Abstract: The proposed rule would amend the regulations on the 
exportation of unapproved new drug products, including biological 
products, for investigational use. In general, the proposed 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 recent changes in FDA's 
export authority resulting from the FDA Export Reform and Enhancement 
Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-

[[Page 21218]]

23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




930. ADVERSE DRUG REACTION REPORTING AND RECORDKEEPING REQUIREMENTS FOR 
MARKETED OTC DRUGS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 
USC 375; 21 USC 379; 42 USC 216

CFR Citation:  21 CFR 201; 21 CFR 211; 21 CFR 327; 21 CFR 330

Legal Deadline: None

Abstract: The proposed rule would require manufacturers of marketed 
nonprescription human drug products to report to FDA information they 
receive about adverse drug reactions, maintain records of adverse drug 
reactions, and permit access by FDA to adverse drug reaction records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/00
NPRM Comment Period End         05/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA86
_______________________________________________________________________




931. INFORMED CONSENT FOR HUMAN DRUGS AND BIOLOGICS; DETERMINATION THAT 
INFORMED CONSENT IS NOT FEASIBLE

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 352; 21 USC 353; 21 USC 355; 21 
USC 357; 21 USC 360; 21 USC 371; 21 USC 381; 42 USC 216; 42 USC 241; 42 
USC 262

CFR Citation:  21 CFR 50; 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to revoke the 
interim final rule which permitted the Commissioner to determine, based 
on a request by the Department of Defense, that obtaining informed 
consent from military personnel for the use of investigational products 
is not feasible in certain military combat situations. The rule was 
used to permit a waiver from the informed consent requirements for 
pyridostigmine bromide and the botulinum toxoid vaccine during the Gulf 
War. The agency is proposing this action after reviewing comments it 
received in response to a July 1997 Request for Comment as to whether 
the agency should revise or revoke the rule.
At the same time, it will propose to amend its new drug and biological 
product regulations to identify the kind of evidence needed to 
demonstrate the efficacy of drug and biological products used to treat 
or prevent the toxicity of potentially devastating chemical or 
biological substances when efficacy studies in humans ethically cannot 
be conducted because they would involve administering a lethal or 
permanently disabling toxic substance to healthy human volunteers 
without a proven treatment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bonnie M. Lee, Senior Policy Analyst, Office of the 
Executive Secretariat (HF-40), Department of Health and Human Services, 
Food and Drug Administration, Office of the Commissioner, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 827-4450
Fax: 301 443-1863

RIN: 0910-AA89
_______________________________________________________________________




932. DIRECT-TO-CONSUMER PROMOTION REGULATIONS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 334; 21 USC 351; 21 
USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360e to 360i; 21 
USC 360k; 21 USC 361; 21 USC 362; 21 USC 371

CFR Citation:  21 CFR 200; 21 CFR 800

Legal Deadline: None

Abstract: The Food and Drug Administration will issue proposed 
regulations for direct-to-consumer promotion of human and animal 
prescription drugs, biologics, and restricted devices. The regulations 
will set forth the requirements for what information shall be contained 
in the consumer directed advertisements for these products and how the 
information shall be presented.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99
NPRM Comment Period End         03/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising, 
and Communications, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-40), 
Room 17B-04, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828

RIN: 0910-AA90
_______________________________________________________________________




933. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

[[Page 21219]]

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 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

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The proposed regulation would amend the regulations governing 
the format and content of professional labeling for human prescription 
drug and biologic products, 21 CFR 201.56 and 201.57. The proposal 
would require that professional labeling include a section containing 
highlights of prescribing information, 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. The proposal would also 
eliminate certain unnecessary statements that are currently required to 
appear on prescription drug labels and move certain information to 
patient labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99
NPRM Comment Period End         10/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: Legal Authority continued: 42 USC 216; 42 USC 
241; 42 USC 262; 42 USC 264

Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising, 
and Communications, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-40), 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
Fax: 301 594-6759
  
Lee Korb, Regulatory Counsel, Department of Health and Human Services, 
Food and Drug Administration, Center for Drug Evaluation and Research 
(HFD-7), 1451 Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-5626
Fax: 301 827-5562

RIN: 0910-AA94
_______________________________________________________________________




934. ADVERSE DRUG REACTION REPORTING REQUIREMENTS FOR HUMAN DRUG AND 
BIOLOGICAL PRODUCTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 216; 21 USC 262; 21 USC 263; 21 USC 263a; 21 
USC 264; 21 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 
USC 355; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 20; 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 
600

Legal Deadline: None

Abstract: 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 Harmonization and to define new terms; to 
add to or revise current reporting requirements; to revise certain 
reporting time frames; and to make other revisions to these regulations 
to enhance the quality of adverse drug reaction reports received by 
FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/99
NPRM Comment Period End         01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




935. USE OF OZONE-DEPLETING SUBSTANCES

Priority:  Other 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 346a; 21 USC 348; 21 USC 351; 21 USC 352; 
21 USC 355; 21 USC 360b; 21 USC 361; 21 USC 371

CFR Citation:  21 CFR 2

Legal Deadline: None

Abstract: FDA is proposing to amend the regulation that permits the use 
of ozone-depleting substances in particular circumstances to set the 
standard FDA will use to determine when the use of ozone-depleting 
substances (ODS) is no longer essential under the Clean Air Act (CAA) 
and set a new standard to determine when a new essential-use 
designation should be granted after the effective date of the rule. FDA 
is also proposing to amend the regulations to better conform to other 
statutes and regulations relating to ozone-depleting substances to 
eliminate potential confusion and conflicts. FDA is proposing to 
eliminate out-of-date transitional provisions and make other 
nonsubstantive housekeeping changes to its regulations on ozone-
depleting substances. The intended effect of the proposed rule is to 
protect the health and safety of medical device users while complying 
with the CAA and the Montreal Protocol.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/06/97                    62 FR 10242
ANPRM Comment Period End        05/05/97
NPRM                            09/00/99
NPRM Comment Period End         12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041

[[Page 21220]]

Fax: 301 827-5562

RIN: 0910-AA99
_______________________________________________________________________




936. RADIOACTIVE DRUGS FOR BASIC RESEARCH

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 361

Legal Deadline: None

Abstract: The proposed rule would update FDA's regulations on the use 
of radioactive drugs for basic research to reflect technological 
changes in the field of radiopharmaceuticals. The proposed rule would 
also clarify and correct certain provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99
NPRM Comment Period End         12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB00
_______________________________________________________________________




937. VETERINARY FEED DIRECTIVES

Priority:  Other Significant

Legal Authority:  PL 104-250

CFR Citation:  21 CFR 510; 21 CFR 514; 21 CFR 558

Legal Deadline: None

Abstract: The Animal Drug Availability Act (ADAA) amended the Federal 
Food, Drug, and Cosmetic Act (the act) to create a new section 504, 
Veterinary Feed Directive Drugs (VFD drugs). VFD drugs are animal drugs 
intended for use in or on animal feed which are limited by an approved 
application filed pursuant to section 512(b) of the act for use under 
the professional supervision of a licensed veterinarian in the course 
of the veterinarian's professional practice. This section requires, 
among other things, that the labeling, distribution and use of a VFD 
drug be consistent with its approval; that persons involved in the 
distribution and use of a VFD drug maintain copies of the VFD; and that 
persons distributing animal feed provide a one time notice upon first 
engaging in the distribution of VFD drugs. The proposed rule will 
provide guidance to the industry about how to comply with section 504 
of the act and will serve as a basis for enforcement action.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: George Graber, Department of Health and Human Services, 
Food and Drug Administration, Center for Veterinary Medicine (HFV-220), 
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6651
Fax: 301 594-1812

RIN: 0910-AB09
_______________________________________________________________________




938. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND 
GUIDELINES

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  15 USC 1451 to 1461; 21 USC 41 to 50; 21 USC 141 to 
149; 21 USC 321 to 394; 21 USC 467f; 21 USC 679; 21 USC 821; 21 USC 
1034; 42 USC 201; 42 USC 262; 42 USC 263b; 42 USC 264

CFR Citation:  21 CFR 10; 21 CFR 808

Legal Deadline:  NPRM, Statutory, July 1, 2000.

Abstract: This proposed rule would amend FDA regulations in 21 CFR part 
10 concerning advisory opinions and guidelines to implement the Food 
and Drug Administration Modernization Act of 1997 requirement in 21 
U.S.C. 371(h) to issue regulations on good guidance practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea Masciale, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB14
_______________________________________________________________________




939. EXPORTS; REPORTING AND RECORDKEEPING REQUIREMENTS

Priority:  Routine and Frequent

Legal Authority:  15 USC 1453 to 1455; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 381; 21 
USC 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 243; 42 USC 262

CFR Citation:  21 CFR 1

Legal Deadline: None

Abstract: The proposed rule would establish the recordkeeping and 
notification requirements for persons exporting human drugs, animal 
drugs, biologics, and devices under the FDA Export Reform and 
Enhancement Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB16


_______________________________________________________________________



[[Page 21221]]

940. REGISTRATION OF FOREIGN ESTABLISHMENTS AND PRODUCT LISTING

Priority:  Routine and Frequent

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 352; 21 USC 355; 21 
USC 360; 21 USC 360b to 360c; 21 USC 360e; 21 USC 360i to 360j; 21 USC 
371; 21 USC 374; 42 USC 216; 42 USC 262

CFR Citation:  21 CFR 207; 21 CFR 607; 21 CFR 807

Legal Deadline: None

Abstract: The proposal would amend the establishment registration and 
product listing regulations for human drugs, biologics, animal drugs, 
and devices to require foreign establishments engaged in the 
manufacture, preparation, propagation, compounding, or processing of 
such products that are imported or offered for import into the United 
States to register and to register the name of a United States agent 
for the foreign establishment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB21
_______________________________________________________________________




941. SUITABILITY DETERMINATION FOR DONORS OF HUMAN CELLULAR AND TISSUE-
BASED PRODUCTS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42 
USC 264; 42 USC 271

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

Legal Deadline: None

Abstract: As part of implementing the proposed regulatory approach to 
human cellular and tissue-based products, the Food and Drug 
Administration is proposing to require manufacturers of human cellular 
and tissue-based products to screen and test the donors of cells and 
tissues used in those products for evidence of or risk factors for 
relevant communicable disease. As part of this action, the agency is 
proposing to amend the current good manufacturing practice regulations 
that apply to human cellular and tissue-based products regulated as 
drugs, medical devices, and/or biological products in order to 
incorporate the new donor suitability requirements into existing good 
manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210

RIN: 0910-AB27
_______________________________________________________________________




942. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLULAR 
AND TISSUE-BASED PRODUCTS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42 
USC 264; 42 USC 271

CFR Citation:  21 CFR 1271

Legal Deadline: None

Abstract: As part of implementing the proposed regulatory approach to 
human cellular and tissue-based products, the Food and Drug 
Administration (FDA) is proposing to require manufacturers of human 
cellular and tissue-based products to follow current good tissue 
practice (GTP), which includes proper handling, processing, and storage 
of human cellular and tissue-based products, recordkeeping, and the 
maintenance of a quality program. FDA is also proposing to amend the 
current good manufacturing practice regulations that apply to human 
cellular and tissue-based products regulated as drugs, medical devices, 
and/or biological products in order to incorporate the new GTP 
requirements into existing good manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210

RIN: 0910-AB28
_______________________________________________________________________




943. SHELL EGGS: WARNING, NOTICE AND SAFE HANDLING LABELING STATEMENTS 
AND REFRIGERATION REQUIREMENTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority:  21 USC 321; 42 USC 264

CFR Citation:  21 CFR 101.17(g); 21 CFR 115.50; 21 CFR 16.5

Legal Deadline: None

Abstract: There have been numerous foodborne outbreaks of 
salmonellosis, principally due to Salmonella Enteritidis (SE), that 
have been traced to the consumption of temperature abused and/or 
undercooked shell eggs. The Food and Drug Administration has received 
petitions from Rose Acres Farm, Inc., and the Center for Science in the 
Public Interest that request, in part, that FDA establish safe handling 
statements for shell eggs. FDA intends

[[Page 21222]]

to propose to require safe handling statements on labeling of shell 
eggs that have not been treated to destroy Salmonella microorganisms 
that may be present. In accordance with amendments to the Egg Products 
Inspection Act, USDA published on August 27, 1998, a final rule to 
require that shell eggs be stored at an ambient temperature of 7 
degrees Celsius (45 degrees Fahrenheit). However, the USDA rulemaking 
does not include refrigeration at retail. FDA intends to propose 
regulations to mandate that shell eggs be stored for retail sale at 7 
degrees celsius (45 degrees Fahrenheit) or less. FDA is proposing this 
measure to ensure that shell eggs are handled in a manner to decrease 
the possible growth of any SE that may be present in shell eggs. All of 
these actions are intended to reduce the occurrence of illnesses and 
deaths associated with the consumption of improperly cooked shell eggs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Geraldine A. June, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, (HFS-158), 200 C Street SW., 
Washington, DC 20204
Phone: 202 205-5099
Fax: 202 205-4594
Email: [email protected]

RIN: 0910-AB30
_______________________________________________________________________




944. ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  PL 105-115, sec 125

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would implement the incorporation of 
antibiotics, which were formerly regulated under authority of section 
507 of the Federal Food, Drug, and Cosmetic Act, into the new drug 
regulatory scheme under section 505 of the Act. The regulation will 
describe which antibiotics are excepted under section 125(d) of the 
Food and Drug Administration Modernization Act of 1997 from certain 
provisions in section 505, including the exclusivity provisions under 
sections 505(c) and 505(j) of the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/99
NPRM Comment Period End         11/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne Mitchell, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB33
_______________________________________________________________________




945. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR ANTIBIOTIC 
DRUG; COMPLETE RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/99
NPRM Comment Period End         11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB34
_______________________________________________________________________




946. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 360bbb

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: The proposed rule would revise the investigational new drug 
regulations to clarify the conditions under which individual patients 
may receive investigational drugs for treatment use; to clarify the 
conditions under which a small group of patients may receive 
investigational drugs for treatment use under an expanded access 
protocol; and to clarify the criteria under which sponsors can recover 
costs for providing investigational drugs to patients for certain 
treatment uses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99
NPRM Comment Period End         02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451

[[Page 21223]]

Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB37
_______________________________________________________________________




947. AMENDMENT OF REGULATIONS REGARDING CERTAIN LABEL STATEMENTS ON 
PRESCRIPTION DRUGS

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 126

CFR Citation:  21 CFR 201; 21 CFR 250; 21 CFR 310; 21 CFR 329; 21 CFR 
361; 21 CFR 369

Legal Deadline: None

Abstract: This proposed rule would revise 21 CFR parts 201, 250, 310, 
and 361 by removing the requirement that prescription drugs be labeled 
``Caution: Federal law prohibits the dispensing without prescription'' 
and substituting a requirement that prescription drugs be labeled ``Rx 
only''. The rule would also revise parts 201, 329, and 369 by removing 
the requirement that certain habit-forming narcotics or hypnotics bear 
the statement ``Warning--May be habit forming.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/99
NPRM Comment Period End         08/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB39
_______________________________________________________________________




948. ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION REPORTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 216; 21 USC 262; 21 USC 263; 21 USC 263a; 21 
USC 264; 21 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 251 to 353; 21 
USC 355; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 20; 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 
600

Legal Deadline: None

Abstract: The proposed rule would set forth requirements on the 
electronic submission of adverse drug reaction reports using 
international medical terminology, electronic data format, and 
electronic transmission standards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/05/98                    63 FR 59746
ANPRM Comment Period End        02/03/99
NPRM                            01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB42
_______________________________________________________________________




949. DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING INSULIN

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 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

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The proposed rule would set forth a new system of distinctive 
colors and marks to identify different types of insulin-containing drug 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99
NPRM Comment Period End         02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB43
_______________________________________________________________________




950. PROGESTATIONAL DRUG PRODUCTS FOR HUMAN USE; REQUIREMENTS FOR 
LABELING DIRECTED TO THE PATIENT

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 360b to 360f; 21 USC 360j; 21 USC 361(a); 
21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e

CFR Citation:  21 CFR 310

Legal Deadline: None

Abstract: The proposed rule would revoke 21 CFR 310.516 which requires 
that progestational drug products be dispensed with a patient package 
insert containing a discussion of the risks of birth defects resulting 
from the use of these drugs during the first four months of pregnancy. 
The Food and Drug Administration is proposing to revoke this labeling 
requirement because of changes in the currently available scientific 
information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99
NPRM Comment Period End         07/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451

[[Page 21224]]

Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB45
_______________________________________________________________________




951. SUPPLEMENTAL MANUFACTURING CHANGES FOR NEW ANIMAL DRUGS

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 116

CFR Citation:  21 CFR 514.8

Legal Deadline:  Final, Statutory, November 21, 1999.

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 added a new section to the Federal Food, Drug, and Cosmetic 
Act that sets forth categories for the reporting of manufacturing 
changes to a drug product. These categories are based on the potential 
of the change to adversely affect the identity, strength, quality, 
purity, and potency of the drug as they may relate to the safety and 
effectiveness of the drug. The rulemaking will propose the procedures 
for determining what information the agency would require before drugs 
manufactured subject to these changes may be distributed. The Center 
for Veterinary Medicine is proposing to amend the regulations regarding 
supplementary new animal drug regulations to incorporate the 
requirements of section 116.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Marnane, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-140), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6966
Fax: 301 594-2297

RIN: 0910-AB49
_______________________________________________________________________




952. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED 
FEED

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-25; 21 USC 360b

CFR Citation:  21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

Abstract: In response to a citizen petition filed by the American Feed 
Industry Association, the Food and Drug Administration (FDA) is 
proposing to amend the requirements for liquid medicated animal feed to 
clarify what information and data are required to demonstrate chemical 
and positional stability. The amended regulations would also clarify 
the provisions for the submission of such data through a master file 
and the reference to master files by subsequent applicants. 
Additionally, FDA is proposing to amend the regulations for free-choice 
medicated feed in order to ensure consistency with the requirements for 
liquid medicated feed. Finally, FDA is proposing to amend the 
regulations for free -choice medicated feed and liquid medicated feed 
so that these provisions comply with the terms of the Animal Drug 
Availability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Price, Department of Health and Human Services, 
Food and Drug Administration, Center for Veterinary Medicine (HFV-200), 
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6652

RIN: 0910-AB50
_______________________________________________________________________




953. PHARMACY COMPOUNDING; GENERAL REGULATIONS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 127

CFR Citation:  21 CFR 216

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 USC 353A). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. This rule will 
propose regulations for the interpretation and enforcement of section 
503A. The proposed regulations will delineate the conditions under 
which compounding is exempt from the manufacturing, misbranding, and 
new drug provisions of the Food, Drug, and Cosmetic Act. The proposed 
regulations will also set forth other definitions and conditions for 
distinguishing legitimate pharmacy compounding from pharmaceutical drug 
manufacturing performed under the guise of compounding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB58
_______________________________________________________________________




954. DRUG PRODUCTS THAT PRESENT DEMONSTRABLE DIFFICULTIES FOR 
COMPOUNDING BECAUSE OF REASONS OF SAFETY OR EFFECTIVENESS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 127

CFR Citation:  21 CFR 216

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 USC 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding, and exempts

[[Page 21225]]

compounded drug products, under certain circumstances, from several key 
provisions of the Food, Drug, and Cosmetic Act. Section 503A(b)(3)(A) 
directs FDA to issue by regulation a list of drug products that, if 
compounded, will not qualify for these exemptions because their 
compounding would be demonstrably difficult in terms of assuring the 
safety or effectiveness of the compounded product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB59
_______________________________________________________________________




955. DISCONTINUATION OF A LIFE-SAVING PRODUCT

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 131

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: Section 131 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 506C to the Food, Drug, and 
Cosmetic Act (21 USC 356C). This proposed rule would set forth 
requirements on issues related to the implementation of section 131, 
which requires that the sole manufacturer of certain life-saving drug 
products notify the Secretary of the discontinuance of the manufacture 
of the product at least six months prior to the discontinuance of the 
drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea Masciale, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB60
_______________________________________________________________________




956. MANUFACTURING CHANGES FOR DRUGS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 116

CFR Citation:  21 CFR 314

Legal Deadline:  Final, Statutory, November 21, 1999.

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 506A to the Food, Drug, and 
Cosmetic Act (21 USC 356A). Pursuant to section 116, the rulemaking 
will propose to revise current procedures for approving manufacturing 
changes and generally classify such changes into three categories. 
Major manufacturing changes, which are of a type determined by the 
Secretary to have a substantial potential to adversely affect the 
identity, strength, quality, purity, and potency of the drug as they 
may relate to the safety and effectiveness of a drug, require prior 
approval of a supplemental application. Other changes may be made 
pending review of a supplemental application if FDA has not notified 
the company within 30 days after the submission of a supplement that 
prior approval is required. The proposed rule would also identify 
another category of changes that may be made without the submission of 
a supplement but which must be reported in an annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB61
_______________________________________________________________________




957. PEDIATRIC STUDIES OF DRUGS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 111

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: Section 111 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 505A to the Food, Drug, and 
Cosmetic Act (21 USC 355A). Section 505A permits certain applications 
to obtain an additional six months of marketing exclusivity if, in 
accordance with the requirements of the statute, the sponsor submits 
information relating to the use of the drug in the pediatric 
population. The proposed regulations would implement the pediatric 
exclusivity provisions of section 111. FDA is proposing to amend 21 CFR 
part 314 to add pediatric exclusivity to FDA's new drug product 
exclusivity regulations. FDA is also proposing to add new regulations 
describing the requirements an applicant must fulfill in order to 
qualify for pediatric exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99
NPRM Comment Period End         02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041

[[Page 21226]]

Fax: 301 827-5562

RIN: 0910-AB62
_______________________________________________________________________




958. 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                            09/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB63
_______________________________________________________________________




959. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING AND NUTRIENT 
CONTENT CLAIMS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 343; 21 USC 371

CFR Citation:  21 CFR 101

Legal Deadline: None

Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act, 
which was added by the Nutrition Labeling and Education Act of 1990, 
requires that the label or labeling of food products bear nutrition 
information. Among other things, section 403(q) authorizes the Food and 
Drug Administration (FDA) to add or delete nutrients that are to be 
declared on the labels or labeling of food products by regulation if it 
finds such action necessary to assist consumers in maintaining healthy 
dietary practices. In response to this section, FDA published a 
proposal on November 27, 1991 (56 FR 60366). Among other things, FDA 
discussed including trans fatty acids among the nutrients that could 
voluntarily be listed on the nutrition label but concluded that there 
was no basis for doing so. On January 6, 1993, FDA issued a final rule 
entitled ``Food Labeling: Mandatory Status of Nutrition Labeling and 
Nutrient Content Revision, Format for Nutrition Label'' (58 FR 2079) 
prescribing how nutrition labeling is to be provided on the food. Based 
on its review of the comments to the proposal, the agency stated that 
it was premature to consider the listing of trans fatty acids on the 
nutrition label because of a lack of consensus on the dietary 
implications of trans fatty acids intake. However, the agency 
acknowledged that it might be necessary to readdress the labeling of 
trans fatty acids in the future. FDA subsequently received a citizen 
petition requesting that FDA amend the definition of saturated fatty 
acid in section 101.9(c)(2)(i) to include trans fatty acid. In response 
to this petition and based on new evidence, FDA is proposing to amend 
its regulations to provide for the declaration of trans fatty acids in 
nutrition labeling, to add a requirement that prevents foods from 
bearing nutrient content claims for saturated fat (i.e., saturated 
fatty acids) and cholesterol if they contain trans fatty acids above a 
specified level, and to define a ``trans fatty acids free'' nutrient 
content claim.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Susan Thompson, Chemist, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, (HFS-165), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5587
Fax: 202 205-5532
Email: [email protected]

RIN: 0910-AB66
_______________________________________________________________________




960. DESIGNATED JOURNALS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 510.95

Legal Deadline: None

Abstract: FDA intends to remove this rule. The current rule lists the 
veterinary and scientific journals available in FDA's library and 
allows sponsors to reference an article from a listed journal in 
applications rather than submitting a copy of the article. FDA is 
taking this action because the list of journals is outdated and is no 
longer being used by sponsors except on an extremely limited basis. 
Also, the application of this rule is not an efficient use of agency 
resources.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Margaret Miller, Deputy Director, Office of New Animal 
Drug Evaluation, Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 594-1620

RIN: 0910-AB67
_______________________________________________________________________




961. 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

[[Page 21227]]

reach an agreement establishing a submission or investigational 
requirement. This rule would describe how to request a presubmission 
conference and describe the procedures for the conduct of presubmission 
conferences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-100), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0205
Fax: 301 594-2297

RIN: 0910-AB68
_______________________________________________________________________




962. CLASSIFICATION OF SHEEP AS A MINOR SPECIES FOR ALL DATA COLLECTION 
PURPOSES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 514.1

Legal Deadline: None

Abstract: This rule would amend 21 CFR 514.1(d) to state that sheep are 
minor species for all data collection purposes, thereby allowing 
extrapolation from major species data and limited studies to fulfill 
the human food safety data requirements for New Animal Drug 
Applications. Sheep were originally classified as major species for 
human food safety requirements based upon certain expectations of 
consumption levels. However, over the years, domestic production of 
sheep for food has declined drastically.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Margaret Oeller, Veterinary Medical Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-130), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-7581

RIN: 0910-AB69
_______________________________________________________________________




963. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  21 USC 351; 21 USC 352; 21 USC 360b; 21 USC 371; 21 
USC 374

CFR Citation:  21 CFR 225

Legal Deadline: None

Abstract: Proposal is in response to a citizen petition request to 
merge the separate requirements of the current good manufacturing 
practice (CGMP) regulations, 21 CFR part 225 applicable to licensed and 
unlicensed feed manufacturing facilities, respectively. The merger 
would produce a single set of updated, streamlined CGMPs that apply to 
all medicated feed manufacturers. This consolidation of existing CGMPs 
would preserve and strengthen food safety, be more appropriate given 
the changing structure of the medicated feed industry, and enhance 
uniformity and enforcement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Procurement: This is a procurement-related action for which there is no 
statutory requirement. There is a paperwork burden associated with this 
action.

Agency Contact: George Graber, Director, Division of Animal Feeds, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine (HFV-220), 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6651
Fax: 301 594-1812
Email: [email protected]

RIN: 0910-AB70
_______________________________________________________________________




964. IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE ANIMAL 
DRUG AVAILABILITY ACT OF 1996 AND THE SAFE LEVEL PROVISIONS OF THE 
ANIMAL MEDICINAL DRUG CLARIFICATION ACT OF 1994

Priority:  Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 556

Legal Deadline: None

Abstract: Section 4 of the Animal Drug Availability Act of 1996 (Pub. 
L. 104-250) permits the Secretary of HHS establish tolerances for 
animal drugs used or intended for use in animals grown in an exporting 
nation from which an edible portion is imported into the United States. 
The standards used to establish tolerances are to be similar to the 
food safety criteria used by the Secretary to establish tolerances for 
drugs administered to animals grown in the United States. The data used 
for establishing the tolerances may be from the manufacturer and 
include data upon which a foreign approval is based or data available 
to an international organization such as the Codex Alimentarius 
Commission. The Animal Medicinal Drug Clarification Act of 1994 (Pub. 
L. 103-396) allows the Secretary to establish a safe level for a 
residue of an animal drug when the drug is used in an extralabel 
manner, if the Secretary finds that there is a reasonable probability 
that an extralabel use may present a risk to the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Margaret Miller, Deputy Director, Office of New Animal 
Drug Evaluation, Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 594-1620

RIN: 0910-AB71


_______________________________________________________________________



[[Page 21228]]

965. MANDATORY HACCP REGULATIONS FOR MANUFACTURERS OF RENDERED PRODUCTS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 
USC 371

CFR Citation:  21 CFR 589

Legal Deadline: None

Abstract: During the notice and comment rulemaking for 21 CFR part 589, 
``Listing of Specific Substances Prohibited from Use in Animal Food or 
Feed; Animal Proteins Prohibited in Ruminant Feed;'' FDA received 
several comments supporting the application of mandatory Hazard 
Analysis Critical Control Point (HACCP) regulations for renderers. Some 
of these comments were from renderers. Because of the need to expedite 
the rulemaking for 21 CFR part 589, FDA stated that it would take up 
the HACCP regulations for renderers as a separate initiative. This 
rulemaking is to address the need expressed in the comments to 21 CFR 
part 589 by promulgating mandatory HACCP regulations for renderers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Daniel G. McChesney, Team Leader, Feed Safety Team, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine (HFV-222), 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6653

RIN: 0910-AB72
_______________________________________________________________________




966. SURGEON'S AND PATIENT EXAMINATION GLOVES; RECLASSIFICATION

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 352; 21 USC 
357; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 
USC 360l; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 801.440; 21 CFR 878.4460; 21 CFR 878.4461; 21 CFR 
880.6250; 21 CFR 880.6251

Legal Deadline: None

Abstract: FDA is considering revising its present regulations governing 
the classification of surgeon's and patient examination gloves. The 
present rule classifies surgeon's and patient examination gloves as 
class I devices. FDA is considering reclassifying surgeon's and patient 
examination gloves as class II devices subject to special controls. FDA 
is also considering requiring additional labeling concerning powder and 
protein levels for these devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 594-4765

RIN: 0910-AB74
_______________________________________________________________________




967. CURRENT GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD 
COMPONENTS: NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD 
COMPONENTS AT INCREASED RISK FOR TRANSMITTING HCV INFECTION

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 
USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

CFR Citation:  21 CFR 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 a comprehensive review of the 
regulations performed by FDA, and are 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; the Institute of Medicine, as well as public 
comments. In this rulemaking, FDA will propose to 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 at increased risk for transmitting hepatitis 
C virus (HCV) infection have been collected from a donor who, at a 
later date, tested repeatedly reactive for evidence of HCV.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: See RIN 0910-AB26.

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Biologics Evaluation and Research (HFM-17), 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210

RIN: 0910-AB76
_______________________________________________________________________




968.  ANTIBIOTIC RESISTANCE LABELING

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 371; 
21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; ...

CFR Citation:  21 CFR 201.57

Legal Deadline: None

Abstract: The proposed rule would require the inclusion of statements 
on

[[Page 21229]]

antibiotic prescription drug labeling concerning inappropriate 
antibiotic use and the prevalence of drug resistant microorganisms.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/99
NPRM Comment Period End         11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB78
_______________________________________________________________________




969.  FIXED-COMBINATION DOSAGE FORM PRESCRIPTION DRUGS FOR HUMAN 
USE

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 360b; 21 USC 361; 21 USC 371

CFR Citation:  21 CFR 300.50

Legal Deadline: None

Abstract: The proposed rule would amend 21 CFR 300.50 which states that 
two or more drugs may be combined in a single dosage form when each 
component makes a contribution to the claimed effects and the dosage of 
each component is such that the combination is safe and effective for a 
significant patient population requiring such concurrent therapy as 
defined in the labeling for the drug. The proposed rule would state how 
this provision will apply to fixed combination prescription drugs 
derived from two or more botanical raw materials.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/99
NPRM Comment Period End         01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB79
_______________________________________________________________________




970.  180-DAY GENERIC DRUG EXCLUSIVITY FOR ABBREVIATED NEW DRUG 
APPLICATIONS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation:  21 CFR 314.107

Legal Deadline: None

Abstract: The proposed rule would amend regulations governing 180-day 
generic drug exclusivity to clarify existing eligibility requirements 
and conditions for abbreviated new drug application sponsors, to modify 
current eligibility requirements, and to impose new eligibility 
conditions. These revisions are the result of a court decision in Mova 
Pharmaceutical v. Shalala, 140 F. 3d 1060 (D.C. Cir. 1998), 
invalidating an eligibility requirement for exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99
NPRM Comment Period End         10/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB80
_______________________________________________________________________




971.  REPACKAGING APPROVAL REQUIREMENTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would set forth requirements for FDA prior 
approval of certain types of repackaging of approved drug products by 
persons who are not holders of approved applications for the products. 
The proposed rule would ensure that FDA approves changes to drug 
product containers and closure systems by both application holders and 
repackagers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99
NPRM Comment Period End         02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB81
_______________________________________________________________________




972.  STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would specify required stability data that 
must be submitted with new drug applications.

[[Page 21230]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99
NPRM Comment Period End         12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB82
_______________________________________________________________________




973.  POSTMARKETING STUDIES FOR HUMAN DRUGS AND LICENSED 
BIOLOGICAL PRODUCTS: STATUS REPORTS

Priority:  Other Significant

Legal Authority:  PL 105-115

CFR Citation:  21 CFR 314.81; 21 CFR 601.70

Legal Deadline:  Other, Statutory, October 1, 2001.
Section 130(b) requires the FDA to report by 10/01/01 to the House and 
Senate committees summarizing submitted postmarketing study reports 
evaluating sponsor performance and the timeliness

Abstract: Section 130(a) of the Food and Drug Administration 
Modernization Act of 1997 adds a new section 506B to the Federal Food, 
Drug, and Cosmetic Act requiring a drug sponsor that has agreed to 
conduct a postmarketing study to submit within one year after the 
drug's approval and annually thereafter until the study's conclusion, 
(1) A progress report or, (2) an explanation of why no study has been 
conducted.
Any information pertaining to postmarketing study reports will be 
considered public to identify the sponsor or explain the status of the 
study or why it has not been carried out. FDA is required to publish 
annually in the Federal Register the status of postmarketing studies 
that sponsors have agreements to conduct and those with filed reports.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99
NPRM Comment Period End         09/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Description of Legal Deadline continued... of 
FDA review.

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB83
_______________________________________________________________________




974.  AMENDMENT OF VARIOUS FOOD ADDITIVE AND DEVICE REGULATIONS 
TO REFLECT CURRENT AMERICAN SOCIETY FOR TESTING AND MATERIALS CITATIONS

Priority:  Routine and Frequent

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 341; 21 USC 342; 21 
USC 343; 21 USC 346; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 360i; 
21 USC 360j; 21 USC 371; 21 USC 373; 21 USC 374; 21 USC 379e

CFR Citation:  21 CFR 172.210; 21 CFR 172.250; 21 CFR 172.615; 21 CFR 
172.862; 21 CFR 172.864; 21 CFR 172.882; 21 CFR 173.25; 21 CFR 175.250; 
21 CFR 175.270; 21 CFR 175.300; 21 CFR 176.170; 21 CFR 176.180; 21 CFR 
177.1040; 21 CFR 177.1200; 21 CFR 177.1210; ...

Legal Deadline: None

Abstract: The proposed rule would amend various food additive and 
medical device regulations. The amendments would update the references 
in those regulations to various standards of the American Society for 
Testing and Materials (ASTM) to reflect the current standards 
designations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB84

[[Page 21231]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




975. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE 
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT (GADPTRA)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 360b; 21 
USC 371; 21 USC 379e; 21 USC 381

CFR Citation:  21 CFR 514

Legal Deadline:  Final, Statutory, November 16, 1989.
The deadline applies to the GADPTRA sections. There is no deadline 
relating to the other sections.

Abstract: On December 17, 1991, the Agency published a proposed 
revision of the existing regulations that is consistent with the 
current procedural regulations for human drugs, where appropriate. The 
New Animal Drug Application (NADA) revisions articulate general 
requirements in regulations containing performance standards and would 
complement these regulations through detailed guidances on, among other 
matters, appropriate ways of meeting requirements for submission of 
chemistry, pharmacology, and statistical data that would better address 
the intricate scientific issues involved. A separate proposed rule for 
reporting requirements for marketed animal drugs also was published on 
that date. The agency intends to repropose the NADA proposed rule to 
incorporate some recent changes in procedure. The NADA revisions are 
expected to include regulations to implement the provisions of the 
Animal Drug Availability Act of 1996, specifically the definition of 
flexible labeling, and implement parts of the President's National 
Performance Report ``Reinventing the Regulation of Animal Drugs,'' May 
1996. In the reinventing regulations report, FDA proposed to revise its 
regulations to reflect numerous new process changes and programs that 
will maintain safety and effectiveness of new animal drugs and enable a 
more streamlined animal drug application review and approval process 
which will result in less regulatory burden upon industry and FDA. The 
Agency also proposes to amend its regulations to implement title I of 
the Generic Animal Drug and Patent Term Restoration Act, which 
established new standards for marketing approval of generic copies of 
animal drugs approved after 1962.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM To 
Be Determined

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 12/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AA96.
For information concerning reporting requirements for marketed animal 
drugs, contact William C. Keller, Director, Division of Epidemiology 
and Surveillance, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-
6642. For further information concerning generic animal drugs, contact 
Lonnie W. Luther, Chief, Quality Assurance Support Team, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, (301) 827-0209.

Agency Contact: Margaret Miller, Deputy Director, Office of New Animal 
Drug Evaluation, Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 594-1620

RIN: 0910-AA02
_______________________________________________________________________




976. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION, 
GUIDANCE, AND CLARIFICATIONS

Priority:  Other Significant

Legal Authority:  PL 100-293 Prescription Drug Marketing Act of 1987

CFR Citation:  21 CFR 203

Legal Deadline: None

Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended 
the Federal Food, Drug, and Cosmetic Act to: (1) require State 
licensing of wholesale distributors of prescription human drugs under 
Federal guidelines including minimum standards for storage, handling, 
and recordkeeping; (2) ban the reimportation of prescription human 
drugs produced in the United States, except when reimported by the 
manufacturer or for emergency use; (3) ban the sale, trade, or purchase 
of drug samples; (4) ban trafficking in or counterfeiting of drug 
coupons; (5) mandate storage, handling, and recordkeeping requirements 
for drug samples; (6) require licensed practitioners to request drug 
samples in writing; (7) prohibit, with certain exceptions, the resale 
of prescription human drugs purchased by hospitals or health care 
facilities; and (8) set forth criminal and civil penalties for 
violations of these provisions. In the Federal Register of September 
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal 
guidelines for State licensing of wholesale drug distributors. This 
final rule would provide information, guidance, and clarification of 
those sections of PDMA that are not related to State licensing of 
wholesale distributors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/94                    59 FR 11842
NPRM Comment Period End         08/01/94
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD44.

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041

[[Page 21232]]

Fax: 301 827-5562

RIN: 0910-AA08
_______________________________________________________________________




977. FRUIT AND VEGETABLE JUICES: DEVELOPMENT OF HACCP AND LABEL WARNING 
STATEMENTS FOR JUICES

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  21 USC 321 et seq; 42 USC 264

CFR Citation:  21 CFR 120

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) announced in an 
advance notice of proposed rulemaking of August 4, 1994, its plans to 
consider the development of regulations establishing requirements for a 
new comprehensive food safety assurance program that would be based on 
the principles of Hazard Analysis Critical Control Points (HACCP). The 
new food safety program would respond to new challenges, such as new 
food processing and packaging technologies, new food distribution and 
consumption patterns, exposure to industrial chemicals and chemical 
waste, the increasing importation of foods, new microbial pathogens, 
and resource constraints. Current information shows that the most 
serious of these challenges is presented by food-borne pathogens. The 
number of recognized food-borne pathogens has broadened considerably, 
as has the awareness of long-term complications from certain food-borne 
illnesses--such as arthritis, heart disease, and kidney and 
neurological damage. To meet such challenges, FDA intends to shift the 
focus of its food safety assurance program away from periodic visual 
inspection and end-product testing and toward prevention of food safety 
risks and problems, utilizing the state-of-the-art HACCP preventive 
approach. A first step was taken when FDA published a HACCP regulation 
for fish and fishery products on December 18, 1995. Consistent with 
FDA's HACCP efforts, USDA published a HACCP regulation for meat and 
poultry on July 25, 1996. FDA proposed on April 24, 1998 to adopt a 
HACCP regulation for the processing of juice. The agency simultaneously 
proposed to require a warning statement on the labels or in labeling 
for juice products that have not been processed to reduce, control, or 
eliminate the presence of harmful bacteria. Such labeling would serve 
to reduce the risk of food-borne illness, pending development of a 
final HACCP rule for juice. As part of the development of the HACCP 
proposal, FDA considered information obtained during agency HACCP pilot 
activities, and comments and scientific and technological information 
relating to fresh juices provided during and after an agency public 
meeting on juice held on December 16 and 17, 1996. On July 8, 1998, the 
agency finalized the warning statement requirement. FDA held two 
technical scientific workshops, one November 12, 1998, in Lake Alfred, 
Florida and the other November 29, 1998, in Irvine, California, to 
discuss and clarify issues related to the implementation of the 
agency's rule requiring a warning statement for certain juice products. 
The workshops addressed citrus juice production and the methods for 
measuring and validating such systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/04/94                    59 FR 39888
ANPRM Comment Period End        12/02/94
Economic Analysis for Juice HACCP and Labeling  PRIA 05/01/98 (63 FR 
24254)  PRIA Comment Period End 06/22/98

HACCP for Juice  NPRM 04/24/98 (63 FR 20450)  NPRM Comment Period End 
08/07/98  NPRM Comment Period Reopened 12/17/98 (63 FR 69579)  NPRM 
Reopened Comment Period End 01/19/99  Final Action 01/00/00

Label Warning Statements for Juice  Notice of Intent 08/28/97 (62 FR 
45593)  NPRM 04/24/98 (63 FR 20496)  NPRM Comment Period End 06/21/
98  Final Action 07/08/98 (63 FR 37029)

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE60.

Agency Contact: John E. Kvenberg, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition (HFS-10), 200 C Street SW., Washington, DC 20204
Phone: 202 205-4020
Fax: 202 205-4018
Email: [email protected]

RIN: 0910-AA43
_______________________________________________________________________




978. CURRENT GOOD MANUFACTURING PRACTICE; AMENDMENT OF CERTAIN 
REQUIREMENTS FOR FINISHED PHARMACEUTICALS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 351 to 352; 21 USC 355; 21 USC 
360b; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 210.3; 21 CFR 211.22; 21 CFR 211.68; 21 CFR 
211.82; 21 CFR 211.84; 21 CFR 211.101; 21 CFR 211.103; 21 CFR 211.110; 
21 CFR 211.111; 21 CFR 211.113; 21 CFR 211.115; 21 CFR 211.160; 21 CFR 
211.166; 21 CFR 211.192; 21 CFR 211.220; ...

Legal Deadline: None

Abstract: FDA is finalizing revisions to the current good manufacturing 
practice (CGMP) regulations at 21 CFR parts 210 and 211 regarding 
finished pharmaceuticals. The new regulations codify current agency 
policies or current industry practices. Among other things, the rule 
will create or clarify requirements for process and methods validation, 
appropriate laboratory testing procedures, and protection against 
contamination. The rule is designed to update the CGMP regulations in 
response to technological changes and the agency's experience with the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/96                    61 FR 20104
NPRM Comment Period End         09/30/96
Final Action                    12/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE63.

Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA45


_______________________________________________________________________



[[Page 21233]]

979. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 371

CFR Citation:  21 CFR 320

Legal Deadline: None

Abstract: The final rule revises and clarifies certain sections of part 
320 and eliminate duplication and inconsistencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/19/98                    63 FR 64222
NPRM Comment Period End         02/02/99
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA51
_______________________________________________________________________




980. PARENTERAL DRUG PRODUCTS CONTAINING ALUMINUM AS AN INGREDIENT OR 
CONTAMINANT; LABELING REQUIREMENTS; WARNING STATEMENT

Priority:  Other Significant. 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 371; 21 USC 374; 21 USC 379; 42 USC 
216; 42 USC 241; 21 USC 262; 21 USC 264

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The rule will establish a maximum level of aluminum permitted 
in large volume parenterals used in total parenteral nutrition therapy; 
require that the maximum aluminum content present at the time of 
release be stated on the immediate container label of certain small 
volume parenterals and pharmacy bulk packages; require that the package 
insert of all parenterals include a warning statement on the effects of 
aluminum toxicity in patients with impaired kidneys receiving total 
parenteral nutrition therapy; and require manufacturers to develop 
validated assay methods for determining the aluminum content.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/05/98                      63 FR 176
NPRM Comment Period End         04/06/98
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA74
_______________________________________________________________________




981. NEW DRUG APPLICATIONS; DRUG MASTER FILE

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 371; 21 USC 374; 21 USC 379

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The final rule eliminates Type I Drug Master Files, which 
contain information about manufacturing sites, facilities, operating 
procedures, and personnel, because these files contain outdated 
information, duplicate information contained in marketing applications, 
and are not used by application review divisions or field inspectors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/03/95                    60 FR 34486
NPRM Comment Period End         10/02/95
Final Action                    05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Lee D. Korb, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA78
_______________________________________________________________________




982. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 360; 21 USC 371

CFR Citation:  21 CFR 201; 21 CFR 330

Legal Deadline: None

Abstract: The final rule will provide standardized format and content 
requirements for over-the-counter (OTC) drug product labeling, 
including legibility and design features for the presentation of such 
information as the uses for the drug, directions for use, warnings, 
drug interactions, active ingredients, and other information that the 
consumer would need to know to use the product safely and effectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/27/97                     62 FR 9024
NPRM Comment Period End         10/06/97                    62 FR 33379
Reopening of Comment Period 
(Study B)                       12/30/97                    62 FR 67770
Reopening of Comment Period 
(Study A)                       02/13/98                     63 FR 7331
Final Action                    04/00/99

[[Page 21234]]

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Debra Bowen, M.D., Division of OTC Drug Evaluation, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research (HFD-560), 9201 Corporate 
Blvd., Rockville, MD 20850
Phone: 301 827-2222

RIN: 0910-AA79
_______________________________________________________________________




983. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS FOR DRUGS FOR 
LIFE-THREATENING ILLNESSES

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: The final rule amends the provisions governing 
investigational new drug applications to permit FDA to place a clinical 
hold on one or more studies under an IND involving a drug that is 
intended to treat a life-threatening disease affecting both genders if 
men or women with reproductive potential who have the disease are 
excluded from eligibility in any phase of the investigation because of 
a risk or potential risk of reproductive or developmental toxicity from 
use of the investigational drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/24/97                    62 FR 49946
NPRM Comment Period End         12/23/97
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea Masciale, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-5), 1451 Rockville Pike, Suite 6027, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA84
_______________________________________________________________________




984. STERILITY REQUIREMENTS FOR INHALATION SOLUTION PRODUCTS

Priority:  Other Significant. 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 371; 21 USC 374 to 375

CFR Citation:  21 CFR 200

Legal Deadline: None

Abstract: The final rule requires that all inhalation solution products 
be manufactured to be sterile. Based on reports of adverse drug 
experiences from contaminated nonsterile inhalation solution products 
and recalls of these products, FDA is taking this action to prevent 
future additional adverse health consequences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/97                    62 FR 49638
NPRM Comment Period End         12/22/97
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA88
_______________________________________________________________________




985. CURRENT GOOD MANUFACTURING PRACTICE; REVISION OF CERTAIN LABELING 
CONTROLS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 360b; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 210; 21 CFR 211

Legal Deadline: None

Abstract: The final rule amends the labeling control provisions in the 
current good manufacturing practice regulations to make the provisions 
less burdensome while still reducing the frequency of drug product 
mislabeling and associated drug product recalls associated with cut 
labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
NPRM Comment Period End         10/27/97
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA98
_______________________________________________________________________




986. DEFINITION OF SUBSTANTIAL EVIDENCE

Priority:  Other Significant

Legal Authority:  21 USC 360b; PL 104-250

CFR Citation:  21 CFR 514.4

Legal Deadline:  NPRM, Statutory, October 9, 1997. Final, Statutory, 
October 9, 1998.

Abstract: The Animal Drug Availability Act (ADAA) requires FDA to issue 
within 24 months after the date of its enactment final regulations to 
encourage dose range labeling and to further define the term 
``substantial evidence,'' as the term is defined in section 512(d)(3) 
of the Federal Food, Drug, and Cosmetic Act, as amended by the ADAA, in 
a manner that encourages the submission of applications and 
supplemental applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
NPRM                            11/05/97                    62 FR 59830
Final Action                    07/00/99

[[Page 21235]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-100), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0205
Fax: 301 594-2297

RIN: 0910-AB08
_______________________________________________________________________




987. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR PATENT 
HOLDER NOTIFICATION

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 314

Legal Deadline: None

Abstract: This final rule will clarify the methods by which application 
holders may provide notice to patent holders.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/06/98                    63 FR 11174
NPRM Comment Period End         06/04/98
Final Action                    11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB12
_______________________________________________________________________




988. MEDICATED FEED MILL LICENSES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-250

CFR Citation:  21 CFR 5; 21 CFR 207; 21 CFR 225; 21 CFR 510; 21 CFR 
514; 21 CFR 515; 21 CFR 558

Legal Deadline: None

Abstract: The Animal Drug Availability Act of 1996 (ADAA) amends 
sections 512(a) and 512(m) of the Federal Food, Drug, and Cosmetic Act 
(the act) to require a single facility license for the manufacture of 
feeds containing approved new animal drugs, rather than multiple 
medicated feed applications (MFAs) for each feed mill, as previously 
required by the act. Prior to the passage of the ADAA, an approved 
medicated feed application was required by the act for the manufacture 
of medicated feed. The ADAA eliminates the requirement that a feed mill 
submit a separate medicated feed application for the manufacture of 
each type of medicated feed and instead provides for feed mills to be 
licensed and allows a licensed facility to manufacture any feed 
containing an approved new animal drug. Additionally, the act, as 
amended by the ADAA, provides the agency with the authority to exempt 
facilities that manufacture certain types of medicated feed from the 
requirement of a medicated feed mill license.
The Food and Drug Administration published on July 30, 1997, a proposed 
rule to amend the animal drug regulations and add a new part (21 CFR 
515) to provide for feed mill licensing in accordance with the ADAA. 
The proposed regulation implements the requirements for feed mill 
licensing set forth in the ADAA. Under this proposal, those medicated 
feeds exempted from the MFA requirement under 21 CFR 558.4 will also be 
exempt from the requirement of a medicated feed mill license.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/97                    62 FR 40765
NPRM Comment Period End         10/28/97
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William D. Price, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6652
Fax: 301 594-4512

RIN: 0910-AB18
_______________________________________________________________________




989. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN 
GOVERNMENT OFFICIALS

Priority:  Info./Admin./Other

Legal Authority:  5 USC 552; 18 USC 1905; 19 USC 2531 to 2582; 21 USC 
321 to 393; 21 USC 1401 to 1403; 42 USC 241; 42 USC 242; 42 USC 242a; 
42 USC 242e; 42 USC 242l; 42 USC 242n; 42 USC 243; 42 USC 262; 42 USC 
263; 42 USC 263b to 263n

CFR Citation:  21 CFR 20.88; 21 CFR 20.89

Legal Deadline: None

Abstract: The final rule would amend the regulations governing 
communications with State and foreign government officials. The 
proposed rule would permit the Food and Drug Administration (FDA) to 
disclose confidential commercial information to international 
organizations having responsibility to facilitate global or regional 
harmonization of standards and requirements. These disclosures would, 
in almost all instances, occur only with the consent of the person 
providing the confidential commercial information to FDA. The proposed 
rule would also eliminate the need for a written statement by a State 
or foreign government official establishing that government's ability 
to protect from public disclosure nonpublic, predecisional documents 
(such as draft rules and guidance documents) provided by FDA that do 
not include confidential commercial information. These changes are 
intended to facilitate information exchanges with State and foreign 
governments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/27/98                    63 FR 40069
NPRM Comment Period End         10/13/98
Final Rule                      04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: 5 USC 552

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906

[[Page 21236]]

Email: [email protected]

RIN: 0910-AB22
_______________________________________________________________________




990. 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

Priority:  Substantive, Nonsignificant

Legal Authority:  15 USC 1453 to 1455; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 
USC 381; 21 USC 382; 21 USC 393; 42 USC 216

CFR Citation:  21 CFR 1.84

Legal Deadline: None

Abstract: The proposed rule would establish reporting and recordkeeping 
requirements to implement sections 801(d)(3) and 801(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food 
and Drug Administration (FDA) Export Reform and Enhancement Act of 
1996. Section 801(d)(3) of the act provides that, under prescribed 
conditions, drug and device components, food and color additives, and 
dietary supplements may be imported if they are to be further processed 
or incorporated into products that are to be exported from the United 
States in accordance with sections 801(e) or 802 of the act or section 
351(h) of the Public Health Service (PHS) Act. Section 801(d)(4) of the 
act provides that blood, blood components, source plasma, or source 
leukocytes, or a component, accessory, or part thereof, may not be 
imported under section 801(d)(3) of the act unless the importation 
complies with section 351(a) of the PHS Act or FDA permits the 
importation under FDA-determined appropriate circumstances and 
conditions. Additionally, section 801(d)(4) of the act prohibits the 
importation of tissue or a component or part of tissue under section 
801(d)(3) of the act unless the importation complies with section 361 
of the PHS Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/24/98                    63 FR 64930
NPRM Comment Period End         02/08/99
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB24
_______________________________________________________________________




991. BIOLOGICAL PRODUCTS REGULATED UNDER SECTION 351 OF THE PUBLIC 
HEALTH SERVICE ACT; IMPLEMENTATION OF BIOLOGICS LICENSE; ELIMINATION OF 
ESTABLISHMENT LICENSE AND PRODUCT LICENSE

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 262; PL 105-115

CFR Citation:  21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 20; 21 CFR 207; 21 
CFR 310; 21 CFR 312; 21 CFR 316; 21 CFR 600; 21 CFR 601; 21 CFR 607; 21 
CFR 610; 21 CFR 640; 21 CFR 660

Legal Deadline: None

Abstract: As a ``Reinventing Government'' initiative and to amend 
regulations to implement section 123 of the Food and Drug 
Administration Modernization Act of 1997, FDA is eliminating the 
requirement and use of establishment licenses and product licenses for 
biological products regulated under section 351 of the Public Health 
Service Act. In lieu of product licenses and establishment licenses, 
FDA will require submission and approval of a biologics license 
application in order to market these biologic products in interstate 
commerce.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/31/98                    63 FR 40858
Public Workshop                 08/11/98                    63 FR 42773
Final Action                    04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert A. Yetter, Department of Health and Human 
Services, Food and Drug Administration, Center for Biologics Evaluation 
and Research (HFM-10), 1401 Rockville Pike, Suite 200N, Rockville, MD 
20852
Phone: 301 827-0373

RIN: 0910-AB29
_______________________________________________________________________




992. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL 
PRODUCTS; DIRECT FINAL RULE

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 351

CFR Citation:  21 CFR 610.11(g)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) issued a direct final 
rule and companion proposed rule to amend the biologics regulations by 
adding ``cellular therapy products'' to the list of products excepted 
from the general safety test (GST) and by adding an administrative 
procedure for obtaining an exemption from the GST requirements for 
other biological products. Because the agency received significant 
adverse comment on the administrative procedure portion of the direct 
final rule, FDA withdrew that portion of the rule and confirmed the 
remaining portion. FDA intends to finalize the companion proposed rule 
to respond to the significant adverse comment on the administrative 
procedure portion of the rule. FDA is taking this action because the 
GST may not be relevant or necessary for all biological products, 
including cellular therapy products, currently in various stages of 
development. This action is part of FDA's continuing effort to achieve 
the objectives of the President's ``Reinventing Government'' 
initiative, and is intended to reduce the burden of unnecessary 
regulations on biological products without diminishing the protection 
of the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/20/98                    63 FR 19399

[[Page 21237]]

Proposed Rule - Companion 
Document to Direct Final Rule   04/20/98                    63 FR 19431
Direct Final Rule Confirmation 
in Part                         08/05/98                    63 FR 41718
Direct Final Rule Withdrawal in 
Part                            08/05/98                    63 FR 41718
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB51
_______________________________________________________________________




993. RADIOPHARMACEUTICALS USED FOR IN VIVO DIAGNOSIS AND MONITORING

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 122

CFR Citation:  21 CFR 315; 21 CFR 601

Legal Deadline:  NPRM, Statutory, May 20, 1998. Final, Statutory, May 
20, 1999.

Abstract: Section 122 of FDAMA, Requirements for Radiopharmaceuticals, 
requires the Secretary, HHS, after consultation with patient advisory 
groups, associations, physicians licensed to use radiopharmaceuticals, 
and the regulated industry, to issue proposed regulations governing the 
approval of radiopharmaceuticals. The regulations shall provide that 
the determination of safety and effectiveness of a radiopharmaceutical 
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 
262) shall include consideration of the proposed use of the 
radiopharmaceutical in the practice of medicine, the pharmacological 
and toxicological activity of the radiopharmaceutical (including any 
carrier or ligand component of the radiopharmaceutical), and the 
estimated radiation dose of the radiopharmaceutical. In addition, the 
indication for which a radiopharmaceutical is approved for marketing 
may, in appropriate cases, refer to manifestations of disease (such as 
biochemical, physiological, anatomical, or pathological processes) 
common to, or present in, one or more disease states.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/22/98                    63 FR 28301
Final Action                    05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
  
Steven F. Falter, Director, Regulations and Policy Staff, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB52
_______________________________________________________________________




994. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 127

CFR Citation:  21 CFR 216

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 USC 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. Section 
503A(b)(1)(A) directs FDA to issue by regulation a list of bulk drug 
substances that may be used in compounding that are not covered by a 
United States Pharmacopeia (USP) or National Formulary (NF) monograph 
and are not components of FDA-approved drugs. Bulk drug substances that 
do not appear on the list may not be used in compounding under section 
127 unless such substances are covered by a USP or NF monograph or are 
components of approved drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/07/99                      64 FR 996
NPRM Comment Period End         03/23/99
Final Action                    08/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB57

[[Page 21238]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




995. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 343; 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 
will establish current good manufacturing practice regulations, quality 
control procedures, quality factors, notification requirements, and 
records and reports for the production of infant formulas. This 
proposal was issued in response to the Infant Formula Act of 1986.

Timetable:

Current Good Mfg. Practices; Qual Control Proc  NPRM 07/09/96 (61 FR 
36154)  NPRM Comment Period End 12/06/96  Final Rule To Be Determined

Infant Form Cons Comp, Micro Test & Recd Retention Req  NPRM 01/26/89 
(54 FR 3783)  NPRM Comment Period End 03/27/89  Final Rule 12/24/91 (56 
FR 66566)

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

Agency Contact: Nicholas Duy, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-456), 200 C Street SW., 
Washington, DC 20204
Phone: 202 205-5374

RIN: 0910-AA04
_______________________________________________________________________




996. BIOLOGICAL PRODUCTS: REPORTING OF ERRORS AND ACCIDENTS IN 
MANUFACTURING

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374; 42 
USC 216; 42 USC 262 to 264; 42 USC 300aa-25

CFR Citation:  21 CFR 600; 21 CFR 606

Legal Deadline: None

Abstract: FDA is amending the regulations that require licensed 
manufacturers of biological products to report errors and accidents in 
manufacturing that may affect the safety, purity, or potency of a 
product. FDA defines terms used; establishes a reporting period for all 
licensed biological products; and amends the current good manufacturing 
practice (CGMP) regulations for blood and blood components to require 
error and accident reporting by unlicensed registered blood 
establishments and transfusion services currently reporting on a 
voluntary basis. The reporting requirements will expedite reporting of 
errors and accidents in manufacturing of biological products; provide 
FDA with a more accurate surveillance of the Nation's blood supply 
enabling FDA to monitor actions taken in response to the errors and 
accidents detected for all establishments involved in the manufacture 
of blood and blood components; and facilitate a rapid response where 
public health may be at risk. The cost to licensed establishments would 
be minimal, since they already are required to report. Unlicensed 
establishments would only have to make some changes in standard 
operating procedures. Unlicensed establishments are already required to 
keep records and conduct investigations. Under the final rule they 
would have to establish reporting procedures and report to FDA. The 
transfusion services would have to assure that their recordkeeping and 
investigation procedures are sufficient, and establish reporting 
procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/97                    62 FR 49642
NPRM Comment Period End         12/22/97
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

Agency Contact: Valerie A. Butler, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AA12
_______________________________________________________________________




997. FOOD LABELING REVIEW

Priority:  Routine and Frequent

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

CFR Citation:  21 CFR 100; 21 CFR 101; 21 CFR 102; 21 CFR 161

Legal Deadline: None

Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA) 
requires that most foods bear nutrition labeling. The agency issued 
final rules implementing most of the provisions contained in the NLEA 
on January 6, 1993. Subsequently, however, the agency has identified 
additional areas that should be the subject of rulemaking. FDA issued a 
proposal on January 6, 1993, to establish requirements for the 
identification of certain ingredients on food labels. FDA proposed on 
June 15, 1993, to amend its January 6, 1993, final rules on nutrient 
content and health claims to remove the provisions that exempted 
restaurant menus from the requirements for how nutrient content claims 
and health claims are to be made. The agency proposed on January 4, 
1994, to establish reference daily intakes based on the 9th and 10th 
editions of the National Research Council's Recommended Dietary 
Allowances. On March 14, 1994, FDA published a proposal implementing 
the provisions for exemptions from nutrition labeling for low-volume 
food products of small businesses that were established by the 
Nutrition Labeling and Education Act Amendments of 1993. On August 18, 
1993, FDA published a proposal concerning the placement of the 
nutrition facts panel on food labels. Finally, on July 18, 1994, FDA 
published proposed revised guidelines for the voluntary declaration of 
nutrition labeling for raw produce and fish. A final rule concerning 
the placement of the nutrition facts panel was published on April 5, 
1995. A final rule establishing reference daily intakes based on the 
9th and 10th editions of Recommended Dietary Allowances was published 
on December 28, 1995.
FDA published a final rule on August 2, 1996, on nutrient content 
claims and health claims to remove the provisions

[[Page 21239]]

that exempted restaurant menus from the requirements for how nutrient 
content claims and health claims are to be made. FDA published a final 
rule on August 7, 1996, implementing the exemption for small businesses 
from the requirements for nutrition labeling and providing instructions 
on how to file a notice claiming the exemption. FDA published on August 
16, 1996, final guidelines on the voluntary declaration of nutrition 
labeling for raw produce and fish.

Timetable:

Amend Standard of Identity for Grain Products (Folic Acid)  NPRM 10/14/
93 (58 FR 53305)  Final Action 03/05/96 (61 FR 8781)

Health Claims and Label Statements  NPRM Folic Acid and Neural Tube Def 
10/14/93 (58 FR 53254)  Final Action 03/05/96 (61 FR 8752)

Misleading Containers; Nonfunctional Slack Fill  NPRM 01/06/93 (58 FR 
2957)  Final Action 12/06/93 (58 FR 64123)

Nutrient Content Claims and Health Claims; Restaurant Foods  NPRM 06/
15/93 (58 FR 33055)  Final Action 08/02/96 (61 FR 40320)

Nutrient Content, Definition of the Term, Healthy  NPRM 01/06/93 (58 FR 
2944)  Final Action 05/10/94 (59 FR 24232)

Placement of Nutrition Facts Panel  NPRM 08/18/93 (58 FR 44091)  Final 
Action 04/05/95 (60 FR 17202)  Final Action Effective 05/05/95  Final 
Action Correction 06/12/95 (60 FR 30788)

Protein Hydrolysates; Broth in Tuna; and/or Labeling  NPRM (Declaration 
of Ingredients) 01/06/93 (58 FR 2950)  Final Action (Dec. of 
Ingredients) To Be Determined

Reference Daily Intakes  NPRM 01/04/94 (59 FR 427)  Final Action 12/28/
95 (60 FR 67164)

Small Business Exemption, Nutrition Labeling  NPRM 03/14/94 (59 FR 
11872)  Final Action 08/07/96 (61 FR 40963)

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 08/16/96 (61 FR 42742)

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD89.

Agency Contact: Gerard L. McCowin, Acting Deputy Director, Office of 
Food Labeling, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-150), 
200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
Fax: 202 205-4594

RIN: 0910-AA19
_______________________________________________________________________




998. MEDICAL FOODS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 341; 21 USC 342; 21 USC 343; 21 
USC 348; 21 USC 350; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360ee; 
21 USC 371

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: The Food and Drug Administration is considering development 
of regulations for medical foods, as defined by the Orphan Drug Act 
Amendments of 1988 (21 USC 360ee(b)(3)) to assure, among other things, 
the safety and effectiveness of these products, proper labeling of the 
nutrient content and purported uses, including adequate and appropriate 
directions for use, and quality control and good manufacturing 
practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/29/96                    61 FR 60661
ANPRM Comment Period End        04/28/97
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD91.

Agency Contact: Robert Moore, Senior Regulatory Scientist, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-456), 200 C Street SW., 
Washington, DC 20204
Phone: 202 205-4605
Fax: 202 260-8957

RIN: 0910-AA20
_______________________________________________________________________




999. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321(h); 21 USC 351; 21 USC 352; 21 USC 360; 21 
USC 360c to 360l; 21 USC 371 to 374

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: FDA is considering whether to classify stand-alone computer 
software products that fit the definition of a medical device under the 
Federal Food, Drug, and Cosmetic Act. Although the Secretary has not 
made a final decision to initiate such a program, the agency is 
considering classifying these devices by using a risk-based approach as 
required under the Medical Device Amendments to the act. In addition, 
the agency would use existing exemptions from regulation where 
appropriate. Under this approach, low risk medical software devices 
would be subject only to the adulteration and misbranding provisions of 
the act. Moderate risk devices would additionally be subject to the 
registration, listing, good manufacturing practice requirements, and 
reporting and recordkeeping requirements. High risk devices would be 
the only products to require premarket submissions. FDA is also seeking 
comment on potential criteria related to the intended uses of medical 
software devices that might be used in determining the level of risk.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE58.

Agency Contact: Chuck Furfine, Regulatory Review Scientist/Software 
Expert, Department of Health and Human Services, Food and Drug 
Administration, Center for Devices and Radiological Health (HFZ-84), 
2098 Gaither Road, Rockville, MD 20850
Phone: 301 443-2536

RIN: 0910-AA41


_______________________________________________________________________



[[Page 21240]]

1000. REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN 
COMMERCIAL DISTRIBUTION

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 360; 21 USC 371

CFR Citation:  21 CFR 207

Legal Deadline: None

Abstract: The proposed rule would revise the regulations under part 207 
to clarify the burden on manufacturers, packers, and distributors and 
to consolidate, reorganize, and streamline the requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA49
_______________________________________________________________________




1001. REINVENTING FDA FOOD REGULATIONS

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321 et 
seq

CFR Citation:  21 CFR 101; 21 CFR 102; 21 CFR 103; 21 CFR 131; 21 CFR 
133; 21 CFR 135; 21 CFR 136; 21 CFR 137; 21 CFR 139; 21 CFR 145; 21 CFR 
146; 21 CFR 150; 21 CFR 152; 21 CFR 155; 21 CFR 156; ...

Legal Deadline: None

Abstract: In response to President Clinton's memorandum to heads of 
departments and agencies entitled ``Regulatory Reinvention 
Initiative,'' FDA has initiated rulemaking to retain, revise, or revoke 
certain of its regulations for food. FDA published an advance notice of 
proposed rulemaking (ANPRM) on December 29, 1995, requesting 
information on the need to retain, revise, or revoke its food standards 
of identity regulations and its common or usual name regulations. In 
the same issue of the Federal Register FDA proposed to improve the 
coordination of the food additive, GRAS, and color additive approval 
process with USDA for substances used in meat and poultry products. FDA 
proposed to revoke several lower fat milk standards on November 9, 
1995. On June 12, 1996, FDA published an ANPRM announcing its intention 
to review (1) its human food labeling regulations pertaining to the 
exemption for soft drinks from requirements for the type size and 
placement of certain information on the information panel, requirements 
for listing ``statements of identity,'' and requirements for flavor 
labeling; (2) its infant formula regulations to ensure that they fully 
reflect the Federal Food, Drug, and Cosmetic Act; (3) its regulations 
pertaining to the discharge of waste aboard casino ships, passenger 
ships, and ferries; and (4) its food additive regulations to 
consolidate certain existing regulations. In the same June 12 issue of 
the Federal Register, FDA published a second ANPRM seeking public 
comment on possible ways to streamline various food additive 
regulations. FDA also proposed on June 12, 1996, to revoke certain food 
labeling regulations pertaining to labeling of food with number of 
servings and labeling Kosher and Kosher-style foods and to revoke the 
agency's voluntary filing of cosmetic product experiences. The latter 
was published August 12, 1997.
On October 13, 1995, FDA proposed to revoke certain agency regulations 
that were obsolete or no longer necessary to achieve public health 
goals. The final rule (pertaining to food regulations only) was 
published on June 3, 1996. A confirmation of effective date (CED) on 
those regulations promulgated under the formal rulemaking procedures of 
section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 USC 
371(e)) pertaining to diabetic labeling (21 CFR 105.67) and sodium 
intake labeling (21 CFR 105.69) was published on August 27, 1996.
In the Federal Register of April 17, 1997 (62 FR 18938), FDA proposed 
to establish a notification procedure for companies to use to inform 
FDA of a company's determination that use of a substance in food is 
generally recognized as safe (GRAS).

Timetable:

Exempt Infant Formula; Plan for Revisions  ANPRM 06/12/96 (61 FR 
29701)  Comment Period Ended 10/10/96  NPRM To Be Determined

Food Standards of Identity, Quality, and Fill of Container  ANPRM 12/
29/95 (60 FR 67492)  Comment Period Ended 06/28/96  NPRM To Be 
Determined

Food, Color Additive, GRAS Regulations  ANPRM 06/12/96 (61 FR 
29701)  Comment Period Ended 09/10/96  NPRM To Be Determined

Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry)  NPRM 
12/29/95 (60 FR 67490)  Comment Period Ended 03/14/96  Extension of 
Comment Period 06/03/96  Final Action To Be Determined

Notification Procedures for Independent GRAS Determinations  NPRM 04/
17/97 (62 FR 18938)  NPRM Comment Period Ended 07/16/97  Final Action 
To Be Determined

Revocation of Certain Food Labeling and Cosmetic Regulations  NPRM 06/
12/96 (61 FR 29708)  Comment Period Ended 08/26/96  Final Action 08/12/
97 (62 FR 43071)

Revocation of Lower Fat Milk Standards  NPRM 11/09/95 (60 FR 
56541)  Comment Period Ended 01/23/96  Partial Final 11/20/96 (61 FR 
58991)  Confirmation of Effective Date 02/24/97 (62 FR 8163)

Revocation of Lower Fat Yogurt Standards  NPRM 11/09/95 (60 FR 
56541)  Confirmation of Effective Date To Be Determined  Final Action 
(Yogurt) To Be Determined

Revocation of Obsolete Regulations  NPRM 10/13/95 (60 FR 
53480)  Comment Period Ended 01/11/96  Final Action 06/03/96 (61 FR 
27771)  Confirmation of Eff. Date 08/27/96 (61 FR 43963)

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State

[[Page 21241]]

Additional Information: ABSTRACT CONT: labeling (21 CFR 105.69) was 
published on August 27, 1996.
In the Federal Register of April 17, 1997 (62 FR 18938), FDA proposed 
to establish a notification procedure for companies to use to inform 
FDA of a company's determination that use of a substance in food is 
generally recognized as safe (GRAS).

Agency Contact: L. Robert Lake, Director, Office of Policy Planning and 
Strategic Initiatives, Department of Health and Human Services, Food 
and Drug Administration, Center for Food Safety and Applied Nutrition 
(HFS-150), 200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
Fax: 202 401-7739

RIN: 0910-AA58
_______________________________________________________________________




1002. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority:  Other Significant

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 351; 21 USC 352; 21 
USC 355; 21 USC 371

CFR Citation:  21 CFR 101

Legal Deadline: None

Abstract: On January 4, 1994, FDA published final rules relative to 
nutrition labeling, nutrient content claims and health claims for 
dietary supplements. The Dietary Supplement Health and Education Act 
(DSHEA) was enacted on October 25, 1994, modifying the statutory 
provisions governing labeling of dietary supplements. FDA has initiated 
rulemaking to modify its regulations for dietary supplements 
accordingly. One proposal would modify the nutrition labeling and 
ingredient declaration requirements. A second proposal would provide 
for the use of nutrient content claims and health claims on dietary 
supplements and establish procedures for the use of a disclaimer to 
accompany statements of nutritional support. A third proposal would 
define the terms ``high potency'' and ``antioxidant.'' These three 
proposals were published in the Federal Register on December 28, 1995. 
An ANPRM was published in February 1997 seeking public comments on 
issues related to the establishment of current good manufacturing 
practices for dietary supplements. FDA published three final rules on 
September 23, 1997, responding to the proposals of December 28, 1995, 
and entitled: (1) ``Food Labeling; Statement of Identity, Nutrition 
Labeling and Ingredient Labeling of Dietary Supplements; Compliance 
Policy Guide, Revocation;'' (2) ``Food Labeling; Requirements for 
Nutrient Content Claims, Health Claims, and Statements of Nutritional 
Support for Dietary Supplements;'' and (3) ``Food Labeling; Nutrient 
Content Claims: Definition for ``High Potency'' and Definition for 
``Antioxidant'' for Use in Nutrient Content Claims for Dietary 
Supplements and Conventional Foods.'' The agency received several 
petitions for reconsideration of aspects of the final rule on nutrition 
labeling and ingredient declaration for dietary supplements. In 
response to these petitions, FDA published a final rule revising the 
nutrition labeling requirements for dietary supplements that contain 
liquid or dried extracts.
DSHEA provides that FDA may, by regulation, prescribe current good 
manufacturing practices (CGMPs) for dietary supplements. On February 6, 
1997, FDA announced in an advance notice of proposed rulemaking that it 
was considering whether it should develop CGMPs for dietary 
supplements, and if so, what constitutes CGMPs for these products. The 
ANPR included an industry-sponsored outline for the development of CGMP 
regulations and requested public comment on the outline and other 
issues raised by the agency.
DHSEA also established an independent agency within the Executive 
Branch known as the Commission on Dietary Supplement Labels. The 
Commission was charged with conducting a study on, and providing 
recommendations for, regulating label claims and statements for dietary 
supplements, including the use of literature in connection with the 
sale of dietary supplements and procedures for evaluating such claims. 
On November 24, 1997, the Commission's final report was released. On 
April 29, 1998, FDA issued a notice on its views on the Commission's 
report and a proposed rule that responds to guidance in the report 
concerning statements about the effect of dietary supplements on the 
structure or function of the body.

Timetable:

Comments on Report of the Commission on Dietary Supp. Labels  Notice 
04/29/98 (63 FR 23633)

CGMPs in the Manufacturing, Packing, or Holding of Dietary 
Supps.  ANPRM 02/06/97 (62 FR 5700)  Comment Period End 06/06/97  NPRM 
To Be Determined

High Potency and Antioxidant Terms; Dietary Supplements  NPRM 12/28/95 
(60 FR 67184)  Comment Period End 06/10/96  Final Action 09/23/97 (62 
FR 49808)

Nutrient Content and Health Claims; Dietary Supplements  NPRM 12/28/95 
(60 FR 67176)  Comment Period End 06/10/96  Final Action 09/23/97 (62 
FR 49859)

Nutrient Labeling and Ingredient Labeling; Dietary Supplements  NPRM 
12/28/95 (60 FR 67194)  Comment Period End 06/10/96  Final Action 09/
23/97 (62 FR 49826)  Final Action 06/05/98 (63 FR 30615)

Regs on Statements Made for Diet. Supps re Effect of Product  NPRM 04/
29/98 (63 FR 23624)

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Elizabeth A. Yetley, Director, Office of Special 
Nutritionals, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-450), 
200 C Street SW. Washington, DC 20204
Phone: 202 205-4168
Fax: 202 205-5295

RIN: 0910-AA59
_______________________________________________________________________




1003. DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  15 USC 1451 to 1461; 21 USC 321; 21 USC 331; 21 USC 
335; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 
21 USC 379; 21 USC 381 to 382; 42 USC 216; 42 USC 241; 42 USC 262 to 
263

CFR Citation:  21 CFR 314; 21 CFR 514; 21 CFR 601

Legal Deadline: None

[[Page 21242]]

Abstract: The proposed rule would amend the regulations to require 
applicants to submit a debarment certification statement in accordance 
with 21 U.S.C. 335a(k).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA76
_______________________________________________________________________




1004. INVESTIGATIONAL NEW DRUG APPLICATIONS; REQUEST FOR INFORMATION AND 
COMMENTS

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

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 56; 21 CFR 312

Legal Deadline: None

Abstract: The rulemaking would permit certain uses of investigational 
new drugs by individual investigators who are not included in a 
commercial sponsor's application provided that, among other things, the 
drugs are in Phase 2 of commercial development.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                            To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-5562

RIN: 0910-AA83
_______________________________________________________________________




1005. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 353; 21 USC 360b; 21 
USC 371; 21 USC 381

CFR Citation:  21 CFR 511; 21 CFR 512

Legal Deadline: None

Abstract: FDA is proposing to revise its regulations governing 
investigational use of new animal drugs by proposing to delete 21 CFR 
511 and establish in 21 CFR part 512 revised investigational use new 
animal drug regulations. The investigational use new animal drug 
regulations are expected to include regulations to implement provisions 
of the Animal Drug Availability Act of 1996, specifically presubmission 
conferences, and implement parts of the President's National 
Performance Report, ``Reinventing the Regulation of Animal Drugs,'' May 
1996. In the reinventing regulations report, FDA proposed to revise its 
regulations to reflect numerous new process changes and programs that 
will enable a more streamlined animal drug application review and 
approval process, and which would result in less regulatory burden upon 
industry and FDA while maintaining safety and effectiveness of new 
animal drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-126), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB02
_______________________________________________________________________




1006. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLULAR AND 
TISSUE-BASED PRODUCTS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 264

CFR Citation:  21 CFR 207; 21 CFR 807; 21 CFR 1271

Legal Deadline: None

Abstract: This action is a continuation of FDA's approach for the 
regulation of human tissues and is part of FDA's reinventing government 
initiative. The final rule requires manufacturers of human cellular and 
tissue-based products to register with the agency and submit a list of 
all such products produced. Future regulations would include the 
promulgation of good tissue practices (GTP) that will provide good 
manufacturing standards and regulations for donor screening and 
testing, and compliance and procedural issues. The proposed approach 
would provide a rational, comprehensive, and clear framework under 
which tissue processors can develop and market their products without 
being subjected to unnecessary regulation and without sacrificing the 
protection of the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/14/98                    63 FR 26744
NPRM Comment Period End         08/12/98
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 21243]]

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville 
Pike, Suite 200N, Rockville MD 20852
Phone: 301 827-6210

RIN: 0910-AB05
_______________________________________________________________________




1007. REQUIREMENTS PERTAINING TO THE SALE AND DISTRIBUTION OF CIGARETTES 
AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS; USE OF 
NONTOBACCO TRADE OR BRAND NAMES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352; 21 USC 360; 21 USC 360(j); 21 USC 371; 21 
USC 372

CFR Citation:  21 CFR 897

Legal Deadline: None

Abstract: The proposed rule would clarify the restrictions on the use 
of nontobacco product names and other identification on tobacco 
products and would modify the list of established names for smokeless 
tobacco products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB17
_______________________________________________________________________




1008. EXEMPTION FROM PREEMPTION OF STATE AND LOCAL CIGARETTE AND 
SMOKELESS TOBACCO REQUIREMENTS; APPLICATIONS FOR EXEMPTION SUBMITTED BY 
VARIOUS STATE GOVERNMENTS; GROUP 1; GROUP 2

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360k; 21 USC 371

CFR Citation:  21 CFR 808

Legal Deadline: None

Abstract: FDA published a notice of proposed rulemaking on November 7, 
1996, announcing that the agency would be accepting applications for 
exemption from Federal preemption for State and local cigarette and 
smokeless tobacco requirements. The notice explained that FDA would 
consider the applications in two groups and set deadlines for 
submitting applications. Group 1 applications, due December 9, 1996, 
pertain to State and local requirements governing the sale and 
distribution of cigarettes and smokeless tobacco that are different 
from, or in addition to, FDA requirements under section 897.14(a) and 
section 897.14(b) of the final tobacco rule (the age and identification 
requirements). Group 2 applications, due May 6, 1997, pertain to State 
and local requirements governing the sale and distribution of 
cigarettes and smokeless tobacco that are different from, or in 
addition to, all other requirements under the final tobacco rule.

Timetable:

Group 1  NPRM 02/19/97 (62 FR 7390)  NPRM Comment Period End 06/23/
97  Final Action 11/28/97 (62 FR 63271)

Group 2  NPRM To Be Determined

Groups 1 and 2  Notice 11/07/96 (61 FR 57685)

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Additional Information: Formerly listed under RIN 0910-AB03.

Agency Contact: Anne M. Kirchner, Policy Analyst, Department of Health 
and Human Services, Food and Drug Administration, Office of Policy 
(HFD-11), 5600 Fishers Lane, Room 14-72, Rockville, MD 20857
Phone: 301 827-5321
Fax: 301 443-5169

RIN: 0910-AB19
_______________________________________________________________________




1009. CITIZEN PETITIONS; ACTIONS THAT CAN BE REQUESTED BY PETITION; 
SUMMARY DENIAL; AND REFERRAL FOR OTHER ADMINISTRATIVE ACTION

Priority:  Info./Admin./Other

Legal Authority:  5 USC 551 to 558; 5 USC 701 to 706; 15 USC 1451 to 
1461; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 321 to 393; 21 USC 
467f; 21 USC 679; 21 USC 821; 21 USC 1034; 28 USC 2112; 42 USC 201; 42 
USC 262; 42 USC 263b to 263n; 42 USC 264

CFR Citation:  21 CFR 10

Legal Deadline: None

Abstract: The proposed rule would amend the agency's regulations 
pertaining to citizen petitions by specifying the types of actions that 
could be requested through a petition. The proposal would also revise 
the content requirements for citizen petitions and would establish a 
mechanism for receiving and filing citizen petitions. These changes are 
intended to improve the citizen petition mechanism by focusing FDA's 
resources on important public health issues.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB73

[[Page 21244]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1010. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY 
INFORMATION UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY 
ACT OF 1986

Priority:  Other Significant

CFR Citation:  21 CFR 601

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - The Agency Plans to 
Issue A Guidance                03/12/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Steven F. Falter
Phone: 301 827-6210

RIN: 0910-AA14
_______________________________________________________________________




1011. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER HUMAN 
DRUG PRODUCTS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 211

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/04/98                    63 FR 59463
Final Action Effective          12/04/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Howard P. Muller
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA26
_______________________________________________________________________




1012. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 801

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No action planned at 
this time                       03/12/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan
Phone: 301 594-4765

RIN: 0910-AA33
_______________________________________________________________________




1013. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Priority:  Other Significant

CFR Citation:  21 CFR 201; 21 CFR 208; 21 CFR 314; 21 CFR 600

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/01/98                    63 FR 66378
Final Action Effective          06/01/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Nancy M. Ostrove
Phone: 301 594-6828

RIN: 0910-AA37
_______________________________________________________________________




1014. LONG-TERM CONTRACEPTIVE DRUG PRODUCTS AND MEDICAL DEVICES; 
INFORMED CONSENT REQUIREMENTS

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

CFR Citation:  21 CFR 201; 21 CFR 801

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       01/28/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Christine M. Everett
Phone: 301 827-0938

RIN: 0910-AA75
_______________________________________________________________________




1015. ANIMAL DRUG APPROVALS FOR MINOR SPECIES AND MINOR USAGE

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No further action 
will be taken at this time      03/12/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Linda Wilmot
Phone: 301 827-0135

RIN: 0910-AB07
_______________________________________________________________________




1016. REGULATIONS REQUIRING MANUFACTURERS TO ASSESS THE SAFETY AND 
EFFECTIVENESS OF NEW DRUGS AND BIOLOGICAL PRODUCTS IN PEDIATRIC PATIENTS

Priority:  Other Significant

CFR Citation:  21 CFR 200; 21 CFR 312; 21 CFR 314; 21 CFR 601

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/02/98                    63 FR 66632
Final Action Effective          04/01/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula Botstein
Phone: 301 827-3144
Fax: 301 480-3761
Email: [email protected]

RIN: 0910-AB20
_______________________________________________________________________




1017. DISSEMINATION OF TREATMENT INFORMATION ON UNAPPROVED USES FOR 
MARKETED DRUGS AND DEVICES

Priority:  Other Significant

CFR Citation:  21 CFR 99

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/20/98                    63 FR 64556

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Margaret Dotzel
Phone: 301 827-5321
Fax: 301 443-5169

RIN: 0910-AB23
_______________________________________________________________________




1018. REVOCATION OF ANTIBIOTIC CERTIFICATION REQUIREMENTS; CONFORMING 
REVISIONS TO REGULATIONS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

CFR Citation:  21 CFR 2; 21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 12; 21 
CFR

[[Page 21245]]

16; 21 CFR 20; 21 CFR 25; 21 CFR 50; 21 CFR 54; 21 CFR 56; 21 CFR 58; 
21 CFR 60; 21 CFR 70; 21 CFR 71; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/05/99                      64 FR 396
Final Action Effective          05/20/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Christine Rogers
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB32
_______________________________________________________________________




1019. LIST OF DRUGS THAT HAVE BEEN WITHDRAWN OR REMOVED FROM THE MARKET 
FOR REASONS OF SAFETY AND EFFECTIVENESS

Priority:  Other Significant

CFR Citation:  21 CFR 216

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/08/99                    64 FR 10944

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB40
_______________________________________________________________________




1020. CLINICAL HOLD; STREAMLINING CLINICAL RESEARCH

Priority:  Other Significant

CFR Citation:  21 CFR 312

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/14/98                    63 FR 68676
Final Action Effective          04/28/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Andrea Masciale
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB41
_______________________________________________________________________




1021. MEDICAL DEVICES; IDE MODIFICATIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 812

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/23/98                    63 FR 64617

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan
Phone: 301 827-2974

RIN: 0910-AB53
_______________________________________________________________________




1022. DISPUTE RESOLUTION

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 10

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/18/98                    63 FR 63978

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Suzanne O'Shea
Phone: 301 827-3390

RIN: 0910-AB54
_______________________________________________________________________




1023. EFFECTIVE DATE OF APPROVAL OF AN ABBREVIATED NEW DRUG APPLICATION

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/05/98                    63 FR 59710
Final Action Effective          11/10/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Virginia G. Beakes
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB64
_______________________________________________________________________




1024. MUTUAL RECOG. OF PHARMACEUTICAL GOOD MANUFACTURING INSPECTION 
RPTS., MED. DEVICE QUALITY SYS. AUDIT RPTS., AND CERTAIN MEDICAL DEVICE 
PRODUCT EVAL. RPTS.; THE U.S. AND THE EUROPEAN COMMUNITY

Priority:  Other Significant

CFR Citation:  21 CFR 26

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/06/98                    63 FR 60122

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Merton V. Smith
Phone: 301 443-4480
Email: [email protected]

RIN: 0910-AB75
_______________________________________________________________________




1025.  FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 353; 21 
USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21 USC 360c to 360j; 21 
USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 
...

CFR Citation:  21 CFR 54

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is revising the 
requirements regarding financial disclosure by clinical investigators 
in order to add material to the codified language that was 
inadvertently omitted and to clarify the compliance dates to, in some 
cases, restrict the retroactive application of certain requirements of 
the rule. This final rule amends a final rule which published in the 
Federal Register on February 2, 1998, and appeared in previous Unified 
Agendas under RIN 0910-AA30.
FDA is making these changes in order to respond to concerns raised by 
the Pharmaceutical Research Manufacturers Association (hereinafter 
referred to as ``PhRMA''). By making these changes, FDA will be 
reducing the administrative burden for manufacturers and other affected 
parties while, at the same time, ensuring that the agency obtains the 
information that is most relevant to its review of clinical data 
submitted in marketing applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/31/98                    63 FR 72171

Regulatory Flexibility Analysis Required: No

[[Page 21246]]

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary C. Gross, Office of External Affairs, Department 
of Health and Human Services, Food and Drug Administration, Office of 
the Commissioner, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3440

RIN: 0910-AB77
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1026. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: CORPORATE SHIELD

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 11131

CFR Citation:  45 CFR 60.7

Legal Deadline: None

Abstract: This NPRM proposes to require that, in addition to reporting 
to the National Practitioner Data Bank medical malpractice payments 
made where physicians or other health care practitioners are named in 
medical malpractice actions or claims, judgments or settlements, 
payments be reported where they are made for the benefit of physicians 
or other health care practitioners not named in the judgments or 
settlements but who furnished or failed to furnish the health care 
services upon which the actions or claims were based. The purpose of 
this NPRM is to prevent the evasion of the medical malpractice payment 
reporting requirement of the Data Bank through the agreement of the 
parties to a lawsuit to use the corporate health care entity to 
``shield'' the parties.
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, the name of the hospital or health care organization for 
whose benefit the payment was made.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
NPRM Comment Period End         02/22/99
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Thomas C. Croft, Director, Division of Quality 
Assurance, Bureau of Health Professions, HRSA, Department of Health and 
Human Services, Health Resources and Services Administration, Parklawn 
Building, Room 8A-55, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2300

RIN: 0906-AA41
_______________________________________________________________________




1027. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH 
PROFESSIONAL SHORTAGE AREAS

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

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 (MUPs) and Primary Care 
Health Professional Shortage Areas (HPSAs).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
NPRM Comment Period End         01/04/99
Final Action                    05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Richard Lee, Public Health Analyst, Bureau of Primary 
Health Care, Department of Health and Human Services, Health Resources 
and Services Administration, 4350 East-West Highway, Bethesda, MD 20814
Phone: 301 594-4280

RIN: 0906-AA44
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1028. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: CHARGE FOR SELF-QUERIES

Priority:  Info./Admin./Other

CFR Citation:  45 CFR 60

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/01/99                     64 FR 9921

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

  

Agency Contact: Thomas C. Croft
Phone: 301 443-2300

RIN: 0906-AA42


_______________________________________________________________________



[[Page 21247]]

1029. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 60

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Thomas C. Croft
Phone: 301 443-2300

RIN: 0906-AA43
_______________________________________________________________________




1030. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PROVIDERS: CLARIFICATION AND 
MODERNIZATION OF REGULATORY TERMS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 60

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/18/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Thomas C. Croft
Phone: 301 443-2300

RIN: 0906-AA48
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Indian Health Service (IHS)



_______________________________________________________________________




1031. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority:  Info./Admin./Other

Legal Authority:  25 USC 3201 et seq

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: The Indian Health Service (IHS) is proposing to establish 
regulations as mandated by the Indian Child Protection and Family 
Violence Protection Act, P.L. 101-630, 25 U.S.C. 3201-3211, that 
prescribe minimum standards of character for individuals whose duties 
and responsibilities involve regular contact with, or control over, 
Indian children.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/99                    64 FR 14559
NPRM Comment Period End         05/24/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Ramona D. Williams, Child Protection Coordinator, 
Department of Health and Human Services, Indian Health Service, 5300 
Homestead Road NE., Albuquerque, NM 87110
Phone: 505 837-4245

RIN: 0917-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


Indian Health Service (IHS)



_______________________________________________________________________




1032. CURRENTLY EFFECTIVE INDIAN HEALTH SERVICE ELIGIBILITY REGULATIONS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 2001; 42 USC 2003

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: The Department of Health and Human Services is publishing in 
the Federal Register, final regulations governing eligibility for 
Indian Health Service. The regulations currently codified at 42 CFR 36 
are under moratorium of undetermined length. For the convenience of the 
public and in conformance with the Administrative Procedures Act, 5 USC 
552(a) that the CFR contain currently effective regulations, these 
regulations are to be codified side by side with the regulation under 
moratorium.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: Tribal

Agency Contact: Betty J. Penn, Regulations Officer, Department of 
Health and Human Services, Indian Health Service, 12300 Twinbrook 
Parkway, Suite 450, Rockville, MD 20857
Phone: 301 443-1116
Fax: 301 443-2316
Email: [email protected]

RIN: 0917-AA03

[[Page 21248]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1033. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority:  Substantive, Nonsignificant

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD18.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA02
_______________________________________________________________________




1034. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE 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 the NIH. For each year of scholarship support, the recipient 
agrees to service (employment) after graduation, at the NIH, for one 
year. Additionally, the individual agrees to at least ten consecutive 
weeks of service (employment) at the NIH during which the individual is 
attending the institution and receiving the NIH scholarship. The 
proposed new regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

Agency Contact: Jerry Moore, NIH Regulations Officer Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169

RIN: 0925-AA10
_______________________________________________________________________




1035. NATIONAL RESEARCH SERVICE AWARDS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 288

CFR Citation:  42 CFR 66

Legal Deadline: None

Abstract: Current HHS regulations will be amended to reflect provisions 
of the ADAMHA Reorganization Act and the National Institutes of Health 
Revitalization Act of 1993. New language concerning the service payback 
obligation will set forth, specifically, that a service payback 
obligation is incurred only during the first twelve months of 
postdoctoral support and individuals may pay back this service 
obligation by engaging in an equal period of health-related teaching 
or, if the individual finished the first twelve months of support, by 
engaging in a second year of NRSA supported research training.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

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, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA16
_______________________________________________________________________




1036. REMOVAL OF NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION 
PROGRAM

Priority:  Info./Admin./Other

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  42 USC 216

CFR Citation:  42 CFR 52d

Legal Deadline: None

Abstract: Current regulations relating to the National Cancer Institute 
(NCI) Clinical Cancer Education Program will be rescinded because the 
regulations are obsolete. Current guidelines by NCI with respect to the 
care of cancer patients no longer reflect the type of program described 
in the current regulations. This action will not affect the authority 
of the Director, NCI, to support appropriate programs of education and 
training, including clinical research training set forth in section 414 
of the Public Health Service Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

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, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA17


_______________________________________________________________________



[[Page 21249]]

1037. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH

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 for research authorized under section 487C 
of the Public Health Service Act, as added by provisions of the 
National Institutes of Health Revitalization Act of 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99

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, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 496-0125
Email: [email protected]

RIN: 0925-AA18
_______________________________________________________________________




1038. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 288-2

CFR Citation:  42 CFR 68c

Legal Deadline: None

Abstract: Section 487B of the Public Health Service Act creates a 
program through which appropriately qualified health professionals may 
obtain federally funded repayment of education loans by conducting 
research with respect to contraception and/or infertility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

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, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA19
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1039. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 216; 42 USC 285a-2; 42 USC 285a-3; 42 USC 
285b-3; 42 USC 285b-4; 42 USC 285d-6; 42 USC 285i; 42 USC 285m-3; 42 
USC 285o-4; 42 USC 287a-2; 42 USC 287a-3; 42 USC 300cc-41

CFR Citation:  42 CFR 52b

Legal Deadline: None

Abstract: Regulations concerning NCI construction grants will be 
amended to make them generally applicable to all NIH extramural 
programs with construction grant authority. Additionally, the 
regulations will be amended to show new administrative and technical 
requirements, add new procedures for the recovery of grant funds for 
facilities no longer used for biomedical research, show new Public 
Health Service Act section numbers, and update the listing of other HHS 
regulations relevant to construction grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD49.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA04
_______________________________________________________________________




1040. TRAINEESHIPS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 283g(d)(2); 42 USC 284(b)(1)(C); 
42 USC 286b-3

CFR Citation:  42 CFR 63

Legal Deadline: None

Abstract: Regulations governing NIH traineeships will be amended to set 
forth additional conditions under which awards may be terminated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/30/98                    63 FR 58336
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE62.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA11


_______________________________________________________________________



[[Page 21250]]

1041. ADDITIONAL DHHS PROTECTIONS FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED AS SUBJECTS IN RESEARCH, AND PERTAINING TO HUMAN IN VITRO 
FERTILIZATION

Priority:  Other Significant

Legal Authority:  5 USC 301; 42 USC 289

CFR Citation:  45 CFR 46, subpart B

Legal Deadline: None

Abstract: Current regulations which have been in effect for two decades 
will be revised to reflect provisions of Public Law 103-43 and recent 
changes in NIH and FDA policies on the involvement of women and human 
fetuses in research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/20/98                    63 FR 27794
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Michele Russell-Einhorn, J.D., Director of Regulatory 
Affairs, Department of Health and Human Services, National Institutes 
of Health, Office for Protection from Research Risks, 6100 Executive 
Blvd., Ste. 3B01, MSC 7507, Rockville, MD 20892-7507
Phone: 301 435-5649
Fax: 301 402-2071

RIN: 0925-AA14
_______________________________________________________________________




1042. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 
AND DEVELOPMENT CONTRACT PROJECTS

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 216; 42 USC 282(b)(6); 42 USC 284(c)(3); 42 
USC 289a; 42 USC 290aa-3

CFR Citation:  42 CFR 52h

Legal Deadline: None

Abstract: NIH staff have been reexamining the peer review process as 
part of its reinvention initiatives and have found ambiguities, 
misstatements, and voids in the existing regulations. These 
regulations, which govern the first level of review, are being amended 
to reflect current policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/00/99

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, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA20
_______________________________________________________________________




1043. FEDERAL POLICY (COMMON RULE) FOR THE PROTECTION OF HUMAN SUBJECTS

Priority:  Other Significant

Legal Authority:  5 USC 301; 42 USC 289; 42 USC 300v-1(b)

CFR Citation:  45 CFR 46

Legal Deadline: None
The President's Memorandum prohibits agencies from conducting or 
supporting classified human subject research without having proposed 
and promulgated the common rule and the changes.

Abstract: In compliance with the President's Memorandum of March 27, 
1997, this interim final rule would amend the Federal Policy (common 
rule) for the Protection of Human Subjects to add a new section that 
applies only to classified research involving human subjects. The new 
section would modify the Federal Policy by (1) prohibiting any 
executive branch agency from engaging in classified research involving 
human subjects unless the agency has adopted the Federal Policy and the 
interim final rule; (2) eliminating the availability of waiver of 
informed consent and expedited review for classified research involving 
human subjects; (3) enhancing the informed consent requirements and 
allowing for disclosure of classified information if necessary; and (4) 
changing the composition of the institutional review board (IRB) and 
establishing a process for individual IRB approvals of classified 
research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michele Russell-Einhorn, J.D., Director of Regulatory 
Affairs, Department of Health and Human Services, National Institutes 
of Health, Office for Protection from Research Risks, 6100 Executive 
Blvd., Room 3B01, MSC 7505, Rockville, MD 29852
Phone: 301 496-7005
Fax: 301 402-2071

RIN: 0925-AA21
_______________________________________________________________________




1044. SERVICE FELLOWSHIPS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 209; 42 USC 210; 42 USC 216

CFR Citation:  42 CFR 61, subpart B

Legal Deadline: None

Abstract: This interim final rule would amend the regulations governing 
service fellowships by revising the current authority citation, 
extending the time limitation on initial appointments from 2 to 5 
years, permitting extensions of appointments for up to 5 years rather 
than year-to-year, and removing obsolete references to the Surgeon 
General and obsolete requirements regarding the qualifications of 
applicants. These changes are being made to provide HHS health agencies 
with greater flexibility to recruit and retain their talented 
scientists and to update obsolete references.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/27/98                     63 FR 9949
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 21251]]

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA22
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1045. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 68a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/30/98                    63 FR 58312

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA09
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1046. 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, Public Law 103-43), the Department is 
proposing to add 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 
adequately respond 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                            04/00/99
NPRM Comment Period End         07/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State

Agency Contact: Barbara Bullman, Policy Analyst, Office of Research 
Integrity, Department of Health and Human Services, 5515 Security Lane, 
Suite 700, Rockville, MD 20852
Phone: 301 443-5300
Fax: 301 443-5351

RIN: 0940-AA01
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1047. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 300a-4

CFR Citation:  42 CFR 59

Legal Deadline: None

Abstract: This rule would return the Family Planning Service Program, 
funded under title X of the Public Health Service Act, to the 
regulatory standard operative prior to February 2, 1988, with regard to 
the statutory provision prohibiting abortion as a method of family 
planning in projects funded under that title.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/05/93                     58 FR 7464
NPRM Comment Period End         08/09/93                    58 FR 34024
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE03.

Agency Contact: Denise Shervington, Acting Deputy Assistant Secretary 
for Population Affairs, Department of Health and Human Services, East-
West Towers, Suite 200, West Bldg., 4350 East-West Highway, Bethesda, 
MD 20814
Phone: 301 594-4001

RIN: 0940-AA00

[[Page 21252]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of Assistant Secretary for Health (OASH)



_______________________________________________________________________




1048. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Transfer Development to - RIN 
0940-AA00                       04/15/99

RIN: 0937-AA00
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Public Health Service (PHS)



_______________________________________________________________________




1049. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH 
MISCONDUCT WHISTLEBLOWERS

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Transfer Development to - RIN 
0940-AA01                       04/15/99

RIN: 0905-AE71
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1050. MEDICARE COVERAGE OF HEART, LIVER, AND LUNG TRANSPLANTATION (HCFA-
3835-PN)

Priority:  Other Significant

Legal Authority:  42 USC 1395y(a)(1)(A)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice proposes to revise the criteria for approval of a 
facility to perform Medicare covered transplants. The revised criteria 
would focus on a facility's ability to perform successful transplants, 
rather than on a facility's policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 09/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-3835-PN

Agency Contact: Jacqueline Sheridan, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AH17
_______________________________________________________________________




1051. CHILDREN'S HEALTH INSURANCE: PROGRAM IMPLEMENTATION; STATE PLAN 
APPROVAL; STATE PAYMENT; COORDINATION WITH STATE MEDICAID PROGRAM (HCFA-
2006-P)

Priority:  Economically Significant

Legal Authority:  PL 105-33, sec 4901 to 4913

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: Several proposed rules will include regulations for States on 
the implementation of the new State Children's Health Insurance Program 
(CHIP) under title XXI of the Social Security Act and corresponding 
changes to title XIX (Medicaid). The CHIP program was established to 
provide Federal funding to help States to initiate and expand child 
health assistance to uninsured, low-income children. The regulations 
will address a variety of aspects of CHIP, including but not limited to 
the procedure for approving State child health plans, policies on the 
issuance of grants and the distribution of payments to States with 
approved plans and the coordination of a State's approved child health 
plan with its Medicaid program. The following changes related to title 
XIX will be included among the regulations: (1) the Medicaid option for 
targeted low-income children; (2) Medicaid optional presumptive 
eligibility for children; and (3) the Medicaid option to accelerate 
phase-in of poverty level group for children up to 19. The regulations 
will also establish financial rules that would apply to the treatment 
of various program expenditures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM Allotments and State 
Payment Policies                06/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

[[Page 21253]]

Government Levels Affected: State, Local, Federal

Agency Contact: Rick Fenton, Center for Medical and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5647

RIN: 0938-AI28
_______________________________________________________________________




1052. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (HCFA-6003-P)

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 would establish an administrative appeal process 
whereby suppliers can request an appeal for a determination that 
affects their Medicare part B billing number. The purpose of this rule 
is to update and clarify our policy and extend administrative appeal 
rights to all current and prospective suppliers who are denied 
enrollment in the Medicare program or whose Medicare billing privileges 
are revoked. This rule does not apply to those suppliers covered under 
the appeals provisions for our regulations at 42 CFR 498.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Charles Waldhauser, Division of Provider/Supplier 
Enrollment, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244-1850
Phone: 410 786-6140

RIN: 0938-AI49
_______________________________________________________________________




1053. PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-1002-NR)

Priority:  Other Significant

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

Legal Authority:  PL 105-33, sec 4531(b)

CFR Citation:  42 CFR 410

Legal Deadline:  Final, Statutory, January 1, 2020.

Abstract: The Balanced Budget Act of 1997 requires that the Secretary 
establish a fee schedule for ambulance services through negotiated 
rulemaking. The fee schedule is to be effective beginning with services 
furnished on or after January 1, 2000. In addition to setting the 
payment rates, the Secretary is to ensure that the aggregate amount of 
payment made for ambulance services in 2000 may not exceed the amount 
of payment that would have been made absent the fee schedule. This is a 
cap on payment, not a budget neutrality adjustment. The Secretary is to 
consult with national organizations representing individuals and 
entities that furnish and regulate ambulance services and share 
relevant data with these organizations. This provision will be met 
through the negotiated rulemaking process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent To Negotiate   01/22/99                     64 FR 3474
NPRM                            09/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nancy Edwards, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4531
Email: [email protected]

RIN: 0938-AI72
_______________________________________________________________________




1054. COVERAGE AND ADMINISTRATIVE POLICIES FOR CLINICAL DIAGNOSTIC 
LABORATORY TESTS; INTENT TO FORM NEGOTIATED RULEMAKING COMMITTEE (HCFA-
3250-NOI)

Priority:  Other Significant

Legal Authority:  PL 105-33, sec 4554(b)(i)

CFR Citation:  42 CFR ch IV

Legal Deadline:  Final, Statutory, January 1, 1999.

Abstract: The Balanced Budget Act of 1997 requires the Secretary to 
establish a negotiated rulemaking committee under the Negotiated 
Rulemaking Act and Federal Advisory Committee Act. The Negotiated 
Rulemaking Committee's (the Committee's) purpose will be to negotiate 
national coverage and administrative policies for clinical diagnostic 
laboratory tests under part B of the Medicare program. The Committee 
will consist of representatives of interested parties that are likely 
to be significantly affected by the proposed rule. The Committee will 
be assisted by a neutral facilitator. This notice outlines the scope of 
issues to be negotiated by the Committee and requests public comments 
as to whether we have identified the interests that will be affected by 
the key issues.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent to Negotiate   06/03/98                    63 FR 30166
NPRM                            09/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Jackie Sheridan, Office of Clinical Standards & 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AI92
_______________________________________________________________________




1055.  MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF 
PROGRAM ISSUANCES--THIRD QUARTER, 1998 (HCFA-9000-N)

Priority:  Routine and Frequent

Legal Authority:  PL 105-33, sec 1871

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice lists HCFA manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published during July, August and September of 1998 that relate to the 
Medicare and Medicaid programs. It also identifies certain devices with 
investigational device exemption numbers approved by the Food and Drug 
Administration that may be potentially covered under Medicare.

[[Page 21254]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kristy Nishimoto, OCOS, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
C5-16-03, Baltimore, MD 21244
Phone: 410 786-8517

RIN: 0938-AJ37
_______________________________________________________________________




1056.  RECOGNITION OF THE COMMUNITY HEALTH ACCREDITATION 
PROGRAM, INC., (CHAP), (HCFA-2029-FN)

Priority:  Routine and Frequent

Legal Authority:  42 USC 1395bb

CFR Citation:  42 CFR ch IV

Legal Deadline:  Other, Statutory, February 5, 1999.
On 12/10/98 CHAP, rather than be denied and have to reapply, requested 
an extension of the time period to all resolution of outstanding 
issues. Extension was granted.

Abstract: This notice recognizes the Community Health Accreditation 
Program Inc. (CHAP) as a national accreditation organization for 
hospices that request participation in the Medicare program. We believe 
that accreditation of hospices by CHAP demonstrates that all Medicare 
hospice conditions of participation are met or exceeded. Thus, we grant 
deemed status to those hospices accredited by CHAP.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Joan Berry, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-7233

RIN: 0938-AJ42
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1057. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (HCFA-3781-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(n); 42 USC 1395y(a)(1)(A)

CFR Citation:  45 CFR 500

Legal Deadline: None

Abstract: Intermittent positive pressure breathing (IPPB) machine 
therapy is currently covered under Medicare as durable medical 
equipment for patients whose ability to breathe is severely impaired. 
Based on an Office of Health Technology Assessment recommendation, we 
will place limitations on Medicare coverage of IPPB machine therapy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-781

Agency Contact: Francine Spencer, Office of Clinical Standards and 
Quality, Coverage and Analysis Group, Department of Health and Human 
Services, Health Care Financing Administration, C4-04-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4614

RIN: 0938-AG44
_______________________________________________________________________




1058. TELEPHONE REQUESTS FOR REVIEW OF PART B INITIAL CLAIM 
DETERMINATIONS (HCFA-4121-F)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395ff(b); 42 USC 1395hh; 42 USC 
1395ii; 42 USC 1395u(b)(3)(C)

CFR Citation:  42 CFR 405.802; 42 CFR 405.807

Legal Deadline: None

Abstract: This rule will make it easier for beneficiaries, providers, 
and suppliers, who are entitled to appeal Medicare part B initial claim 
determinations to request a review of the carrier's initial 
determination. Currently, these initial claim requests must be in 
writing. This final rule will allow those requests to be made by 
telephone, which will expedite the appeals process, and save time and 
costs for all parties. Allowing the use of telephone requests will 
supplement, not replace, the current procedures for initiating appeals. 
By providing quick and easy access to the appeals process, this rule 
will also improve carrier relationships with the beneficiary, physician 
and other suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/10/95                    60 FR 35544
NPRM Comment Period End         09/08/95
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPO-121

Agency Contact: Rosalind Little, Center for Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-05-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6972

RIN: 0938-AG48


_______________________________________________________________________



[[Page 21255]]

1059. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HCFA-2225-FC)

Priority:  Other Significant. Major under 5 USC 801.

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.2; 42 CFR 493.7; 42 CFR 493.8; 42 CFR 493.9; 
42 CFR 493.15; 42 CFR 493.20; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 
493.37; 42 CFR 493.39; 42 CFR 493.45; 42 CFR 493.47; 42 CFR 493.49; 42 
CFR 493.53; 42 CFR 493.1775

Legal Deadline: None

Abstract: As part of the CLIA program (see RIN: 0938-AE47), this rule 
will revise our current process of evaluating tests against generic 
criteria. A waiver will be granted to any test that meets the statutory 
criteria, provided that scientifically valid data are submitted 
verifying that the criteria were met.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/13/95                    60 FR 47534
NPRM Comment Period End         11/13/95
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-225

Agency Contact: Judy Yost, Division of Outcomes and Improvements, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-09-28, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AG99
_______________________________________________________________________




1060. ADDITIONAL SUPPLIER STANDARDS (HCFA-6004-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 424.57

Legal Deadline: None

Abstract: This rule will establish additional standards for entities 
seeking to qualify as Medicare suppliers for purposes of submitting 
claims for durable medical equipment and supplies. This rule is part of 
HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/20/98                     63 FR 2926
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1864-P

Agency Contact: Charles Waldhauser, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-13-03, 7500 Security Boulevard, Baltimore, 
MD 21214
Phone: 410 786-6140

RIN: 0938-AH19
_______________________________________________________________________




1061. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (HCFA-2047-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(10); 42 USC 1396a(u)(1); 42 USC 
1396d(a); 42 USC 1396a(a)(25); 42 USC 1396a(e); 42 USC 1396e

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This final rule with comment period amends our regulations to 
incorporate an optional statutory requirement that States may require, 
as a condition of Medicaid eligibility, enrollment of certain Medicaid 
eligibles in employer-based group health plans determined cost-
effective by States under guidelines approved by HCFA. If this option 
is elected by the State, it also requires States to pay all premiums, 
deductibles, coinsurance, and other cost-sharing obligations under 
these group health plans for services otherwise covered under the 
approved Medicaid State plans. In addition, this final rule with 
comment period provides for Medicaid payment of premiums for certain 
individuals who are entitled to elect continuation coverage provided 
for in the Consolidated Omnibus Budget Reconciliation Act of 1985 
(``COBRA''), Public Law 99-272, under a group health plan provided by 
an employer with 75 or more employees.
This final rule with comment period conforms our regulations to 
sections 4402 and 4713 of the Omnibus Budget Reconciliation Act of 1990 
and section 4741 of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/20/94                    59 FR 31569
NPRM Comment Period End         08/19/94
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: MB-047
Previously published under RIN 0938-AF64.

Agency Contact: Gwendolyn Talvert, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-15-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-5928
Email: [email protected]

RIN: 0938-AH48
_______________________________________________________________________




1062. TERMS, DEFINITIONS, AND ADDRESSES: TECHNICAL AMENDMENTS (HCFA-
9877-FC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395x(v)(1)(A); 42 USC 1395hh

CFR Citation:  42 CFR 400 to 420; 42 CFR 421 to 430; 42 CFR 431 to 440; 
42 CFR 442 to 447; 42 CFR 455 to 456; 42 CFR 462 to 466; 42 CFR 473 to 
476; 42 CFR 482 to 489; 42 CFR 491 to 498

Legal Deadline: None

Abstract: This is a technical final rule with comment period that will 
initiate the rationalization of our system of definitions, correct 
outdated addresses and formulas, clarify which steps of the appeals 
process are binding and which

[[Page 21256]]

are final, remove content that is duplicative or unnecessary, and make 
other clarifying editorial changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final With Comment Period       09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-877

Agency Contact: Luisa V. Iglesias, Division of Regulation and 
Issuances, Department of Health and Human Services, Health Care 
Financing Administration, Room 409-B, Hubert H. Humphrey Bldg., 200 
Independence Avenue SW., Washington, DC
Phone: 202 690-6383

RIN: 0938-AH53
_______________________________________________________________________




1063. UTILIZATION CONTROL AND DISCONTINUED REVIEW ACTIVITIES; MEDICAID 
(HCFA-2101-FC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(26); 42 USC 
1396a(a)(30); 42 USC 1396a(a)(31); 42 USC 1396a(a)(44); 42 USC 1396b(g)

CFR Citation:  42 CFR 400; 42 CFR 431; 42 CFR 456

Legal Deadline: None

Abstract: This final rule with comment period amends current 
regulations to reflect statutory changes under which physician 
certification, plan of care, and utilization review requirements become 
State plan requirements and are no longer included in the quarterly 
``showings'' of compliance that States must submit. Those showings are 
now limited to inspection of care reviews in institutions for mental 
diseases and intermediate care facilities for the mentally retarded. 
The rule also reflects the discontinuance of the State-operated claims 
processing assessment system and of regional office review of a 
subsample of each State's Medicaid quality control sample.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: MB-101

Agency Contact: Pamelia Butler, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6776

RIN: 0938-AH64
_______________________________________________________________________




1064. INDIVIDUAL MARKET HEALTH INS. REFORM PORTABILITY FROM GROUP TO 
INDIV. COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIV. MARKET; STATE 
ALTERNATIVE MECHANISMS TO FEDERAL RULES (HCFA-2882-F)

Priority:  Other Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

Legal Authority:  42 USC 300gg-41 et seq

CFR Citation:  45 CFR 148

Legal Deadline: None

Abstract: This final rule will address comments received on the interim 
final rule published on April 8, 1997 and further clarifies the 
Departmental position on HIPAA requirements in the individual market.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16985
Interim Final Rule Effective 
Date                            04/08/97
Interim Final Rule Comment 
Period End                      07/07/97
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: BPD-882-F

Agency Contact: Gertrude Saunders, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5888

RIN: 0938-AH75
_______________________________________________________________________




1065. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS EFFECTIVE 
FOR CALENDAR YEAR 1998 (HCFA-1885-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 13951(i)(2)(A)

CFR Citation:  42 CFR 416.61(b); 42 CFR 416.65(a)(4); 42 CFR 416.65(c); 
42 CFR 416.120(c)(1); 42 CFR 416.125; 42 CFR 416.130; 42 CFR 
416.140(a); 42 CFR 416.140(b); 42 CFR 488.1

Legal Deadline: None

Abstract: This proposed rule discusses several policy changes affecting 
coverage of and payment for Ambulatory Surgical Center (ASC) facility 
services as provided under sections 1833(i)(1A) and (2A) of the Social 
Security Act. It would include the criteria for identifying procedures 
that are appropriate and safely performed in an ASC; the method used to 
set ASC payment rates; and the schedule for publishing and implementing 
payment and coverage updates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/12/98                    63 FR 32290
Final Action                    12/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-885-P

Agency Contact: Joan Sanow, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5723

RIN: 0938-AH81


_______________________________________________________________________



[[Page 21257]]

1066. MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE REFORM (HCFA-2109-
IFC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(10)(C)

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This interim final rule with comment period will revise our 
rules to allow States to include individuals who are described as 
categorically needy to be covered as medically needy. The State must 
specify the income and resources criteria for the medically needy group 
in the State plan. If an individual is also described as categorically 
needy, the individual would receive Medicaid as categorically needy if 
the State elected to cover the categorically needy group into which the 
individual fits. If the State has not elected to cover that group, the 
individual would be medically needy. This change will allow more 
individuals to become eligible for Medicaid as medically needy and 
eliminate an inequity in current regulations. This revision also allows 
some individuals who would otherwise lose their Medicaid benefits to 
retain their eligibility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/99
Final Action                    09/00/00

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Additional Information: MB-109

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, S2-16-17, Baltimore, MD 
21244
Phone: 410 786-4579

RIN: 0938-AH92
_______________________________________________________________________




1067. MEDICARE+CHOICE PROGRAM (HCFA-1030-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395(w)21 to 27; 42 USC 1395hh

CFR Citation:  42 CFR 422

Legal Deadline: None

Abstract: The purpose of this final rule is to set forth limited 
changes to the Medicare+Choice regulations published in our June 26, 
1998 interim final rule (63 FR 34968). Those regulations implemented 
section 4001 of the Balanced Budget Act of 1997 (BBA), which 
established the Medicare+Choice (M+C) program. This final rule 
addresses selected issues raised by commenters on the June 26, 1998 
interim final rule where we have identified the need for changes or 
where we believe that clarifications are needed as soon as possible. 
Among these issues are provider participation procedures, beneficiary 
enrollment options, and several access-related issues, including 
initial care assessment requirements, notification requirements when 
specialists are terminated from an M+C plan, and several coordination 
of care requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/26/98                    63 FR 34968
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Anthony Hausner, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1093

RIN: 0938-AI29
_______________________________________________________________________




1068. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED 
BILLING FOR SKILLED NURSING FACILITIES. (HCFA-1913-IFC)

Priority:  Economically Significant

Legal Authority:  PL 105-33, sec 4432(a)

CFR Citation:  42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 413; 42 CFR 
483; 42 CFR 489

Legal Deadline: None

Abstract: This interim final rule implements provisions in section 4432 
of the Balanced Budget Act of 1997 related to Medicare payment for 
skilled nursing facility services. These include the implementation of 
a Medicare prospective payment system for skilled nursing facilities, 
consolidated billing, and a number of related changes. The prospective 
payment system described in this rule replaces the retrospective 
reasonable cost based system currently utilized by Medicare for payment 
of skilled nursing facility services under part A of the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/12/98                    63 FR 26252
Final Action                    07/00/99
Final Action Effective          10/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal

Agency Contact: Laurence Wilson, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., C4-7-04, Baltimore, MD 21244
Phone: 410 786-4603

RIN: 0938-AI47
_______________________________________________________________________




1069. SURETY BOND REQUIREMENTS FOR COMPREHENSIVE OUTPATIENT REHAB. 
FACILITIES, REHAB. AGENCIES, COMMUNITY MENTAL HEALTH CENTERS, AND 
INDEPENDENT DIAGNOSTIC TESTING FACILITIES (HCFA-6005-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395x(v); 42 USC 1395hh

CFR Citation:  42 CFR 413; 42 CFR 489

Legal Deadline: None

Abstract: The Balanced Budget Act of 1997 (BBA 1997) requires suppliers 
of durable medical equipment, home health agencies, comprehensive 
outpatient rehabilitation facilities, and rehabilitation agencies to 
furnish us with a surety bond in order to participate in the Medicare 
Program. The BBA 1997 also affords us the discretion to require other 
health care providers (other than physicians or

[[Page 21258]]

other practitioners) to furnish us with a surety bond to participate in 
the Medicare program. This proposed rule discusses the implementation 
of these provisions to require comprehensive outpatient rehabilitation 
facilities, rehabilitation agencies, and certain other providers and 
suppliers we have selected to furnish us with a surety bond on a 
continuing basis in order to participate in the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AI48
_______________________________________________________________________




1070. MEDICAID PROGRAM; HOME AND COMMUNITY-BASED SERVICES (HCFA-2010-FC)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority:  42 USC 1302; PL 105-33, sec 4743

CFR Citation:  42 CFR 440; 42 CFR 441

Legal Deadline: None

Abstract: This final rule with comment period expands State flexibility 
in providing prevocational, educational and supported employment 
services under the Medicaid home and community-based services waiver 
provisions of section 1915(c) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Bill Coons, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5921

RIN: 0938-AI67
_______________________________________________________________________




1071. SOLVENCY STANDARDS FOR PROVIDER-SPONSORED ORGANIZATIONS (HCFA-
1011-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395w-21 to 1395w-27; 42 USC 
1395hh

CFR Citation:  42 CFR 422

Legal Deadline: None

Abstract: This final rule establishes solvency standards for provider-
sponsored organizations (PSOs) under the new Medicare+Choice Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/07/98                    63 FR 25360
Interim Final Rule Effective    05/07/98
Interim Final Rule Comment 
Period End                      07/06/98
Final Action                    07/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marty Abeln, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1032

RIN: 0938-AI83
_______________________________________________________________________




1072. COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS (HCFA-
1909-IFC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-5; 42 USC 1395x(e), (y), and (ss); 42 
USC 1395ff; 42 USC 1395oo; 42 USC 1302

CFR Citation:  42 CFR 403; 42 CFR 412.90; 42 CFR 412.98; 42 CFR 
431.610; 42 CFR 440.155; 42 CFR 442.12; 42 CFR 456.351; 42 CFR 456.601; 
42 CFR 466.1; 42 CFR 440.170; 42 CFR 488.2; 42 CFR 488.6; 42 CFR 
489.102

Legal Deadline:  Final, Statutory, July 1, 1998.

Abstract: This final rule with comment period implements section 4454 
of the Balanced Budget Act of 1997 (BBA 1997), which amended section 
1861 of the Social Security Act (the Act) and added a new section 1821 
to the Act. Section 4454 of BBA 1997 removed all references to 
Christian Science and Christian sanatoria from the Act and substituted 
religious nonmedical health care institutions in their place. This 
change permits any religious organization to apply to be paid for 
furnishing nonmedical services under Medicare. Section 4454 also 
authorizes payment for such services as an option benefit under State 
Medicaid plans. The rule sets forth minimum requirements and conditions 
of participation to qualify as a religious nonmedical health care 
institution for purposes of receiving payment for services furnished 
under Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jean Marie Moore, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




1073. REPORTING OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA AS 
PART OF THE CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES (HCFA-
3006-IFC)

Priority:  Substantive, Nonsignificant

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 interim final rule with comment period requires 
electronic reporting of data from the Outcome and Assessment 
Information Set (OASIS) as a condition of participation for HHAs.

[[Page 21259]]

Specifically, this rule provides guidelines for HHAs for the electronic 
transmission of the OASIS data set as well as responsibilities of the 
State agency or contractor in collecting and transmitting this 
information to HCFA. This interim final rule also sets forth provisions 
concerning the privacy of patient identifiable information generated by 
the OASIS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Tracey Mummert, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD
Phone: 410 786-3398

RIN: 0938-AJ10
_______________________________________________________________________




1074.  ESTABLISHMENT OF A PROGRAM TO COLLECT SUGGESTIONS FOR 
IMPROVING MEDICARE PROGRAM EFFICIENCY AND TO REWARD SUGGESTORS (HCFA-
4000-FC)

Priority:  Other Significant

Legal Authority:  PL 104-191, sec 203(c)1; 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 420.410

Legal Deadline: None

Abstract: This rule establishes a suggestion program as a means of (1) 
encouraging individuals to submit suggestions and (2) rewarding 
individuals who make suggestions for improving the efficiency of the 
Medicare program in those instances in which HCFA deems that it is 
appropriate and when a reward is not otherwise provided by law. The 
rule describes the program, lists information requirements and 
eligibility criteria, establishes an upper limit for payments, and 
outlines the process and time limitations for obtaining a reward.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sam Della Vecchia, CBS, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-4481

RIN: 0938-AJ30
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1075. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (HCFA-1309-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g; 42 USC 
1395k; 42 USC 1395l; 42 USC 1395x; 42 USC 1395hh; 42 USC 1395rr; 42 USC 
1395tt; 42 USC 1395ww; 42 USC 1396b

CFR Citation:  42 CFR 405; 42 CFR 413; 42 CFR 414; 42 CFR 424; 42 CFR 
431; 42 CFR 447

Legal Deadline: None

Abstract: This rule will incorporate provisions of the Deficit 
Reduction Act of 1984, COBRA '85, OBRA '86, OBRA '87, TMRA '88, OBRA 
'89, and OBRA '90 regarding payment and ``assignment'' for diagnostic 
clinical laboratory tests establishing in regulations the methods for 
implementing fee schedules. This rule will set forth the methods by 
which the fee schedules will be updated and will allow certain 
adjustments for exceptions to the fee schedule. It will also reflect a 
statutory revision mandated by OBRA '93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/18/93                    58 FR 43156
NPRM Comment Period End         10/18/93


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: BPD-309

Agency Contact: Cathy Black, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4544

RIN: 0938-AB50
_______________________________________________________________________




1076. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HCFA-3135-F)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1320c; 42 USC 1396a(a)(30); 42 USC 1395cc(a)

CFR Citation:  42 CFR 400.200; 42 CFR 411.15; 42 CFR 431.630; 42 CFR 
433.15; 42 CFR 462.1; 42 CFR 462.101; 42 CFR 462.102; 42 CFR 462.106; 
42 CFR 462.107; 42 CFR 466.1; 42 CFR 466.71; 42 CFR 466.76; 42 CFR 
466.78; 42 CFR 466.83

Legal Deadline: None

Abstract: This rule will set forth several changes to regulations that 
govern Peer Review Organizations (PROs) and is based on statutory 
changes contained in COBRA '85 and OBRA '86. In addition, several 
technical changes will be included as a result of experience gained 
with the PRO program by HCFA. This rule also implements the new quality 
review requirements for certain Medicaid health maintenance 
organization contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/16/88                     53 FR 8654
NPRM Comment Period End         05/16/88


Next Action Undetermined

[[Page 21260]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: HSQ-135

Agency Contact: Bill Roskey, Office of Clinical Standards and Quality, 
Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S1-09-18, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AD38
_______________________________________________________________________




1077. OMNIBUS NURSING HOME REFORM REQUIREMENTS (HCFA-3488-F)

Priority:  Other Significant. Major under 5 USC 801.

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1395i-3; 42 USC 1395x; 42 USC 1396r; 42 USC 
1302

CFR Citation:  42 CFR 431; 42 CFR 482; 42 CFR 483; 42 CFR 488

Legal Deadline: None

Abstract: This final rule will implement several provisions of OBRA '87 
that concern services to residents of nursing homes. This rule will 
implement provisions that include Federal standards for evaluating 
State waivers of nursing facility nurse staffing requirements, use of 
physical and chemical restraints in nursing facilities, qualifications 
of facility administrators, notice of Medicaid rights to be given to 
persons admitted to nursing facilities, and other technical changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/05/92                     57 FR 4516
NPRM Comment Period End         04/06/92


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-488

Agency Contact: Nancy Archer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-0596

RIN: 0938-AD81
_______________________________________________________________________




1078. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (HCFA-1719-P)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1395gg

CFR Citation:  42 CFR 401; 42 CFR 403.310; 42 CFR 405; 42 CFR 410.1; 42 
CFR 411.23; 42 CFR 411.28; 42 CFR 413.20; 42 CFR 413.153; 42 CFR 
447.31; 42 CFR 466.86; 42 CFR 466.94; 42 CFR 473.14; 42 CFR 493.1834

Legal Deadline: None

Abstract: This rule would amend the Medicare regulations to clarify our 
interpretation of ``without fault'' as it applies to physician, 
provider, supplier, and beneficiary liability for overpayments. This 
definition would result in greater uniformity of determinations by 
carriers and intermediaries. Additionally, this rule would amend the 
Medicare regulations governing liability for overpayments to eliminate 
application of certain regulations of the Social Security 
Administration and to replace them with HCFA regulations more specific 
to circumstances involving Medicare overpayments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-719

Agency Contact: David Walczak, Center for Health Plans and Providers, 
Plan & Provider Purchasing Policy Group, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-07, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4475

RIN: 0938-AD95
_______________________________________________________________________




1079. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (HCFA-2023-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-5; 42 USC 1302

CFR Citation:  42 CFR 435.650 to 674; 42 CFR 435.750 to 754

Legal Deadline: None

Abstract: This rule would interpret statutory changes made in 1988, 
1989, 1990 and 1993 that allocate income and resources between an 
institutionalized spouse and the spouse remaining in the community. It 
would also provide special post-eligibility rules for institutionalized 
individuals who have spouses in the community to retain more income to 
meet living expenses.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local

Additional Information: HCFA-2023

Agency Contact: Roy Trudel, Center for Medicaid & State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-20-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3417

RIN: 0938-AE12
_______________________________________________________________________




1080. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HCFA-2169-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395bbb; 42 USC 1395hh; 42 USC 1302

CFR Citation:  42 CFR 488; 42 CFR 489; 42 CFR 498

Legal Deadline: None

Abstract: These rules will establish periodic, unannounced surveys of 
home health agencies (HHAs) and other survey requirements and also will 
specify sanctions that could be used when an HHA is out of compliance 
with Federal requirements (as an alternative or in addition to 
terminating an HHA's participation in the Medicare program).

[[Page 21261]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/91                    56 FR 37054
NPRM Comment Period End         10/01/91


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-169
Pending completion of RIN 0938-AG81 (HCFA-3819-P)

Agency Contact: Patricia Miller, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-19-14, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-6780

RIN: 0938-AE39
_______________________________________________________________________




1081. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (HCFA-2028-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(43); 42 USC 1396d(r)

CFR Citation:  42 CFR 441.50; 42 CFR 440.40

Legal Deadline: None

Abstract: Section 1905(r) of the Social Security Act, added by section 
6403 of OBRA '89, defines the following EPSDT services: screening 
services, vision services, dental services and hearing services. EPSDT 
services also are defined to include such other necessary health care, 
diagnostic services, treatment, and other measures described in section 
1905(a) of the Act to correct or ameliorate defects, illnesses and 
conditions discovered by the screening services whether or not the 
services are covered under the State plan. Section 1902(a)(43) of the 
Act requires States to report to the Secretary certain information 
about EPSDT services provided under the plan during each fiscal year. 
This rule would set forth requirements to implement these statutory 
provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/93                    58 FR 51288
NPRM Comment Period End         11/30/93


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local

Additional Information: MB-028

Agency Contact: Cindy Ruff, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-16-08, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5916

RIN: 0938-AE72
_______________________________________________________________________




1082. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (HCFA-
1685-F)

Priority:  Other Significant

Legal Authority:  PL 101-239, Sec 6205; PL 101-508, Sec 4004; PL 101-
508, Sec 4159; 42 USC 1395x

CFR Citation:  42 CFR 413

Legal Deadline:  Final, Statutory, June 30, 1990.

Abstract: This rule will set forth our policy for the payment of the 
costs of approved nursing and allied health science programs, as 
directed by section 6205(b)(2) of OBRA '89. For the most part, the 
provisions set forth in this rule restate or clarify our current 
policies governing these costs, which were previously set forth in the 
provider reimbursement manual and other documents, but have never been 
included in the regulations. In addition, we are amending the list of 
approved programs and clarifying payment rules for certified registered 
nurse anesthetist programs. This rule will also address section 4004 of 
OBRA '90 which provides that, effective with cost reporting periods 
beginning on or after October 1, 1990, under certain conditions, costs 
incurred by a hospital or educational institution related to the 
hospital for clinical training are treated as pass-through costs and 
paid on the basis of reasonable cost even though the hospital does not 
operate the education programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/92                    57 FR 43659
NPRM Comment Period End         11/23/92


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: HCFA-1685

Agency Contact: Marc Hartstein, Center for Health Plans & Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4539

RIN: 0938-AE79
_______________________________________________________________________




1083. COVERAGE OF SCREENING PAP SMEARS (HCFA-3705-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 410.10; 42 CFR 410.32; 42 CFR 410.56; 42 CFR 
411.15

Legal Deadline: None

Abstract: This rule establishes regulations under section 6115 of OBRA 
'89 to govern Medicare part B coverage of screening pap smears 
(including a physician's interpretation of the test results) provided 
to a woman for the early detection of cervical cancer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/26/93                    58 FR 62312
NPRM Comment Period End         01/24/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-705

Agency Contact: Joyce Eng, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4619

RIN: 0938-AE98


_______________________________________________________________________



[[Page 21262]]

1084. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HCFA-3175-
FC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  PL 101-239, Sec 6901(a); 42 USC 1395i-3; 42 USC 
1395aa(d); 42 USC 1396r

CFR Citation:  42 CFR 442; 42 CFR 488

Legal Deadline: None

Abstract: This final rule with comment period will amend the Medicare 
and Medicaid regulations by removing obsolete long-term care survey 
forms, guidelines, and procedures used by State agencies when they 
evaluate a Medicare skilled nursing facility or a Medicaid nursing 
facility for compliance with Federal certification requirements. 
Effective October 1, 1990, the application of new Federal participation 
requirements for these facilities with an increased focus on actual or 
potential resident outcomes has made the survey forms and process in 
existing regulations outdated. Retention of the outdated items can 
cause confusion in connection with directions State survey agencies 
must follow in determining facility compliance. This rule is part of 
the Administration's reinventing government and regulatory reform 
initiatives. Publication of this regulation is dependent upon court 
approval which has been sought.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: HSQ-175
This regulation may be published only with the concurrence of the U.S. 
District Court in Smith v. Shalala.

Agency Contact: Helene Fredeking, Director, Division of Outcomes and 
Improvements, Department of Health and Human Services, Health Care 
Financing Administration, S2-21-28, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-7304

RIN: 0938-AF02
_______________________________________________________________________




1085. CASE MANAGEMENT (HCFA-2027-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d; 42 USC 1396n

CFR Citation:  42 CFR 431.51(c); 42 CFR 431.54; 42 CFR 440.169; 42 CFR 
440.250; 42 CFR 441.10; 42 CFR 441.18; 42 CFR 447.327

Legal Deadline: None

Abstract: This rule will incorporate provisions of COBRA '85, OBRA '86, 
TEFRA '86, OBRA '87 and TMRA '88 dealing with case management services. 
It will provide for optimal Medicaid coverage of case management 
services furnished to specific groups in specific geographic areas or 
political subdivisions within a State.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/15/93                    58 FR 53481
NPRM Comment Period End         12/14/93


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Additional Information: HCFA-2027-F

Agency Contact: Bob Weaver, Disabled & Elderly Health Program Group, 
Center for Medicaid and State Operations, Department of Health and 
Human Services, Health Care Financing Administration, S2-14-26, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-5914

RIN: 0938-AF07
_______________________________________________________________________




1086. REQUIREMENTS FOR CERTAIN HEALTH INSURING ORGANIZATIONS AND OBRA 
'90 TECHNICAL AMENDMENTS (HCFA-1018-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(m); 42 USC 1396a(e)(2)(A)

CFR Citation:  42 CFR 434.20 to 72; 42 CFR 435.212; 42 CFR 435.326

Legal Deadline: None

Abstract: This final rule amends the Medicaid regulations to apply 
Medicaid regulations governing prepaid health plans to those health 
insuring organizations that provide or arrange for health care services 
to Medicaid recipients but are not subject to the requirements for 
health maintenance organizations (HMOs) set forth in section 
1903(m)(2)(A) of the Social Security Act. It also incorporates 
technical amendments relating to HMO and/or competitive medical plan 
enrollment, disenrollments, guaranteed eligibility, and provisional 
status included in OBRA '90 and the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/09/94                    59 FR 23820
NPRM Comment Period End         07/08/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: OMC-018

Agency Contact: Betty Stanton, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-25-13, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-3247

RIN: 0938-AF15
_______________________________________________________________________




1087. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (HCFA-1727-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(a); 42 USC 
1395l; 42 USC 1395x(v); 42 USC 1395x(v)(1)(A); 42 USC 1395hh; 42 USC 
1395ii; 42 USC 1395oo; 42 USC 1395ww; 42 USC 405; 42 USC 300e; 42 USC 
300e-5; 42 USC 300e-9; 31 USC 9701

CFR Citation:  42 CFR 405.1801 to 405.1889; 42 CFR 413.30 to 413.64; 42 
CFR 417.576; 42 CFR 417.810

Legal Deadline: None

Abstract: Section 1878 of the Social Security Act and 42 CFR part 405, 
subpart R, provide for administrative and judicial review, in 
accordance with prescribed requirements, of certain disputes regarding 
Medicare reimbursement for participating providers of services. This 
proposed rule would revise, update, and clarify various provisions of 
the regulations pertaining to provider appeals and make conforming 
changes to other regulations.

[[Page 21263]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: BPD-727

Agency Contact: Morty Marcus, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-26-22, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477

RIN: 0938-AF28
_______________________________________________________________________




1088. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HCFA-2191-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395cc; 42 USC 1396a

CFR Citation:  42 CFR 488

Legal Deadline: None

Abstract: This proposed rule would provide an alternative to 
terminating a psychiatric hospital's participation in the Medicare and 
Medicaid programs for facilities found to be out of compliance with 
participation requirements. Alternative sanctions could be imposed 
instead of, or in addition to, terminating a psychiatric hospital's 
participation in the Medicare and Medicaid programs when deficiencies 
do not pose immediate jeopardy to the health and safety of psychiatric 
hospital patients. These amendments are necessary to conform HCFA 
regulations to changes made by OBRA '89 and OBRA '90. The statutory and 
regulatory revisions are intended to encourage correction of 
deficiencies that do not jeopardize patient health and safety before 
termination of a facility becomes necessary.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: HSQ-191

Agency Contact: Terry Derville, Center for Medicaid and State 
Operations, Disabled and Elderly Health Program Group, Department of 
Health and Human Services, Health Care Financing Administration, S2-14-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6810

RIN: 0938-AF32
_______________________________________________________________________




1089. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (HCFA-2046-FC)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1396a(a); 42 USC 1396r-8; 42 USC 1396b(a); 42 
USC 1302

CFR Citation:  42 CFR 447; 42 CFR 441

Legal Deadline: None

Abstract: This final rule with comment period will incorporate section 
4401 of OBRA '90 to add specific requirements for Medicaid payment for 
covered outpatient drugs. The requirements concern: denial of Federal 
financial participation unless rebate agreements and drug use review 
are in effect; prohibiting some State plan drug access limitations for 
drugs covered under a rebate agreement; and the content of the rebate 
agreements. (The drug rebate agreement was previously published in the 
Federal Register on February 21, 1991 (56 FR 7049)). This rule will 
reflect statutory revisions mandated by the Veteran's Health Care Act 
of 1992 and OBRA '93. Revision of the drug rebate dispute resolution 
process is part of the Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/95                    60 FR 48442
NPRM Comment Period End         11/20/95


Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: HCFA-2046-FC

Agency Contact: Tami Bruce, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1519

RIN: 0938-AF42
_______________________________________________________________________




1090. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (HCFA-2051-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396k; 42 USC 1302

CFR Citation:  42 CFR 433.135; 42 CFR 433.137; 42 CFR 433.151; 42 CFR 
433.160

Legal Deadline: None

Abstract: This rule will require State Medicaid agencies to refer 
Medicaid families with an absent parent to child support enforcement 
(CSE) agencies. Section 9142 of OBRA '87 required CSE agencies to 
provide all CSE services to such Medicaid families who have assigned to 
the State their rights to medical support. The purpose of these rules 
is to require States to make this referral to State CSE agencies to 
ensure that those recipients requiring CSE services receive them.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/93                    58 FR 49272
NPRM Comment Period End         11/22/93


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: HCFA-2051-F

Agency Contact: Robert Nakielny, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4466

RIN: 0938-AF68
_______________________________________________________________________




1091. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS, AND CHILDREN UNDER AGE 19 (HCFA-2052-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(55)

CFR Citation:  42 CFR 435.901; 42 CFR 435.902; 42 CFR 435.903; 42 CFR

[[Page 21264]]

435.904; 42 CFR 435.907; 42 CFR 436.2; 42 CFR 436.3; 42 CFR 435.3

Legal Deadline: None

Abstract: This rule will finalize the interim final rule that requires 
State Medicaid agencies to provide for receipt and initial processing 
of Medicaid applications filed by certain low-income pregnant women, 
infants, and children under age 19, at locations which are other than 
those used for receipt and processing of applications for cash 
assistance under title IV-A of the Social Security Act. The rule is 
based on section 1902(a)(55) of the Social Security Act, as added by 
section 4602 of OBRA '90, PL 101-508.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/23/94                    59 FR 48805
Effective Date                  10/24/94
Comment Period End              11/22/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: HCFA-2052-F

Agency Contact: Robert Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-08-24, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AF69
_______________________________________________________________________




1092. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) DEBTS 
(HCFA-6108-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  31 USC 3711; 42 USC 1395y(b)(2)(B)

CFR Citation:  42 CFR 405.378; 42 CFR 411.24(m); 42 CFR 411.39

Legal Deadline: None

Abstract: This proposed rule would amend the regulations concerning 
interest charges on amounts owed to the Federal government when an 
overpayment occurs because Medicare was billed and made payment as the 
primary payer, rather than as the secondary payer. We also propose to 
clarify the date of determination that an overpayment has occurred so 
that all parties would have a clear understanding of the period subject 
to payment of interest charges.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: BP0-108

Agency Contact: John Albert, Office of Financial Management, Department 
of Health and Human Services, Health Care Financing Administration, S3-
02-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________




1093. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (HCFA-2038-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(r)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice sets forth revised general functional 
requirements for the Medicaid Management Information Systems (MMIS). 
The MMIS consists of software and hardware used to process Medicaid 
claims and to retrieve and produce utilization and management 
information about services that are required by the Medicaid agency or 
Federal Government for administrative or audit purposes. The revised 
requirements allow States more flexibility to exercise variations in 
the implementation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 11/22/93                    58 FR 61692
Comment Period End              01/21/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Additional Information: MB-038

Agency Contact: Richard Friedman, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4451

RIN: 0938-AG10
_______________________________________________________________________




1094. ALTERNATIVE SANCTIONS FOR RENAL DIALYSIS FACILITIES (HCFA-3204-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr(c); 42 USC 1395rr(g)

CFR Citation:  42 CFR 405; 42 CFR 488; 42 CFR 498

Legal Deadline: None

Abstract: This proposed rule would set forth circumstances under which 
HCFA could impose denial of payment sanction as an alternative to 
terminating coverage of the facilities services when an end-stage renal 
dialysis (ESRD) facility is not in substantial compliance with the 
conditions for coverage, but its deficiencies do not pose immediate 
jeopardy to patient health or safety. Before section 1881 of the Social 
Security Act was amended by section 12 of the Medicare and Medicaid 
Patient and Program Protection Act of 1987 (Public Law 100-93), HCFA 
was authorized to impose alternative sanctions only when an ESRD 
facility failed to cooperate in the goals and activities of the ESRD 
network for the area in which the facility is located.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Additional Information: HSQ-204

Agency Contact: Judith Kari, Center for Medicaid and State Operations, 
Division of Outcomes and Improvements, Department of Health and Human 
Services, Health Care Financing Administration, S2-19-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6829

RIN: 0938-AG31
_______________________________________________________________________




1095. DESCRIPTION OF HCFA'S EVALUATION METHODOLOGY FOR THE PEER REVIEW 
ORGANIZATIONS FIFTH SCOPE OF WORK CONTRACTS (HCFA-3207-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1320c; 42 USC 1320c-(2)(h)(2)

CFR Citation:  42 CFR 462

Legal Deadline: None

[[Page 21265]]

Abstract: This notice with a comment period would provide general 
criteria and standards that will be used to evaluate the effective and 
efficient performance of Utilization and Quality Control Peer Review 
Organizations (known as PROs) for contracts entered into on or after 
April 1, 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/02/97                    62 FR 35824
NPRM Comment Period End         09/02/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Additional Information: HSQ-207-NC

Agency Contact: Heidi Gelzer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-08-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________




1096. DISCLOSURE OF CONFIDENTIAL PRO AND ESRD NETWORK ORGANIZATION 
INFORMATION FOR RESEARCH PURPOSES (HCFA-3208-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-9; 42 USC 1302

CFR Citation:  42 CFR 405.2115; 42 CFR 476.144

Legal Deadline: None

Abstract: This rule would allow Peer Review Organizations (PROs) to 
disclose confidential information to researchers without the consent of 
the individuals who would be identified. The research must be directly 
related to the purposes of the PRO or ESRD program. Currently, PROs can 
only disclose to the public nonconfidential aggregate data where no one 
is specifically identified. The statute, however, provides for limited 
disclosure and allows the Secretary to provide for disclosure in the 
regulations while assuring adequate protection of the rights and 
interests of patients, health care practitioners, and providers. HCFA 
is now emphasizing the sharing of PRO data for educational and research 
purposes as evidenced by the implementation of the Uniform Clinical 
Data Set and the Health Care Quality Improvement Initiative. This 
regulatory revision would make confidential PRO information accessible 
to researchers while still protecting the identities of beneficiaries 
and practitioners from unwarranted disclosure.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: HSQ-208

Agency Contact: Bill Roskey, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-09-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AG33
_______________________________________________________________________




1097. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, UNDERPAYMENTS AND OVERPAYMENTS (HCFA-2215-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(a); 42 USC 
1395hh; 42 USC 1395ii; 42 USC 1395oo; 42 USC 1395xx; 42 USC 1395x(v); 
42 USC 13951; 42 USC 405; 42 USC 1395ww

CFR Citation:  42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 42 
CFR 405.1843; 42 CFR 405.1805; 42 CFR 489.2; 42 CFR 489.18

Legal Deadline: None

Abstract: This rule would amend the regulations on provider and certain 
supplier agreements by clarifying the effect a change of ownership has 
on penalties and sanctions incurred by the former provider or supplier. 
It also would clarify our policy on changes involving leased 
departments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Additional Information: HSQ-215

Agency Contact: Mike Goldman, Division of Integrated Health Systems, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-14-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6813

RIN: 0938-AG59
_______________________________________________________________________




1098. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (HCFA-2082-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(10)(A)(ii); PL 103-66, Sec 13603; 42 
USC 1396a(z)

CFR Citation:  42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR 
436.201; 42 CFR 436.219; 42 CFR 440.164

Legal Deadline: None

Abstract: This rule would provide for optional Medicaid coverage of 
low-income individuals infected with tuberculosis (TB). These 
individuals would be eligible only for specified tuberculosis related 
services. The rule would incorporate and interpret provisions of 
section 13603 of OBRA '93.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Additional Information: HCFA-2082-P

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-16-25, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________




1099. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(HCFA-3745-F)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or

[[Page 21266]]

duplication, or streamline requirements.

Legal Authority:  42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 
1395(hh); 42 USC 1320(b)(8)

CFR Citation:  42 CFR 416; 42 CFR 482; 42 CFR 485; 42 CFR 489

Legal Deadline: None

Abstract: This final rule will revise the requirements that hospitals 
must meet to participate in the Medicare and Medicaid programs. The 
revised requirements focus on patient care and the outcomes of that 
care, reflect a cross-functional view of patient treatment, encourage 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements. These changes are necessary to reflect 
advances in health care practices since the requirements were last 
revised in 1986.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66726
NPRM Comment Period End         03/20/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3745-F

Agency Contact: Doris Jackson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S3-05-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4656

RIN: 0938-AG79
_______________________________________________________________________




1100. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES (HCFA-
1809-F)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395nn

CFR Citation:  42 CFR 411.1; 42 CFR 411.350 to 411.361; 42 CFR 424.22; 
42 CFR 435.1002; 42 CFR 435.1012; 42 CFR 455.100 to 455.109

Legal Deadline: None

Abstract: This rule provides that a physician who has (or whose 
immediate family member has) a financial relationship with a health 
care entity may not make referrals to that entity for certain services 
(designated health services) under the Medicare program except under 
specified circumstances. In the Medicaid context, this rule would deny 
payment to a State for expenditures for designated health services 
furnished on the basis of a physician referral that, all things being 
equal, would result in denial of payment under Medicare. The provisions 
of the rule are based on sections 13562 and 13624 of OBRA '93 and 
section 152 of SSAA '94.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/09/98                     63 FR 1659
NPRM Comment Period End         05/11/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-1809-P

Agency Contact: Joanne Sinsheimer, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-02-04, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4620

RIN: 0938-AG80
_______________________________________________________________________




1101. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (HCFA-3819-F)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

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 final rule will revise home health agency conditions of 
participation to center on the patient, using outcome-oriented 
measures. Most of the current HHA conditions of participation have 
remained unchanged since home health services became a Medicare benefit 
in 1966. Some limited modifications have been made over the years to 
comply with legislative changes. As a result, most of the conditions of 
participation continue to be structure and process oriented. In 
addition, this final rule will require that HHAs use a standard core 
assessment data set, the ``Outcome and Assessment Information Set'' 
(OASIS), when evaluating adult, non-maternity patients receiving home 
health care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3819-F

Agency Contact: Mary Vienna, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6940

RIN: 0938-AG81
_______________________________________________________________________




1102. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (HCFA-3818-
P)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

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 413; 42 CFR 414; 42 CFR 489; 42 CFR 492

Legal Deadline: None

Abstract: This proposed rule would revise the current conditions for 
coverage for end stage renal disease (ESRD) facilities approved to 
provide ESRD service under Medicare. It would

[[Page 21267]]

update the conditions to reflect developments in technology and 
equipment, emphasize the total patient experience and develop 
performance expectations for the facility that result in quality, 
comprehensive care for the dialysis patient.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3818-P

Agency Contact: Lynn Merritt-Nixon, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S3-04-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4652

RIN: 0938-AG82
_______________________________________________________________________




1103. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION OF 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (HCFA-3815-
P)

Priority:  Other Significant

Legal Authority:  42 USC 1395i-3; 42 USC 1396r(a); 42 USC 1302; 42 USC 
1395hh

CFR Citation:  42 CFR 409; 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule would define ``distinct part'' by 
specifying that a distinct part is a physically identifiable unit of an 
institution (that is, an entire ward, wing, floor, or building) 
including all beds in the unit. This proposed rule would also prohibit 
nursing homes from financially screening private pay applicants for 
admission. Instead, nursing homes would be permitted to charge private 
pay applicants up to a 2-month deposit before admission to ensure that 
sufficient funds are available to pay for care which the individual may 
receive before discharge.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-815

Agency Contact: Nancy Archer, Office of Clinical Standards & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-05-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 401 786-0596

RIN: 0938-AG84
_______________________________________________________________________




1104. LIABILITY FOR THIRD PARTIES TO PAY FOR CARE AND SERVICES (HCFA-
2080-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(25)(A); 42 USC 1396b(o)

CFR Citation:  42 CFR 433.135 to 433.152

Legal Deadline: None

Abstract: This rule would incorporate provisions of OBRA '93 by 
amending the regulations governing third party liability. It would add 
ERISA plans, service benefit plans, and health maintenance 
organizations to the definition of liable third parties. It would 
require States to prohibit any health insurer from taking into account, 
when enrolling or making payments, that an individual is eligible for 
or receiving Medicaid. It would also require States to enact a law 
under which the State is deemed to have acquired a recipient's right to 
payment by a third party.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: MB-080

Agency Contact: Robert Nakielny, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-21-01, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4466

RIN: 0938-AH01
_______________________________________________________________________




1105. ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR 
LENSES (HCFA-3831-F)

Priority:  Economically Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1395k(a)(2); 42 USC 1395l

CFR Citation:  42 CFR 416

Legal Deadline:  NPRM, Statutory, October 31, 1995.

Abstract: This rule establishes a process under which interested 
parties could request, with respect to a class of new technology 
intraocular lenses (IOLs), a review of the appropriateness of the 
current payment amount for IOLs furnished by Medicare-participating 
ambulatory surgical centers. This rule is part of HCFA's regulatory 
reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/04/97                    62 FR 46698


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: HCFA-3831-F

Agency Contact: Claude Mone, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-04-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5666

RIN: 0938-AH15
_______________________________________________________________________




1106. DEFINITION OF SKILLED NURSING FACILITY (SNF) FOR COVERAGE OF 
DURABLE MEDICAL EQUIPMENT (DME) AND HOME HEALTH (HCFA-1834-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(n); 42 USC 1395i-3(a)(1); 42 USC 
1396r(a)(1)

CFR Citation:  42 CFR 409; 42 CFR 410

Legal Deadline: None

Abstract: This proposed rule would define skilled nursing facilities 
(SNFs) under section 1819(A)(1) of the Social Security Act for purposes 
of Medicare coverage of durable medical equipment (DME) and home health 
services. A Medicare SNF (as defined under section 1819 of the Social 
Security Act) cannot be considered a home under Medicare part B for DME 
and home

[[Page 21268]]

health coverage. This proposed rule would presume that all Medicare 
nursing facilities are section 1819(A)(1) facilities and thus would not 
be considered a home for DME coverage. This would define non-Medicare 
nursing homes as skilled facilities based upon the receipt of skilled 
care at least once a week by a proportion of its residents population.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-834

Agency Contact: Thomas Hoyer, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-16, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________




1107. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (HCFA-2096-P)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1316; 42 USC 1396a(a)

CFR Citation:  42 CFR 430.18; 42 CFR 430.60

Legal Deadline: None

Abstract: This proposed rule would revise and streamline the State Plan 
Amendment (SPA) reconsideration process. Currently, when a State 
requests reconsideration of a denied SPA, a hearing is held in all 
cases, even when the only dispute is over the interpretation of the 
statute. Under the proposed regulation, the State and HCFA could avoid 
the cost and delay of the hearing process when the only issue is 
interpretation of the statute by permitting the State expedited 
judicial review, without a full administrative hearing, after HCFA has 
a brief opportunity to reconsider its decision.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Additional Information: HCFA-2096-P

Agency Contact: Robert Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-20-21, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AH24
_______________________________________________________________________




1108. HOSPICE CARE--CONDITIONS OF PARTICIPATION (HCFA-3844-P)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395x(dd); 42 USC 1395hh

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would revise the Medicare conditions of 
participation for hospices to help ensure the provision of quality care 
through an emphasis on patient-centered outcomes. Areas of change would 
include, among others, assessment of patient needs, clarification of 
physician roles, coordination of care for hospice patients residing in 
nursing homes, clarification of nursing roles, patient rights, and 
provision of services.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3844

Agency Contact: Lynn Merritt-Nixon, Office of Clinical Standard & 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S3-04-25, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4652

RIN: 0938-AH27
_______________________________________________________________________




1109. CLIA PROGRAM; CYTOLOGY PROFICIENCY TESTING (HCFA-2233-N)

Priority:  Other Significant

Legal Authority:  42 USC 263a(f)(4)(B)(iv)

CFR Citation:  42 CFR 493.855

Legal Deadline: None

Abstract: This notice announces the withdrawal of a proposed rule on 
cytology proficiency testing that was published in the Federal Register 
November 30, 1995, and instead, announces a supplement to the 
rulemaking record of a final rule published February 28, 1992. In 
publishing the proposed rule, HHS complied with a Federal court order 
requiring publication of a proposal that would require that cytology 
proficiency testing be conducted to the extent practicable, under 
normal working conditions. As required, we proposed to revise 
regulations to require that proficiency testing be conducted at a pace 
corresponding to the maximum workload rate for individuals examining 
slides. We also solicited comments on the use of computer facsimile 
representations of cytology specimens, as an alternative to glass-slide 
proficiency testing. After the proposed rule was published, the appeals 
court revised the lower court's order, allowing us to withdraw the 
proposed rule and supplement the record to the final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/95                    60 FR 61509
NPRM Comment Period End         01/29/96


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-233-N. We are publishing a notice to advise 
the public that no final rule is necessary because the court decided 
the case in our favor.

Agency Contact: Rhonda Whalen, Senior Health Scientist, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
4770 Buford Highway, NE., MS F 11, Atlanta, GA 30341-3724
Phone: 770 488-8155

RIN: 0938-AH35


_______________________________________________________________________



[[Page 21269]]

1110. MEDICARE COVERAGE OF SERVICES OF SPEECH-LANGUAGE PATHOLOGISTS AND 
AUDIOLOGISTS (HCFA-1843-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395x; 42 USC 1395x(cc)(1); 42 
USC 1395x(ll)

CFR Citation:  42 CFR 484; 42 CFR 485

Legal Deadline: None

Abstract: This proposed rule would implement SSA '94 provisions to 
provide coverage for speech-language pathology services furnished by a 
qualified pathologist.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-843

Agency Contact: Jackie Gordon, Division of Cost Reporting, Department 
of Health and Human Services, Health Care Financing Administration, C4-
07-14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4517

RIN: 0938-AH37
_______________________________________________________________________




1111. PAYMENT AMOUNT IF CUSTOMARY CHARGES ARE LESS THAN REASONABLE COSTS 
(HCFA-1860-FC)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

Legal Authority:  42 USC 1395f(b); 42 USC 1395l(a); 42 USC 1395m(a)

CFR Citation:  42 CFR 413.13

Legal Deadline: None

Abstract: A provider whose charges are lower than its reasonable costs 
for those services in any cost reporting period beginning January 1, 
1974, but before April 28, 1988, may carry forward costs that are 
unreimbursed for two succeeding cost reporting periods. Sufficient time 
has passed since the publication of this provision to warrant the 
deletion from the regulation text of any reference to the carryover 
provision. Since payment for durable medical equipment (DME) provided 
by home health agencies (HHAs) is no longer based on the lesser of the 
reasonable cost or reasonable charge but rather on 80 percent of the 
lesser of the actual charge for the item or the payment amount 
recognized under the DME fee schedule and, for nominal charge HHAs, on 
80 percent of the DME fee schedule amount, the lesser of costs or 
charges provision no longer applies and should be deleted from the CFR.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-860

Agency Contact: Ward Pleines, Chronic Care Purchasing Policy Group, 
Division of Cost Reporting, Department of Health and Human Services, 
Health Care Financing Administration, C5-02-23, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4528

RIN: 0938-AH49
_______________________________________________________________________




1112. LIMITATIONS ON LIABILITY (HCFA-4859-FC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395pp

CFR Citation:  42 CFR 411.404

Legal Deadline: None

Abstract: This final rule with comment period will implement section 
1879 (h) of the Social Security Act, which limits beneficiary liability 
for certain medical equipment and supplies. This rulemaking is part of 
the Reinventing Government effort. We are working with industry 
representatives to develop guidelines that will streamline 
requirements, reduce burden and duplication, and give beneficiaries the 
opportunity to make informed consumer decisions regarding certain 
medical equipment and supplies.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: BPD-859

Agency Contact: Denis Garrison, Division of Beneficiary Protections, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-06-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5643

RIN: 0938-AH51
_______________________________________________________________________




1113. MEDICARE SECONDARY PAYER CLARIFICATIONS AND AMENDMENTS (HCFA-1865-
P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This proposed rule would codify in regulations policies 
regarding liability insurance, such as structured liability 
settlements, future medical expenses, provider malpractice, wrongful 
death, and Federal Tort Claims Act policy. It would also clarify the 
rules dealing with group health plan bankruptcies, religious orders, 
and foreign group health plans, and make numerous other changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-865

Agency Contact: Herb Pollock, Center for Health Plans & Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AH52
_______________________________________________________________________




1114. REVISION TO ACCRUAL BASIS OF ACCOUNTING POLICY (HCFA-1876-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v); 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 413.100

Legal Deadline: None

[[Page 21270]]

Abstract: The proposed rule would specify the providers' share of the 
costs of FICA and other employee payroll taxes that will be allowable 
under Medicare when the payroll period ends subsequent to the end of 
the reporting period. The proposed rule would provide that if payment 
would be made to an employee during a cost reporting period but for the 
fact that the regularly scheduled payment date is after the end of the 
period, that portion of employees FICA or other taxes that have accrued 
up to the end of the reporting period will be treated as allowable 
costs in the current reporting period.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1876-P

Agency Contact: John Eppinger, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-03-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4518

RIN: 0938-AH61
_______________________________________________________________________




1115. MEDICAID; ESTATE RECOVERIES (HCFA-2083-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a; 42 USC 1396p

CFR Citation:  42 CFR 433.36

Legal Deadline: None

Abstract: This proposed rule is being developed as a result of the OBRA 
1993 provisions that mandated States to seek adjustment or recovery 
from the estates of Medicaid beneficiaries for amounts correctly spent 
by Medicaid on permanently institutionalized individuals (any age) and 
individuals age 55 or older for certain services. The OBRA 1993 
provision also defines ``estate,'' and further requires States to 
establish hardship procedures, in accordance with standards specified 
by the Secretary for waiver of recovery in cases where undue hardship 
would result.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Additional Information: HCFA-2083-P

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-16-25, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4461

RIN: 0938-AH63
_______________________________________________________________________




1116. MEDICAID HOSPICE CARE (HCFA-2016-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395hh; 42 USC 1302

CFR Citation:  42 CFR 418.24; 42 CFR 418.28; 42 CFR 418.98; 42 CFR 
440.167; 42 CFR 440.250(q); 42 CFR 441; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would provide for optional Medicaid 
coverage of hospice care for terminally ill recipients who elect to 
receive care from a participating hospice, establish eligibility 
requirements, covered services, reimbursement procedures, and 
conditions that a hospice must meet to provide services to Medicaid 
recipients. It would make conforming technical revisions to the 
Medicare regulations governing hospice care.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: HCFA-2016-P

Agency Contact: Tom Shenk, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295

RIN: 0938-AH65
_______________________________________________________________________




1117. PROVIDER AND SUPPLIER BILLING WHEN MEDICARE IS SECONDARY PAYOR TO 
LIABILITY INSURANCE (HCFA-1848-P)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395cc; 42 USC 1395dd; 42 USC 
1395hh; 42 USC 1395ww; 42 USC 1395x; 42 USC 1395aa

CFR Citation:  42 CFR 411; 42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would revise current regulations to 
require that providers and suppliers attempt to collect payment from 
the proceeds of liability insurance during the ``promptly period.'' 
This rule would also permit providers and suppliers to choose either to 
pursue collection of payment from the proceeds of liability insurance 
after the ``promptly period'' has ended or to bill Medicare.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-848

Agency Contact: Anita Heygster, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-08-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4486

RIN: 0938-AH66
_______________________________________________________________________




1118. MEDICARE TECHNICAL CONFORMING AMENDMENTS (HCFA-1858-FC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395k

CFR Citation:  42 CFR 409.50; 42 CFR 409.61; 42 CFR 410.152

Legal Deadline: None

Abstract: This final rule with comment period will update our 
regulations to reflect that payment for durable medical equipment is on 
the basis of a fee schedule.

[[Page 21271]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-858

Agency Contact: Martha Kuespert, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4605

RIN: 0938-AH67
_______________________________________________________________________




1119. ELIMINATION OF CERTAIN REQUIREMENTS FOR PEER REVIEW ORGANIZATIONS 
IN THE UTILIZATION AND QUALITY REVIEW PROCESS AND A CHANGE IN THE LENGTH 
OF PEER REVIEW ORGANIZATION CONTRACTS (HCFA-3235-FC)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 462.107; 42 CFR 466.71; 42 CFR 466.73

Legal Deadline: None

Abstract: This rule would eliminate the requirement that Peer Review 
Organizations (PROs) conduct quarterly random sample reviews of 
hospital discharges. It would also change the period for PRO contracts 
from 2 years to 3 years and would eliminate certain notification 
requirements regarding contract awards.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-235-FC

Agency Contact: Bill Roskey, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-09-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AH68
_______________________________________________________________________




1120. DETERMINATION OF SUBSTANDARD CARE IN SNFS AND NFS (HCFA-2240-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-3; 42 USC 1396r

CFR Citation:  42 CFR 488.301

Legal Deadline: None

Abstract: This proposed rule would revise the definition of 
``substandard quality of care'' as it applies to skilled nursing 
facilities, in the Medicare program, and nursing facilities, in the 
Medicaid program. ``Substandard quality of care'' is one type of 
noncompliance with Federal participation requirements that carries with 
it statutory consequences to facilities providing such care. The 
purpose of this proposed revision is to improve the definition of 
substandard quality of care so that the process can make a more 
meaningful distinction between facility noncompliance that warrants the 
consequences mandated by the statute for a finding of substandard 
quality of care and noncompliance that does not.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-240

Agency Contact: Pat Miller, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-19-14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6780

RIN: 0938-AH69
_______________________________________________________________________




1121. WAIVER OF STAFFING REQUIREMENTS FOR END STAGE RENAL DISEASE (ESRD) 
FACILITIES PARTICIPATING IN AN EXPERIMENT (HCFA-2236-GNC)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1320; 42 USC 1395x; 42 USC 1395y; 
42 USC 1395hh; 42 USC 1395rr

CFR Citation:  42 CFR 405.2136; 42 CFR 405.2161; 42 CFR 405.2162; 42 
CFR 405.2163

Legal Deadline: None

Abstract: This general notice with comment period announces our 
intention to conduct a demonstration that would grant selected ESRD 
facilities a 2-year waiver of staffing requirements. The ESRD staffing 
requirements pertain to: the governing body and management, director of 
a facility, on-duty licensed health care professionals, and providing 
adequate laboratory, social, and dietetic services. Facilities would be 
given flexibility to deviate from specified regulation requirements, 
provided assurances are in place ensuring that quality of care 
standards are not being compromised.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-236

Agency Contact: William Roskey, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S1-09-07, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-0433

RIN: 0938-AH72
_______________________________________________________________________




1122. PROVIDER AND SUPPLIER ENROLLMENT PERIODIC RENEWAL OF ELIGIBILITY 
REQUIREMENTS (HCFA-6002-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 424; 42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would establish conditions for enrolling 
providers and suppliers that furnish items or services to Medicare 
beneficiaries. These conditions would improve current enrollment 
procedures to more accurately identify providers and suppliers, and 
secure information and documentation necessary for the effective and 
efficient administration of

[[Page 21272]]

the Medicare program. The improved identification of providers and 
suppliers, coupled with the collection of certain information, would 
facilitate the administration of many aspects of the Medicare program 
including, but not necessarily limited to, monitoring for compliance 
with program rules and combating fraud and abuse. Improvements in 
enrolling providers and suppliers would afford both the Medicare Trust 
Funds and program beneficiaries with greater protection.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Formerly known as HCFA-1023-P

Agency Contact: Michael Collett, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




1123. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (HCFA-3887-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 416

Legal Deadline: None

Abstract: This proposed rule would revise the ambulatory surgical 
center conditions for coverage to reflect current innovations in 
healthcare delivery, quality assessment, and performance improvement. 
The focus would be to improve outcomes of health care and satisfaction 
for Medicare beneficiaries, while streamlining structural and 
procedural requirements where possible.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-887

Agency Contact: Judy Goldfarb, Office of Clinical Standards & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, S2-199.06, Baltimore, MD 21244
Phone: 410 786-6747

RIN: 0938-AH83
_______________________________________________________________________




1124. DISCLOSURE OF PEER REVIEW ORGANIZATION INFORMATION IN RESPONSE TO 
BENEFICIARY COMPLAINTS (HCFA-3241-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 466.70(a); 42 CFR 476.101; 42 CFR 476.107; 42 CFR 
476.132; 42 CFR 476.133(b)(4)

Legal Deadline: None

Abstract: This proposed rule would change our policy regarding the 
disclosure of peer review organization (PRO) information in responding 
to beneficiary complaints about physicians, other practitioners, and 
other institutional and non-institutional providers of health care, 
including Health Maintenance Organizations and Competitive Medical 
Plans. Under the proposal, we would permit the disclosure of PRO 
information about physicians and other individual practitioners without 
their permission to the extent necessary to comply with section 
1154(a)(14) of the Social Security Act. This section requires PROs to 
conduct reviews of beneficiary complaints about the quality of services 
that do not meet professionally recognized standards of health care and 
inform each beneficiary of the final disposition of his or her 
complaint.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-241-P

Agency Contact: William Roskey, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, S1-09-07, Baltimore, MD 
21244-1850
Phone: 410 786-0433

RIN: 0938-AH85
_______________________________________________________________________




1125. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (HCFA-4145-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This 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 in section 262 of the Health Insurance 
Portability and Accountability Act of 1996.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: BPO-145

Agency Contact: Faye Broseker, Center for Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-07-06, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3342

RIN: 0938-AH87
_______________________________________________________________________




1126. MEDICAID PROGRAM; AMENDMENT TO THE PREADMISSION SCREENING AND 
ANNUAL RESIDENT REVIEW PROGRAM (HCFA-2107-P)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1396r(e); 42 USC 1396r(b)

CFR Citation:  42 CFR 405; 42 CFR 431; 42 CFR 433; 42 CFR 441; 42 CFR 
483

Legal Deadline: None

Abstract: This proposed rule would make changes to the preadmission 
screening and annual resident review program in accordance with the 
provisions of Public Law 104-315, which were included in the 
Reinventing Government effort. The

[[Page 21273]]

rule would repeal the Medicaid program requirement for an annual review 
of nursing facility (NF) residents with mental illness or mental 
retardation. This proposed rule also would add the requirement for NFs 
to notify the State when there is a significant change in the physical 
or mental condition of a resident and add a statutory requirement that 
the State conduct a review promptly after notification of the 
resident's change in condition.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: HCFA-2107-P

Agency Contact: Jan Earle, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, S2-15-10, Baltimore, MD 21244
Phone: 410 786-9004
Fax: 410 786-3262

RIN: 0938-AH89
_______________________________________________________________________




1127. MEDICAID PROGRAM; COVERAGE AND PAYMENT FOR FEDERALLY QUALIFIED 
HEALTH CENTER SERVICES (HCFA-2043-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(13); 42 USC 1396d(a)

CFR Citation:  42 CFR 431; 42 CFR 440; 42 CFR 441; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would incorporate and interpret in 
regulations coverage and payment requirements for services furnished by 
a federally qualified health center (FQHC) under the Medicaid program. 
This rule will include changes in the payment provisions to FQHCS made 
by section 4712 of the Balanced Budget Act of 1997 PL-105-33.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: MB-43

Agency Contact: David Worgo, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-15-18, Baltimore, MD 21244
Phone: 410 786-5919

RIN: 0938-AH95
_______________________________________________________________________




1128. REVISION TO THE DEFINITION OF AN UNEMPLOYED PARENT (HCFA-2106-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 607; 42 USC 1396u-1

CFR Citation:  45 CFR 233

Legal Deadline: None

Abstract: This final rule with comment period will make a change 
necessary for a State to further facilitate coordination of its 
Medicaid and foster care program in cases where coverage has been 
expanded under its Temporary Assistance for Needy Families beyond the 
definition of unemployed parent contained in existing Aid to Families 
with Dependent Children regulations. This rule revises the definition 
of unemployment of a principal wage earner for purposes of coverage of 
dependent children of unemployed parents. It will also allow States to 
eliminate inequitable policies that are a disincentive to family unity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  08/07/98                    63 FR 42270


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Additional Information: HCFA-2106-FC

Agency Contact: Judith Rhoades, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., S2-08-05, Baltimore, MD 
21244
Phone: 410 786-4462
Fax: 410 786-3252

RIN: 0938-AH98
_______________________________________________________________________




1129. NATIONAL STANDARD HEALTH CARE PROVIDER IDENTIFIER (HCFA-0045-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule addresses the health care industry's need for a 
standardized provider identifier. It implements one of the requirements 
for administrative simplification in section 262 of the Health 
Insurance Portability and Accountability Act of 1996. A standard 
provider identifier will save the health insurance industry significant 
costs incurred in maintaining multiple identifier systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25340
NPRM Comment Period End         07/06/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: HCFA-0045-P

Agency Contact: Pat Peyton, Office of Information Services, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd., N3-20-05, Baltimore, MD 212244
Phone: 410 786-1812

RIN: 0938-AH99
_______________________________________________________________________




1130. PORTABILITY AND NONDISCRIMINATION IN THE GROUP HEALTH INSURANCE 
MARKET (HCFA-2890-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 300gg et seq

CFR Citation:  45 CFR 146

Legal Deadline: None

Abstract: This final rule will address comments received on the interim 
final rule published April 8, 1997. It will also further clarify the 
Department's position on the minimum requirements applicable with 
respect to group health plans and health insurance issuers

[[Page 21274]]

offering group health insurance coverage. A group health plan or health 
insurance issuer offering group health coverage may provide greater 
rights to participants and beneficiaries than those currently provided. 
This rule will include the following: (1) limitations on preexisting 
condition exclusion periods; (2) certification and disclosure of 
previous coverage; (3) special enrollment periods for individuals (and 
dependents) losing other coverage; (4) use of affiliation period by 
HMOs as alternative to preexisting condition exclusion; (5) prohibited 
discrimination against individual participants and beneficiaries based 
on health status; (6) guaranteed availability in the small group 
market; and (7) guaranteed renewability in the large and small group 
markets.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Effective    06/07/97
Interim Final Rule Comment 
Period End                      07/07/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: BPD-890-IFC

Agency Contact: Dave Holstein, Insurance Standards Team, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AI08
_______________________________________________________________________




1131. MEDICARE PROGRAM; MEDICARE INTEGRITY PROGRAM (HCFA-7020-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  PL 104-191

CFR Citation:  42 CFR 400; 42 CFR 421

Legal Deadline: None

Abstract: This rule implements section 1893 of the Social Security Act 
(added by section 202 of the Health Insurance Portability and 
Accountability Act of 1996) by establishing the Medicare Integrity 
Program to carry out Medicare payment integrity activities. Under this 
program HCFA may enter into new contracts with entities to perform 
these activities. This rule will identify the services to be procured; 
competitive requirements; procedures for identification, evaluation, 
and resolution of conflicts of interest; and rules regarding contractor 
liability. In addition, this rule will revise the list of intermediary 
and carrier functions set forth in existing regulations to make them 
consistent with sections 1816, 1842, and 1893 of the Social Security 
Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/19/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: OFH-020-P, PL 104-191, sec. 202

Agency Contact: Brenda Thew, OICS, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4889

RIN: 0938-AI09
_______________________________________________________________________




1132. MEDICARE PROGRAM; IMPROVEMENTS TO THE APPEALS PROCESS FOR MEDICARE 
BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (HCFA-4024-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm(c)(5)

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This proposed rule would establish new administrative review 
requirements for Medicare beneficiaries enrolled in health maintenance 
organizations (HMOs), competitive medical plans (CMPs), and health care 
prepayment plans. This rule would implement section 1876(c)(5) of the 
Social Security Act, which specifies the appeal and grievance rights of 
Medicare enrollees in HMOs and CMPs. This rule would reduce time lines 
for nonurgent denials of care and make other improvements. We will also 
address related requirements of the Balanced Budget Act of 1997.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Cheryl Slay, Director, Division of Beneficiary 
Protections, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244-1850
Phone: 410 786-6478

RIN: 0938-AI11
_______________________________________________________________________




1133. MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF PROGRAM 
ISSUANCES AND COVERAGE DECISIONS--SECOND QUARTER, 1998 (HCFA-9002-N)

Priority:  Routine and Frequent

Legal Authority:  42 USC 1395hh(c)(1)

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice lists HCFA manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published during April, May, and June of 1998 that relate to Medicare 
and Medicaid programs.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kristy Nishimoto, Office of Communications and 
Operations, Support, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-8517

RIN: 0938-AI13
_______________________________________________________________________




1134. MEDICARE PROGRAM; PHYSICIAN FEE SCHEDULE CONVERSION FACTOR FOR 
CALENDAR YEAR 1998 AND SUSTAINABLE GROWTH RATE FOR FISCAL YEAR 1998 
(HCFA-1893-FN)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395w-4

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice announces the calendar year 1998 Medicare 
physician

[[Page 21275]]

fee schedule conversion factor and the fiscal year 1998 sustainable 
growth rate for expenditures for physicians' services under the 
Medicare Supplementary Medical Insurance (part B) program as required 
by sections 1848(d) and (f) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/31/97                    62 FR 59261


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Terrence Kay, Center for Health Plans and Providers, 
Division of Practitioner and Ambulatory Care, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Blvd., C4-10-26, Baltimore, MD 21244
Phone: 410 786-4497

RIN: 0938-AI16
_______________________________________________________________________




1135. MEDICAID: MEDICAL CHILD SUPPORT (HCFA-2081-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(60); 42 USC 1396g

CFR Citation:  42 CFR 433

Legal Deadline: None

Abstract: This proposed rule would require States to provide assurances 
satisfactory to the Secretary that the State has in effect laws 
relating to medical child support. This requirement would implement 
section 13623 of the Omnibus Budget Reconciliation Act of 1993 (Public 
Law 103-66), commonly cited as OBRA 1993. The medical child support 
laws that the States must have in effect are set forth in section 1908 
of the Social Security Act (the Act). These laws would impose 
requirements on insurers, employers, and State Medicaid agencies.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: HCFA-2081-P

Agency Contact: Sue Knefley, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0488

RIN: 0938-AI21
_______________________________________________________________________




1136. GME: INCENTIVE PAYMENTS UNDER PLANS FOR VOLUNTARY REDUCTION IN 
NUMBER OF RESIDENTS (HCFA-1001-IFC)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority:  42 USC 1395ww(h); PL 105-33, Sec 4626

CFR Citation:  42 CFR 413

Legal Deadline:  Other, Statutory, February 5, 1998.
Interim final regulations with comment period must be published within 
6 months of the date of enactment of the Balanced Budget Act 1997 
(August 5, 1997).

Abstract: Under current law and regulations, hospitals are paid for 
direct medical education based on the number of residents participating 
in accredited graduated medical education programs. This interim final 
rule would implement section 4626 of the Balanced Budget Act of 1997 
which allows hospitals to apply to receive incentive payments for 
reducing the number of residents in training. The hospital must submit 
a plan to the Secretary outlining how it will make voluntary residency 
reductions.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State, Local, Federal

Additional Information: HCFA-1003-IFC

Agency Contact: Marc Hartstein, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244-1850
Phone: 410 786-4539

RIN: 0938-AI27
_______________________________________________________________________




1137. MEDICARE PROGRAM: PHYSICIANS' REFERRALS; ISSUANCE OF ADVISORY 
OPINIONS (HCFA-1902-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395nn(g)(6); 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 411.370 to 411.389

Legal Deadline: None

Abstract: This final rule will set forth the procedures HCFA will use 
to issue written advisory opinions to outside parties concerning 
whether a physician's referral of a Medicare beneficiary for certain 
designated health services is prohibited under section 1877 of the 
Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/09/98                     63 FR 1646


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Technical Assistant, CHPPS, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AI38
_______________________________________________________________________




1138. MEDICARE/MEDICAID PROGRAM; USER FEES (HCFA-6021-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  31 USC 9701

CFR Citation:  42 CFR 401

Legal Deadline: None

Abstract: This proposed rule would establish regulations relating to 
user fees for services we provide that confer benefits on specific 
individuals that are over and above those benefits received by the 
general public.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: David Escobedo, Office of Financial Management, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244

[[Page 21276]]

Phone: 410 786-5401

RIN: 0938-AI46
_______________________________________________________________________




1139. SECURITY AND ELECTRONIC SIGNATURE STANDARDS (HCFA-0049-F)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule would implement some of the requirements of the 
administrative simplification subtitle of the Health Insurance 
Portability and Accountability Act of 1996. It proposes standards for 
the security of individual health information and electronic signature 
use by health plans, health care clearing houses, and health care 
providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/12/98                    63 FR 43242


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: John Parmigiani, Office of Internal Customer Support, 
Department of Health and Human Services, Health Care Financing 
Administration, N3-14-14, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-2976

RIN: 0938-AI57
_______________________________________________________________________




1140. STANDARDS FOR ELECTRONIC TRANSACTIONS (HCFA-0149-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 1, 1998.

Abstract: The rule puts in place code-set standards and standards for 
eight electronic transactions to be used by health plans, certain 
health care providers, and health care clearing houses. It would 
implement requirements for administrative simplification in section 262 
of the Health Insurance Portability and Accountability Act of 1996. The 
standards will significantly reduce costs for processing health care 
transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25277
NPRM Comment Period End         07/06/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Barbara Redding, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-03-27, 7500 Security Blvd., Baltimore, MD 21228
Phone: 410 786-6165
Email: [email protected]

RIN: 0938-AI58
_______________________________________________________________________




1141. NATIONAL STANDARD EMPLOYER IDENTIFIER (HCFA-0047-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule institutes the employer identification number as 
the standard for identifying employers for purposes of administrative 
simplification, as required by the Health Insurance Portability and 
Accountability Act of 1996. Use of one standard in the health care 
industry will reduce the cost of identifying employers in electronic 
health care transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/98                    63 FR 32784
NPRM Comment Period End         08/17/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Mary Emerson, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., N2-12-22, Baltimore, MD 21244
Phone: 410 786-7065
Email: [email protected]

RIN: 0938-AI59
_______________________________________________________________________




1142. STATE PLAN REQUIREMENTS FOR DURABLE MEDICAL EQUIPMENT PROVIDERS 
(HCFA-2007-P)

Priority:  Other Significant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority:  42 USC 1396a(a)(65)(B)

CFR Citation:  42 CFR 441

Legal Deadline: None

Abstract: This proposed rule would establish in regulations a 
requirement that durable medical equipment suppliers be required to 
furnish Medicaid State agencies with a surety bond in order to 
participate in the Medicaid program. This proposed rule would implement 
section 4724(g) of the Balanced Budget Act of 1997.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Mary Linda Morgan, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., S2-26-12, Baltimore, MD 
21244
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AI63
_______________________________________________________________________




1143. RECOGNITION OF THE COMMUNITY HEALTH ACCREDITATION PROGRAM, INC. 
(CHAP) AND JOINT COMMISSION FOR ACCREDITATION OF HEALTHCARE 
ORGANIZATIONS (JCAHO) FOR HOSPICES (HCFA-2029-PN)

Priority:  Routine and Frequent

Legal Authority:  42 USC 1395bb

CFR Citation:  42 CFR ch IV

Legal Deadline:  Other, Statutory, September 8, 1998.

[[Page 21277]]

The statue requires us to publish a notice within 60 days of receipt of 
a completed application.

Abstract: This notice announces the receipt of an application from the 
Community Health Accreditation Program, Inc. (CHAP) and Joint 
Commission for Accreditation of Healthcare Organizations (JCAHO) for 
recognition as a national accreditation program for hospices that wish 
to participate in the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/11/98                    63 FR 48735


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joan Barry, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244-1850
Phone: 410 786-7233
Email: [email protected]

RIN: 0938-AI69
_______________________________________________________________________




1144. MEDICAID MANAGED CARE; REGULATORY PROGRAM TO IMPLEMENT CERTAIN 
MEDICAID PROVISIONS OF THE BALANCED BUDGET ACT OF 1997 (HCFA-2001-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  PL 105-33, sec 4701 to 4710

CFR Citation:  42 CFR 438; 42 CFR 430; 42 CFR 431; 42 CFR 434; 42 CFR 
435; 42 CFR 438; 42 CFR 440; 42 CFR 447

Legal Deadline: None

Abstract: This notice of proposed rulemaking establishes rules for 
Medicaid managed care programs which involve quality of care and 
services under Medicaid managed care programs. It implements certain 
provisions in sections 4701 through 4710 of the Balanced Budget Act of 
1997 (BBA) (Pub. L. 105-33).

Statement of Need: The BBA significantly modifies Medicaid managed care 
programs by providing a new state plan amendment vehicle for States to 
furnish managed health care to beneficiaries, enhanced enrollee 
protections; and an emphasis on the quality of health care delivered to 
Medicaid enrollees.

Summary of the Legal Basis: Section 1903(m) of the Social Security Act 
and implementing regulations at 42 CFR part 434 contain a number of 
requirements related to Medicaid managed care contracts. Among other 
things, the requirements relate to contract provisions involving 
enrollment and disenrollment in a Medicaid managed care organization 
(MCO), marketing, choice of health professionals within an MCO, quality 
assurance systems, grievance procedures, and plan solvency. Statutory 
amendments made by sections 4701 through 4710 of the BBA modify those 
requirements.
To control cost while enhancing quality of care, States are 
increasingly delivering services to their Medicaid populations through 
Medicaid managed care organizations (MCOs) and other managed care 
arrangements. These arrangements vary according to the 
comprehensiveness of the services they provide and the degree to which 
they accept risk. Fully capitated plans contract on a risk basis to 
provide beneficiaries with a comprehensive set of covered services in 
return for a monthly capitation payment. In general, partially 
capitated plans provide a less than comprehensive set of services on a 
risk basis; services not included in the contract are reimbursed on a 
fee-for-service basis. In addition, some States implement a primary 
care case management (PCCM) system in which a Medicaid beneficiary 
selects or is assigned to a single primary care provider that provides 
or arranges for all covered services and is reimbursed on a fee-for-
service basis. Under each of these managed care arrangements, 
beneficiaries have a regular source of coordinated care and States have 
predictable, controlled spending per beneficiary.
The BBA creates a new section of the Social Security Act relating to 
managed care arrangements. The new section 1932 establishes increased 
enrollee protections, quality assessment and performance improvement 
strategies for States, and enrollee rights and responsibilities.

Alternatives: If this rule is not published, we would not implement 
many of the provisions in the Balanced Budget Act of 1997 related to 
Medicaid managed care.

Anticipated Costs and Benefits: Estimates of the economic impact (if 
any) that will stem from these rules have not yet been completed.

Risks: This rule will potentially improve the quality of health care 
provided to Medicaid managed care enrollees and provide States with new 
tools to become more effective purchasers of health care services. 
Failure to publish this rule would jeopardize broad-based improvement 
in the quality of care our beneficiaries receive and would deprive 
States of many tools that would improve their managed care programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/29/98                    63 FR 52021
NPRM Comment Period End         11/30/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State, Federal

Agency Contact: Mike Fiore, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-0623

RIN: 0938-AI70
_______________________________________________________________________




1145. ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL PARTICIPATION 
LIMITS (HCFA-2111-IFC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435

Legal Deadline: None

Abstract: This interim final rule with comment period eliminates the 
requirement that Federal financial participation income limits be 
applied when States use less restrictive income and resource 
methodologies to determine eligibility for aged, blind and disabled 
individuals, as well as for the optional categorically needy and the 
medically needy. This rule conforms the application of the FFP limits 
to the policy that the use of less restrictive

[[Page 21278]]

income methodologies are not subject to FFP limits. This change will 
give States additional flexibility in setting Medicaid eligibility 
requirements.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., C4-22-06, Baltimore, MD 
21244
Phone: 410 786-4579
Email: [email protected]

RIN: 0938-AI73
_______________________________________________________________________




1146. MEDICAID PROGRAM; CHANGES TO ELIGIBILITY OF NON-U.S. CITIZENS 
(HCFA-2108-P)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; PL 104-193, sec 401 to 403

CFR Citation:  42 CFR 435; 42 CFR 436; 42 CFR 440

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 created changes in Federal law making most 
non-U.S. citizens ineligible for Supplemental Security Income (SSI). In 
most States, receipt of SSI confers automatic Medicaid eligibility. 
Although many States have elected optional eligibility groups that 
provide a basis for covering persons who do not receive SSI, some 
States have not done so. In these States, these individuals would be 
left without access to Medicaid (including emergency services). To 
conform with the new law, we are proposing regulations that would 
result in the loss of Medicaid for qualified aliens in those States 
that cover only SSI recipients. We are also seeking comments on whether 
there remains any statutory basis to continue Medicaid coverage for 
these individuals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Bob Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4463

RIN: 0938-AI74
_______________________________________________________________________




1147. MEDICARE PROGRAM; ADVANCE REFUNDING OF DEBT AND METHODOLOGY FOR 
REPAYMENT OF LOAN (HCFA-1777-P)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395x(v)

CFR Citation:  42 CFR 413

Legal Deadline: None

Abstract: This proposed rule would amend current regulations to clarify 
our policies regarding the treatment of interest expense. The rule 
would require that, when only part of the interest on a loan is 
allowable, repayment would be made first to that portion of the loan on 
which expense is allowable. This rule also would clarify how this 
policy is to be applied in situations in which there are multiple loans 
and one or more of the loans are not related to patient care. In 
addition, we would define the allowable costs associated with advance 
refunding of debt, and clarify the treatment of revenue and expenses.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Ann Pash, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AI75
_______________________________________________________________________




1148. MEDICARE HOSPICE CARE (HCFA-1022-P)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4446; 
PL 105-33, sec 4448

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would implement section 4441(a), 4442-
4446, and 4448 of the Balanced Budget Act of 1997. Specific changes 
include: updating hospice payment rates, specifying payment according 
to the site of service, modifying the hospice benefit periods, 
clarifying the services covered under the benefit, allowing hospices to 
contract for physician services, allowing waivers of certain staffing 
requirements for hospice care programs in non-urbanized areas, and 
extending the period for physician certification of an individual's 
terminal illness. Additionally, the proposed rule would also clarify 
other current policies.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is no paperwork burden associated with 
this action.

Agency Contact: Carol Blackford, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AI77
_______________________________________________________________________




1149. REVISION OF PROCEDURES FOR REQUESTING EXCEPTIONS TO COST LIMITS 
FOR SNFS AND ELIMINATION OF RECLASSIFICATIONS (HCFA-1883-P)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395hh

[[Page 21279]]

CFR Citation:  42 CFR 413.30

Legal Deadline: None

Abstract: This proposed rule would revise the procedures for granting 
exceptions to the cost limits for skilled nursing facilities and retain 
the current procedures for exceptions to the cost limits for home 
health agencies. It would remove the provision allowing 
reclassification for all providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/11/98                    63 FR 42797


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Procurement: This is a procurement-related action for which there is a 
statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.

Agency Contact: Steve Raitzyk, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4599

RIN: 0938-AI80
_______________________________________________________________________




1150. MEDICARE PROGRAM; STANDARDIZATION OF MEDICARE COVERAGE FOR BONE 
MASS MEASUREMENTS (HCFA-3004-IFC)

Priority:  Economically Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395rr(b)(1); 42 
USC 4106

CFR Citation:  42 CFR 410; 42 CFR 414

Legal Deadline:  Other, Statutory, July 1, 1998.
BBA Section 4106

Abstract: This interim final rule with comment period provides for the 
standardization of coverage of bone mass measurements for qualified 
Medicare beneficiaries for services furnished on or after July 1, 1998. 
It implements provisions in section 4106 of the Balanced Budget Act of 
1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/24/98                    63 FR 34320


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Bill Larson, Office of Communications & Operations 
Support, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4639

RIN: 0938-AI89
_______________________________________________________________________




1151. HEALTH INSURANCE REFORM UNIVERSAL HEALTH CARE IDENTIFIER (HCFA-
0048-NOI)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1320d-2

CFR Citation:  42 CFR ch IV

Legal Deadline:  Final, Statutory, February 28, 1998.

Abstract: This notice announces our intent to publish a proposed rule 
on requirements for a unique health identifier for individuals. These 
requirements are mandated by law and are part of a national framework 
for health data standards and health information privacy that will 
support the efficient electronic exchange of specified administrative 
and financial health care transactions. This notice discusses the 
options for the identifier that have been put forward for consideration 
and asks for public comments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Mary Emerson, Office of Information Services, 
Information Management, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-7065

RIN: 0938-AI91
_______________________________________________________________________




1152. PEER REVIEW ORGANIZATION CONTRACTS: SOLICITATION OF STATEMENTS OF 
INTEREST FROM IN-STATE ORGANIZATIONS (HCFA-3009-N)

Priority:  Other Significant

Legal Authority:  44 USC 35

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice, in accordance with section 1153(i) of the Social 
Security Act, gives at least 6 months' advance notice of the expiration 
dates of contracts with out-of-state utilization and quality control 
peer review organizations. It also specifies the period of time in 
which in-state organizations may submit a statement of interest so that 
they may be eligible to compete for these contracts.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is no 
statutory requirement. There is a paperwork burden associated with this 
action.

Agency Contact: Udo Nwachukwu, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 75OO Security Blvd., Baltimore, MD 21244
Phone: 410 786-7234

RIN: 0938-AI99
_______________________________________________________________________




1153. REPLACEMENT OF REASONABLE CHARGE METHODOLOGY BY FEE SCHEDULES 
(HCFA-1010-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 13945u

CFR Citation:  42 CFR 414

Legal Deadline: None

Abstract: We are proposing to implement fee schedules to be used for 
payment of services, excluding ambulance services, still subject to the 
reasonable charge payment methodology.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

[[Page 21280]]

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joel Kaiser, Center for Health Plan and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AJ00
_______________________________________________________________________




1154. EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE ORGANIZATIONS 
(HCFA-2015-P)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 438

Legal Deadline: None

Abstract: This proposed rule would amend the regulation to conform with 
the provisions of section 4705 of the Balanced Budget Act of 1997. It 
would require State agencies that contract with managed care 
organizations to implement quality improvement strategies that address 
access and other aspects of care and services directly related to the 
quality of care provided by these managed care organizations and 
performance through annual external, independent reviews conducted by 
accrediting organizations that are approved by HCFA.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Sharon Gilles, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1177

RIN: 0938-AJ06
_______________________________________________________________________




1155. HHS' RECOGNITION OF NAIC MODEL STANDARDS FOR REGULATION OF MEDIGAP 
POLICY (HCFA-2025-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395ss

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice describes changes made by the Balanced Budget Act 
of 1997 and the Health Insurance Portability and Accountability Act of 
1996 to section 1882 of the Social Security Act, which governs Medicare 
supplemental insurance. It also provides notice that the model 
regulation adopted by the National Association of Insurance 
Commissioners (NAIC) on April 29, 1998, and reprinted in its entirety 
as an addendum to this notice, constitutes the applicable NAIC model 
regulation that is incorporated by reference in section 1882.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/30/98                    63 FR 67078


Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Cutler, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5903

RIN: 0938-AJ07
_______________________________________________________________________




1156. MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF PROGRAM 
ISSUANCES--FIRST QUARTER 1998 (HCFA-9879-N)

Priority:  Routine and Frequent

Unfunded Mandates: Undetermined
Major: Undetermined

Legal Authority:  42 USC 1395hh(c)(1)

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice lists regulations and notices that relate to the 
Medicare and Medicaid programs that were published during January, 
February, and March of 1998.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kristy Nichimoto, OCOS, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-8517

RIN: 0938-AJ12
_______________________________________________________________________




1157. MEDICARE PROGRAM; CRITERIA AND STANDARDS FOR EVALUATING 
INTERMEDIARY AND CARRIER PERFORMANCE: MILLENNIUM COMPLIANCE (HCFA-4002-
GNC)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1395(h); 42 USC 1395 (u)

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice revises the criteria and standards to be used for 
evaluating the performance of our contractors in administering the 
Medicare program. The revisions establish a performance standard 
requiring contractors to meet requirements for millennium compliance. 
We require contractors to certify that they have made all necessary 
system(s) changes and have tested those systems in accordance with our 
guideline.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is no 
statutory requirement. There is a paperwork burden associated with this 
action.

Agency Contact: Sue Lathroum, Center for Beneficiary Service, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-7409

RIN: 0938-AJ15
_______________________________________________________________________




1158. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS, AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
IMPROVEMENT PROGRAM (HCFA-1910-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

[[Page 21281]]

CFR Citation:  42 CFR 405

Legal Deadline: None

Abstract: This proposed rule would amend our requirements to revise 
certification and payment requirements for rural health clinics (RHCs) 
as required by section 4205 of the Balanced Budget Act of 1997 (BBA 
1997). It would include new refinements of what constitutes a 
qualifying rural shortage area in which a Medicare RHC must be located; 
establish criteria for identifying RHCs essential to delivery of 
primary care services that can continue to be approved as Medicare RHCs 
in areas no longer designated as medically underserved; and include 
recent statutory provisions that provide a temporary waiver of certain 
nonphysician practitioner staffing requirements. It would impose 
payment limits on provider based RHCs, prohibit commercial use, the use 
of space equipment, and other resources of an RHC by another entity. 
The rule also requires establishment of a quality assessment and 
performance improvement program.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Worgo, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5919
Email: [email protected]

RIN: 0938-AJ17
_______________________________________________________________________




1159. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM (HCFA-1102-FC)

Priority:  Other Significant

Legal Authority:  PL 105-33, sec 4603

CFR Citation:  42 CFR ch IV

Legal Deadline:  NPRM, Statutory, October 1, 2000.

Abstract: This interim final rule will establish requirements for the 
new prospective payment system (PPS) for home health agencies as 
governed by section 4603 of the Balanced Budget Act of 1997 (BBA) (Pub. 
L. 105-33).

Statement of Need: The BBA significantly changed the way we pay for 
Medicare home health services. It requires the establishment of a 
facility-specific PPS and provide for interim steps until the PPS is 
established. Under the interim system HHAs will receive payment under 
the interim payment system in accordance with section 4602 of the 
Balanced Budget Act of 1997. The interim payment system establishes two 
sets of cost limits for home health agencies. The long-standing home 
health per visit cost limits are reduced from 112 percent of the mean 
labor-related and non-labor per visit costs for freestanding agencies 
to 105 percent of the median. In addition, home health agency costs 
will be subject to an aggregate per beneficiary cost limitation. For 
those providers with a cost report ending in Federal fiscal year 1994, 
the per-beneficiary cost limitation is based on a blend of costs (75 
percent on 98 percent of the agency-specific costs and 25 percent on 98 
percent of the standardized regional average of the costs for the 
agency's census region). For new providers and those providers without 
a 12-month cost reporting period ending in fiscal year 1994, the per 
beneficiary limitation will be the national median of the per 
beneficiary limits for HHAs. Under the interim system, HHAs will be 
paid the lesser of 1) actual costs; 2) the per visit limits; 3) the per 
beneficiary limits. The result of the interim system will be to create 
a strong incentive for HHAs to reduce utilization to at least 1994 
levels to fall within the aggregate cost limit. Effective 10/1/97, the 
interim payment system will exist until prospective payment for home 
health agencies is implemented.
Section 4603 of the BBA establishes section 1895 of the Social Security 
Act, which specifies the authority for the development of a prospective 
payment system for home health services effective 10/1/99 which will 
ultimately be based on units of payment, most likely episodes of care. 
In developing the PPS, the Secretary will consider: an appropriate unit 
of service, the number of visits provided within the unit, and their 
cost. Payment for a unit of home health service will be modified by a 
case mix adjustor, set by the Secretary, to explain a significant 
amount of the variation in the cost of different units of service. The 
HHA would have the potential of profit or loss on each individual 
patient. Over many patients, the HHA would presumably make or lose 
money based on its ability to provide needed care effectively and 
efficiently.

Summary of the Legal Basis: Section 1861(v)(1)(A) of the Social 
Security Act requires the limits that comprise the interim system. 
Under this authority, HCFA has maintained limitations on home health 
agency per visit costs since 1975. Additional statutory provisions 
specifically governing limitations applicable to home health agencies 
are contained at section 1861(v)(1)(L) of the Social Security Act. 
These limits will be replaced by the establishment of a prospective 
payment system as defined in section 4603 of the BBA that requires the 
Secretary to establish and implement the prospective payment system for 
home health services.

Alternatives: Section 4603 of the BBA specifies the authority for the 
development of a prospective payment system for home health services 
effective 10/1/99. However, there is contingency language for the home 
health prospective payment system provided in BBA. If the Secretary for 
any reason does not establish and implement the prospective payment 
system for home health services, the Secretary shall provide for a 
reduction by 15 percent of the per visit cost limits and per 
beneficiary limits, as those limits would otherwise be in effect on 
September 30, 1999.

Anticipated Costs and Benefits: The Congress anticipates that the 
implementation of a PPS for home health services will achieve the 
combined benefits of establishing a system which will enable HCFA to 
find the provision of medically necessary HHA care to beneficiaries 
consistent with the HHA's own case mix and will also prevent the 
development of further unsustainable growth in HHA costs. The combined 
effects of the ``interim'' and final systems are required to achieve 
this result.

Risks: The statutory contingency for reducing cost caps under the 
interim system by 15 percent, if the PPS is not timely implemented, is 
not the preferred method for achieving the desired savings because the 
interim system does not adjust fully for case mix, as the PPS is 
required to do. Therefore, the longer the delay in implementation of 
the PPS, the greater the potential disparity between the case

[[Page 21282]]

mix of an individual HHA and its payments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bob Wardwell, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3254

RIN: 0938-AJ24
_______________________________________________________________________




1160.  MEDICARE PROGRAM STATE ALLOTMENTS FOR PAYMENTS OF 
MEDICARE PART B PREMIUM FOR QUALIFYING INDIVIDUALS: FEDERAL FISCAL YEAR 
FOR 1999 (HCFA-2032-N)

Priority:  Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority:  42 USC 1396(a)(10)e(IV); 42 USC 1396(u)(3)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: The Social Security Act provides for the Medicaid program to 
pay all or part of the Medicare part B premiums for beneficiaries 
belonging to two specific eligibility groups of low-income Medicare 
beneficiaries. This notice announces the Federal fiscal year 1999 
allotments that are available for State agencies to pay Medicare part B 
premiums for these two eligibility groups.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State, Federal

Agency Contact: Miles McDermott, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-3722

RIN: 0938-AJ28
_______________________________________________________________________




1161.  HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES 
(HCFA-3 014-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 482.27

Legal Deadline: None

Abstract: This proposed rule would require hospitals that transfuse 
blood and blood products to (1) prepare and follow written procedures 
for appropriate action when it is determined that blood and blood 
products are at increased risk for transmitting hepatitis C virus 
(HCV); (2) quarantine prior collections from a donor who is at 
increased risk for transmitting HCV infection; (3) notify transfusion 
recipients, as appropriate, of the need for HCV testing and counseling; 
and (4) maintain records for at least 10 years.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Mary Collins, OCSQ, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29
_______________________________________________________________________




1162.  MEDICARE PROGRAM; PROCEDURES FOR MAKING MEDICAL SERVICES 
NATIONAL COVERAGE DECISIONS (HCFA-3432-FNC)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority:  42 USC 1302; 40 USC 1395hh

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice withdraws the proposed rule that we published in 
the Federal Register on January 30, 1989 (54 FR 4302), in which we 
proposed to establish in regulations generally applicable criteria and 
procedures for HCFA decisions regarding whether and under what 
circumstances specific health care technologies could be considered 
``reasonable'' and ``necessary'' and, therefore, covered under 
Medicare. We are withdrawing the proposed rule and announcing our 
intention to issue a new notice of proposed rulemaking concerning the 
criteria to be used in making national coverage decisions.
This notice also describes the procedures we use for making national 
decisions regarding the coverage of a payment for specific medical 
items and services under Medicare.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Ron Milhorn, OCSQ, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD
Phone: 410 786-5563

RIN: 0938-AJ31
_______________________________________________________________________




1163.  MEDICARE PROGRAM; SPECIAL PAYMENT LIMITS FOR CERTAIN 
DURABLE MEDICAL EQUIPMENT AND PROSTHETIC DEVICES (HCFA-1050-PN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395m; 42 USC 1395u

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice proposes special payment limits, for five items 
of durable medical equipment and one prosthetic device, to replace the 
current fee schedule amounts for these items.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Kaiser, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AJ34


_______________________________________________________________________



[[Page 21283]]

1164.  MEDICAID PROGRAM; CIVIL MONEY PENALTIES FOR NURSING HOMES 
(SNF/NF), CHANGE IN NOTICE REQUIREMENTS, AND EXPANSION OF DISCRETIONARY 
REMEDY (HCFA-2035-FC)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395i-3; 42 USC 
1396r

CFR Citation:  42 CFR 488.402; 42 CFR 488.408; 42 CFR 488.430; 42 CFR 
488.432; 42 CFR 488.434; 42 CFR 488.438; 42 CFR 488.440; 42 CFR 
488.442; 42 CFR 488.454; 42 CFR 435.1001(c)

Legal Deadline: None

Abstract: This rule will add a new type of civil money penalty that 
HCFA may impose on nursing homes. HCFA will be able to impose a penalty 
for each instance of noncompliance, by a nursing home facility or 
skilled nursing facility, that we find as a result of an inspection 
(survey). The rule also will change the maximum number of days there 
are between the time we notify a nursing home of a deficiency and when 
we may impose a penalty.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Fred Galdden, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-3033

RIN: 0938-AJ35
_______________________________________________________________________




1165.  MEDICARE HOSPICE CARE (HCFA-1022-P)

Priority:  Routine and Frequent

Unfunded Mandates: Undetermined
Major: Undetermined

Legal Authority:  PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4446; 
PL 105-33, sec 4448

CFR Citation:  48 CFR 418

Legal Deadline: None

Abstract: This proposed rule would implement sections 4441(a), 4442 to 
4446, and 4448 of the Balanced Budget Act of 1997. Specific changes 
include updating hospice payment rates, specifying payment according to 
the site of service, modifying the hospice benefit periods, clarifying 
the services covered under the benefit, allowing hospices to contract 
for physician services, allowing waivers of certain staffing 
requirements for hospice care provided in non-urbanized areas, and 
extending the period for physician certification of an individual's 
terminal illness. Additionally, the proposed rule would clarify other 
current policies.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is no paperwork burden associated with 
this action.

Agency Contact: Carol Blackford, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-5909

RIN: 0938-AJ36
_______________________________________________________________________




1166.  EMERGENCY MEDICAL TREATMENT AND LABOR ACT (EMTALA) (HCFA-
1063-FC)

Priority:  Other Significant

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1395cc, sec 1866; 42 USC 1395dd

CFR Citation:  42 CFR 489.24

Legal Deadline: None

Abstract: This final rule with comment period clarifies the extent of 
the Emergency Medical Treatment and Labor Act (EMTALA) application.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: George Morey, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AJ39
_______________________________________________________________________




1167.  RECOGNITION OF THE JOINT COMMISSION FOR ACCREDITATION OF 
HEALTHCARE ORGANIZATIONS (JCAHO FOR HOSPICES) (HCFA-2039-FN)

Priority:  Routine and Frequent

Legal Authority:  42 USC 1395bb

CFR Citation:  42 CFR ch IV

Legal Deadline:  Other, Statutory, February 5, 1999.
On 12/14/98, rather than be denied and have to reapply, JCAHO requested 
an extension of the time period to allow resolution of outstanding 
issues.

Abstract: This notice recognizes the Joint Commission for Accreditation 
of Healthcare Organizations (JCAHO) as a national accreditation 
organization for hospices that request participation in the Medicare 
program. We believe that accreditation of hospices by JCAHO 
demonstrates that all Medicare hospice conditions of participation are 
met or exceeded. Thus, we grant deemed status to those hospices 
accredited by JCAHO.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joan Berry, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-7233

RIN: 0938-AJ41
_______________________________________________________________________




1168.  DECISION ON THE FUNDING FOR THE AIDS HEALTHCARE 
FOUNDATION START PROGRAM, (HCFA-2041-N)

Priority:  Info./Admin./Other

Legal Authority:  PL 105-33, sec 1110

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the award of a grant in the sum of $2 
million to the AIDS Healthcare Foundation of Los Angeles, California, 
for a demonstration project entitled, ``START PROGRAM: Success Through 
Anti-Retroviral Therapy.''

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

[[Page 21284]]

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Wayne Smith, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-6762

RIN: 0938-AJ43
_______________________________________________________________________




1169.  PROTECTION FOR WOMEN WHO ELECT RECONSTRUCTION AFTER A 
MASTECTOMY (HCFA-2040-IFC)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 300gg-6

CFR Citation:  45 CFR 146; 45 CFR 148

Legal Deadline: None

Abstract: This IFC will implement the requirements of the Women's 
Health and Cancer Rights Act of 1998 (WHCRA). It will provide 
protection for patients who elect breast reconstruction following a 
mastectomy.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Suzanne Long, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-0970

RIN: 0938-AJ44
_______________________________________________________________________




1170.  ACCELERATED PAYMENTS TO PROVIDERS FURNISHING SERVICES 
UNDER MEDICARE PART A AND PART B AND ADVANCE PAYMENTS TO SUPPLIERS 
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (HCFA-1066-FC)

Priority:  Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  PL 91-190; 42 USC 1302; 42 USC 1395g; 42 USC 1395l; 
42 USC 1395hh

CFR Citation:  42 CFR 412.116; 42 CFR 413.64; 42 CFR 421.214

Legal Deadline: None

Abstract: This final rule would ensure continued payments to providers 
and suppliers in the event of a national, regional, or a local 
emergency, such as national disasters including fire, flood, earthquake 
and the year 2000 computer system difficulties and related breakdowns. 
The intent of the final rule is to give HCFA broad discretion in 
implementing procedures to provide appropriate payments to providers 
and suppliers in the event of a national, regional, or a local 
emergency that may prevent the submission or processing of Medicare 
claims.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Geraldine Nicholson, CHPP, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6967

RIN: 0938-AJ45
_______________________________________________________________________




1171.  MEDICARE/MEDICAID AND CLIA PROGRAMS: CLINICAL LABORATORY 
IMPROVEMENT AMENDMENTS OF 1988 EXEMPTION OF LABORATORIES IN THE STATE OF 
CALIFORNIA (HCFA-2245-N)

Priority:  Other Significant

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This notice grants all State-licensed or approved 
laboratories in California exemption from the requirements of the 
Clinical Laboratory Improvement Amendments of 1998, based on the 
State's demonstrated compliance with all the exemption requirements.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State, Federal

Agency Contact: Jim Cometa, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-6720

RIN: 0938-AJ47
_______________________________________________________________________




1172.  FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH 
INSURANCE MARKETS (HCFA-2019-FC)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 300gg

CFR Citation:  45 CFR 150

Legal Deadline: None

Abstract: This rule adds more specific requirements for enforcing 
legislative requirements concerning the portability and availability of 
health insurance. It specifies the Federal Government's role in 
enforcing the insurance requirements in States that do no enforce the 
requirements. It also specifies how the government will impose civil 
money penalties on health insurance issuers in those states and states 
appeal rights and procedures.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Rochelle Shevitz, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, S3-
16-26, Baltimore, MD 21244
Phone: 410 786-1570

RIN: 0938-AJ48
_______________________________________________________________________




1173.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND FISCAL YEAR 2000 RATES (HCFA-1053-P)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 412; 42 CFR 413; 42 CFR 483; 42 CFR 485

Legal Deadline:  NPRM, Statutory, April 1, 1999. Final, Statutory, 
August 1, 1999.

Abstract: We are proposing to revise the Medicare hospital inpatient 
prospective payment systems for

[[Page 21285]]

operating costs and capital-related costs to implement changes arising 
from our continuing experience with the systems. In addition, in the 
addendum to this proposed rule, we are describing proposed changes in 
the amounts and factors necessary to determine rates for Medicare 
hospital inpatient services for operating costs and capital-related 
costs. These changes would be applicable to discharges occurring on or 
after October 1, 1999. We are also setting forth proposed rate-of-
increase limits as well as proposed policy changes for hospitals and 
hospital unites excluded from the prospective payment systems. Finally, 
we are proposing changes to the policies governing payment to hospitals 
for the direct costs of graduate medical education.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
C4-07-17, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AJ50
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1174. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (HCFA-2020-F)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

CFR Citation:  42 CFR 435.831; 42 CFR 436.831

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/12/94                     59 FR 1659
Final Action Effective          03/14/94

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Jackie Wilder
Phone: 410 786-4579
Email: [email protected]

RIN: 0938-AB07
_______________________________________________________________________




1175. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (HCFA-1393-IFC)

Priority:  Other Significant

CFR Citation:  42 CFR 488.18; 42 CFR 489.20; 42 CFR 489.24; 42 CFR 
489.25; 42 CFR 489.26; 42 CFR 489.27; 42 CFR 489.53; 42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action - Published        08/15/88                    53 FR 22513
Final Action Effective          08/15/88

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter
Phone: 410 786-1304

RIN: 0938-AC58
_______________________________________________________________________




1176. CRITERIA AND PROCEDURES FOR DEVELOPING MEDICAL SERVICES COVERAGE 
POLICY (HCFA-3546-F)

Priority:  Other Significant

CFR Citation:  42 CFR 400.404; 42 CFR 405.201; 42 CFR 405.203; 42 CFR 
405.205; 42 CFR 405.207; 42 CFR 405.211

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Scheduled to Merge 
with Another Regulation         02/10/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Ron Milhorn
Phone: 410 786-5663

RIN: 0938-AD07
_______________________________________________________________________




1177. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (HCFA-1482-F)

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

CFR Citation:  42 CFR 400; 42 CFR 411

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/31/95                    60 FR 45344
Final Action Effective          10/02/95

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eve Fisher
Phone: 410 786-5641

RIN: 0938-AD73
_______________________________________________________________________




1178. REVISIONS TO REGULATIONS IMPLEMENTING CLIA (HCFA-2226-F)

Priority:  Other Significant

CFR Citation:  42 CFR 493

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/28/92                     57 FR 7002

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: David Cade
Phone: 410 786-3870

RIN: 0938-AE47
_______________________________________________________________________




1179. MEDICARE COVERAGE OF, AND APPLICATION OF THE OUTPATIENT MENTAL 
HEALTH TREATMENT LIMITATION TO, CLINICAL PSYCHOLOGIST AND CLINICAL 
SOCIAL WORKER SERVICES (HCFA-3706-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 410; 42 CFR 417; 42 CFR 424

[[Page 21286]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/23/98                    63 FR 20110

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Regina Walker-Wren
Phone: 410 786-6735

RIN: 0938-AE99
_______________________________________________________________________




1180. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (HCFA-1016-P)

Priority:  Other Significant

CFR Citation:  42 CFR 471.800; 42 CFR 417.801; 42 CFR 417.806; 42 CFR 
417.812; 42 CFR 417.814; 42 CFR 417.816; 42 CFR 417.818; 42 CFR 
417.820; 42 CFR 417.822; 42 CFR 417.824

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Superceded by 
Medicare+Choice Rules           06/26/98                    63 FR 34968

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tracy Jensen
Phone: 410 786-1033

RIN: 0938-AF97
_______________________________________________________________________




1181. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH 
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (HCFA-1015-F)

Priority:  Other Significant

CFR Citation:  42 CFR 417.448; 42 CFR 417.450; 42 CFR 417.456; 42 CFR 
417.460; 42 CFR 417.461; 42 CFR 417.462; 42 CFR 417.464; 42 CFR 
417.584; 42 CFR 417.436

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Superceded by 
Medicare+Choice Rules           06/26/98                    63 FR 34968

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Anne Manley
Phone: 410 786-1096

RIN: 0938-AF98
_______________________________________________________________________




1182. PAYMENT FOR PREADMISSION SERVICES (HCFA-1731-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 412.2(c); 42 CFR 413.40

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/11/98                     63 FR 6864

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Nancy Edwards
Phone: 410 786-4531

RIN: 0938-AG00
_______________________________________________________________________




1183. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
PERFORMANCE IMPROVEMENT PROGRAM (HCFA-1910-P)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AJ17      02/08/99

RIN: 0938-AG05
_______________________________________________________________________




1184. REQUEST FOR ASSESSMENT ON THE SALITRON SYSTEM FOR THE TREATMENT OF 
XEROSTOMIA SECONDARY TO SJOGREN'S SYNDROME (HCFA-3782-NC)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/01/98                    63 FR 29743

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Francine Spencer
Phone: 410 786-4614

RIN: 0938-AG45
_______________________________________________________________________




1185. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE SCHEDULE 
REVISION (HCFA-3219-GNC)

Priority:  Other Significant

CFR Citation:  42 CFR 493.638; 42 CFR 493.639

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/10/99                    62 FR 45815

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Judy Yost
Phone: 410 786-3531

RIN: 0938-AG87
_______________________________________________________________________




1186. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW 
SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HCFA-2222-F)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

CFR Citation:  42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.18; 
42 CFR 493.20; 42 CFR 493.21; 42 CFR 493.25; 42 CFR 493.43; 42 CFR 
493.45; 42 CFR 493.48; 42 CFR 493.49; 42 CFR 493.51; 42 CFR 493.53; 42 
CFR 493.638

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Scheduled to Merge 
with Another Regulation         02/10/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Judy Yost
Phone: 410 786-3531

RIN: 0938-AG98
_______________________________________________________________________




1187. AMBULANCE SERVICES (HCFA-1813-F)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

[[Page 21287]]

CFR Citation:  42 CFR 410.40; 42 CFR 410.41; 42 CFR 424.124

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/25/99                     64 FR 3648

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Margot Blige
Phone: 410 786-4642

RIN: 0938-AH13
_______________________________________________________________________




1188. CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO CERTAIN DEVICES 
AND RELATED SERVICES (HCFA-3841-F)

Priority:  Other Significant

CFR Citation:  42 CFR 405.201 to 215; 42 CFR 411.15; 42 CFR 411.406

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/19/95                    60 FR 48417

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sharon Hippler
Phone: 410 786-4633

RIN: 0938-AH21
_______________________________________________________________________




1189. DELEGATION OF CIVIL MONEY PENALTIES (HCFA-6135-FC)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 402

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/14/98                    63 FR 68687

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Cohen
Phone: 410 786-3349

RIN: 0938-AH22
_______________________________________________________________________




1190. SUPPLIER PARTICIPATION AGREEMENTS AND LIMITS ON ACTUAL CHARGES OF 
NONPARTICIPATING PHYSICIANS (HCFA-1862-P)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

CFR Citation:  42 CFR 400; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With HCFA-1006-P         11/30/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anita Heygster
Phone: 410 786-4486

RIN: 0938-AH50
_______________________________________________________________________




1191. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 1998 RATES (HCFA-1878-F)

Priority:  Other Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 412; 42 CFR 413; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/12/98                    63 FR 26318

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Tzvi Hefter
Phone: 410 786-4487

RIN: 0938-AH55
_______________________________________________________________________




1192. CONDITIONS FOR CERTIFICATION OF COMMUNITY MENTAL HEALTH CENTERS 
AND COVERAGE REQUIREMENTS FOR PARTIAL HOSPITALIZATION SERVICES (HCFA-
1871-P)

Priority:  Other Significant

CFR Citation:  42 CFR 410.43; 42 CFR 410.110; 42 CFR 410.150; 42 CFR 
410.172

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With HCFA-3736-F         02/10/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Janet Samen
Phone: 410 786-9161

RIN: 0938-AH58
_______________________________________________________________________




1193. MEDICAID PROGRAM; REDETERMINATIONS OF MEDICAID ELIGIBILITY DUE TO 
WELFARE REFORM (HCFA-2105-IFC)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 435.1003; 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/13/97                     62 FR 1682
Final Action Effective          01/13/97

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Bob Tomlinson
Phone: 410 786-4463

RIN: 0938-AH76
_______________________________________________________________________




1194. MEDICARE PROGRAM; BENEFICIARY INCENTIVE PROGRAMS (HCFA-6144-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 420.400; 42 CFR 420.405; 42 CFR 420.410

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/08/98                    63 FR 31123

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Delilah Schmitt
Phone: 410 786-4300

RIN: 0938-AH86
_______________________________________________________________________




1195. ALLOCATION OF ENHANCED FEDERAL MATCHING FUNDS FOR INCREASED 
ADMINISTRATIVE COSTS (MB-103-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/14/97                    62 FR 26545

Regulatory Flexibility Analysis Required: No

[[Page 21288]]

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019

RIN: 0938-AH90
_______________________________________________________________________




1196. FINAL LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE SHARE 
HOSPITALS: FEDERAL FISCAL YEAR 1998 (HCFA-2110-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With HCFA-2012           10/08/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019

RIN: 0938-AH93
_______________________________________________________________________




1197. MEDICARE COVERAGE OF CERTIFIED NURSE-MIDWIFE SERVICES (HCFA-1496-
P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405.2411; 42 CFR 405.2414; 42 CFR 405.2415; 42 
CFR 410.10; 42 CFR 410.77

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With HCFA-1006-P         11/30/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Roberta Epps
Phone: 410 786-4475

RIN: 0938-AH96
_______________________________________________________________________




1198. HEALTH INSURANCE REFORM: PARITY IN THE APPLICATION OF CERTAIN 
LIMITS TO MENTAL HEALTH BENEFITS (HCFA-2891-IFC)

Priority:  Other Significant

CFR Citation:  45 CFR 146

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/22/97                    62 FR 66932

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Marc Thomas
Phone: 410 786-7154

RIN: 0938-AI05
_______________________________________________________________________




1199. PART A PREMIUM FOR 1998 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (HCFA-5056-N)

Priority:  Other Significant. Major under 5 USC 801.

CFR Citation:  45 CFR 300

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice - (Effective 01/01/99)   10/21/98                    63 FR 56212

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: John Wandishin
Phone: 410 786-6389

RIN: 0938-AI10
_______________________________________________________________________




1200. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1998 (HCFA-5057-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/21/98                    63 FR 56199

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: John Wandishin
Phone: 410 786-6389

RIN: 0938-AI12
_______________________________________________________________________




1201. HEALTH INSURANCE PORTABILITY: NEWBORNS' AND MOTHERS' HEALTH 
PROTECTION (HCFA-2892-IFC)

Priority:  Other Significant

CFR Citation:  45 CFR 146.136; 45 CFR 148.151

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/26/98                    63 FR 57546

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marc Thomas
Phone: 410 786-7154

RIN: 0938-AI17
_______________________________________________________________________




1202. MEDICAID PROGRAM: CHARGES FOR VACCINE ADMINISTRATION UNDER THE 
VACCINES FOR CHILDREN (VCF) PROGRAM (HCFA-2084-FNC)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/10/95                    60 FR 18136

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joan Mahanes
Phone: 410 786-4583

RIN: 0938-AI20
_______________________________________________________________________




1203. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND 
FISCAL YEAR 1999 RATES (HCFA-1003-P)

Priority:  Other Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 412; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/31/98                    63 FR 40954

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

[[Page 21289]]

Government Levels Affected: Federal

Agency Contact: Tzvi Hefter
Phone: 410 786-4487

RIN: 0938-AI22
_______________________________________________________________________




1204. MEDICARE PROGRAM; NOTICE FOR THE SOLICITATION FOR PROPOSALS FOR A 
CASE MANAGEMENT DEMONSTRATION PROJECT FOCUSED ON CONGESTIVE HEART 
FAILURE OR DIABETES MELLITUS (HCFA-1104-N)

Priority:  Info./Admin./Other

CFR Citation:  Not yet determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/11/98                    63 FR 32015

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Catherine Jansto
Phone: 410 786-7762
Email: [email protected]

RIN: 0938-AI26
_______________________________________________________________________




1205. COLLECTION OF USER FEES FROM MEDICARE+CHOICE PLANS AND RISK-
SHARING CONTRACTORS (HCFA-1911-IFC)

Priority:  Other Significant

CFR Citation:  42 CFR 417.470; 42 CFR 417.472

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/02/97                    62 FR 63669

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marty Abeln
Phone: 410 786-1032

RIN: 0938-AI35
_______________________________________________________________________




1206. MEDICAID PROGRAM; STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B 
PREMIUMS FOR QUALIFIED INDIVIDUALS: FEDERAL FISCAL YEAR 1998 (HCFA-2005-
NC)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AJ28      02/11/99

RIN: 0938-AI39
_______________________________________________________________________




1207. MEDICARE PROGRAM: PAYMENTS FOR TELECONSULTATIONS IN RURAL HEALTH 
PROFESSIONAL SHORTAGE AREAS (HCFA-1906-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 410.75; 42 CFR 414.1; 42 CFR 414.62

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With HCFA-1006-P         11/30/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Craig Dobyski
Phone: 410 786-4584

RIN: 0938-AI44
_______________________________________________________________________




1208. REVIEW AND PAYMENT FOR CLAIMS FILED ON BEHALF OF MEDICARE/MEDICAID 
DUALLY ELIGIBLE BENEFICIARIES (HCFA-2097-3)

Priority:  Other Significant

CFR Citation:  42 CFR 489.53

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       01/26/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State, Tribal

Agency Contact: Robert Nakielng
Phone: 410 786-4466

RIN: 0938-AI50
_______________________________________________________________________




1209. MEDICARE PROGRAM; REVISIONS TO PAYMENT POLICIES UNDER THE 
PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 1999 (HCFA-1006-FC) (HCFA-1006-
P)

Priority:  Other Significant

CFR Citation:  42 CFR 410; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/02/98                    63 FR 58814
Final Action Effective          01/01/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stanley Weintraub
Phone: 410 786-4498

RIN: 0938-AI52
_______________________________________________________________________




1210. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT SERVICES (HCFA-1005-P)

Priority:  Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

CFR Citation:  42 CFR 409.10; 42 CFR 410.2; 42 CFR 410.27; 42 CFR 
410.28; 42 CFR 410.30; 42 CFR 411.15; 42 CFR 412.50; 42 CFR 413.118; 42 
CFR 413.122; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 413; 42 CFR 489.20; 
42 CFR 1003.101 to 102; 42 CFR 1003.105

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/08/98                    63 FR 47552

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janet Wellham
Phone: 410 786-4510

RIN: 0938-AI56
_______________________________________________________________________




1211. MEDICARE PROGRAM; DEFINITION OF PROVIDER-SPONSORED ORGANIZATION 
AND RELATED REQUIREMENTS (HCFA-1027-IFC)

Priority:  Other Significant

CFR Citation:  42 CFR 422.350; 42 CFR 422.352; 42 CFR 422.354; 42 CFR 
422.356

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With HCFA-1031-F         02/04/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Maureen Miller
Phone: 410 786-1097
Email: [email protected]

RIN: 0938-AI60


_______________________________________________________________________



[[Page 21290]]

1212. CHILD HEALTH INSURANCE ALLOTMENTS FY 1999 (HCFA-2014-N)

Priority:  Other Significant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/08/99                     64 FR 6102

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2014
Email: [email protected]

RIN: 0938-AI64
_______________________________________________________________________




1213. STATE CHILDREN'S HEALTH INSURANCE PROGRAM ALLOTMENTS AND PAYMENTS 
TO STATES (HCFA-2114-P)

Priority:  Economically Significant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

CFR Citation:  42 CFR 457.200; 42 CFR 457.202; 42 CFR 457.204; 42 CFR 
457.206; 42 CFR 457.208; 42 CFR 457.210; 42 CFR 457.212; 42 CFR 
457.216; 42 CFR 457.218; 42 CFR 457.600; 42 CFR 457.602; 42 CFR 
457.606; 42 CFR 457.608; 42 CFR 457.610; 42 CFR 457.614

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/04/99                    64 FR 12404

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Federal

Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AI65
_______________________________________________________________________




1214. DSH PAYMENTS - INSTITUTION FOR MENTAL DISEASE (HCFA-2012-N)

Priority:  Other Significant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/08/98                    63 FR 54142

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Christine Hinds
Phone: 410 786-4578

RIN: 0938-AI66
_______________________________________________________________________




1215. NEW AND PENDING DEMONSTRATION PROJECT PROPOSALS SUBMITTED PURSUANT 
TO SECTION 1115(A) OF THE SOCIAL SECURITY ACT JULY, AUGUST, SEPTEMBER, 
OCTOBER, AND NOVEMBER 1997

Priority:  Substantive, Nonsignificant

CFR Citation:  Not yet determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/04/98                     63 FR 5809

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Gloria Smiddy
Phone: 410 786-7723

RIN: 0938-AI71
_______________________________________________________________________




1216. MEDICARE PROGRAM; ADVERTISING COSTS (HCFA-1880-P)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

CFR Citation:  Not yet determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Merged with another 
regulation per CHPP             10/27/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Gill
Phone: 410 786-7156
Fax: 410 786-0594

RIN: 0938-AI76
_______________________________________________________________________




1217. STATE ALLOTMENTS FOR ADDITIONAL FEDERAL FUNDING OF EMERGENCY 
HEALTH SERVICES FURNISHED TO UNDOCUMENTED ALIENS: FEDERAL FISCAL YEARS 
1998 THROUGH (HCFA-2000-N)

Priority:  Other Significant

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/03/98                    63 FR 10400

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State, Federal

Agency Contact: Miles McDermott
Phone: 410 786-3722
Email: [email protected]

RIN: 0938-AI78
_______________________________________________________________________




1218. MEDICAID PROGRAM; EXTENSION OF WAIVER TO EXTEND MEDICAID 
ELIGIBILITY TIMEFRAMES (HCFA-2009-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  Not yet determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/17/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Mark Ross
Phone: 410 786-5855
Email: [email protected]

RIN: 0938-AI79
_______________________________________________________________________




1219. MEDICARE AND MEDICAID PROGRAMS; SURETY BOND REQUIREMENTS FOR HOME 
HEALTH AGENCIES (HCFA-1038-NC)

Priority:  Routine and Frequent

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/04/98                    63 FR 10732

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

[[Page 21291]]

Agency Contact: Ralph Goldberg
Phone: 410 786-4870

RIN: 0938-AI82
_______________________________________________________________________




1220. SCHEDULE OF PER-BENEFICIARY LIMITATIONS ON HOME HEALTH AGENCY 
COSTS FOR COST REPORTING PERIODS BEGINNING ON OR AFTER OCTOBER 1, 1997 
(HCFA-1905-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 413.30

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/31/98                    63 FR 15718

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mike Bussacca
Phone: 410 786-4602

RIN: 0938-AI84
_______________________________________________________________________




1221. EXPANDED COVERAGE OF BLOOD GLUCOSE MONITORS AND TEST STRIPS (HCFA-
3003-IFC)

Priority:  Other Significant

CFR Citation:  42 CFR 410.38

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       07/09/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Betty S. Burrier
Phone: 410 786-4649

RIN: 0938-AI85
_______________________________________________________________________




1222. MEDICARE PROGRAM; HOSPICE WAGE INDEX (HCFA-1039-N)

Priority:  Other Significant

CFR Citation:  42 CFR 418.306(c)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/05/98                    63 FR 53446

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Blackford
Phone: 410 786-5909
Fax: 410 786-0169
Email: [email protected]

RIN: 0938-AI87
_______________________________________________________________________




1223. RECOGNITION OF THE AMERICAN ASSOCIATION FOR ACCREDITATION OF 
AMBULATORY SURGERY FACILITIES, INC. FOR AMBULATORY SURGICAL CENTERS 
PROGRAM (HCFA-2008-PN)

Priority:  Info./Admin./Other

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

CFR Citation:  Not yet determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/02/98                    63 FR 66554

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Joan C. Berry
Phone: 410 786-7233

RIN: 0938-AI90
_______________________________________________________________________




1224. MEDICAID, MEDICARE CLIA PROGRAM; EXTENSION OF CERTAIN EFFECTIVE 
DATES FOR CLINICAL LABORATORY REQUIREMENTS UNDER CLIA (HCFA 2024-IFC)

Priority:  Other Significant

CFR Citation:  42 CFR 493

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/14/98                    63 FR 55031

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Judy Yost
Phone: 410 786-3531

RIN: 0938-AI94
_______________________________________________________________________




1225. HOSPITAL CONDITIONS OF PARTICIPATION, IDENTIFICATION OF POTENTIAL 
ORGAN, TISSUE, AND EYE DONOR AND TRANSPLANT HOSPITALS PROVISIONS OF 
TRANSPLANT RELATED DATA (HCFA-3005-F)

Priority:  Other Significant

CFR Citation:  42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/22/98                    63 FR 33856

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Marcia Newton
Phone: 410 786-5265

RIN: 0938-AI95
_______________________________________________________________________




1226. EXPANDED COVERAGE FOR DIABETES OUTPATIENT SELF-MANAGEMENT TRAINING 
SERVICES (HCFA-3002-P)

Priority:  Economically Significant

CFR Citation:  42 CFR 410; 42 CFR 414; 42 CFR 424; 42 CFR 476; 42 CFR 
498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/11/99                     64 FR 6827

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Claude Mone
Phone: 410 786-5666

RIN: 0938-AI96
_______________________________________________________________________




1227. MEDICARE PROGRAM; MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 1999 
(HCFA-8003-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/21/98                    63 FR 56201

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

[[Page 21292]]

Government Levels Affected: None

Agency Contact: Carter S. Warfield
Phone: 410 786-6396

RIN: 0938-AI98
_______________________________________________________________________




1228. NOTICE ANNOUNCING REVISED POSITRON EMISSION TOMOGRAPHY (PET) 
POLICY (HCFA-3008-NC)

Priority:  Other Significant

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       01/22/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Ron Milhourn
Phone: 410 786-5666
Email: [email protected]

RIN: 0938-AJ01
_______________________________________________________________________




1229. MEDICARE PROGRAM; INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND 
EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR 1999 (HCFA-8001-N)

Priority:  Economically Significant. Major under 5 USC 801.

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/21/98                    63 FR 56199

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AJ02
_______________________________________________________________________




1230. MEDICARE PROGRAM; PART A PREMIUM FOR 1999 FOR THE UNINSURED AGED 
AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER 
ENTITLEMENT (HCFA-8000-N)

Priority:  Other Significant

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/21/98                    63 FR 56212

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Clare McFarland
Phone: 410 786-6390
Fax: 410 786-1295

RIN: 0938-AJ03
_______________________________________________________________________




1231. INPATIENT PSYCHIATRIC SERVICES BENEFIT FOR INDIVIDUALS UNDER AGE 
21 (HCFA-2060-F)

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/19/98                    63 FR 64195

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Winona Hocutt
Phone: 410 786-4666

RIN: 0938-AJ05
_______________________________________________________________________




1232. PHYSICIAN SUSTAINABLE GROWTH RATE OF INCREASE FOR FY 1999 (HCFA-
1021-FN)

Priority:  Other Significant

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/02/98                    63 FR 59188

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Elizabeth Holland
Phone: 410 786-1309

RIN: 0938-AJ09
_______________________________________________________________________




1233. COMPREHENSIVE ASSESSMENT AND USE OF OASIS AS PART OF CONDITIONS OF 
PARTICIPATION FOR HOME HEALTH AGENCIES (HCFA-3007-F)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

CFR Citation:  42 CFR 484.18; 42 CFR 484.55

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/25/99                     64 FR 3764
Final Action Effective          02/24/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janice Stevenson
Phone: 410 786-4882
Mary Weakland
Phone: 410 786-6835

RIN: 0938-AJ11
_______________________________________________________________________




1234. REQUEST FOR PUBLIC COMMENTS ON IMPLEMENTATION OF RISK ADJUSTED 
PAYMENT FOR THE MEDICARE+CHOICE PROGRAM AND NOTICE OF PUBLIC MEETING

Priority:  Info./Admin./Other

CFR Citation:  42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/08/98                    63 FR 47506

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Cynthia Tudor
Phone: 410 786-6499

RIN: 0938-AJ16
_______________________________________________________________________




1235. ADJUSTMENTS TO PAYMENT AMOUNT FOR ERYTHROPOIETIN/EPOIETIN FOR END-
STAGE RENAL DISEASE PATIENTS (HCFA-1098-PN)

Priority:  Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

CFR Citation:  42 CFR 413.174

[[Page 21293]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Action on this 
notice not anticipated during 
this cycle.                     02/01/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Henry E. Richter
Phone: 410 786-4562

RIN: 0938-AJ18
_______________________________________________________________________




1236. RECOGNITION OF THE COMMISSION FOR ACCREDITATION OF REHABILITATION 
FACILITIES (HCFA-2036-NC)

Priority:  Info./Admin./Other

CFR Citation:  42 CFR 785

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/24/98                    63 FR 71296

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Susan Cuerdon
Phone: 410 786-1146

RIN: 0938-AJ25
_______________________________________________________________________




1237. MEDICARE PROGRAM; LIMITED ADDITIONAL OPPORTUNITY TO REQUEST 
CERTAIN HOSPITAL WAGE DATA REVISIONS FOR FY 1999 (HCFA-1049-FC)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/19/98                    63 FR 64191

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AJ26
_______________________________________________________________________




1238.  REQUEST FOR NOMINATIONS FOR MEMBERS FOR PRACTICING 
PHYSICIANS ADVISORY COUNCIL (HCFA-1048-N)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1395ee; PL 101-508

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice requests nominations from physician medical 
organizations for individuals to serve on the Practicing Physicians 
Advisory Council.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice - No Further Action 
Planned                         11/10/98                    63 FR 63068

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Aaron Primack, MD, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, Room 435-H, HHH Bldg., 
Washington, DC 20201
Phone: 202 205-2505

RIN: 0938-AJ27
_______________________________________________________________________




1239.  MEDICARE AND MEDICAID PROGRAMS; ANNOUNCEMENT OF 
ADDITIONAL APPLICATION FROM HOSPITALS REQUESTING WAIVERS FOR ORGAN 
PROCUREMENT SERVICE AREA (HCFA-1062-N)

Priority:  Routine and Frequent

Legal Authority:  42 USC 1138(a)(2)(A)

CFR Citation:  42 CFR 316(a) to 486

Legal Deadline: None

Abstract: This notice announces additional applications that we have 
received from hospitals requesting waivers from entering into 
agreements with their designated organ procurement organizations (OPOs) 
in accordance with section 1138(a)(2) of the Social Security Act. It 
supplements notices published in the Federal Register on January 19, 
1996, May 17, 1996, November 8, 1996, April 21, 1997, and September 17, 
1997, that announced hospital waiver requests received by us. This 
notice requests comments from OPOs and the general public for our 
consideration in determining whether these waivers should be granted.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice - No Further Action 
Planned                         01/12/99                     64 FR 1811

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mark Horney, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4554

RIN: 0938-AJ32
_______________________________________________________________________




1240.  MEDICARE PROGRAM; JANUARY 6, 1999, MEETING OF THE 
COMPETITIVE PRICING ADVISORY COMMITTEE (HCFA-1061-N)

Priority:  Info./Admin./Other

Legal Authority:  PL 103-33, sec 4011

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice announces a meeting of the Competitive Pricing 
Advisory Committee on January 6, 1999.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Meeting Notice - No Further 
Action Planned                  12/17/98                    63 FR 69638

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sharon Arnold, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD
Phone: 410 786-0291

RIN: 0938-AJ33
_______________________________________________________________________




1241.  MEDICARE PROGRAM; MARCH 15, 1999, MEETING OF THE 
PRACTICING PHYSICIAN ADVISORY COUNCIL (HCFA-1064-N)

Priority:  Routine and Frequent

Legal Authority:  PL 105-33, sec 1868

CFR Citation:  None

Legal Deadline: None

Abstract: In accordance with section 10(a) of the Federal Advisory

[[Page 21294]]

Committee Act, this notice announces a meeting of the Practicing 
Physician Advisory Council (the Council) on March 15, 1999. This 
meeting is open to the public. The Council was mandated by section 1868 
of the Social Security Act and meets quarterly to discuss certain 
proposed changes in regulations and carrier manual instructions related 
to physicians' services, as identified by the Secretary of the 
Department of Health and Human Services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Meeting Notice - No Further 
Action Planned                  02/12/99                     64 FR 7198

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: John Lanigan, Department of Health and Human Services, 
Health Care Financing Administration, HHH Building, Wasnington, DC 
20201
Phone: 202 690-7418

RIN: 0938-AJ38
_______________________________________________________________________




1242.  MARCH 9, APRIL 8, AND MAY 12, 1999 MEETINGS OF THE KANSAS 
CITY METROPOLITAN AREA, COMPETITIVE PRICING DEMONSTRATION AREA ADVISORY 
COMMITTEE (HCFA-1068-N)

Priority:  Info./Admin./Other

Legal Authority:  PL 105-33, sec 4012(b)

CFR Citation:  None

Legal Deadline: None

Abstract: In accordance with section 10(a) of the Federal Advisory 
Committee Act, this notice announces three meetings of the Competitive 
Pricing Demonstration Area Advisory Committee for the Kansas City 
metropolitan area. Section 4011 of the Balanced Budget Act of 1997 
(BBA) requires the Secretary of the Department of Health and Human 
Services (the Secretary) to establish a demonstration project under 
which payments to Medicare+Choice organizations in designated areas are 
determined in accordance with a competitive pricing methodology. After 
an area is designated as a demonstration site, section 4012(b) of the 
BBA requires the Secretary to appoint an Area Advisory Committee (AAC). 
The AAC is directed to advise the Secretary on the marketing and 
pricing of the plan in the area and other salient factors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Meeting Notice - No Further 
Action Planned                  03/11/99                    64 FR 12172

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Richard P. Brummel, CHPP, Deputy Regional 
Administrator, Department of Health and Human Services, Health Care 
Financing Administration, Room 235, 601 East 12th Street, Kansas City, 
MO 64106
Phone: 816 426-5233

RIN: 0938-AJ46
_______________________________________________________________________




1243.  MEDICARE COORDINATED CARE DEMONSTRATION PROJECT AND 
REQUEST FOR COMMENTS ON POTENTIAL BEST PRACTICES OF COORDINATED CARE 
(HCFA-1100-N)

Priority:  Info./Admin./Other

Legal Authority:  PL 105-33

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice announces HCFA's intent to conduct a Medicare 
Coordinated Care Demonstration and solicit comments on potential best 
practices of coordinated care and on aspects of the overall 
demonstration.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice - No Further Action 
Planned                         03/23/99                    64 FR 13998

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Catherine Jansto, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-7762

RIN: 0938-AJ49
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Administration for Children and Families (ACF)



_______________________________________________________________________




1244. CONSTRUCTION OF HEAD START FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This rule establishes procedures to be used by Head Start 
agencies in requesting to use Head Start grant funds to construct or 
renovate a Head Start facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/08/99                     64 FR 6013
NPRM Comment Period End         04/09/99
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB54
_______________________________________________________________________




1245. BONUS TO REWARD HIGH PERFORMANCE STATES UNDER THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority:  Other Significant

Legal Authority:  42 USC 603 (a)(4)

CFR Citation:  45 CFR 270 (New)

[[Page 21295]]

Legal Deadline: None

Abstract: The Administration for Children and Families, in consultation 
with the National Governor's Association and the American Public Human 
Services Association (formerly the American Public Welfare 
Association), will propose specific performance measures and a funds 
allocation formula for measuring State performance under the Temporary 
Assistance for Needy Families Block Grant as the basis for payment of a 
bonus to high performing States.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., 7th Floor West, 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB66
_______________________________________________________________________




1246. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority:  Other Significant

Legal Authority:  42 USC 655(f)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This NPRM will specify how tribes can obtain direct payments 
from the Department of Health and Human Services for provision of child 
support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity, 
modification and enforcement of support orders, and location of absent 
parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Paige Biava, Division of Policy and Planning, 
Department of Health and Human Services, Administration for Children 
and Families, OCSE, 370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-5635
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB73
_______________________________________________________________________




1247. INCENTIVE PAYMENTS AND AUDIT PENALTIES TO STATES AND POLITICAL 
SUBDIVISIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 609(a)(8); 42 USC 658A

CFR Citation:  45 CFR 305; 45 CFR 302.55; 45 CFR 304.12

Legal Deadline:  NPRM, Statutory, April 1999.

Abstract: This regulation proposes to implement the requirements in 42 
USC 609(a)(8) which provide for a penalty of 1 percent to 5 percent of 
a State's Temporary Assistance for Needy Families (TANF) funds if the 
Secretary of HHS determines that the State failed to meet the paternity 
establishment percentages or other performance measures established by 
the Secretary. It would also implement a new incentive system, enacted 
under Pub.L. 105-200. Based on 42 USC 658A States will receive 
incentives according to their performance on key statutory indicators 
and performance standards from a capped pool of funds beginning in FY 
2000. These funds must be reinvested in the IV-D program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Joyce Pitts, Division of Policy and Planning, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., Mail Stop OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-5374
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB85
_______________________________________________________________________




1248. FAMILY CHILD CARE PROGRAM OPTION FOR HEAD START PROGRAMS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1304,1306

Legal Deadline: None

Abstract: This rule would allow Head Start programs to choose Family 
Child Care as a Head Start program option.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, ACYF, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB90
_______________________________________________________________________




1249. IMPLEMENTATION OF AFCARS CORRECTIVE ACTION AND PENALTIES AND CAPTA 
AMENDMENTS

Priority:  Other Significant

Legal Authority:  42 USC 5101 et seq; 42 USC 674 to 679; 42 USC 1320a-
2a

CFR Citation:  45 CFR 1355; 45 CFR 1356; 45 CFR 1340

Legal Deadline: None

Abstract: This NPRM will: revise the Child Abuse and Neglect Prevention 
and Treatment regulation to implement the requirements of the Child 
Abuse Prevention and Treatment Act Amendments of 1996 (Pub. L. 104-
235); address the adoption and foster care analysis and reporting 
system correction action and penalties; make changes to the collection 
of data; and make other technical changes, including, reporting dates 
in century date format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/99

Regulatory Flexibility Analysis Required: No

[[Page 21296]]

Government Levels Affected: State

Additional Information: Merge RIN 0970-AB86 with RIN 0970-AB94

Agency Contact: Kathleen McHugh, Director, Policy Division, Department 
of Health and Human Services, Administration for Children and Families, 
330 C Street SW., Wasington, DC 20201
Phone: 202 401-5789
Email: [email protected]

RIN: 0970-AB94
_______________________________________________________________________




1250. STATE SELF ASSESSMENTS TO DETERMINE COMPLIANCE WITH FEDERAL 
REGULATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 654(15)(A)

CFR Citation:  45 CFR 306

Legal Deadline: None

Abstract: Would require States to conduct annual reviews on certain 
aspects of the State Title IV-D Programs and provide a report to the 
Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Jan Rothstein, Program Specialist, Office of Child 
Support Enforcement/DHHS, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5073
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB96
_______________________________________________________________________




1251.  PRIORITY FOR PREVIOUSLY SELECTED HEADSTART AGENCIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1302.12

Legal Deadline: None

Abstract: NPRM proposes to amend 45 CFR part 1302 by removing section 
1302.12 for clarification purposes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/24/99                    64 FR 14202
NPRM Comment Period End         05/24/99
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: Local, Tribal

Agency Contact: James Kolb, Head Start Bureau, ACYF, Department of 
Health and Human Services, Administration for Children and Families, 
330 C Street SW., Washington, DC 20201
Phone: 202 205-8580

RIN: 0970-AB98
_______________________________________________________________________




1252.  PROGRAM PERFORMANCE STANDARDS FOR THE OPERATION OF HEAD 
START PROGRAMS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9831 et seq; sec 641A of the Head Start Act

CFR Citation:  45 CFR 1304

Legal Deadline: None

Abstract: The education component of the Head Start Performance 
Standards will be revised to ensure the school readiness of children 
participating in a Head Start program and to assure that Head Start 
children have certain understandings in the areas of language and 
numeracy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: None

Agency Contact: Doug Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C St SW., Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AB99
_______________________________________________________________________




1253.  SAFEGUARDING CHILD SUPPORT AND EXPANDED FPLS INFORMATION

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 452 to 454A

CFR Citation:  45 CFR 303.21

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to Title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997 and the Child Support Performance and Incentive 
Act of 1998 further amended Title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
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                            03/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Eileen C. Brooks, Program Specialist, DHHS/OCSE, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., 4th Floor East, OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-5369
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1254.  ASSETS FOR INDEPENDENCE RESERVE ACCOUNT

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 105-285

CFR Citation:  Not yet determined

[[Page 21297]]

Legal Deadline: None

Abstract: The Office of Community Services (OCS) is administering a new 
demonstration project that will establish, support, and participate in 
the evaluation of Individual Development Accounts (IDA) for lower 
income individuals and families, as enacted in Title IV, Human Services 
Reauthorization Act of 1998 (P.L. 105-285). Section 407(b)(2) of Title 
IV, Human Services Reauthorization Act of 1998 (P.L. 105-285), states 
that the Secretary is to prescribe regulations on accounting for 
amounts in the IDA reserve fund. This regulation would address that 
requirement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Richard Saul, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, 370 
L'Enfant Promenade SW., 5th Floor - OCS, Washington, DC 20447
Phone: 202 401-9341
Fax: 202 401-4687
Email: [email protected]

RIN: 0970-AC02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage


Administration for Children and Families (ACF)



_______________________________________________________________________




1255. TITLE IV-E FOSTER CARE ELIGIBILITY REVIEWS AND CHILD AND FAMILY 
SERVICES STATE PLAN REVIEWS, MEPA IMPLEMENTATION, AND ASFA 
IMPLEMENTATION

Priority:  Other Significant

Legal Authority:  42 USC 622; 42 USC 671; 42 USC 1302; 42 USC 1320a-2a

CFR Citation:  45 CFR 1355; 45 CFR 1356; 45 CFR 1357

Legal Deadline:  Final, Statutory, July 1, 1995.

Abstract: This rule will contain requirements that implement the Social 
Security Act Amendments of 1994 on review of State programs under parts 
B and E of the Social Security Act for conformity with State Plan 
requirements as well as Adoption and Safe Families Act requirements 
related to State plan issues. It will contain requirements that govern 
on-site eligibility reviews that the Administration for Children and 
Families conducts to assure State agencies' compliance with the 
statutory requirements under Title IV-E of the Social Security Act for 
the eligibility of foster care providers and the eligibility of 
children in foster care. The rule will provide for enforcement of the 
prohibition on race-based discrimination in foster care and adoptive 
placements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/18/98                    63 FR 50058
NPRM Comment Period End         12/17/98
Final Action                    11/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: This action was previously reported under RIN 
0970-AB60.

Agency Contact: Kathleen McHugh, ACYF/Children's Bureau, Department of 
Health and Human Services, Administration for Children and Families, 
Washington, DC 20013
Phone: 202 401-5789
Email: [email protected]

RIN: 0970-AA97
_______________________________________________________________________




1256. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: This rule establishes Head Start Performance Standards for 
the safe transportation of Head Start children, including vehicle 
requirements, driver qualifications and training and safety rules for 
children and staff while en route and loading and unloading of 
vehicles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/15/95                    60 FR 31612
NPRM Comment Period End         08/14/95
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB24
_______________________________________________________________________




1257. METHODOLOGY FOR DETERMINING WHETHER AN INCREASE IN A STATE'S CHILD 
POVERTY RATE IS THE RESULT OF THE TANF PROGRAM

Priority:  Other Significant

Legal Authority:  42 USC 613(i)

CFR Citation:  45 CFR 284 (New)

Legal Deadline: None

Abstract: This rule will set forth a methodology to determine whether 
an increase in a State's child poverty rate is the result of the TANF 
Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/98                    63 FR 50837
NPRM Comment Period End         11/23/98
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 7th Floor, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB65


_______________________________________________________________________



[[Page 21298]]

1258. TEMPORARY ASSISTANCE FOR NEEDY FAMILIES (TANF)

Priority:  Other Significant

Legal Authority:  42 USC 601; 42 USC 601 note; 42 USC 603 to 604; 42 
USC 606 to 611; 42 USC 613; 42 USC 617; 42 USC 619; 42 USC 862a; 42 USC 
1302; 42 USC 1308

CFR Citation:  45 CFR 260 to 265 (New)

Legal Deadline: None

Abstract: This regulation governs key provisions of the new welfare 
block grant program enacted in August 1996 as part of the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996 
(PRWORA). This new program, called the Temporary Assistance for Needy 
Families -- or TANF -- program, replaced the national welfare program 
known as Aid to Families with Dependent Children (AFDC) and the related 
programs known as the Job Opportunities and Basic Skills Training 
Program (JOBS) and the Emergency Assistance (EA) program. The 
regulation addresses the five-year time limit, work, accountability, 
and data collection and reporting provisions of the new TANF program.

Statement of Need: This regulation is necessary to provide States with 
a basic set of rules which will assist them in implementing the TANF 
program.

Alternatives: There are no viable alternatives.

Anticipated Costs and Benefits: This regulation reflects the intent of 
PRWORA to achieve a balance between granting States the flexibility 
they need to develop and operate effective and responsive programs, and 
ensuring that the objectives of the programs are met. The financial 
impact of these rules should be minimal because of the fixed level of 
funding provided through the block grant. A State's Federal grant could 
be affected by the penalty decisions made under the law in these rules, 
and State expenditures on needy families could be affected by the rules 
on caseload reduction. Otherwise, the regulation should not affect the 
overall level of expenditures. However, it could have minor impacts on 
the nature and distribution of such expenditures. The impacts of these 
rules on needy individuals and families will depend on the choices the 
State makes in implementing the new law.

Risks: None.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/20/97                    62 FR 62124
NPRM Comment Period End         02/18/98
Final Action                    04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal, Federal

Additional Information: This action includes information previously 
reported under RIN 0970-AB64 and RIN 0970-AB76. The CFR citation for 
the NPRM was 45 CFR 270 to 275.

Agency Contact: Mack Storrs, Director, Division of Self-Sufficiency 
Programs, Department of Health and Human Services, Administration for 
Children and Families, Office of Family Assistance, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-9289
Fax: 202 205-5887
Email: [email protected]

RIN: 0970-AB77
_______________________________________________________________________




1259. REQUIREMENTS FOR THE TRIBAL PROGRAMS

Priority:  Other Significant

Legal Authority:  42 USC 612

CFR Citation:  45 CFR 286 (New); 45 CFR 287 (New)

Legal Deadline: None

Abstract: This rule sets forth a process for: the completion and 
submission of tribal TANF plans; the determination of funding levels 
for tribal TANF grants; the establishment of criteria to determine 
minimum work participation requirements and time limits for tribal TANF 
programs; and the review and approval of tribal TANF plans. This rule 
sets forth program requirements for the application of penalties and 
for data collection and reporting.
The rule also sets forth procedures for planning and operating a 
program to make work activities available to tribal members. Funds for 
this program are available to Indian tribes and Alaska Native 
organizations that operated a Job Opportunities and Basic Skills 
Training (JOBS) program in fiscal year 1995. This tribal work 
activities program is called the Native Employment Works (NEW) Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/22/98                    63 FR 39366
NPRM Comment Period End         11/20/98
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal, Federal

Agency Contact: John Bushman, Director, Division of Tribal Services, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Community Services, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-2418
Fax: 202 205-5887
Email: [email protected]

RIN: 0970-AB78
_______________________________________________________________________




1260. BONUS TO REWARD DECREASE IN ILLEGITIMACY RATIO

Priority:  Other Significant

Legal Authority:  42 USC 603(a)(2)

CFR Citation:  45 CFR 283 (New)

Legal Deadline: None

Abstract: This regulation describes how bonuses will be awarded to 
those States that experience the largest decreases in out-of-wedlock 
childbearing and also reduce their abortion rates. The total amount of 
the bonus will be $100 million in each of fiscal years 1999 through 
2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/02/98                    63 FR 10264
NPRM Comment Period End         05/01/98
Final Action                    04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Kelleen Kaye, Office of the Assistant Secretary for 
Planning and Evaluation, Department of Health and Human Services, 
Administration for Children and Families, 200 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 401-6634
Fax: 202 690-6562
Email: [email protected]

RIN: 0970-AB79


_______________________________________________________________________



[[Page 21299]]

1261. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 304; 45 CFR 305; 45 CFR 301; 45 CFR 302; 45 CFR 
303

Legal Deadline: None

Abstract: This rule eliminates child support enforcement program 
regulations rendered obsolete or inconsistent with the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/09/99                     64 FR 6237
Final Action                    02/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Marilyn R. Cohen, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5366
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1262. REFUGEE RESETTLEMENT PROGRAM: PUBLIC/PRIVATE PARTNERSHIP

Priority:  Other Significant

Legal Authority:  8 USC 1522(a)(9)

CFR Citation:  45 CFR 400

Legal Deadline: None

Abstract: This regulation will establish the refugee cash assistance 
program as a public/private partnership between States and local 
resettlement agencies, make several revisions to the Refugee Medical 
Assistance Program, and other technical changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/99                     64 FR 1159
NPRM Comment Period End         03/09/99
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Toyo Biddle, Director, Division of Refugee Self-
Sufficiency, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-9250

RIN: 0970-AB83
_______________________________________________________________________




1263. HEAD START APPEAL TIMELINES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1303

Legal Deadline: None

Abstract: This amendment to part 1303 will provide timelines and 
selected procedural changes for conducting administrative hearings on 
adverse actions taken against Head Start agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/30/98                    63 FR 35554
NPRM Comment Period End         08/31/98
Final Action                    08/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Commissioner, Head Start 
Bureau, Department of Health and Human Services, Administration for 
Children and Families, ACYF, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB87
_______________________________________________________________________




1264. WELFARE-TO-WORK DATA COLLECTION

Priority:  Other Significant

Legal Authority:  42 USC 611

CFR Citation:  45 CFR 276

Legal Deadline: None

Abstract: This interim final rule specifies the data elements that 
grantees must report for the Welfare-to-Work program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/29/98                    63 FR 57919
Final Action                    09/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., 7th Floor West, 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB92
_______________________________________________________________________




1265. NATIONAL MEDICAL SUPPORT NOTICE

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 666(19); PL 105-200, sec 401(b)(4); Child 
Support Performance and Incentive Act of 1998

CFR Citation:  45 CFR 303.32

Legal Deadline:  Final, Statutory, May 16, 2000.

Abstract: Joint DHHS/DOL regulations mandating use of a national 
medical support notice and including procedures for issuance and 
transmittal to employers by States to enforce health care coverage in a 
child support order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: John Seneta, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, 370 
L'Enfant Promenade SW., Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5154
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB97


_______________________________________________________________________



[[Page 21300]]

1266.  TECHNICAL REVISION OF HEAD START REGULATIONS TO MAKE THEM 
CONFORM TO RECENT STATUTORY REVISIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9831 et seq

CFR Citation:  45 CFR 1301; 45 CFR 1302; 45 CFR 1303; 45 CFR 1308

Legal Deadline: None

Abstract: This rule will correct several Head Start regulations which 
define Head Start programs as ``non-profit'' agencies. Recent statutory 
changes now allow ``for-profit'' agencies to receive Head Start grant 
funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Agency Contact: Doug Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, ACYF-HSB, 330 C St SW., Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AC00
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1267. STANDARDS FOR PURCHASE OF FACILITIES

Priority:  Other Significant

CFR Citation:  45 CFR 1309

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/08/99                     64 FR 5939

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569

RIN: 0970-AB31
_______________________________________________________________________




1268. STATE LAW CONCERNING PATERNITY ESTABLISHMENT

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 302.70; 45 CFR 303.5; 45 CFR 304.20

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/10/99                    64 FR 11802

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Jan Rothstein
Phone: 202 401-5073
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB69
_______________________________________________________________________




1269. GRANTS TO STATES FOR ACCESS AND VISITATION PROGRAMS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 303.109 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/30/99                    64 FR 15132

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: David Arnaudo
Phone: 202 401-5364
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB72
_______________________________________________________________________




1270. CASE CLOSURE

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

CFR Citation:  45 CFR 303.11

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/10/99                    64 FR 11810

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Paige Biava
Phone: 202 401-5635
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB82

[[Page 21301]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage


Administration on Aging (AOA)



_______________________________________________________________________




1271. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, INTRASTATE 
FUNDING FORMULAS; TRAINING, RESEARCH AND DISCRETIONARY PROGRAMS; 
VULNERABLE ELDER RIGHTS; AND GRANTS TO INDIANS & NATIVE HAWAIIANS

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority:  42 USC 3001 et seq

CFR Citation:  45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45 
CFR 1328

Legal Deadline: None

Abstract: The Administration on Aging in consultation with the Office 
of Management and Budget, has determined that it is no longer necessary 
to pursue final action on rules earlier proposed to implement the 1992 
amendments to the Older Americans Act. The provisions of the Act remain 
in force and need no further regulations to implement them. AoA 
anticipates promulgating rules in the latter part of 1999 to implement 
the provisions to the next reauthorization of the Older Americans Act, 
if necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - OAA Amendments in FY '98 12/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: The Administration on Aging, in consultation 
with the Office of Management and Budget, has determined that it is no 
longer necessary to pursue final action on rules earlier proposed to 
implement the 1992 amendments to the Older Americans Act. The 
provisions of the Act remain in force and need no further regulations 
to implement them. AoA anticipates promulgating rules in the latter 
part of 1998 to implement the provisions to the next reauthorization of 
the Older Americans Act, if necessary.

Agency Contact: Edwin Walker, Director, Office of Program Operations 
and Development, Department of Health and Human Services, 
Administration on Aging, 330 Independence Avenue SW., Room 4733, Cohen 
Bldg., Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
[FR Doc. 99-7567 Filed 04-23-99; 8:45 am]
BILLING CODE 4150-04-F
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