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



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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 September 30, 1993, Executive Order 12866 and 
the Regulatory Flexibility Act require that the Department semiannually 
publish an agenda summarizing all rulemaking under development and 
indicating those regulatory actions being analyzed for impact on small 
businesses. The Department published its last such agenda on November 
29, 1996.

    The agenda set out below continues to reflect the Department's 
efforts to exemplify in its rulemaking practices and products the 
President's initiative to reinvent the Federal regulatory system so 
that it provides important benefits to the American people while 
creating fewer burdens. Comments are invited to assist the 
Department in continuing to pursue the President's purposes.

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 division or agency of the Department as listed 
below.

SUPPLEMENTARY INFORMATION: On September 30, 1993, President Clinton 
issued Executive Order 12866 to reform the Federal regulatory process. 
The order and the Clinton Administration's implementation of it have 
brought about substantial improvement in the Department's regulatory 
products and practices. Much remains, of course, to be done.

    The President's approach to rulemaking insists that regulations 
be based on thoroughgoing analysis of their impact; that they be 
framed only after careful consultation with those affected, 
particularly our State and local government partners; that 
regulations be tailored to specific and clearly identified 
problems, avoiding overly broad, one-size-fits-all approaches; that 
flexible performance standards and market incentives be used rather 
than command-and-control requirements; and that regulatory burden 
be streamlined and simplified to the maximum extent possible.

    The agenda that follows constitutes the Department's most 
recent inventory of the regulatory actions to be taken in light of 
these and the other regulatory policy priciples established by 
Executive Order 12866. As we continue with this effort, we invite 
comments on the agenda entries and look forward to receiving 
suggestions for furthering the President's strategy.

    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: Mary Ann Troanovitch, 
Executive for Regulations Management, Health Care Financing 
Administration, Room 309G, Hubert H. Humphrey Building, Washington, 
DC 20201; phone 202-690-7890.

    Food and Drug Administration: Edwin 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, Wilbur H. Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201; phone 202-260-0669.

    Agency for Health Care Policy and Research: Peggy Washburn, 
2101 East Jefferson Street, Suite 603, Rockville, Maryland 20852; 
phone 301-594-1455.

    Centers for Disease Control/Agency for Toxic Substances and 
Disease Registry: Karen Deasy, 1600 Clifton Road NE., Mail Stop D-
23, Atlanta, Georgia 30333; phone 404-639-7073.

    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, 9000 Rockville 
Pike, Building 31, Room 1B25, Bethesda, Maryland 20892; 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.

Claudia Cooley,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
925         Revised OIG Exclusion Authorities Resulting From Public Law 104-191...................    0991-AA87 
926         Indirect Cost Appeals.................................................................    0991-AA88 
927         Revised OIG Civil Money Penalties Resulting from Public Law 104-191...................    0991-AA90 
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                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
928         Clarification of the Initial OIG Safe Harbor Provisions and Establishment of                        
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
929         Reproduction and Sale of Official Forms and Publications..............................    0991-AA83 
930         Revised PRO Sanctions for Failing to Meet Statutory Obligations.......................    0991-AA86 
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                                   Office of the Secretary--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
931         Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans...........    0991-AA45 
932         Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
933         Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
934         Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community-Based              
            Health Care Center or Provider, of a Standard Survey..................................    0991-AA79 
935         Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and                  
            Rebate Agreements.....................................................................    0991-AA80 
936         Senior Biomedical Research Services...................................................    0991-AA82 
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                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
937         Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory                      
            Opinions by the OIG...................................................................    0991-AA85 
938         Civil Money Penalties Inflation Adjustments...........................................    0991-AA89 
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                   Substance Abuse and Mental Health Services Administration--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
939         Protection and Advocacy for Individuals With Mental Illness...........................    0930-AA02 
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                  Substance Abuse and Mental Health Services Administration--Long-Term Actions                  
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                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
940         Block Grants for Prevention and Treatment of Substance Abuse..........................    0930-AA01 
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
941         Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0990-AA02 
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                                   Food and Drug Administration--Prerule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
942         Medical Foods.........................................................................    0910-AA20 

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943         Investigational New Drug Applications; Request for Information and Comments...........    0910-AA83 
944         Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That                  
            Uses Are No Longer Essential..........................................................    0910-AA99 
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                                Food and Drug Administration--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
945         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug              
            and Patent Term Restoration Act (GADPTRA).............................................    0910-AA02 
946         Fees for Certification Services; Insulin and Color Additive Certification Programs....    0910-AA07 
947         Biological Product Reporting of Errors and Accidents in Manufacturing.................    0910-AA12 
948         Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0910-AA14 
949         Amalgam Ingredient Labeling...........................................................    0910-AA33 
950         Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................    0910-AA39 
951         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution....    0910-AA49 
952         Bioavailability and Bioequivalence Requirements.......................................    0910-AA51 
953         Drugs Used for Treatment of Narcotic Addicts..........................................    0910-AA52 
954         Reinventing FDA Food Regulations......................................................    0910-AA58 
955         Dietary Supplement Regulations in Response to DSHEA...................................    0910-AA59 
956         Investigational New Drug Applications; Clinical Holds.................................    0910-AA73 
957         Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant; Labeling              
            Requirements; Warning Statement.......................................................    0910-AA74 
958         Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent                         
            Requirements..........................................................................    0910-AA75 
959         Debarment Certification Regulations for Drug Applications.............................    0910-AA76 
960         Certification of Drugs Composed Wholly or Partly of Insulin...........................    0910-AA77 
961         Over-the-Counter Human Drugs; Labeling Requirements...................................    0910-AA79 
962         Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening                
            Illnesses.............................................................................    0910-AA84 
963         Adverse Experience Reporting, Recordkeeping, and Records Access Requirements for                    
            Marketed OTC Drugs That Are Now the Subjects of Approved New Drug Apps................    0910-AA86 
964         Sterility Requirements for Inhalation Solution Products...............................    0910-AA88 
965         Direct-to-Consumer Promotion Regulations..............................................    0910-AA90 
966         Revision of the Requirements for a Responsible Head for Biological Establishments.....    0910-AA93 
967         Labeling for Human Prescription Drugs; Revised Format.................................    0910-AA94 
968         Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products;                
            Expedited Reports.....................................................................    0910-AA97 
969         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Labeling              
            of Drugs; Revision of Certain Labeling Controls.......................................    0910-AA98 
970         Radioactive Drugs for Basic Research..................................................    0910-AB00 
971         Definition of Adequate and Well Controlled Studies....................................    0910-AB01 
972         Investigational New Animal Drug Regulations...........................................    0910-AB02 
973         Establishment Registration and Listing of Human Cellular and Tissue-Based Products....    0910-AB05 
974         FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping                          
            Requirements for Unapproved or Violative Products Imported for Further Processing or                
            Incorporation and Later Export........................................................    0910-AB06 
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                                 Food and Drug Administration--Final Rule Stage                                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
975         Over-the-Counter (OTC) Drug Review....................................................    0910-AA01 
976         Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0910-AA08 
977         Implementation of the Safe Medical Devices Act of 1990................................    0910-AA09 
978         Mammography Quality Standards Act of 1992.............................................    0910-AA24 
979         Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0910-AA25 
980         Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products........    0910-AA26 

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981         Adverse Experience Expedited Reporting Requirements for Human Drug and Licensed                     
            Biological Products...................................................................    0910-AA28 
982         Financial Disclosure by Clinical Investigators........................................    0910-AA30 
983         Latex Condoms: Expiration Date Labeling...............................................    0910-AA32 
984         Latex Warning.........................................................................    0910-AA34 
985         Prescription Drug Product Labeling; Medication Guide..................................    0910-AA37 
986         Human Tissue Intended for Transplantation.............................................    0910-AA40 
987         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding               
            of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals.....    0910-AA45 
988         Changes to an Approved Application....................................................    0910-AA57 
989         Export Requirements for Medical Devices...............................................    0910-AA62 
990         Adverse Experience Reporting for Human Drug and Licensed Biological Products;                       
            Increased Frequency Reports...........................................................    0910-AA72 
991         New Drug Applications; Drug Master File...............................................    0910-AA78 
992         National Environmental Policy Act; Policies and Procedures............................    0910-AA80 
993         Current Good Manufacturing Practice for Finished Pharmaceutical; Positron Emission                  
            Tomography............................................................................    0910-AA81 
994         Investigational New Drug Applications and New Drug Applications.......................    0910-AA82 
995         Postmarketing Periodic Adverse Experience Reporting Requirements for Human Drug and                 
            Licensed Biological Products..........................................................    0910-AA85 
996         New Drugs for Human Use; Clarification of Requirements for Application Supplements....    0910-AA87 
997         Substances Prohibited From Use in Animal Food or Feed; Protein Derived From Ruminants               
            Prohibited in Ruminant Feed...........................................................    0910-AA91 
998         Treatment Use of Investigational Device Exemptions....................................    0910-AA92 
999         Disqualification of a Clinical Investigator...........................................    0910-AA95 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1000        Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality                    
            Factors, Notification Requirements, and Records and Reports...........................    0910-AA04 
1001        Food Labeling Review..................................................................    0910-AA19 
1002        Classification of Computer Software Programs That Are Medical Devices.................    0910-AA41 
1003        Development of Hazard Analysis Critical Control Points for the Food Industry; Request               
            for Comments; Proposed Rule...........................................................    0910-AA43 
1004        Habit Forming Drugs...................................................................    0910-AA50 
1005        Revocation of Certain Regulations.....................................................    0910-AA54 
1006        Export Requirements for Drugs for Investigational Use in Other Countries..............    0910-AA61 
1007        Reinvention of Administrative Procedures Regulations..................................    0910-AA69 
1008        Informed Consent for Human Drugs and Biologics; Determination That Informed Consent Is              
            Not Feasible..........................................................................    0910-AA89 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1009        Disqualification of Clinical Investigators............................................    0910-AA21 
1010        Investigational Device Exemption; Intraocular Lenses..................................    0910-AA22 
1011        Electronic Signatures; Electronic Records.............................................    0910-AA29 
1012        Iron Containing Drugs and Supplements.................................................    0910-AA42 
1013        Consolidation of Regulations..........................................................    0910-AA53 
1014        Human Tissue Intended for Transplantation and Human Reproductive Tissue Intended for                
            Insemination, Fertilization, and Transfer.............................................    0910-AA70 
1015        Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter                  
            Drug Monograph System; Request for Information and Comments...........................    0910-AA96 
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                        Health Resources and Services Administration--Proposed Rule Stage                       
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1016        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Corporate Shield..................................................    0906-AA41 
1017        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Charge for Self-Queries...........................................    0906-AA42 
1018        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Reporting Adverse and Negative Actions............................    0906-AA43 
1019        Designation of Medically Underserved Populations and Health Professional Shortage                   
            Areas.................................................................................    0906-AA44 
1020        Drug Pricing Program: Prime Vendor User Charge........................................    0906-AA45 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1021        Organ Procurement and Transplantation Network Rules...................................    0906-AA32 
1022        Health Education Assistance Loan (HEAL) Program: Lenders'/ Holders' Performance                     
            Standards.............................................................................    0906-AA33 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1023        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine                
            Injury Table--II......................................................................    0906-AA36 
1024        Removal of Obsolete Regulations of the Title VII Grant for the Construction of                      
            Teaching Facilities for Health Professions Personnel..................................    0906-AA39 
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                                   Indian Health Service--Proposed Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1025        Indian Child Protection and Family Violence Prevention Act Minimum Standards of                     
            Character.............................................................................    0917-AA02 
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                                     Indian Health Service--Final Rule Stage                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1026        Acquisition Under the Buy Indian Act..................................................    0917-AA00 
----------------------------------------------------------------------------------------------------------------


                          Agency for Health Care Policy and Research--Completed Actions                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1027        Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer               
            Review of Grants and Contracts........................................................    0919-AA00 
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                               National Institutes of Health--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1028        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA02 
1029        National Institutes of Health Clinical Research Loan Repayment Program for Individuals              
            From Disadvantaged Backgrounds........................................................    0925-AA09 
1030        Undergraduate Scholarship Program Regarding Professions Needed by the NIH.............    0925-AA10 
1031        Traineeships (Termination Policies)...................................................    0925-AA11 
1032        Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects               
            in Research, and Pertaining to Human In Vitro Fertilization...........................    0925-AA14 
1033        National Research Service Awards......................................................    0925-AA16 
1034        National Institutes of Health Loan Repayment Program for Research.....................    0925-AA18 
1035        National Institutes of Child Health and Human Development Contraception and                         
            Infertility Research Loan Repayment Program...........................................    0925-AA19 
1036        Scientific Peer Review of Research Grant Applications and Research and Development                  
            Contract Projects.....................................................................    0925-AA20 
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1037        National Institutes of Health Construction Grants.....................................    0925-AA04 
1038        Removal of National Cancer Institute Clinical Cancer Education Program................    0925-AA17 
----------------------------------------------------------------------------------------------------------------


                           Office of Assistant Secretary for Health--Long-Term Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1039        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................    0937-AA00 
----------------------------------------------------------------------------------------------------------------


                                   Public Health Service--Proposed Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1040        Public Health Service Standards for the Protection of Research Misconduct                           
            Whistleblowers........................................................................    0905-AE71 
----------------------------------------------------------------------------------------------------------------


                                    Public Health Service--Completed Actions                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1041        Additional Requirements for Facilities Transferring or Receiving Select Agents........    0905-AE70 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1042        ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare                      
            Overpayment Liability (BPD-719-P).....................................................    0938-AD95 
1043        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1044        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1045        Assessing Interest Against Medicare Secondary Payer (MSP) Debts (BPO-108-P)...........    0938-AF87 
1046        Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................    0938-AF97 
1047        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1048        Alternative Sanctions for Renal Dialysis Facilities (HSQ-204-P).......................    0938-AG31 

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1049        Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth                
            Scope of Work Contracts (HSQ-207-NC)..................................................    0938-AG32 
1050        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1051        Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech                     
            Pathology, and Occupational Therapy (BPD-808-P).......................................    0938-AG70 
1052        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1053        Revision of Medicare Hospital Conditions of Participation (BPD-745-P).................    0938-AG79 
1054        Physicians' Referrals to Health Care Entities With Which They Have Financial                        
            Relationships--Expanded to Designated Health Services (BPD-809-P).....................    0938-AG80 
1055        Home Health Agency (HHA) Conditions of Participation (BPD-819-P)......................    0938-AG81 
1056        End-Stage Renal Disease (ESRD) Conditions for Coverage (BPD-818-P)....................    0938-AG82 
1057        Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-GNC)..........    0938-AG87 
1058        Liability for Third Parties To Pay for Care and Services (MB-080-P)...................    0938-AH01 
1059        Ambulance Services (BPD-813-P)........................................................    0938-AH13 
1060        Adjustment in Payment Amounts for New Technology Intraocular Lenses (BPD-831-P).......    0938-AH15 
1061        Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical Equipment              
            (DME) (BPD-834-P).....................................................................    0938-AH16 
1062        Additional Supplier Standards (BPD-864-P).............................................    0938-AH19 
1063        State Plan Amendment (SPA) Reconsideration Process (MB-096-P).........................    0938-AH24 
1064        Changes in Coverage and Payment Policies for Physician Assistant Services (BPD-829-P).    0938-AH26 
1065        Hospice Care--Conditions of Participation (BPD-844-P).................................    0938-AH27 
1066        Limitations on Payment for Home Oxygen Therapy Based on Inherent Reasonableness                     
            Criteria (BPD-845-PN).................................................................    0938-AH28 
1067        Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (BPD-                
            843-P)................................................................................    0938-AH37 
1068        Medicare: Amount of Payments If Customary Charges for Services Furnished Are Less Than              
            Reasonable Costs (BPD-860-P)..........................................................    0938-AH49 
1069        Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating                  
            Physicians (BPD-862-P)................................................................    0938-AH50 
1070        Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998                   
            Rates (BPD-878-P).....................................................................    0938-AH55 
1071        Conditions for Certification of Community Mental Health Centers and Coverage                        
            Requirements for Partial Hospitalization Services (BPD-871-P).........................    0938-AH58 
1072        Allowable Costs for FICA and Other Payroll Taxes; Medicare (BPD-876-P)................    0938-AH61 
1073        Medicaid; Estate Recoveries (MB-083-P)................................................    0938-AH63 
1074        Medicare as Secondary Payor to Liability Insurance (BPD-848-P)........................    0938-AH66 
1075        Reduction and Elimination of Certain Requirements for Peer Review Organizations in the              
            Utilization and Quality Review Process (HSQ-235-P)....................................    0938-AH68 
1076        Initiative to Recognize Hemodialysis Facilities of Achievement (HSQ-232-N)............    0938-AH71 
1077        Conditions of Enrollment for Health Care Providers Serving Medicare Beneficiaries (BPO-             
            143-P)................................................................................    0938-AH73 
1078        Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies                
            (HSQ-238-P)...........................................................................    0938-AH74 
1079        Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical                   
            Procedures for Ambulatory Surgical Centers Effective for Calendar Year 1998 (BPD-885-               
            P)....................................................................................    0938-AH81 
1080        Conditions For Coverage For Ambulatory Surgical Center (BPD-887-P)....................    0938-AH83 
1081        Disclosure of Peer Review Organization Information in Response to Beneficiary                       
            Complaints (HSQ-241-P)................................................................    0938-AH85 
1082        Medicare Program; Beneficiary Incentives Programs (BPO-144-P).........................    0938-AH86 
1083        Standard Payer Identifier (BPO-145-P).................................................    0938-AH87 
1084        Medicare Program; Schedule of Limits on Home Health Agency Cost Per Visit for Cost                  
            Reporting Periods Beginning on or After July 1, 1997 (BPD-889-NC).....................    0938-AH88 
1085        Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review                
            Program (MB-107-P)....................................................................    0938-AH89 
1086        Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB-               
            103-NC)...............................................................................    0938-AH90 
1087        Revisions to Payment Policies Under the Physicians Fee Schedule for Calendar Year                   
            1998, (BPD-884-P).....................................................................    0938-AH94 
1088        Medicare Coverage of Certified Nurse-Midwife Services, (BPD-496-P)....................    0938-AH96 
1089        Standard Health Care Provider (BDM-45-P)..............................................    0938-AH99 
1090        Medicare Program; Medicare Integrity Program; (OFH-020-P).............................    0938-AI09 
1091        Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries                    
            Enrolled in HMOs, CMPs, and HCPPs (OMC-024-P).........................................    0938-AI11 
----------------------------------------------------------------------------------------------------------------


[[Page 21669]]


                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1092        Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F).........................    0938-AB07 
1093        Payment for Clinical Diagnostic Laboratory Tests (BPD-309-F)..........................    0938-AB50 
1094        Effective Dates for Provider Agreements and Supplier Approvals (HSQ-139-F)............    0938-AC88 
1095        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1096        Medicare Secondary Payer for Disabled Individuals (BPD-482-F).........................    0938-AD73 
1097        Revisions to Regulations Implementing CLIA (HSQ-226-F)................................    0938-AE47 
1098        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1099        Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................    0938-AE63 
1100        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1101        Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care               
            Facilities for the Mentally Retarded (BPD-650-FC).....................................    0938-AE97 
1102        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 
1103        Medicare Coverage of and Application of the Outpatient Mental Health Treatment                      
            Limitation to, Clinical Psychologist, and Clinical Social Worker Services (BPD-706-F).    0938-AE99 
1104        OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-F)..............    0938-AF15 
1105        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-F)......    0938-AF42 
1106        Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and               
            Competitive Medical Plans (OMC-015-F).................................................    0938-AF98 
1107        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1108        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1109        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1110        End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs               
            (BPD-763-F)...........................................................................    0938-AG20 
1111        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-FN)................................................    0938-AG44 
1112        Telephone and Electronic Requests for Review of Part B Initial Claim Determinations                 
            (BPO-121-F)...........................................................................    0938-AG48 
1113        Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare                     
            Program (BPD-820-F)...................................................................    0938-AG93 
1114        CLIA Program: Categorization of Waived Tests (HSQ-225-F)..............................    0938-AG99 
1115        Medicaid Coverage of Personal Care Services (MB-071-F)................................    0938-AH00 
1116        Update of the Reasonable Compensation Equivalent Limits for Services Furnished by                   
            Physicians (BPD-816-N)................................................................    0938-AH14 
1117        Delegation of Civil Money Penalties (BPO-135-FC)......................................    0938-AH22 
1118        CLIA Program: Cytology Proficiency Testing (HSQ-233-N)................................    0938-AH35 
1119        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based              
            Group Health Plans (MB-047-F).........................................................    0938-AH48 
1120        Terms, Definitions, and Addresses: Technical Amendments (BPD-877-FC)..................    0938-AH53 
1121        Home Health Agency Physician Certification Regulations (BPD-875-NC)...................    0938-AH59 
1122        Medicare Program; Establishment of an Expedited Review Process for Medicare                         
            Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (OMC-25-FC)...........................    0938-AH62 
1123        Utilization Control and Discontinued Review Activities; Medicaid (MB-101-FC)..........    0938-AH64 
1124        Medicare Technical Conforming Amendments (BPD-858-FC).................................    0938-AH67 
1125        Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities                       
            Participating in an Experiment (HSQ-236-GNC)..........................................    0938-AH72 
1126        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 (BPD-882-IFC)...................................................................    0938-AH75 
1127        CLIA Program; Simplifying CLIA Regulations to Accreditation Exemption of Laboratories               
            Under a State Licensure Program, and Proficiency Testing and Inspection (HSQ-239-FC)..    0938-AH82 
1128        Clinical Laboratory Requirements-Extension of Certain Effective Dates for Clinical                  
            Laboratory Requirements Under CLIA (HSQ-237-FC).......................................    0938-AH84 
1129        Medically Needy Determinations Under Welfare Reform (MB-109-IFC)......................    0938-AH92 
1130        Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal                
            Fiscal Year 1997 (MB-110-N)...........................................................    0938-AH93 
1131        Medicare Appeals of Individual Claims, (BPD-453-FC)...................................    0938-AH97 
1132        Revision to the Definition of an Unemployed Parent, (MB-106-FC).......................    0938-AH98 
1133        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medicare Insurance              
            Premium Rate Beginning January 1, 1998 (OACT-055-N)...................................    0938-AI03 
1134        Health Insurance Reform: Parity in the Application of Certain Lim its to Mental Health              
            Benefits (BPD-891-IFC)................................................................    0938-AI05 
1135        Portability and Nondiscrimination in the Group Health Insurance Market (BPD-890-IFC)..    0938-AI08 
1136        Part A Premium For 1998 For The Uninsured Aged And For Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-056-N).....................................    0938-AI10 

[[Page 21670]]

                                                                                                                
1137        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1998 (OACT-057-N).........................................................    0938-AI12 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Long-Term Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1138        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-F).............    0938-AC58 
1139        Criteria and Procedures for Developing Medical Services Coverage Policy (BPD-432-F)...    0938-AD07 
1140        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1141        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F).................    0938-AD33 
1142        Omnibus Nursing Home Reform Requirements (BPD-488-F)..................................    0938-AD81 
1143        Protection of Income and Resources for Community Spouses of Institutionalized                       
            Individuals (MB-023-P)................................................................    0938-AE12 
1144        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1145        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)....    0938-AE72 
1146        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 
1147        Case Management (MB-27-F).............................................................    0938-AF07 
1148        Presumptive Limits on Payments to HMOs, CMPs, and HCPPs (OMC-006-F)...................    0938-AF16 
1149        Referral to Child Support Enforcement Agencies of Medicaid Families (MB-051-F)........    0938-AF68 
1150        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children Under Age 19 (MB-052-F)..................................................    0938-AF69 
1151        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1152        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-FN)..............................................................    0938-AG45 
1153        Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of              
            Applicants for Nursing Home Admission (BPD-815-P).....................................    0938-AG84 
1154        Categorization and Certification Requirements for a New Subcategory of Moderate                     
            Complexity Testing (HSQ-222-F)........................................................    0938-AG98 
1155        Medicare Coverage of Organ Transplantation (BPD-835-PN)...............................    0938-AH17 
1156        Criteria and Procedures for Extending Coverage to Certain Devices and Related Services              
            (BPD-841-F)...........................................................................    0938-AH21 
1157        Limitations on Liability (BPD-859-FC).................................................    0938-AH51 
1158        Medicare Secondary Payer Clarifications and Amendments (BPD-865-P)....................    0938-AH52 
1159        Designation of Independent Rural Primary Care Hospitals (RPCHs) (BPD-784-N)...........    0938-AH60 
1160        Medicaid Hospice Care (MB-007-P)......................................................    0938-AH65 
1161        Determination of Substandard Care in SNFs and NFs (HSQ-240-P).........................    0938-AH69 
1162        Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform (MB-               
            105-FC)...............................................................................    0938-AH76 
1163        Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services               
            (MB-43-P).............................................................................    0938-AH95 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1164        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1165        Conditions of Coverage for Organ Procurement Organizations (BPD-646-F)................    0938-AE48 
1166        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OMC-010-F).................................................    0938-AF74 
1167        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-F)............................................    0938-AF85 
1168        Intermediary and Carrier Functions (BPO-111-F)........................................    0938-AG06 
1169        Appointment of Representatives for Medicare Appeals (BPO-120-P).......................    0938-AG30 
1170        Medicare Program: Uniform Electronic Cost Reporting for Skilled Nursing Facilities and              
            Home Health Agencies (BPD-788-F)......................................................    0938-AH12 
1171        Medicare Program: Revisions to Payment Policies and Five-Year Review of and                         
            Adjustments to Relative Value Units Under the Physician Fee Schedule for Calendar Year              
            1997 (BPD-852-FC).....................................................................    0938-AH40 

[[Page 21671]]

                                                                                                                
1172        Medicare Program: Physician Fee Schedule Update for Calendar Year 1997 and Physician                
            Volume Performance Standard Rates of Increase for Federal Fiscal Year 1997 (BPD-853-                
            FN)...................................................................................    0938-AH41 
1173        Medicare Program; Schedule of Limits on HHA Costs Per Visit for Cost Reporting Periods              
            Beginning On or After July 1, 1996 (BPD-867-NC).......................................    0938-AH54 
1174        Medicaid Program; Preliminary Limitations on Aggregate Payments to Disproportionate                 
            Share Hospitals: Federal Fiscal Year 1997 (MB-104-N)..................................    0938-AH91 
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1175        Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan                 
            Reviews...............................................................................    0970-AA97 
1176        Designation of Alternative Agency To Serve Indian Tribal Children.....................    0970-AB52 
1177        Construction of Head Start Facilities.................................................    0970-AB54 
1178        Data Collection and Reporting Under the Temporary Assistance for Needy Families Block               
            Grant.................................................................................    0970-AB64 
1179        Methodology for Determining Child Poverty Rates.......................................    0970-AB65 
1180        Bonus to Reward High Performance States Under the Temporary Assistance for Needy                    
            Families Block Grant..................................................................    0970-AB66 
1181        State Directory of New Hires..........................................................    0970-AB67 
1182        State Case Registry and Expansion of FPLS.............................................    0970-AB68 
1183        State Law Concerning Paternity Establishment..........................................    0970-AB69 
1184        Automated Data Processing Requirements................................................    0970-AB70 
1185        Automated Data Processing Funding Limitation..........................................    0970-AB71 
1186        Grants to States for Access and Visitation Programs...................................    0970-AB72 
1187        Child Support Enforcement for Indian Tribes...........................................    0970-AB73 
1188        Child Care Proposed Rule..............................................................    0970-AB74 
1189        TANF Penalties and Administrative Costs...............................................    0970-AB76 
1190        TANF Work Requirements................................................................    0970-AB77 
1191        Tribal Program Requirements...........................................................    0970-AB78 
1192        Illegitimacy Reduction Bonus..........................................................    0970-AB79 
1193        Case Closure Regulation...............................................................    0970-AB82 
1194        Refugee Resettlement Program: Responding and Conforming to TANF Replacing AFDC........    0970-AB83 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1195        Standards for Safe Transportation.....................................................    0970-AB24 
1196        Standards for Purchase of Facilities..................................................    0970-AB31 
1197        Income Eligibility Criteria for Indian Tribes.........................................    0970-AB53 
1198        Income and Resource Disregards Related to Interests of Individual Indians in Trust or               
            Restricted Lands......................................................................    0970-AB59 
1199        Child Support Enforcement Program Omnibus Conforming Regulation.......................    0970-AB81 
1200        Personal Responsibility and Work Opportunity Reconciliation Act of 1996(PRWORA)                     
            Conforming Regulation.................................................................    0970-AB84 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1201        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1202        Family Preservation and Support.......................................................    0970-AB34 
1203        Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and              
            FY 1996 Provisions....................................................................    0970-AB47 
1204        Head Start Fellowship Program.........................................................    0970-AB56 
1205        Extension of Deadline for Certified Statewide Systems and Revisions for the                         
            President's Reform Initiative.........................................................    0970-AB57 

[[Page 21672]]

                                                                                                                
1206        On-Site Foster Care Eligibility Reviews...............................................    0970-AB60 
1207        TANF Program and Financial Requirements...............................................    0970-AB75 
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1208        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............................................................    0985-AA00 
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




925.  REVISED OIG EXCLUSION AUTHORITIES RESULTING FROM PUBLIC 
LAW 104-191

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-191, sec 211; PL 104-191, sec 212; PL 104-191, 
sec 213

CFR Citation:  42 CFR 1001; 42 CFR 1002; 42 CFR 1005

Legal Deadline: None

Abstract: This proposed rule addresses revisions to the OIG's sanction 
authorities in conjunction with sections 211, 212, and 213 resulting 
from the Health Insurance Portability and Accountability Act of 1996, 
along with other technical and conforming changes to the OIG exclusion 
authorities. The revisions are specifically designed to expand the 
protection of certain basic fraud authorities and revise and strengthen 
the current legal authorities pertaining to exclusions from the 
Medicare and State health care programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: None

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

RIN: 0991-AA87
_______________________________________________________________________




926.  INDIRECT COST APPEALS

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:  5 USC 301

CFR Citation:  45 CFR 16; 45 CFR 74; 45 CFR 75; 45 CFR 95

Legal Deadline: None

Abstract: This proposal would remove the informal grant appeals 
procedure for indirect cost rates because it is obsolete.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/05/97                    62 FR 10009
NPRM Comment Period End         05/05/97
Final Action                    09/00/97

Small Entities Affected: None

Government Levels Affected: None

Public Compliance Cost: Initial Cost: $0

Agency Contact: Ronald Speck, Department of Health and Human Services, 
Office of the Secretary, Division of Audit Resolution and Cost Policy, 
300 Independence Avenue SW., Washington, DC 20201
Phone: 202 401-2751
TDD: 202 690-6415

RIN: 0991-AA88
_______________________________________________________________________




927.  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 proposed rule would 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 proposed 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                            10/00/97
NPRM Comment Period End         12/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of

[[Page 21673]]

the Secretary, Office of the Inspector General, OCIG, 330 Independence 
Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA90
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




928. 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, 
7/9/91) to give greater clarity to that 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/93                    58 FR 49008
NPRM Comment Period End         11/22/93
Final Action                    10/00/97

Small Entities Affected: None

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 (59FR37202, July 21, 1994).

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

RIN: 0991-AA66
_______________________________________________________________________




929. 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 newly 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 
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              05/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Walton Francis, Senior Advisor, 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
_______________________________________________________________________




930.  REVISED PRO SANCTIONS FOR FAILING TO MEET STATUTORY 
OBLIGATIONS

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:  PL 104-191, sec 214; PL 104-191, sec 231(f)

CFR Citation:  42 CFR 1004

Legal Deadline: None

Abstract: This final rule amends the OIG PRO Sanction regulations with 
regard to: (1) the determination of ``unwillingness or inability'' of a 
practitioner or other person who fails to comply with statutory 
obligations; (2) the establishment of a minimum period of exclusion; 
and (3) a revised monetary penalty amount that may be imposed for each 
instance of medically improper or unnecessary services provided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/97

Small Entities Affected: None

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

RIN: 0991-AA86

[[Page 21674]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 99-509, Sec 9313(c); PL 101-239, Sec 6003(g)(3); 
PL 101-508, Sec 4204(a)(3); PL 101-508, Sec 4731(b)(1)

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

Abstract: This final rule will prohibit a hospital from knowingly 
making incentive payments to a physician as an inducement to reduce or 
limit services provided to Medicare or Medicaid beneficiaries who are 
under the direct care of that physician. The rule would also set forth 
standards governing the imposition of CMPs for each such individual for 
whom payments are made.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/94                    59 FR 61571
NPRM Comment Period End         01/30/95
Final Action                    00/00/00

Small Entities Affected: None

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-AA45
_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 100-360, Sec 428(b); PL 101-508, Sec 4204(g)(1); 
PL 101-508, Sec 4351; PL 101-508, Sec 4354(a)(1)(E); PL 101-508, Sec 
4354(a)(2); PL 101-508, Sec 4355(a); PL 101-508, Sec 4357

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This rule would authorize CMPs against any individual or 
entity who knowingly and willfully uses misleading or fraudulent 
practices in the advertisement, solicitation, offering for sale or 
delivery of Medicare supplemental health insurance (Medigap) policies. 
Penalties would also be established for failure to (1) meet Medigap 
policy loss-ratio requirements, (2) comply with policy simplification 
standards, or (3) obtain Secretarial certification of Medigap policies 
in States with non-approved regulatory programs. In addition, this rule 
would also set forth CMPs for the failure of sellers or issuers to 
solicit information, and to provide notice, about Medicaid status and 
eligibility before selling or issuing Medigap policies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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-AA53
_______________________________________________________________________




933. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL TO 
CERTAIN HEALTH CARE ENTITIES

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:  PL 101-239, Sec 6204; PL 101-508, Sec 4207(e); PL 
101-508, Sec 4207(m)(a); PL 103-66, Sec 13562

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

Abstract: This revised final rule is designed to implement civil money 
penalty authority for prohibited physician ownership and referral 
arrangements set forth in section 1877 of the Social Security Act. This 
rule addresses comments raised as a result of the final rule with 
comment period (60 FR 16580), and several technical changes to 42 CFR 
1001 and 1003 resulting from Government reinvention efforts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/20/93                    58 FR 54096
NPRM Comment Period End         12/20/93
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA65
_______________________________________________________________________




934. 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

Legal Authority:  PL 100-203, Sec 4022(a); PL 100-360, Sec 
411(d)(2)(A); PL 100-485, Sec 608(d)(20)(A); PL 101-508, Sec 4711(b)(a)

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would set forth civil money penalties 
against any individual or entity that notifies, or causes to notify, a 
home health agency, or a home or community-based health care center or 
provider, of the time or date on which a standard survey is scheduled 
to be conducted by a State or local agency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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-AA79

[[Page 21675]]

_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 101-508, Sec 4401(a)(3)

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would set forth civil money penalties 
against any wholesaler, manufacturer or seller of outpatient drugs that 
fails to respond to a request for information about charges or prices, 
or to knowingly provide false information, in a survey by the Secretary 
to verify manufacturers' reported prices. In addition, this rule would 
set forth civil money penalties against any drug manufacturer doing 
business with Medicaid that, in accordance with section 1927(b)(3)(A) 
of the Social Security Act, fails to provide rebate agreement price 
information on a timely basis, and for knowingly providing false 
information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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-AA80
_______________________________________________________________________




936. SENIOR BIOMEDICAL RESEARCH SERVICES

Priority:  Info./Admin./Other

Legal Authority:  42 USC 228

CFR Citation:  42 CFR 24

Legal Deadline: None

Abstract: This regulation implements the Senior Biomedical Research 
Service (SBRS), a personnel system established in the Public Health 
Service by Section 304 of Public Law 101-509. The SBRS will consist of 
500 members appointed by the Secretary without regard to the provisions 
of Title 5, U.S. Code, regarding appointment, who are outstanding in 
the field of biomedical research or clinical research evaluation. 
Appointments to the SBRS will be only to individuals with doctoral-
level degrees in biomedicine or a related field. The regulation 
describes basic eligibility criteria, pay rates, performance appraisal 
system, optional retirement system, and procedure for removal from the 
SBRS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/21/96                     61 FR 6557
Interim Final Rule Comment 
Period End                      03/31/96
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: Federal

Agency Contact: Rosemary Taylor, Personnel Management Specialist, 
Department of Health and Human Services, Office of the Secretary, 200 
Independence Avenue SW., Room 522A, Washington, DC 20201
Phone: 202 690-7358
Fax: 202 690-6758

RIN: 0991-AA82
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




937.  MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; 
ISSUANCE OF ADVISORY OPINIONS BY THE OIG

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

Legal Authority:  PL 104-191, sec 205

CFR Citation:  42 CFR 1008

Legal Deadline:  NPRM, Statutory, February 17, 1997.

Abstract: This final rule establishes a new part 1008 in 42 CFR chapter 
V to address the OIG advisory opinion process. The regulations set 
forth the specific procedures and process by which the OIG will adopt 
and, in consultation with the Department of Justice, issue advisory 
opinions to outside parties regarding the interpretation and 
applicability of certain statues relating to the Medicare and health 
care programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/19/97                     62 FR 7350

Small Entities Affected: None

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

RIN: 0991-AA85
_______________________________________________________________________




938.  CIVIL MONEY PENALTIES INFLATION ADJUSTMENTS

Priority:  Routine and Frequent

Legal Authority:  PL 101-410; PL 104-134

CFR Citation:  42 CFR 1003

Legal Deadline:  Final, Statutory, October 23, 1996.
This Debt Collection Improvement Act of 1996 stipulates that any 
increases in a CMP due to the calculated inflation adjustments should 
apply to violations that occur after October 23, 1996.

Abstract: In accordance with the Federal Civil Monetary Penalty 
Inflation Adjustment Act of 1990, as amended by the Debt Collection 
Improvement Act of 1996, this final rule incorporates the penalty 
inflation adjustments for civil money penalties for OIG health care 
fraud and abuse. These inflation adjustment calculations are not 
applicable to those civil money penalties contained in the Social 
Security Act, which are exempted from this adjustment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/07/96                    61 FR 52299

Small Entities Affected: None

Government Levels Affected: None

[[Page 21676]]

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

RIN: 0991-AA89
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




939. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 10801 et seq, as amended by PL 102-173

CFR Citation:  45 CFR 51

Legal Deadline:  Final, Statutory, May 27, 1992.
Section 9 of PL 102-173, enacted on 11/27/91, sets this deadline.

Abstract: Sets requirements for funding State and State-designated 
systems for protecting and advocating for individuals with mental 
illness. By law, these requirements must be set out in regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/94                    59 FR 64367
NPRM Comment Period End         02/13/95
Final Action                    05/00/97

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: Previously reported under RIN 0905-AD99.
Alternate Contact: Sue Martone, DLEA, SAMHSA, PHS; Room 12C-15, 5600 
Fishers Lane, Rockville, MD 20857; 301-443-4640

Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of 
Health and Human Services, Substance Abuse and Mental Health Services 
Administration, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20857
Phone: 301 443-4640

RIN: 0930-AA02
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




940. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

Priority:  Other Significant

Legal Authority:  42 USC 300-x et seq, as amended by PL 102-321

CFR Citation:  45 CFR 96

Legal Deadline:  Final, Statutory, August 25, 1992.
Awards to States after January 1, 1993 cannot be made until 
implementing regulations are published.

Abstract: Sets requirements for block grants for prevention and 
treatment of substance abuse. The requirements include criteria for 
approval of State plans which must by statute be prescribed in 
regulations. These provisions would replace the existing interim final 
rule published March 31, 1993. Given the pending reauthorization of 
SAMHSA and the current Administration's FY 1996 legislative proposal to 
turn the block grant into a ``Performance Partnership,'' publication of 
this regulation has been put on hold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/31/93                    58 FR 17062
Interim Final Rule Comment 
Period End                      06/01/93
Final Action                    00/00/00

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Additional Information: Previously reported under RIN 0905-AD98.
Alternate Contact: Jim Sayers, DSP, C SAT SAMHSA, 5515 Security Lane, 
Suite 800, Rockville, MD 20852; 301-443-3820.

Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of 
Health and Human Services, Substance Abuse and Mental Health Services 
Administration, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20857
Phone: 301 443-4640

RIN: 0930-AA01
_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




941. 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.

[[Page 21677]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Second NPRM                     04/00/97
Final Action                    09/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Leslie L. Clune, 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)



_______________________________________________________________________




942. 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                            00/00/00

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
_______________________________________________________________________




943. 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 
to 357; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 56; 21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/00/97
ANPRM Comment Period End        06/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Murray Lumpkin, M.D., Deputy Center Director, (Review 
Management), Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-2), 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-5417
Fax: 301 594-6197

RIN: 0910-AA83
_______________________________________________________________________




944.  CHLOROFLUOROCARBON PROPELLANTS IN SELF-PRESSURIZED 
CONTAINERS; DETERMINATIONS THAT USES ARE NO LONGER ESSENTIAL

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 357; 21 USC 360b; 21 USC 361; 21 USC 371; ...

CFR Citation:  21 CFR 2

Legal Deadline: None

Abstract: The advance notice of proposed rulemaking (ANPRM) presents 
the policy FDA is considering for adoption on making and implementing 
determinations that uses of chloroflourocarbons (CFC's) currently 
designated essential will no longer be deemed essential under section 
610 of the Clean Air Act due to the availability of safe and effective 
medical product technology that does not use CFC's. The ANPRM requests 
comments on this policy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: 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), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049

[[Page 21678]]

Fax: 301 594-0152

RIN: 0910-AA99
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




945. 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 them through detailed guidelines 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 definitions of 
substantial evidence and 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 04/
00/97

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 11/00/97

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 Surveillance, 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Place, Rockville, MD 20855, (301) 594-1722. For further 
information concerning generic animal drugs, contact Lonnie W. Luther, 
Chief, Generic Animal Drug and Quality Control Staff, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, (301) 594-1623.

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
_______________________________________________________________________




946. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE 
CERTIFICATION PROGRAMS

Priority:  Routine and Frequent

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 356; 21 USC 371; 21 USC 379e(e)

CFR Citation:  21 CFR 80; 21 CFR 429

Legal Deadline: None

Abstract: Insulin Certification Program:
In the Federal Register of October 4, 1991 (56 FR 50248), FDA issued an 
interim rule effective on November 4, 1991, with opportunity for public 
comment, revising the fee schedule for insulin certification services. 
In the Federal Register of November 9, 1995 (60 FR 56515), FDA issued 
an interim final rule, which was effective December 11, 1995. This 
interim final rule decreased the fees charged for insulin certification 
services due to lower program and administrative costs. The public had 
the opportunity to submit written comments to FDA by February 7, 1996. 
The FDA expects to publish a notice of proposed rulemaking by August 
1997. This will rewrite 21 CFR 429 and make final the interim final 
rule.
Color Certification Program:
In the Federal Register of November 29, 1994, FDA issued an interim 
rule effective December 29, 1994, which amended the color additive 
regulations by increasing the fees for certification services. In the 
Federal Register of February 1, 1996 (61 FR 3571), FDA issued a final 
rule, effective March 4, 1996, which incorporated comments FDA received 
from the International

[[Page 21679]]

Association of Color Manufacturers (IACM) on the interim rule. FDA 
received an objection from IACM to an annual escalator provision which 
would have allowed FDA to increase the fees for color certification 
services by a rate proportional with Federal salary increases. After 
considering the objection, FDA decided not to implement this provision. 
The FDA's Office of Financial Management expects to complete a new 
study of the costs of the color certification program and will adjust 
the fee accordingly if necessary.

Timetable:

Color Additives  Interim Final Rule 11/29/94 (59 FR 60898)  Final 
Action 02/01/96 (61 FR 3571)

Insulin  Interim Final Rule 10/04/91 (56 FR 50248)  Interim Final Rule 
11/09/95 (60 FR 56515)  NPRM 08/00/97

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD34 and RIN 
0910-AA27.

Agency Contact: David R. Petak, Director, Division of Accounting, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Financial Management (HFA-120), 5600 Fishers Lane, Rockville, 
MD 20857
Phone: 301 827-5004
Fax: 301 443-6242

RIN: 0910-AA07
_______________________________________________________________________




947. BIOLOGICAL PRODUCT REPORTING OF ERRORS AND ACCIDENTS IN 
MANUFACTURING

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 600; 21 CFR 606

Legal Deadline: None

Abstract: FDA is proposing to amend 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 proposes to define terms used and establish a 
reporting period for all licensed manufacturers of biological products; 
and amend the current good manufacturing practice (CGMP) regulations 
for blood and blood components to require error and accident reporting 
by registered blood establishments and transfusion services currently 
reporting on a voluntary basis. The proposed reporting requirements 
will accelerate 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 manufacturing of blood and blood components; and facilitate 
a rapid response where public health may be at risk. The proposed rule 
would require licensed establishments, unlicensed establishments, and 
transfusion services to report and keep records. The cost to licensed 
establishments would be minimal. Since they already are required to 
report, licensed 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 proposed 
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                            05/00/97
NPRM Comment Period End         08/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

Agency Contact: Paula S. McKeever, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA12
_______________________________________________________________________




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

Priority:  Other Significant

Legal Authority:  PL 99-660, sec 314

CFR Citation:  None

Legal Deadline:  Final, Statutory, June 22, 1989.

Abstract: Section 314 of the National Childhood Vaccine Injury Act of 
1986 mandated that the warnings, use instructions, and precautionary 
information of specified childhood vaccines be reviewed and that their 
adequacy in warning health care professionals of the nature and extent 
of dangers posed by such vaccines be determined. This precautionary 
information is contained in the package insert of each vaccine licensed 
by the agency. FDA held a public meeting to receive public comment on 
the adequacy of these package inserts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Public Meeting; Public 
Comment on Package Inserts      07/31/92                    57 FR 33915
NPRM                            09/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AD72.
A public meeting was held on 9/18/92 on section 314 Labeling Review. 
Presentations were made by FDA, CDC, manufacturers, parents groups, and 
the public on the adequacy of the current labeling.

Agency Contact: Dano B. Murphy, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA14
_______________________________________________________________________




949. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

[[Page 21680]]

Legal Deadline: None

Abstract: Certain dental amalgams may contain ingredients which may 
cause some persons severe adverse reactions. Therefore, FDA would 
propose that labeling for dental amalgams must include the ingredients 
so that health professionals may choose the appropriate dental material 
for the patient.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE39.

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-AA33
_______________________________________________________________________




950. 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. FDA is 
considering eliminating the waiver provision and instead requiring a 
medical evaluation when certain previously undiagnosed medical 
conditions are found or when the prospective hearing aid user is under 
18 years of age. In addition, FDA is considering restricting the 
dispensing of a hearing aid to patients who have undergone a 
comprehensive hearing assessment within the past 12 months and an 
evaluation to select and fit a hearing aid, both of which would be 
required to be conducted by hearing care professionals licensed by the 
States as competent to conduct such assessments and evaluations. FDA is 
also considering revisions to its professional and patient labeling to 
require updated information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/10/93                    58 FR 59695
ANPRM Comment Period End        01/10/94
NPRM                            06/00/97

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
_______________________________________________________________________




951. 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 356; 21 USC 357; 21 USC 360; 21 USC 371

CFR Citation:  21 CFR 207

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97
NPRM Comment Period End         10/00/97

Small Entities Affected: None

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 20850

RIN: 0910-AA49
_______________________________________________________________________




952. 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 357; 21 USC 371

CFR Citation:  21 CFR 320

Legal Deadline: None

Abstract: The proposed rule would revise and clarify certain sections 
of part 320 to eliminate duplication and inconsistencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy E. Derr, Policy Analyst, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA51

[[Page 21681]]

_______________________________________________________________________




953. 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 257; 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 
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                            06/00/97
NPRM Comment Period End         08/00/97

Small Entities Affected: 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: 301 443-1382
Email: [email protected]

RIN: 0910-AA52
_______________________________________________________________________




954. 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; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

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 coordinate the 
food additive, GRAS, and color additive approval process with USDA when 
meat and poultry product uses are petitioned for. 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 its 
human food labeling regulations pertaining to : (1) 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 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.
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 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.

Timetable:

Exempt Infant Formula; Plan for Revisions  ANPRM 06/12/96 (61 FR 
29701)  Comment Period End 10/10/96  NPRM 00/00/00

Food and Color Additive Regulations; Plan for Revisions  ANPRM 06/12/96 
(61 FR 29701)  Comment Period Ends 09/10/96  Final Action 06/00/97

Food Labeling and Interstate Conveyance Sanitation  ANPRM 06/12/96 (61 
FR 29701)  Comment Period End 10/10/96  NPRM 00/00/00

Food Standards of Identity, Quality, and Fill of Container  ANPRM 12/
29/95 (60 FR 67492)  Comment Period Ends 06/28/96  NPRM 00/00/00

Food, Color Additive, GRAS Regulations  ANPRM 06/12/96 (61 FR 
29701)  Comment Period Ends 09/10/96  NPRM 00/00/00

Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry)  NPRM 
12/29/95 (60 FR 67490)  Comment Period End 03/14/96  Extension of 
Comment Period 06/03/96  Final Action 00/00/00

Notification Procedures for Independent GRAS Determinations  NPRM 05/
00/97

Revocation of Certain Food Labeling and Cosmetic Regulations  NPRM 06/
12/96 (61 FR 29708)  Comment Period Ends 08/26/96  Final Action 06/00/
97

[[Page 21682]]

Revocation of Lower Fat Milk Standards  NPRM 11/09/95 (60 FR 
5654)  Comment Period Ends 01/23/96  Partial Final 11/20/96 (61 FR 
58991)  Confirmation of Effective Date 02/24/97 (62 FR 
8163)  Confirmation of Effective Date 00/00/00  Final Action (Yogurt) 
00/00/00

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

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: ABSTRACT:
Finally, FDA will be proposing to establish a notification procedure 
for companies to use for independent GRAS determinations.

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
_______________________________________________________________________




955. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority:  Routine and Frequent

Major: Undetermined

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 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 provisions for 
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 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.

Timetable:

CGMPs in the Manufacturing, Packing, or Holding of Dietary 
Supps.  ANPRM 02/06/97 (62 FR 5700)  Comment Period End 05/07/97  NPRM 
00/00/00

High Potency and Antioxidant Terms; Dietary Supplements  NPRM 12/28/95 
(60 FR 67184)  Comment Period End 06/10/96  Final Action 06/00/97

Nutrient Content and Health Claim; Dietary Supplements  Final Action 
06/00/97

Nutrient Content and Health Claims; Dietary Supplements  NPRM 12/28/95 
(60 FR 67176)  Comment Period End 06/10/96

Nutrient Labeling and Ingredient Labeling; Dietary Supplements  NPRM 
12/28/95 (60 FR 67194)  Comment Period End 06/10/96  Final Action 08/
00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: F. Edward Scarbrough, 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-AA59
_______________________________________________________________________




956. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS

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 356; 21 USC 357; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: The proposed rule would revise existing regulations to state 
that FDA will issue, within five working days after imposing a clinical 
hold, a written explanation to the sponsor describing the reasons for 
imposing the clinical hold. The proposed rule would also state that a 
clinical study may resume 30 calendar days after FDA receives the 
sponsor's complete reply to all issues raised in the clinical hold, 
unless FDA notifies the sponsor that it has reinstated the clinical 
hold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97
NPRM Comment Period End         08/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Murray Lumpkin, MD, Deputy Center Director (Review 
Management), Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-2), 1451 
Rockville Pike Rockville, MD 20852
Phone: 301 594-5417
Fax: 301 594-6197

RIN: 0910-AA73
_______________________________________________________________________




957. 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 
to 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379; 42 USC 216; 42 
USC 241; 42 USC 262; 21 USC 264

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The proposed rule would 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

[[Page 21683]]

bulk packages; require that the package insert of all parenterals 
include a warning statement describing 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                            05/00/97
NPRM Comment Period End         07/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA74
_______________________________________________________________________




958. LONG-TERM CONTRACEPTIVE DRUG PRODUCTS AND MEDICAL DEVICES; INFORMED 
CONSENT 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 356; 21 USC 357; 21 USC 358; 21 USC 360; 21 
USC 371; 21 USC 374; 21 USC 379; 42 USC 216; 42 USC 241; ...

CFR Citation:  21 CFR 201; 21 CFR 801

Legal Deadline: None

Abstract: The proposed rule would require that patient labeling for 
long- acting contraceptive drugs and medical devices include an 
informed consent form that must be signed by the patient before any 
long-acting contraceptive is administered. The proposed rule would help 
ensure that patients receive adequate information to enable them to 
make an informed decision about whether or not to use a long-acting 
contraceptive.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97
NPRM Comment Period End         12/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Nancy E. Derr, Policy Analyst, 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 20850

RIN: 0910-AA75
_______________________________________________________________________




959. DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS

Priority:  Substantive, Nonsignificant. 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 to 357; 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

Abstract: The proposed rule would amend the regulations to require 
applicants to certify that they did not and will not use in any 
capacity the services of a debarred person, and would require certain 
applicants to list certain Federal felony, Federal misdemeanor, or 
State felony convictions of the applicant and affiliated persons 
responsible for the development or submission of the application that 
have occurred within the preceding 5 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Wayne 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA76
_______________________________________________________________________




960. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

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 356; 21 USC 357; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 
374; 21 USC 375

CFR Citation:  21 CFR 200; 21 CFR 429

Legal Deadline: None

Abstract: The proposed rule would revise part 429 to base insulin 
certification on compliance with an approved application and the 
U.S.P.; eliminate certain tests performed by manufacturers as well as 
packaging and labeling requirements; establish a new labeling system; 
and modify the requirement to submit samples.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97
NPRM Comment Period End         09/00/97

Small Entities Affected: Businesses

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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA77

[[Page 21684]]

_______________________________________________________________________




961. 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 330

Legal Deadline: None

Abstract: The proposed rule would provide standardized format and 
content requirements for OTC drug product labeling, including 
legibility and design features of such information as the uses for the 
drug, directions for use, warnings, drug interactions, precautions, 
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         06/27/97
Final Action                    09/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Diana Hernandez, Division of OTC Drug Evaluation, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research (HFD-560), 1451 Rockville Pike, 
Suite 3047, Rockville, MD 20850
Phone: 301 827-2222

RIN: 0910-AA79
_______________________________________________________________________




962. 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 356; 21 USC 357; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: The proposed rule would prohibit the exclusion of women with 
reproductive potential from clinical trials of drugs used to treat 
life-threatening illnesses, when there is no evidence of reproductive 
toxicity resulting from such trials or when there is evidence of such 
toxicity but there are methods available for preventing such exposure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Agency Contact: Nancy E. Derr, Policy Analyst, 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 20850
Phone: 301 594-2041
Fax: 301 827-2041

RIN: 0910-AA84
_______________________________________________________________________




963. ADVERSE EXPERIENCE REPORTING, RECORDKEEPING, AND RECORDS ACCESS 
REQUIREMENTS FOR MARKETED OTC DRUGS THAT ARE NOW THE SUBJECTS OF 
APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPS

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 356; 21 USC 357; 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, packers, and 
distributors of marketed nonprescription human drug products that are 
not the subjects of approved applications to report to FDA information 
they receive about adverse experiences associated with the use of their 
drug products; to maintain records of adverse drug experiences; and to 
permit access by FDA to adverse drug experience records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Audrey Thomas, Consumer Safety Officer, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA86
_______________________________________________________________________




964. 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 
to 358; 21 USC 360; 21 USC 371; 21 USC 374 to 375

CFR Citation:  21 CFR 200

Legal Deadline: None

Abstract: The proposed rule would require 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 proposing to take this 
action to prevent future additional adverse health consequences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97
NPRM Comment Period End         07/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Andrea C. 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, Rockville, MD 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA88
_______________________________________________________________________




965. DIRECT-TO-CONSUMER PROMOTION REGULATIONS

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

Unfunded Mandates: Undetermined

[[Page 21685]]

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 356; 21 USC 357; 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                            07/00/97
NPRM Comment Period End         10/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Ostrove, Public Health Analyst, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation Research, (HFD-40), Room 17B-04, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3882

RIN: 0910-AA90
_______________________________________________________________________




966. REVISION OF THE REQUIREMENTS FOR A RESPONSIBLE HEAD FOR BIOLOGICAL 
ESTABLISHMENTS

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:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 
371; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 
USC 262; ...

CFR Citation:  21 CFR 600; 21 CFR 601; 21 CFR 606

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend the 
biologics regulations by deleting the requirements for a ``Responsible 
Head'' or ``designated responsible person.'' Since most manufacturers 
of biological products tend to be larger firms or multiple firms with 
more than one manufacturing location and complex corporate structures, 
the agency has determined that it is no longer practical to require one 
individual to represent a manufacturer in all matters. This revision 
will provide more flexibility to assign control and oversight 
responsibility for the manufacture of biological products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/29/97                     62 FR 4221
NPRM Comment Period End         04/29/97
Final Action                    09/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 
400S, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA93
_______________________________________________________________________




967. 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.

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 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 rule would revise existing regulations governing 
the format of prescription drug labeling directed toward prescribers 
and other health care professionals to increase the usefulness of this 
labeling. The revisions to part 201.57 would reorder the content areas 
of the labeling; add an introductory section of highlights and an 
index; and institute an identification system to enhance accessibility 
to detailed information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97
NPRM Comment Period End         09/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
Fax: 301 594-6759

RIN: 0910-AA94
_______________________________________________________________________




968.  ADVERSE DRUG REACTION REPORTING REQUIREMENTS FOR HUMAN 
DRUG AND BIOLOGICAL PRODUCTS; EXPEDITED 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 351 to 353; 21 
USC 355 to 357; 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 safety reporting 
regulations for human drugs and biological products to revise certain 
definitions and reporting formats as recommended by the International 
Conference on Harmonization 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 revised by FDA.

[[Page 21686]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97
NPRM Comment Period End         09/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 20850, 
Rockville, MD 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




969.  CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PROCESSING, PACKING, OR LABELING OF DRUGS; 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 356; 21 USC 357; 21 USC 360b; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 210; 21 CFR 211

Legal Deadline: None

Abstract: The proposed rule would amend the labeling control provisions 
in the current good manufacturing practice regulations to reduce the 
frequency of drug product mislabeling and associated drug product 
recalls.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97
NPRM Comment Period End         09/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Thomas Kuchenberg, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA98
_______________________________________________________________________




970.  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 the regulation 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                            05/00/97
NPRM Comment Period End         08/00/97

Small Entities Affected: 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB00
_______________________________________________________________________




971.  DEFINITION OF ADEQUATE AND WELL CONTROLLED STUDIES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-250

CFR Citation:  21 CFR 514.117

Legal Deadline:  NPRM, Statutory, April 9, 1997.

Abstract: FDA, as directed by the Animal Drug Availability Act of 1996, 
is publishing a proposed regulation to further define the term 
``adequate and well-controlled'' to require that field investigations 
be designed and conducted in a scientifically sound manner and generate 
data that are reliable and sufficiently controlled to permit evaluation 
by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-120), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB01
_______________________________________________________________________




972.  INVESTIGATIONAL 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

[[Page 21687]]

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                            10/01/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-120), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB02
_______________________________________________________________________




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

Priority:  Other Significant. 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:  42 USC 264

CFR Citation:  21 CFR ch I

Legal Deadline: None

Abstract: The purpose of the regulation is to acquire a database of all 
establishments and persons that procure, process, screen, test, store, 
or distribute human cellular and tissue-based products. Creation of the 
database through registration will help FDA to determine how extensive 
the industry is and provide a means by which the agency can efficiently 
and effectively communicate with the affected industry regarding FDA 
regulations, policies, and educational activities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/01/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Steven F. Falter, Director, Division of Regulations and 
Policy, Department of Health and Human Services, Food and Drug 
Administration, Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852
Phone: 301 594-3074

RIN: 0910-AB05
_______________________________________________________________________




974.  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:  21 USC 381 to 382

CFR Citation:  21 CFR None

Legal Deadline: None

Abstract: The FDA Export Reform and Enhancement Act of 1996 allows the 
import of FDA regulated products that may not be offered for sale in 
the United States because they are unapproved or adulterated when the 
purpose of the importation is to have the articles processed in the 
United States and then exported. FDA is proposing reporting, 
recordkeeping, and labeling requirements to enable the importer to 
assure, and the FDA to monitor, that the imported products are further 
processed and exported and do not enter domestic commerce.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Eric Flamm, Senior Policy Advisor, Office of Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Office of the Commissioner, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3344

RIN: 0910-AB06
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




975. 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

[[Page 21688]]

(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.

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)

Alcohol (Topical) Products (To be merged w/other rulemkg)  ANPRM 05/21/
82 (47 FR 22324)

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)

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.) 09/00/97  Final Action 09/00/
97

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) 07/00/97

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)

Antiperspirant Products  ANPRM 10/10/78 (43 FR 46694)  NPRM 08/20/82 
(47 FR 36492)  Final Action 09/00/97

Antiseptic First Aid  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Revised) 07/22/91 (56 FR 33644)  Final Action 00/00/00

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

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)  NPRM 10/20/93 (58 FR 54224)

Aspirin (Reye Syndrome)  NPRM 10/20/93 (58 FR 54228)

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)

[[Page 21689]]

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)(Warning) 07/00/97

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)(Warning) 07/00/97

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)

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 09/00/97

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) 09/00/97

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 09/00/97

Emetic Products  ANPRM 03/21/75 (40 FR 12939)  NPRM 09/05/78 (43 FR 
39544)

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) 07/00/97  Final Action 00/00/00

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)

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)

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)  Final Action 
(Cardio/Cerebrvasclar) 07/00/97  NPRM (Amendment)(Alcohol Warning) 08/
00/97  NPRM (Labeling-revised indications) 09/00/97

Internal Analgesic Products (Overindulgence)  Final Action 00/00/00

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 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)  NPRM 
(Format/Examples) 02/27/97 (62 FR 9024)  Final Action 07/00/97  Final 
Action (Format/Examples) 09/00/97

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)  Final Action 
(Sodium Phosphates) 06/00/97  NPRM (Amendment)(Phosphates Label.) 06/
00/97  Final Action 09/00/97

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)

[[Page 21690]]

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

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) 07/00/97

NDA Labeling Exclusivity  NPRM 11/09/93 (58 FR 59622)  Final Action 09/
00/97

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)

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)  Final Action 00/00/00

Oral Mucosal Injury Products (Merged w/Oral Health Care)  ANPRM 11/02/
79 (44 FR 63270)  NPRM 07/26/83 (48 FR 33984)

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) 07/00/97

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)  NPRM (Amendment)(Warning) 05/05/93 (58 FR 26886)

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)

Phenylpropanolamine Products (Labeling)  NPRM 02/14/96 (61 FR 3912)

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) 
07/00/97  Final Action 09/00/97

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 09/00/97

Reporting of Adverse Reactions  NPRM 08/00/97

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 09/00/97

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) 08/00/97  Final Action 08/00/97

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)

Sodium Labeling  NPRM 04/25/91 (56 FR 19222)  Final Action 04/22/96 (61 
FR 17798)  NPRM 07/00/97  Final Action (Technical Amendment) 07/00/97

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 08/00/97

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.) 05/00/97

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)

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

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) 09/00/
97

Small Entities Affected: None

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: William E. Gilbertson, Assoc. Director for OTC Drug 
Monographs, 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: 301 827-2304

RIN: 0910-AA01
_______________________________________________________________________




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)

[[Page 21691]]

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. The 
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                    06/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA08
_______________________________________________________________________




977. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990

Priority:  Other Significant

Legal Authority:  PL 101-629 Safe Medical Devices Act of 1990

CFR Citation:  21 CFR 860; 21 CFR 820; 21 CFR 807; 21 CFR 803; 21 CFR 
17; 21 CFR 812; 21 CFR 7; 21 CFR 814; 21 CFR 821; 21 CFR 861; 21 CFR 
895

Legal Deadline:
NPRM, Statutory, August 28, 1991, for Medical Device Tracking.
Final, Statutory, November 28, 1991, for Exemption ofHumanitarian 
Devices, etc.
Other, Statutory, December 1, 1991, for Classification ofTransitional 
Devices Notice.
Final, Statutory, August 28, 1993, for Medical Device Tracking.

Abstract: The Safe Medical Devices Act of 1990 (SMDA), enacted November 
28, 1990, was intended to assure that marketed devices are safe and 
effective, that FDA learns quickly of device problems, and that FDA has 
authority to remove defective devices from the market. The act directs 
or authorizes FDA to develop these regulations: Medical Device 
Reporting--These rules require healthcare facilities and distributors 
to report deaths and serious injuries/illnesses related to medical 
devices. Medical Device Tracking--This regulation requires 
manufacturers to track certain devices to the user. Classification of 
Transitional Devices--FDA issued a notice to require submission of 
adverse safety and effectiveness data on transitional devices. FDA will 
now propose to keep each transitional device in class III, or 
reclassify it in class I or II. Good Manufacturing Practices for 
Medical Devices--FDA has added preproduction design validation to the 
CGMP regulations. Exemption of Humanitarian Devices--The final rule 
establishes procedures for applications for certain premarket review 
exemptions for humanitarian devices. --Summaries of Safety and 
Effectiveness for Premarket Notification--The final rule sets forth 
information to be included in summaries substantial equivalence 
determinations. Recall of Medical Devices--A proposed rule sets forth 
procedures for using authority to order device recalls and 
notifications. Reports of Removal and Corrections--FDA proposed 
procedures for manufacturers to report to FDA health-related market 
removals and corrections of devices. Civil Money Penalties--A final 
rule established procedures for a hearing to which persons are entitled 
before the imposition of civil money penalties. Procedural Changes in 
Medical Device Regulations--This final rule revised existing 
regulations to conform with procedural changes mandated by the SMDA. 
Premarket Review of Combination Products--FDA published a final rule 
establishing procedures for determining which FDA center will review 
premarket approval applications for products that are a combination of 
a device and a drug or biologic.

Timetable:

Assignment of Agency Component for Review of Premarket Applctns  Notice 
(Public Hearing) 07/12/91 (56 FR 31951)  Final Action 11/21/91 (56 FR 
31951)

Civil Money Penalties  NPRM 05/26/93 (58 FR 30680)  Final Action 07/27/
95 (60 FR 38612)

Classification of Transitional Devices  Notice 11/14/91 (56 FR 
57960)  Notice(Extension of Comment Period) 03/10/92 (57 FR 
8462)  Notice (Extension of Deadline) 11/30/92 (57 FR 56586)  Final 
Rule (Contact Lenses) 03/04/94 (59 FR 10283)

CGMPs for Medical Devices  ANPRM (Revisions;Request for Cmnts) 06/15/90 
(55 FR 24544)  ANPRM (Suggested Changes;Availblty) 11/30/90 (55 FR 
49644)  ANPRM (Extension of Comment Period) 02/14/91 (56 FR 
5965)  Notice (Open Public Advsy Cmte Mtg) 04/17/91 (56 FR 15626)  NPRM 
11/23/93 (58 FR 61952)  NPRM 07/24/95 (60 FR 37856)  Final Action 10/
07/96 (61 FR 52602)  Final Action Effective Date 06/00/97

Distributor Reporting  NPRM 00/00/00

Exemption of Humanitarian Devices  NPRM 12/21/92 (57 FR 60491)  Final 
Action 06/26/96 (61 FR 33232)  Stay of Effective Date 10/29/96 (61 FR 
55741)

Medical Device Recall Authority  NPRM 06/14/94 (59 FR 30656)  NPRM 
(Correction) 06/23/94 (59 FR 32489)  Final Action 11/20/96 (61 FR 
59004)

Medical Device Reporting  Notice (Public Conf; Rqst for Info) 03/28/91 
(56 FR 12934)  NPRM 11/26/91 (56 FR 60024)  Final Rule (Distributor 
Reporting) 09/01/93 (58 FR 46514)  Final Action 12/11/95 (60 FR 
63578)  Final Action(Ext.Eff.Date-7/31/96) 04/11/96 (61 FR 16043)

[[Page 21692]]

Medical Device Tracking  NPRM 03/27/92 (57 FR 10702)  NPRM 05/29/92 (57 
FR 22971)  Final Action 05/29/92 (57 FR 22966)  Final Action-Not Stat 
Eff Date 08/16/93 (58 FR 43442)

Miscellaneous Procedural Changes in Medical Device Regulations  Final 
Action 12/10/92 (57 FR 58400)

Pre-Amendment Class III Devices (merged with 0905-AE34)  Notice 05/06/
94 (59 FR 23731)

Reports of Removals and Corrections of Medical Devices  NPRM 06/04/94 
(59 FR 13828)  Final Action 04/00/97

Safe Medical Devices Act of 1990; Implementation Plans  Notice 04/05/91 
(56 FR 14111)

Summaries of Safety & Effectiveness for Premarket Notification  Final 
Action 04/28/92 (57 FR 18062)  Notice (Stay of Effective Date) 06/01/92 
(57 FR 23059)  Final Action 12/14/94 (59 FR 64287)

Temporary Suspension of a Premarket Approval Application  NPRM 10/12/93 
(58 FR 52729)  Final Action 04/05/96 (61 FR 15180)

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: Previously reported under RIN 0905-AD59.

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-AA09
_______________________________________________________________________




978. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

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

Legal Authority:  PL 102-539 Mammography Quality Standards Act of 1992; 
42 USC 263b

CFR Citation:  21 CFR 900

Legal Deadline:  Final, Statutory, July 27, 1993.
Standards for accreditation bodies are required by July 27, 1993.

Abstract: The purpose of the Mammography Quality Standards Act of 1992 
(MQSA), enacted October 27, 1992, is to assure quality in all aspects 
of the practice of mammography. The primary mechanism for this is 
oversight of all mammography facilities through a certification and 
inspection program. Only facilities certified by the Secretary are 
permitted to produce, process, or interpret mammographic images. The 
statute also required the establishment of an advisory committee to 
advise on appropriate quality standards and also provided for the 
establishment of surveillance systems to evaluate breast cancer 
screening programs.
The agency published interim regulations on December 21, 1993, which 
were drafted and implemented so as to maximize lawful operation by 
facilities under existing quality standards, and to ensure adequate 
examinee access to quality mammography during the transition to more 
comprehensive national standards.
Concurrent with the implementation of the interim rules, FDA proceeded 
with the development of proposed regulations to replace the interim 
rules. The agency recently issued proposed rules, with the advice and 
consultation of the National Mammography Quality Assurance Advisory 
Committee, on requirements for accreditation bodies, equipment and 
quality assurance requirements, facility requirements, and personnel 
requirements.

Statement of Need: Nearly 50,000 women die each year from breast 
cancer. While much research into causes and treatments still needs to 
be done, we do know that, for women over 50, mortality for lesions 
found by mammography is 30 percent less than for larger lesions 
identified by physical examination. Unfortunately, not all mammography 
facilities have offered services commensurate with the value of 
mammography in the abstract. The Congress enacted the MQSA to ensure 
quality mammography services for all women.
The primary mechanism established by the MQSA to ensure quality in 
mammography is oversight of all mammography facilities through a 
certification and inspection program. Only facilities certified by the 
Secretary will be permitted to produce, process, or interpret 
mammographic images. The statute also requires the establishment of a 
committee of experts to offer advice about regulatory quality standards 
and also provides for the establishment of surveillance systems to 
evaluate breast cancer screening programs.
The implementation of these regulations will help ensure that 
mammograms are properly administered and interpreted to provide 
adequate protection, diagnosis, and treatment of breast cancer among 
women. FDA has worked with the Health Care Financing Administration, 
the Centers for Disease Control, and State and local radiation control 
officials to coordinate mammography quality assurance activities and 
the development of policies and regulations for implementation of the 
MQSA, and will continue to coordinate its efforts with these agencies 
as appropriate.

Summary of the Legal Basis: The MQSA established a comprehensive 
statutory scheme for the certification and inspection of mammography 
facilities to ensure that, after October 1, 1994, only those facilities 
that comply with minimum Federal standards for safe, high-quality 
mammography services may lawfully continue to operate. Operation after 
that date is contingent on receipt of an FDA certificate attesting that 
the facility meets the minimum mammography quality standards 
promulgated under section 354(f) of the Public Health Service Act. The 
standards are intended to apply equally to screening and diagnostic 
mammography. The MQSA required: (a) accreditation of mammography 
facilities by private, nonprofit organizations or State agencies 
meeting FDA established standards; (b) annual physics surveys of 
mammography facilities; (c) annual inspections of mammography 
facilities; (d) qualification standards for interpreting physicians, 
radiologic technologists, medical physicists, and mammography facility 
inspectors; (e) specification by FDA of boards or organizations 
eligible to certify mammography personnel; (f) quality standards for 
mammography equipment and practices, including quality assurance; (g) 
establishment of the National Mammography Quality Assurance Advisory 
Committee; and (h) standards governing recordkeeping for examinee files 
and requirements for mammography reporting and examinee notification by 
physicians.

Alternatives: The statute is prescriptive and does not allow for a 
substantially different regulatory approach than is being taken by FDA. 
It allows for

[[Page 21693]]

discretion in the details of individual standards, and FDA has sought 
to avoid unnecessary burden in devising these standards. In order to 
reduce the burden of complying with the MQSA regulations on mammography 
facilities, FDA incorporated existing standards to the maximum extent 
possible; issued Federal certificates, which are required for 
facilities to legally operate after October 1, 1994, to facilities 
already accredited by the American College of Radiology; required 
facilities to submit information for certification only to the 
accrediting body--not to FDA; and allowed flexibility to accrediting 
bodies in developing their standards by requiring that accrediting body 
standards be ``substantially the same as'' FDA's standards, rather than 
identical.

Anticipated Costs and Benefits: Yearly costs to mammography facilities, 
over a 10-year period, were estimated to range from a high of 
approximately $203.2 million to $25.2 million. Yearly costs differed 
due to the phased implementation dates for some proposed requirements. 
Overall, average annualized costs of the proposals are preliminarily 
estimated at $61.4 million.
There are many benefits associated with these proposed rules. High-
quality mammography could significantly reduce breast cancer mortality. 
Early detection could reduce the morbidity associated with treating 
later-stage disease. There may be a reduction in the number of 
malpractice claims filed for failure to diagnose early breast cancer. 
In addition, because of improved mammography quality, the agency 
expects a reduction in the number of follow-up procedures in 
nondiseased patients, resulting in a reduction of annual medical costs. 
By themselves, the health care cost savings are expected to 
substantially exceed the expected average annualized costs.

Risks: The motivation for the MQSA was public response to concerns 
about breast cancer and to concerns about the quality of mammography 
services relied on for early detection of breast cancer. Breast cancer 
is the most prevalent nonskin cancer among women (and the second most 
deadly) with over 175,000 new cases and 45,000 breast cancer-related 
deaths occurring annually. The disease is most treatable in the early 
stages. Missed diagnosis of early lesions due to factors such as poor 
image quality or incorrect interpretation of images could result in 
delayed treatment, leading to otherwise avoidable increases in 
mortality or more complex and costly remediations.

Timetable:

Alternative Approaches  NPRM 04/03/96 (61 FR 14856)  Final Action 10/
00/97

Approval of Accrediting Bodies  Interim Final Rule 12/21/93 (58 FR 
67558)

Draft Proposed Quality Standards  Notice of Availability 01/26/95 (60 
FR 5152)

Draft X-Ray and Medical Physicist Standards Proposals  Notice of 
Availability; 12/30/94 (59 FR 67710)

General Facility Requirements  NPRM 04/03/96 (61 FR 14870)  Final 
Action 10/00/97

Mammography Quality Standards Act of 1992; Inspection Fees  Notice 03/
17/95 (60 FR 4584)

Personnel Requirements  NPRM 04/03/96 (61 FR 14898)  Final Action 10/
00/97

Quality Standards for Mammography Equipment and QA  NPRM 04/03/96 (61 
FR 14908)  Final Action 10/00/97

Quality Standards for Mammography Facilities  Interim Final Rule 12/21/
93 (58 FR 67565)

Quality Standards/Certification Rqmts.  Interim Final Rule 09/30/94 (59 
FR 49808)

Requirements for Accreditation Bodies and Quality Standards  Notice 
(Advisory Committee) 12/21/94 (59 FR 65776)  NPRM 04/03/96 (61 FR 
14884)  Final Action 10/00/97

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Additional Information: Previously reported under RIN 0905-AE07.

Agency Contact: Charles K. Showalter, Office of Health and Industry 
Programs, Department of Health and Human Services, Food and Drug 
Administration, Center for Devices and Radiological Health (HFZ-240), 
1350 Piccard Drive, Rockville, MD 20850
Phone: 301 594-3332

RIN: 0910-AA24
_______________________________________________________________________




979. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE 
LABELING

Priority:  Other Significant

Legal Authority:  21 USC 352; 21 USC 355; 42 USC 262

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: On November 1, 1990 (55 FR 46134), the Agency proposed to 
amend its regulations governing the content and format of labeling for 
human prescription drug products to require a subsection in the 
labeling that would include information on the use of a drug in the 
elderly. This reflects growing recognition by FDA and others of the 
special concerns associated with prescription drug use in this age 
group. FDA believes that providing access to this information is 
important for the safe and effective use of prescription drugs in older 
populations. The final rule will codify these proposed revisions based 
on the comments received.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/01/90                    55 FR 46134
NPRM Comment Period End         12/31/90
Final Action                    05/00/97

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE26.

Agency Contact: Thomas Kuchenberg, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA25
_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

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

[[Page 21694]]

CFR Citation:  21 CFR 211

Legal Deadline: None

Abstract: On January 18, 1994 (59 FR 2542), the Agency proposed to 
amend its tamper-resistant packaging regulations to require that all 
over-the-counter (OTC) human drug products marketed in two-piece, hard 
gelatin capsules be sealed. The proposal also solicited public comments 
on whether additional regulatory changes, such as packaging performance 
standards, may be necessary. FDA has required tamper-resistant 
packaging features for OTC drug products since 1982. The tamper-
resistant packaging regulations were revised in 1989 in response to 
continuing tampering incidents. Despite the regulatory protection 
provided by the regulations, two-piece, hard gelatin capsules remain 
vulnerable to malicious tampering and were implicated in tampering 
incidents in 1991. This regulatory action is in response to the 1991 
tampering incidents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/94                     59 FR 2542
NPRM Comment Period End         03/21/94
Final Action                    05/00/97

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE27.

Agency Contact: Thomas Kuchenberg, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA26
_______________________________________________________________________




981. ADVERSE EXPERIENCE EXPEDITED REPORTING REQUIREMENTS FOR HUMAN DRUG 
AND LICENSED BIOLOGICAL PRODUCTS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 357; 21 USC 371; 21 USC 374; 21 USC 216; 21 USC 262; 21 USC 263; 21 
USC 263a; 21 USC 264; 21 USC 300aa-25

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

Legal Deadline: None

Abstract: The final rule will amend the adverse experience reporting 
regulations for human drug products and licensed biological products to 
make the requirements consistent with a new unified form (FDA Form 
3500A) and require the use of this new reporting form. The new form was 
announced as part of FDA's MedWatch program. The final rule will also 
revise certain definitions and reporting periods and formats as 
recommended by the International Conference on Harmonization of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH) and the World Health Organization's Council for International 
Organizations of Medical Sciences (CIOMS). In addition, the rule will 
amend the regulations governing the safety reporting of data from 
clinical studies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/27/94                    59 FR 54046
NPRM Comment Period End         01/25/95
Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE29.

Agency Contact: Audrey Thomas, Consumer Safety Officer, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA28
_______________________________________________________________________




982. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

Priority:  Other Significant

Legal Authority:  42 USC 262; 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 360; 21 
USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; ...

CFR Citation:  21 CFR 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64; 
21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR 
314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21 
CFR 807.87; 21 CFR 807.100; ...

Legal Deadline: None

Abstract: This final regulation would address the problem of certain 
financial arrangements and interests of clinical investigators that 
have the potential to bias the outcome of clinical trials. The problem 
is significant because clinical research data provide the basis for 
FDA's evaluation of drugs, biologics and devices for marketing. The 
regulation would require the sponsor of a product that is the subject 
of a marketing application to submit either a statement certifying that 
a clinical investigator who participates in a covered study is not a 
party to any certain financial interests and arrangements that could 
potentially bias the outcome of the study, or disclose such interests 
and arrangements if they exist. This information will enable FDA to 
subject clinical research data to an appropriate level of scrutiny and 
help assure its reliability. Alternatives to the regulation would be to 
prohibit investigators from holding certain financial interests 
altogether or to require divestiture by the investigator of a 
prohibited interest. The estimated costs to industry associated with 
preparation, submission, and retention of the information required by 
this final rule are well below the $100 million threshold that defines 
a significant regulatory action. The final rule is not expected to 
impose a significant resource burden on FDA because the submission of 
statements is limited to clinical data submitted in support of 
marketing applications, ruling out data from the large number of 
studies that do not lead to applications, and FDA estimates that 
sponsors will be able to certify for the majority of their clinical 
investigators, so that most submitted data will not require intensified 
scrutiny. The final rule will strengthen the FDA review process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/94                    59 FR 47807
NPRM Comment Period End         12/21/94
Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE32.

[[Page 21695]]

Agency Contact: Mary Gross, Department of Health and Human Services, 
Food and Drug Administration, Office of External Affairs (HF-24) 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-3440
Fax: 301 594-0113

RIN: 0910-AA30
_______________________________________________________________________




983. LATEX CONDOMS: EXPIRATION DATE LABELING

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 351; 21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

Abstract: Latex condoms are used as a barrier to transmission of 
diseases through bodily fluids, including AIDS. Latex deteriorates over 
time, reducing its utility as a barrier. The rule would require 
manufacturers of these products to perform testing to establish an 
appropriate expiration date for their products and to place that date 
on their labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/24/96                    61 FR 26140
NPRM Comment Period End         08/22/96
Final Action                    08/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE37.

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-AA32
_______________________________________________________________________




984. LATEX WARNING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

Abstract: Certain persons may be subject to severe adverse reaction 
upon contact with latex. Therefore, FDA would require that devices 
containing latex have a warning in the labeling concerning the presence 
of latex and the potential risk. This will enable health professionals 
and consumers to make an informed choice concerning the use of a 
device.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/24/96                    61 FR 32618
NPRM Comment Period End         09/23/96
Final Action                    09/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE40.

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-AA34
_______________________________________________________________________




985. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Priority:  Other Significant

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

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

Legal Deadline: None

Abstract: In August, 1995 the Food and Drug Administration (FDA) 
published a proposed rule that specified standards for the distribution 
and quality of useful prescription medication information, designed for 
patients, that voluntary, private-sector efforts should supply to 
patients receiving new prescriptions. On August 6, 1996, section 601 of 
the Agriculture Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 1997 was enacted which places the 
proposed rule as it relates to a voluntary program in abeyance. The 
legislation did not address the provisions that would have required 
mandatory Medication Guides in relatively rare instances where a 
product poses a serious and significant public health concern requiring 
immediate distribution of FDA-approved patient information. FDA is 
currently considering its options concerning whether and how to 
finalize the requirement for mandatory Medication Guides for these 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/24/95                    60 FR 44182
Final Action                    04/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AE43.

Agency Contact: Louis A. Morris, Chief, Marketing Practices & 
Communication Branch, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-240), 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-6828

RIN: 0910-AA37
_______________________________________________________________________




986. HUMAN TISSUE INTENDED FOR TRANSPLANTATION

Priority:  Other Significant

Legal Authority:  42 USC 216; 42 USC 243; 42 USC 264; 42 USC 271

CFR Citation:  21 CFR 1270

Legal Deadline: None

Abstract: In response to comments received, FDA is clarifying those 
requirements previously promulgated by the interim rule. The final rule 
would require certain infectious disease testing, donor screening and 
recordkeeping, and help prevent the transmission of AIDS and hepatitis 
through human tissue used in transplantation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/14/93
Interim Final Rule Opportunity 
for Comment                     12/14/93                    58 FR 65514
Interim Final Rule Comment 
Period End                      03/14/94
Final Action                    05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 21696]]

Additional Information: Previously reported under RIN 0905-AE49.

Agency Contact: Paula S. McKeever, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA40
_______________________________________________________________________




987. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, 
PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN REQUIREMENTS 
FOR FINISHED PHARMACEUTICALS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 351 to 352; 21 USC 355 to 357; 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 either 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                    07/00/97

Small Entities Affected: None

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE63.

Agency Contact: Thomas Kuchenberg, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA45
_______________________________________________________________________




988. CHANGES TO AN APPROVED APPLICATION

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:  15 USC 1451 to 1461; 21 USC 321; 21 USC 331; 21 USC 
351 to 353; 21 USC 355 to 357; 21 USC 360; 21 USC 360c to 360f; 21 USC 
360h to 360j; 21 USC 371; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 
216; 42 USC 241; 42 USC 262 to 264; ...

CFR Citation:  21 CFR 314; 21 CFR 600; 21 CFR 610

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is issuing a final 
rule to revise 21 CFR 601.12, which deals with changes in the 
production of licensed biological products--for example, product, 
labeling, production process, equipment, facilities, and responsible 
personnel. FDA is also amending the corresponding drug regulations for 
specified biotechnology products reviewed in the Center for Drug 
Evaluation and Research (CDER) to harmonize the drug and biologic 
regulations. Currently, licenseholders must obtain FDA preapproval of 
all such changes through supplements to approved applications. In the 
final rule, FDA sets forth a process that is intended to reduce the 
burden on licenseholders by reducing the number of supplements 
submitted for changes and to result in more timely approval of changes 
in their products. The new process creates different mechanisms for 
reporting changes, based on their potential to affect adversely the 
safety, purity, potency, or effectiveness of the product.

Statement of Need: The present system has been shown to be burdensome 
to both licenseholders and to FDA in that licenseholders must submit 
supplements for every proposed change, and FDA must review them. The 
present system is also time-consuming--manufacturers may wait from 6 to 
12 months for approval of supplements--and unnecessarily rigid. FDA 
estimates that the final rule would reduce by 50 percent--from 1,000 to 
500--the number of supplements submitted annually for biologics and 
reviewed by FDA, allowing for more expeditious agency review of 
supplements that are submitted.

Summary of the Legal Basis: The Public Health Service Act (42 USC 216 
et seq.) and the Federal Food, Drug, and Cosmetic Act (21 USC 321 et 
seq.) authorize FDA to regulate the distribution of biological products 
so that the products are safe, pure, potent, and effective. These acts 
authorize FDA to promulgate regulations designed to ensure that the 
public is not exposed to biological products that may not be safe, 
pure, or potent for their intended uses. In order to carry out the 
public health protection purposes of the acts, FDA (a) reviews and 
approves applications for licenses to manufacture biological products; 
(b) inspects establishments involved in manufacturing activities; and 
(c) reviews and approves important changes that have the potential to 
adversely affect the biological product.

Alternatives: FDA considered two alternatives. The first alternative 
was allowing license holders to submit summary data and a certification 
of validation and lack of adverse effect on the product's safety, 
purity, potency, or efficacy. FDA believes this alternative is 
appropriate for some changes, but not adequate or sufficient for 
changes with substantial potential to have an adverse effect.
The second alternative would have required license holders to keep 
validation data and certification of lack of adverse effect, and 
allowed them to report changes to FDA in an annual report. FDA believes 
this alternative is appropriate for changes that have only a minimal 
potential for adverse effect on the product. It is incorporated into 
the final rule.

Anticipated Costs and Benefits: In general, the final rule is expected 
to reduce significantly the burden of preparing supplements for 
proposed changes by eliminating this

[[Page 21697]]

requirement for a number of changes. The final rule will accordingly 
reduce the number of supplements requiring FDA review and allow for 
more expeditious handling of supplements that are submitted. 
Licenseholders are expected to incur no additional costs as a result of 
the proposal; on the other hand it will allow for more timely 
implementation of changes by licenseholders--for example, streamlining 
and updating manufacturing facilities.

Risks: FDA believes the risks posed by the new reporting system are 
minimal. In addition to stating in the revision which changes are 
considered to have substantial, moderate, and minimal potential for 
adverse effects, FDA will provide thorough supplementary guidance to 
manufacturers to help assure adequate assessment of the potential for 
adverse effects.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/29/96                     61 FR 2739
NPRM Comment Period End         04/29/96
Final Action                    05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Steven F. Falter, Director, Division of Regulations and 
Policy, Department of Health and Human Services, Food and Drug 
Administration, Center for Biologics Evaluation and Research (HFM-630), 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA57
_______________________________________________________________________




989. EXPORT REQUIREMENTS FOR MEDICAL DEVICES

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 351 to 353; 21 USC 355 to 357; 21 
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 
372; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 393; 42 USC 216; 42 
USC 241; 42 USC 2421

CFR Citation:  21 CFR 812.18

Legal Deadline: None

Abstract: Prior to the enactment of the FDA Export Reform and 
Enhancement Act of 1996, the Food and Drug Administration (FDA) 
proposed to amend its regulations for investigational devices to 
describe streamlined requirements for exports of unapproved medical 
devices. Under the proposed rule, an approved investigational device 
exemption (IDE) would constitute an agency determination that the 
export of the unapproved device is not contrary to the public health or 
safety. Countries could notify FDA that they do not object to the 
importation of unapproved devices with an approved IDE into their 
countries. Thus, for devices with an FDA-approved IDE, the proposal 
would eliminate the need for FDA to make independent determinations 
either that exportation is not contrary to the public health or safety 
or that an importing country does not object to the importation of a 
specific device. The proposed rule was intended to codify and to 
simplify export requirements for certain unapproved devices pursuant to 
the President's and Vice-President's ``National Performance Review,'' 
as reflected in the April 1995 report titled, ``Reinventing Drug & 
Medical Device Regulations.'' The proposed rule is consistent with the 
Export Reform and Enhancement Act. FDA reopened the comment period to 
seek comments on whether the rulemaking is still needed in view of the 
changes to the export provisions of the Federal Food, Drug, and 
Cosmetic Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/27/95                    60 FR 58308
Comment Period Reopened         01/07/97                      62 FR 953
To Be Withdrawn                 04/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Horton, Director, International Policy Staff, 
Office of Policy (HF-23), Department of Health and Human Services, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3344

RIN: 0910-AA62
_______________________________________________________________________




990. ADVERSE EXPERIENCE REPORTING FOR HUMAN DRUG AND LICENSED BIOLOGICAL 
PRODUCTS; INCREASED FREQUENCY REPORTS

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 216; 21 USC 262 to 264; 21 USC 300; 21 USC 
321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 to 357; 21 USC 371; 21 
USC 374; 42 USC 262

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

Legal Deadline: None

Abstract: The final rule will revoke the requirement for increased 
frequency reports to FDA for postmarketing adverse experience 
reporting.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/28/96                    61 FR 55602
NPRM Comment Period End         01/13/97
Final Action                    05/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy E. Derr, Policy Analyst, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA72
_______________________________________________________________________




991. 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 
to 357; 21 USC 371; 21 USC 374; 21 USC 379

CFR Citation:  21 CFR 314

Legal Deadline: None

[[Page 21698]]

Abstract: The final rule would eliminate 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                    05/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Kuchenburg, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, (HFD-7), 1451 Rockville Pike, Suite 2047, 
Rockville, MD 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA78
_______________________________________________________________________




992. NATIONAL ENVIRONMENTAL POLICY ACT; POLICIES AND PROCEDURES

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:  21 USC 321 to 393; 42 USC 262; 42 USC 263b; 42 USC 
264; 42 USC 4321; 42 USC 4331 to 4335

CFR Citation:  21 CFR 25

Legal Deadline: None

Abstract: The final rule will amend the regulations governing 
compliance with the National Environmental Policy Act (NEPA) as 
implemented by the regulations of the Council on Environmental Quality. 
The rule will increase the efficiency of FDA's implementation of NEPA 
and reduce the regulatory burden by providing for categorical 
exclusions for additional classes of actions that do not individually 
or cumulatively have a significant effect on the human environment and 
for which neither an environmental impact statement nor an 
environmental assessment is required. The rule will also amend the 
regulations to make the agency's NEPA procedures more concise and 
understandable to the public, and to reflect current FDA policy with 
respect to environmental considerations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/03/96                    61 FR 14922
NPRM Comment Period End         11/21/96                    61 FR 54746
Final Action                    05/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Federal

Agency Contact: Nancy Sager, Department of Health and Human Services, 
Food and Drug Administration, Center for Drug Evaluation and Research, 
(HFD-4), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-5413
Fax: 301 594-6197

RIN: 0910-AA80
_______________________________________________________________________




993. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICAL; 
POSITRON EMISSION TOMOGRAPHY

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 351; 21 USC 352; 21 USC 355; 21 
USC 356; 21 USC 357; 21 USC 360; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 211

Legal Deadline: None

Abstract: The final rule will permit manufacturers of positron emission 
tomography radiopharmaceuticals to apply to the agency for approval of 
an exception or alternative to the requirements of the current good 
manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/27/95                    60 FR 10517
NPRM Comment Period End         03/29/95
Final Action                    04/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Kuchenberg, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA81
_______________________________________________________________________




994. INVESTIGATIONAL NEW DRUG APPLICATIONS AND NEW DRUG APPLICATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 357; 21 USC 371; 21 USC 374; 21 USC 379; 42 USC 262

CFR Citation:  21 CFR 312; 21 CFR 314

Legal Deadline: None

Abstract: The final rule will define in the NDA format and content 
requirements the need to present effectiveness and safety data for 
important demographic subgroups, specifically gender, age, and racial 
subgroups, and will require IND sponsors to characterize in their 
annual reports the number of subjects in a clinical study according to 
age group, gender, and race.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/95                    60 FR 46794
NPRM Comment Period End         12/07/95
Final Action                    05/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Nancy E. Derr, Policy Analyst, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA82

[[Page 21699]]

_______________________________________________________________________




995. POSTMARKETING PERIODIC ADVERSE EXPERIENCE REPORTING REQUIREMENTS 
FOR HUMAN DRUG AND LICENSED BIOLOGICAL PRODUCTS

Priority:  Other Significant

Legal Authority:  21 USC 216; 21 USC 262; 21 USC 263; 21 USC 264; 21 
USC 300; 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 374; ...

CFR Citation:  21 CFR 314; 21 CFR 600

Legal Deadline: None

Abstract: The final rule will amend the periodic adverse experience 
reporting requirements to provide new definitions and to revise 
reporting periods and formats as recommended by the International 
Conference on Harmonization of Technical Requirements for Registration 
of Pharmaceuticals for Human Use and the World Health Organization's 
Council for International Organizations of Medical Sciences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/27/94                    59 FR 54046
Final Action                    06/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Audrey Thomas, Consumer Safety Officer, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA85
_______________________________________________________________________




996. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR 
APPLICATION SUPPLEMENTS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 357; 21 USC 371; 21 USC 374; 21 USC 379

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The final rule will clarify the scope of certain reporting 
obligations imposed on holders of approved applications permitting an 
applicant to make certain changes in an approved application without 
submitting a supplemental application if the changes are made to comply 
with an official compendium and are described in the annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/04/86                    51 FR 20310
Final Action                    05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Leanne Cusumano, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA87
_______________________________________________________________________




997. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED; PROTEIN 
DERIVED FROM RUMINANTS PROHIBITED IN RUMINANT FEED

Priority:  Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments.

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

CFR Citation:  21 CFR 589.2000

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing rules providing 
that animal protein derived from ruminant and mink tissues are not 
generally recognized as safe (GRAS) for use in ruminant feed and is a 
food additive subject to section 409 of the Federal Food, Drug, and 
Cosmetic Act. Therefore, in the absence of a food additive regulation 
or exemption, protein derived from ruminants and mink are prohibited 
from use in ruminant feed. The proposed rule would establish a flexible 
system of controls to ensure that ruminant feed does not contain animal 
protein derived from ruminant and mink tissues in a manner that is cost 
effective and encourages innovation. While BSE has not been diagnosed 
in the United States, this rule is intended to prevent the development 
and amplification of bovine spongiform encephalopathy (BSE) in cattle, 
to protect the health of animals, and to minimize any risk which might 
be posed to humans.

Statement of Need: The Food and Drug Administration (FDA) is proposing 
this action to protect the health of animals and to minimize any risk 
which might be posed to humans, through the transmission of 
transmissible spongiform encephalopathies (TSEs). While BSE has not 
been diagnosed in the United States, this rule is intended to prevent 
the development and amplification of bovine spongiform encephalopathy 
in cattle in the United States. Ruminant and mink tissues present a 
risk of transmitting spongiform encephalopathies. These tissues have 
been found through experimental trials and bioassays to transmit 
spongiform encephalopathies. Epidemiological evidence gathered in the 
United Kingdom (UK) suggests an association between an outbreak of BSE, 
a ruminant TSE, and the feeding to cattle of protein derived from sheep 
infected with scrapie, another TSE. The causative agent was further 
spread in the UK cattle population as a result of feeding rendered 
products to cattle. In addition, scientists have postulated an 
epidemiological association between BSE and a variant form of human 
TSE, Creutzfeldt-Jakob Disease (v-CJD) reported recently in England. 
FDA is not aware of a practical assay for the presence of ruminant 
protein in rendered products. Nor is FDA aware of a reliable 
deactivation procedure in the rendering process which is used to 
produce the proteins.

Summary of the Legal Basis: A substance used in food (including animal 
feed) that is not generally recognized as safe is a ``food additive'' 
under section 201(s) of the Food, Drug, and Cosmetic Act. A food 
additive is unsafe under section 409 of the Act unless a food additive 
regulation or an exemption is in effect for the substance. An unsafe 
food additive is adulterated under section 402(a)(2)(C) of the Act. 
Section 701(a) of the Act provides authority to issue regulations for 
the efficient enforcement of the Act, including regulations that 
determine substances to be food additives.

Alternatives: The agency considered a number of alternatives regarding 
the feeding of animal protein to ruminants; including a prohibition of 
feeding protein derived from adult sheep and

[[Page 21700]]

goats, restricting the prohibition only to ruminant tissues that had 
been demonstrated to be potentially TSE infective, and a prohibition of 
feeding of protein derived from mammalians. In addition the agency 
considered not taking any action regarding the feeding on animal 
proteins. The grave potential consequences of exposure to TSE and the 
apparent small intake of the agent needed to achieve infection in small 
animals encourage a conservative regulatory policy.

Anticipated Costs and Benefits: The affected industry sectors are 
predicted to incur total direct compliance costs ranging from $21.4 to 
$48.2 million per year. The benefits of prohibiting ruminant proteins 
in ruminant feeds are the reduced risks to animal and human health and 
to the economic health of the U.S. livestock and livestock dependent 
industries. For analytical purposes, these benefits can be expressed as 
the expected value of the future disease related costs that would be 
averted by the present implementation of the proposed rule. The 
realized benefits depend primarily on two factors: 1) the risk that BSE 
will occur in the U.S. (or currently exists undetected), and 2) the 
incidence rate of BSE once it becomes established. The proposed measure 
is aimed both at reducing the first risk, and at eliminating the second 
if the first should occur. Risks are inherently lower in the United 
States. Similar measures in the U.S., if they occurred immediately upon 
detection of the disease, would result in the one-time destruction of 
$4.58 billion worth of cattle, with a present value of $3.49 billion.

Risks: Based on the scientific information that is available at the 
present time, the primary health concern related to animal feed is the 
possibility of transmission of TSE infectively from BSE-infected 
bovines, with the risk of that threat increasing through the recycling 
of ruminant tissues. Furthermore, there exists the theoretical 
possibility of the transmission of a TSE in animals to a TSE in humans. 
The possibility of other TSE transmissions between species, in addition 
to the postulated transmission of a sheep TSE (scrapie) to cattle, 
supports the agency's concern about TSE transmission and infectivity 
both in animals and humans. The typically long incubation period and 
the potentially devastating effect that a BSE outbreak would have on 
animal health and U.S. agribusiness, support a conservative regulatory 
approach aimed at prevention. While no BSE has been diagnosed in the 
United States, and the current level of exposure to products derived 
from animals with a TSE is extremely low or absent, the potential 
consequences of such exposure and the apparent small intake of the 
agent needed to achieve infection in some animals further encourage a 
conservative regulatory policy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/14/96                    61 FR 24253
ANPRM Comment Period End        06/15/96
NPRM                            01/03/97                      62 FR 551
NPRM Comment Period End         02/18/97
Final Action                    06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: G.A. Mitchell, Deputy Director, Policy and Regulations, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine (HFV-1), 1500 Standish Place, Rockville, 
MD 20832
Phone: 301 827-0139

RIN: 0910-AA91
_______________________________________________________________________




998. TREATMENT USE OF INVESTIGATIONAL DEVICE EXEMPTIONS

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 360j(g)

CFR Citation:  21 CFR 812

Legal Deadline: None

Abstract: The proposed rule would permit an investigational device to 
be used for treatment use under a supplement to the application for 
investigational device exemption (IDE), if the device is intended to 
treat a serious or immediately life threatening disease, there is no 
comparable or satisfactory alternative device or therapy available to 
treat that stage of the disease in the intended patient population, and 
the device is under investigation in a controlled clinical trial under 
an IDE or the clinical trials have been completed.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/96                    61 FR 66954
NPRM Comment Period End         03/19/97
Final Action                    12/00/97

Small Entities Affected: Undetermined

Government Levels Affected: None

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-AA92
_______________________________________________________________________




999. DISQUALIFICATION OF A CLINICAL INVESTIGATOR

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: Section 312.70 authorizes the agency to disqualify a clinical 
investigator ``who submits to the sponsor false information in any 
required report''(21 CFR 312.70(a)). A sponsor-investigator both 
conducts the clinical trial and reports its data directly to the 
agency. Because a sponsor-investigator does not ``submit information to 
the sponsor,'' a literal interpretation of section 312.70 may not 
authorize the agency to disqualify a sponsor-investigator from 
submitting false information. The final rule will clarify the agency's 
authority to disqualify both clinical investigators and sponsor-
investigators for submitting to the agency false information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/16/96                     61 FR 6177
NPRM Comment Period End         05/16/96
Final Action                    05/00/97

Small Entities Affected: None

Government Levels Affected: None

[[Page 21701]]

Agency Contact: Thomas Kuchenberg, 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA95
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1000. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority:  Other Significant

Legal Authority:  21 USC 350a

CFR Citation:  21 CFR 107; 21 CFR 106

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 
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 00/00/00

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)

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

Agency Contact: Carolyn W. Miles, Nutritionist, 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: 202 401-9858

RIN: 0910-AA04
_______________________________________________________________________




1001. FOOD LABELING REVIEW

Priority:  Routine and Frequent

Unfunded Mandates: This action may affect State, local or tribal 
governments.

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. FDA also proposed to modify the 
provisions that delay the effective date of these regulations for small 
restaurant firms for one year. The agency proposed 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 describing the provisions for 
exemptions 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 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, describing provisions for an 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 in the voluntary declaration of (CONT)

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) 00/00/00

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)

[[Page 21702]]

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD89.
ABSTRACT CONT: nutrition labeling for raw produce and fish.

Agency Contact: F. Edward Scarbrough, 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
_______________________________________________________________________




1002. 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(c)

CFR Citation:  None

Legal Deadline: None

Abstract: FDA is considering whether it can or should classify stand-
alone computer software products that fit the definition of a medical 
device under the Federal Food, Drug, and Cosmetic Act. The Secretary 
has made no decision regarding whether or not to initiate such a 
program. The Agency anticipates classifying these devices by using a 
risk-based approach as required under the Medical Device Amendments to 
the act. In addition, the agency will 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, and good 
manufacturing practice requirements for adverse events and complaints. 
High risk devices would be the only products to require premarket 
submissions or premarket approval. 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                            00/00/00

Small Entities Affected: 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: 301 594-4765

RIN: 0910-AA41
_______________________________________________________________________




1003. DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR THE 
FOOD INDUSTRY; REQUEST FOR COMMENTS; PROPOSED RULE

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  21 USC 321 et seq; 21 USC 342(a)(4); 21 USC 371(a); 
42 USC 264

CFR Citation:  21 CFR 120

Legal Deadline: None

Abstract: FDA announced on August 4, 1994, its plans to consider 
developing regulations that would establish requirements for a new 
comprehensive food safety assurance program for both domestically 
produced and imported foods 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. The most serious of these challenges is presented by food 
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 HACCP state-of-the-art 
preventive approach. A first step was taken when FDA published a HACCP 
regulation for fish and fishery products on December 18, 1995. In 
additon, USDA published a HACCP regulation for meat and poultry on July 
25, 1996. As a further step in response to comments on the ANPR, FDA 
proposes to publish a HACCP regulation for all foods that FDA 
regulates, with implementation first for processing of juice. In 
preparation of this document, FDA is also considering information 
obtained during HACCP pilot activities, and comments and scientific and 
technological information relating to fresh juices provided during and 
after the public meeting on juice held on December 16 and 17, 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/04/94                    59 FR 39888
ANPRM Comment Period End        12/02/94
NPRM                            00/00/00
NPRM Comment Period End         00/00/00

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE60.

Agency Contact: John E. Kvenberg, Strategic Manager, 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: John K[email protected]

RIN: 0910-AA43
_______________________________________________________________________




1004. HABIT FORMING DRUGS

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 352; 21 USC 353; 21 USC 355; 21 USC 371

[[Page 21703]]

CFR Citation:  21 CFR 329

Legal Deadline: None

Abstract: The proposed rule would revise and clarify the regulations 
under part 329 to be consistent with the Drug Enforcement 
Administration regulations and the Controlled Substances Act.

Timetable: Next Action Undetermined

Small Entities Affected: 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 20850
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA50
_______________________________________________________________________




1005. REVOCATION OF CERTAIN REGULATIONS

Priority:  Other Significant

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

Legal Authority:  21 USC 321 to 394; 21 USC 41 to 50; 21 USC 141 to 
149; 21 USC 467F; 21 USC 679; 21 USC 821; 21 USC 1034; 42 USC 202; 42 
USC 262; 42 USC 263B; 42 USC 264; 15 USC 1451 to 1461; 5 USC 551 to 
558; 5 USC 701 to 721; 28 USC 2112; ...

CFR Citation:  21 CFR 100 to 101; 21 CFR 103 to 105; 21 CFR 109; 21 CFR 
137; 21 CFR 161; 21 CFR 163; 21 CFR 182; 21 CFR 186; 21 CFR 197; 21 CFR 
505; 21 CFR 507 to 508; 21 CFR 601; 21 CFR 620; 21 CFR 630; 21 CFR 640 
to 660; ...

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to revoke 
certain regulations that either do not achieve public health goals or 
do not need to be codified as regulations to do so. These regulations 
include regulations that are actually statements of policy or guidance, 
that are duplicative, that are obsolete, or that have been made 
inaccurate by changes in legislation and technology.
FDA is taking this action in response to President Clinton's directive 
of March 4, 1995, to all Federal agencies to conduct a page-by-page 
review of their regulations and to eliminate or revise those that are 
outdated or otherwise in need of reform. As a result of its regulations 
review, FDA is proposing to eliminate 36 percent of its regulations 
that it has determined are obsolete or no longer necessary to achieve 
public health goals (735 pages of which will first require 
Congressional action). In addition, FDA plans to revise or modify an 
additional 45 percent of its remaining regulations to ease the burden 
on regulated industry and the consumer without sacrificing public 
health protection. For those regulations requiring Congressional 
permission to eliminate or reform, the Administration is seeking 
legislation. This proposal contains deletions that can be accomplished 
administratively. Examples include regulations that refer to substances 
no longer used in product formulations or to products that are no 
longer marketed; and regulations that codify product standards that can 
be more flexibly handled and updated within the context of the review 
process. FDA is providing a 90-day period for public comment on these 
proposed deletions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/13/95                    60 FR 53480
NPRM Comment Period End         01/11/96
Final Action                    00/00/00
Revocation of Certain Regulations; General  NPRM 01/25/96 (61 FR 
2192)  Final Action 00/00/00

Revocation of Obsolete Animal Food and Drug Regulations  Final Action 
07/19/96 (61 FR 37680)

Revocation of Obsolete Biological Regulations  Final Action 08/01/96 
(61 FR 40153)

Revocation of Obsolete Drug Regulations  Final Action 06/11/96 (61 FR 
29476)

Revocation of Obsolete Food Regulations  Final Action 06/03/96 (61 FR 
27771)

Revocation of Obsolete Medical Device Regulations  Final Action 07/19/
96 (61 FR 37682)

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Lisa M. Helmanis, Office of Policy (HF-26), Department 
of Health and Human Services, Food and Drug Administration, 5600 
Fishers Lane Rockville, MD 20857
Phone: 301 443-3480
Fax: 301 443-2946

RIN: 0910-AA54
_______________________________________________________________________




1006. EXPORT REQUIREMENTS FOR DRUGS FOR INVESTIGATIONAL USE IN OTHER 
COUNTRIES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 331; 21 USC 351 to 352; 21 USC 355 to 357; 21 
USC 360; 21 USC 360b; 21 USC 360aa to 360dd; 21 USC 371 to 372; 21 USC 
374; 21 USC 379e; 21 USC 379g; 21 USC 381 to 382; 21 USC 393; 42 USC 
216; 42 USC 241; 42 USC 242l

CFR Citation:  21 CFR 312.110

Legal Deadline: None

Abstract: FDA is proposing to amend its regulations on investigational 
new drug products to streamline requirements for exports of unapproved 
drugs for investigational use to foreign countries. The proposed rule 
would permit an unapproved drug product to be exported under three 
different options. The first option would permit exportation of a drug 
under an approved investigational new drug application (IND). This 
would be consistent with the preexisting rule. The second option would 
permit exportation of a drug to a country other than one specified in 
section 802 (b)(1)(A) of the Federal Food, Drug, and Cosmetic Act, 
without an IND or prior FDA approval, provided that adverse event 
information is reported to the FDA. This would represent a significant 
change from the existing rule and reflects FDA's experience with drugs 
exported for investigational use (whereby a minute percentage of all 
drugs exported for investigational use result in any safety concerns). 
The third option would permit exportation of drugs for investigational 
use to one of the countries specified in Section 802(b)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act without an IND or prior FDA 
approval. This third option would implement part of the FDA Export 
Reform and Enhancement Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Horton, Director, International Policy Staff, 
Office of Policy (HF-23), Department of

[[Page 21704]]

Health and Human Services, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 827-3344

RIN: 0910-AA61
_______________________________________________________________________




1007. REINVENTION OF ADMINISTRATIVE PROCEDURES REGULATIONS

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:  5 USC 504; 5 USC 551 to 558; 5 USC 701 to 721; 7 USC 
138; 7 USC 2271; 15 USC 638; 15 USC 1261 to 1282; 15 USC 1451 to 1461; 
15 USC 3701 to 3711; 21 USC 41 to 50; 21 USC 61 to 63; 21 USC 141 to 
149; 21 USC 321 to 394

CFR Citation:  21 CFR 1 to 3; 21 CFR 5; 21 CFR 10; 21 CFR 12; 21 CFR 19 
to 20; 21 CFR 56; 21 CFR 58

Legal Deadline: None

Abstract: FDA is considering ways to further streamline its 
administrative procedure regulations that are outdated or otherwise in 
need of reform. The agency is taking this action in response to 
President Clinton's March 4, 1995 directive to all Federal agencies to 
conduct a page-by-page review of their regulations as part of the 
``Reinventing Government'' initiative. FDA plans to reinvent 
approximately 45 percent of its regulations to ease the burden on 
regulated industry and consumers without sacrificing public health 
protection. For those regulations requiring Congressional permission to 
reinvent, the Administration will seek legislative changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           06/04/96                    61 FR 28116
NPRM                            00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: Lisa M. Helmanis, Office of Policy (HF-26), Department 
of Health and Human Services, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 443-3480
Fax: 301 443-2946

RIN: 0910-AA69
_______________________________________________________________________




1008. 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

Legal Deadline: None

Abstract: The Food and Drug Administration is evaluating its interim 
final regulation promulgated December 21, 1990, in light of 
recommendations made by the Presidential Advisory Committee on Gulf War 
Veterans' Illnesses as well as other information that has come to its 
attention. The interim rule established requirements to allow agency 
approval for the waiver of informed consent in the use of 
investigational drugs or biologics in certain military combat 
circumstances. In examining its interim rule, several areas have 
engendered significant discussion and debate. Because these issues are 
complex and will require extensive coordination, it is not possible to 
predict when more definitive guidance will be available in the form of 
a Federal Register document.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Brian J. Malkin, Associate Director for Patents and 
Hearings, Health Assessment Policy Staff (HFY-20), Department of Health 
and Human Services, Food and Drug Administration, Office of Health 
Affairs, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-1698
Fax: 301 443-0232
Email: [email protected]

RIN: 0910-AA89
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1009. DISQUALIFICATION OF CLINICAL INVESTIGATORS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 812

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/14/97                    62 FR 12087

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AA21
_______________________________________________________________________




1010. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES

Priority:  Info./Admin./Other

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

CFR Citation:  21 CFR 813; 21 CFR 812

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/29/97                     62 FR 4164

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0910-AA22
_______________________________________________________________________




1011. ELECTRONIC SIGNATURES; ELECTRONIC RECORDS

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:  21 CFR 11

[[Page 21705]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/20/96                    62 FR 13430

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Agency Contact: Paul J. Motise
Phone: 301 594-1089
Fax: 301 594-2202
Email: [email protected]

RIN: 0910-AA29
_______________________________________________________________________




1012. IRON CONTAINING DRUGS AND SUPPLEMENTS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 101; 21 CFR 111; 21 CFR 310

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/15/97                     62 FR 2218

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Linda Kahl
Phone: 202 418-3101

RIN: 0910-AA42
_______________________________________________________________________




1013. CONSOLIDATION OF REGULATIONS

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.

CFR Citation:  21 CFR 200.30; 21 CFR 200.31; 21 CFR 250.10; 21 CFR 
250.103; 21 CFR 250.106; 21 CFR 310.502; 21 CFR 310.504-510; 21 CFR 
310.513; 21 CFR 310.525; 21 CFR 310.526

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/14/97                    62 FR 12083

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary E. Catchings
Phone: 301 594-2041
Fax: 301 594-0152

RIN: 0910-AA53
_______________________________________________________________________




1014. HUMAN TISSUE INTENDED FOR TRANSPLANTATION AND HUMAN REPRODUCTIVE 
TISSUE INTENDED FOR INSEMINATION, FERTILIZATION, AND TRANSFER

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

Unfunded Mandates: Undetermined

CFR Citation:  21 CFR 1270

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/04/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Steven F. Falter
Phone: 301 594-3074
Fax: 301 443-3874
Email: [email protected]

RIN: 0910-AA70
_______________________________________________________________________




1015. ELIGIBILITY CRITERIA FOR CONSIDERING ADDITIONAL CONDITIONS IN THE 
OVER-THE-COUNTER DRUG MONOGRAPH SYSTEM; REQUEST FOR INFORMATION AND 
COMMENTS

Priority:  Other Significant

CFR Citation:  21 CFR 330

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Listed Under RIN 
0910-AA01                       04/04/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William E. Gilbertson
Phone: 301 827-2304
Fax: 301 827-2317

RIN: 0910-AA96
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1016. 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

Legal Deadline: None

Abstract: This NPRM proposes to require that in addition to reporting 
the National Practitioner Data Bank medical malpractice payments made 
where physicians or other health care practitioners are named in 
judgments or settlements, payments be reported where they are made for 
the benefit of physicians or other health care practitioners not named 
in the judgements 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 shield'' 
to prevent the health care practitioner from being reported.
It would also allow, 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, the amount of payment, and the name (if known) of any 
hospital or health care organization with which the practitioner is 
affiliated or associated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

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

[[Page 21706]]

Phone: 301 443-2300

RIN: 0906-AA41
_______________________________________________________________________




1017.  NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION 
ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: CHARGE FOR SELF-
QUERIES

Priority:  Info./Admin./Other

Legal Authority:  42 USC 11137

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: The NPRM proposes to amend the existing regulations for the 
National Practitioner Data Bank to give the Data Bank the authority to 
charge a fee to practitioners requesting information about themselves 
(self-queries). The current $10 cost per self-query is being 
underwritten by health care provider organizations which query the Data 
Bank directly and are charged a fee based on the number of 
transmissions and payment. The NPRM would amend the existing fee 
structure so that the Data Bank can fully recover its cost, as required 
by law, in an equitable manner.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

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-AA42
_______________________________________________________________________




1018.  NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION 
ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396r-2, note

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: Public Law 100-93 amended section 1921 of the Social Security 
Act to require that each State have in effect a system of reporting 
disciplinary licensure actions taken against all licensed health care 
practitioners and entities. It also requires States to report any 
negative action or finding which a peer review organization, private 
accrediation entity or a State has concluded against a health care 
practitioner or entity. Section 1921 directs the Secretary to provide 
for maximum appropriate coordination in the implementation of these 
reporting requirements with those of the Health Care Quality 
Improvement Act of 1986 (title IV of Public Law 99-660).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0906-AA43
_______________________________________________________________________




1019.  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 254c; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard Lee, Department of Health and Human Services, 
Health Resources and Services Administration, 4350 East/West Highway, 
Bethesday, MD 20814
Phone: 301 594-4283

RIN: 0906-AA44
_______________________________________________________________________




1020.  DRUG PRICING PROGRAM: PRIME VENDOR USER CHARGE

Priority:  Routine and Frequent

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 102-585

CFR Citation:  45 CFR 8

Legal Deadline: None

Abstract: This rule proposes to include a user charge (not over 1/2 of 
1% of total drug sale revenue) to be paid by the prime vendor to HRSA. 
It is intended to cover costs that HRSA incurs in providing information 
and services essential to prime vendor operations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

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: Annette Byrne, Director, Office of Drug Pricing, 
Department of Health and Human Services, Health Resources and Services 
Administration, 4350 East/West Highway, Bethesda, MD 20814
Phone: 301 594-4353
Fax: 301 594-4992

RIN: 0906-AA45

[[Page 21707]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1021. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Priority:  Other Significant

Legal Authority:  42 USC 1320b-8 sec 1138 of the Social Security Act; 
42 USC 274 sec 372 of the Public Health Service Act; 42 USC 274b sec 
374 of the Public Health Service Act; 42 USC 216 sec 215 of the Public 
Health Service Act

CFR Citation:  42 CFR 121

Legal Deadline: None
Section 215, 372 and 374 of the PHS Act provide general authority to 
regulate the activites of the Organ Procurement and Transplantion 
Network (OPTN) establish under section 372

Abstract: Section 1138 of the Social Security Act requires Medicare and 
Medicaid participating hospitals that perform organ transplants to be 
members of and abide by the rules and requirements of the Organ 
Procurement and Transplantation Network (OPTN) as established by 
section 372 of the Public Health Service Act. Section 1138 also 
requires that for organ procurement costs attributable to payments to 
an Organ Procurement Organization (OPO) to be paid by Medicare or 
Medicaid, the OPO must be a member of and abide by the rules and 
requirements of the OPTN. No other entity (for example, a 
histocompatibility laboratory) is required to be a member of or abide 
by the rules of the OPTN under the provisions of the statute. It is the 
Department's position that no rule, requirement, policy, or other 
issuance of the OPTN will be considered to be a ``rule or requirement'' 
of the Network within the meaning of section 1138 unless the Secretary 
has formally approved that rule. The OPTN is currently in operation and 
these rules will impose no further cost.

Statement of Need: These regulations are needed to establish a legally 
binding framwork for the operation of the OPTN and for participation in 
the OPTN by transplant hospitals and OPOs.

Summary of the Legal Basis: Section 215 of the Public Health Service 
Act, along with the provision of sections 372 and 374 of the Act (42 
USC 216, 274 and 274, respectively) provide authority to issue OPTN 
regulations. In addition section 113B of the Social Security Act (42 
USC 1320b-8) requires Medicare and Medicaid participating hospitals 
that perform organ transplants to be members of and abide by the rules 
and requirements of the Organ Procurement and Transplantation Network 
(OPTN) as established by section 372 of the Public Health Service Act 
(42 USC 274).

Alternatives: The alternative was to continue without codifying 
existing policies.

Anticipated Costs and Benefits: There are no anticipated costs beyond 
the cost of preparing the regulations (approximately $100,000.00). The 
anticipated benefit is that the regulations will make mandatory 
adherence to the policies set forth in the regulations.

Risks: None known.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/94                    59 FR 46482
NPRM Comment Period End         12/07/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD26.

Agency Contact: Judy Braslow, Director, Division of Transplantation, 
Bureau of Health Resources Development, Department of Health and Human 
Services, Health Resources and Services Administration, Room 7-29 
Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-7577

RIN: 0906-AA32
_______________________________________________________________________




1022. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS'/ 
HOLDERS' PERFORMANCE STANDARDS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 292 to 292o

CFR Citation:  42 CFR 60

Legal Deadline:  NPRM, Statutory, October 13, 1993.

Abstract: This Final rule amends the existing regulations governing the 
HEAL Program to establish standards for lenders and holders as required 
by the Health Professions Education Extension Amendments of 1992 (Pub. 
L. 102-408). These standards would provide lenders and holders a 
greater incentive to work to maintain low HEAL default rates and, thus, 
improve the long-term solvency of the Student Loan Insurance Fund.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/94                    59 FR 50103
NPRM Comment Period End         12/16/94


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD87.

Agency Contact: Michael Heningburg, Director, Division of Student 
Assistance, Bureau of Health Professions, Department of Health and 
Human Services, Health Resources and Services Administration, 5600 
Fishers Lane, Parklawn Bldg. Room 8-48, Rockville, MD 20857
Phone: 301 443-1173

RIN: 0906-AA33

[[Page 21708]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1023. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS AND 
ADDITIONS TO THE VACCINE INJURY TABLE--II

Priority:  Other Significant

CFR Citation:  42 CFR 100

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/20/97                     62 FR 7685

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas E. Balbier, Jr.
Phone: 301 443-6593

RIN: 0906-AA36
_______________________________________________________________________




1024. REMOVAL OF OBSOLETE REGULATIONS OF THE TITLE VII GRANT FOR THE 
CONSTRUCTION OF TEACHING FACILITIES FOR HEALTH PROFESSIONS PERSONNEL

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 57.101 to 57.108; 42 CFR 57.110 to 57.112

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/13/96                    61 FR 65477

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charlotte Pascoe
Phone: 301 443-5656

RIN: 0906-AA39
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1025. 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                            04/00/97
NPRM Comment Period End         07/00/97

Small Entities Affected: None

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)



_______________________________________________________________________




1026. ACQUISITION UNDER THE BUY INDIAN ACT

Priority:  Substantive, Nonsignificant

Legal Authority:  25 USC 47

CFR Citation:  48 CFR ch 3, app A

Legal Deadline: None

Abstract: This regulation will update and standardize existing 
regulations for the Buy Indian Act to coincide with the Department of 
Interior regulations at 48 CFR chapter 14. There are no costs 
associated with these revised regulations. These revisions will 
increase competition among Indian economic enterprises and facilitate 
economic development of Indian reservations by increasing opportunities 
for Indian businesses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/00/97

Small Entities Affected: None

Government Levels Affected: Tribal

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is a paperwork burden associated with this 
action.
Additional Information: Previously reported under RIN 0905-AE09.

Agency Contact: Myrna Mooney, Small and Disadvantaged Business 
Utilization Specialist, Department of Health and Human Services, Indian 
Health Service, 12300 Twinbrook Parkway, Suite 450, Rockville, MD 20852
Phone: 301 443-1480

RIN: 0917-AA00

[[Page 21709]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Agency for Health Care Policy and Research (AHCPR)



_______________________________________________________________________




1027. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND 
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 67

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/18/97                    62 FR 12906

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Phyllis Zucker
Phone: 301 594-2453

RIN: 0919-AA00
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1028. 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                            05/00/97

Small Entities Affected: 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, Building 31, 
Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA02
_______________________________________________________________________




1029. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 288-5

CFR Citation:  42 CFR 68a

Legal Deadline: None

Abstract: Regulations will be issued to govern the awarding of 
educational loan repayments under the NIH Clinical Research Loan 
Repayment Program for Individuals From Disadvantaged Backgrounds 
authorized by section 487E of the Public Health Service Act, as added 
by provisions of the NIH Revitalization Act of 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/97                     62 FR 5953
NPRM Comment Period End         04/11/97
Final Action Effective          09/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE56.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Building 31, 
Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA09
_______________________________________________________________________




1030. 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 PHS Act, as added by the NIH 
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                            09/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

Agency Contact: Jerry Moore, NIH Regulations Officer, Program, 
Department of Health and Human Services, National Institutes of Health, 
Building 31, Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892
Phone: 301 402-4606

RIN: 0925-AA10
_______________________________________________________________________




1031. TRAINEESHIPS (TERMINATION POLICIES)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 283g(d); 42 USC 284(b)(1)(C); 42 
USC 286b-3; 42 USC 287c(b)

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.

[[Page 21710]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

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, Building 31, 
Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA11
_______________________________________________________________________




1032. 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                            06/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: E. William Dommel, Jr., J.D., Senior Policy Anaylst, 
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: 301 496-7005
Fax: 301 402-2803
Email: [email protected]

RIN: 0925-AA14
_______________________________________________________________________




1033. NATIONAL RESEARCH SERVICE AWARDS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 288

CFR Citation:  45 CFR 66

Legal Deadline: None

Abstract: Current HHS regulations will be amended to reflect provisions 
of the ADAMHA Reorganization Act and the NIH Revitalization Act and the 
NIH Revitalization Act of 1993. New language concerning the service 
payback obligation will set forth 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                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Building 31, 
Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA16
_______________________________________________________________________




1034. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH

Priority:  Substantive, Nonsignificant

Legal Authority:  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 NIH 
Revitalization Act of 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Room 1B25, 31 Center Drive MSC 2075, Bethesda, MD 
20892-0275
Phone: 301 496-4606
Fax: 301 496-0125
Email: [email protected]

RIN: 0925-AA18
_______________________________________________________________________




1035.  NATIONAL INSTITUTES 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. The initial 
implementation of the program will be limited to employees of the three 
NICHD Contraception Research Centers and two NICHD Infertility Research 
Centers due to limited availability of funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Room 1B25, 31 Center DR MSC 2075, Bethesda, MD 20892-
2075
Phone: 301 496-4607
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA19

[[Page 21711]]

_______________________________________________________________________




1036.  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 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 governing peer 
review in NIH, SAMHSA, and HRSA. These regulations, which govern the 
first level of review, would be amended to correct the deficiencies 
which exist in the regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Room 1B25, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA20
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1037. 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 
progrmas 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 PHS Act 
section numbers, and update the listing of other HHS regulations 
releveant to contruction grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    09/00/97

Small Entities Affected: None

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, Building 31, 
Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA04
_______________________________________________________________________




1038. 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 
Clinical Cancer Education Program will be rescinded because the 
regulations are obsolete. Current guidelines communicated 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

________________________________________________________________________

Final Action                    09/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Building 31, 
Room 1B-25, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA17

[[Page 21712]]

_______________________________________________________________________


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


Office of Assistant Secretary for Health (OASH)



_______________________________________________________________________




1039. 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 
compliance standards 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE03.

Agency Contact: Thomas C. Kring, Acting Deputy Assistant Secretary for 
Population Affairs, Department of Health and Human Services, Office of 
Assistant Secretary for Health, East-West Towers, Suite 200, West 
Bldg., 4350 East West Highway, Bethesda, MD 20814
Phone: 301 594-4000

RIN: 0937-AA00
_______________________________________________________________________


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


Public Health Service (PHS)



_______________________________________________________________________




1040.  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 NIH Revitalization Act of 1993, Public Law 
103-43), the Department is proposing to add a new Part 94 to Title 42 
of the Code of Federal Regulations. Under this proposed regulation, 
covered institutions must follow certain requirements for preventing 
and responding to occurrences of retaliation against whistleblowers. 
The purpose of this Part is to protect: (1) persons who make a good 
faith allegation that a covered institution or member thereof engaged 
in, or failed to respond adequately to an allegation of, research 
misconduct, and (2) persons who cooperate in good faith with an 
investigation of research misconduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97
NPRM Comment Period End         10/00/97

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State

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

RIN: 0905-AE71
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Public Health Service (PHS)



_______________________________________________________________________




1041. ADDITIONAL REQUIREMENTS FOR FACILITIES TRANSFERRING OR RECEIVING 
SELECT AGENTS

Priority:  Info./Admin./Other

CFR Citation:  42 CFR 72.6

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/24/96                    61 FR 55190
Final Action Effective          04/15/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Dr. Jonathan Y. Richmond
Phone: 404 639-2453

RIN: 0905-AE70

[[Page 21713]]

_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1042. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (BPD-719-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 405; 42 CFR 401; 42 CFR 466.94; 42 CFR 411.23; 42 
CFR 411.28; 42 CFR 466.86; 42 CFR 473.14; 42 CFR 413.20; 42 CFR 413.153

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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-719

Agency Contact: David Walczak, Health Insurance Specialist, Office of 
Chronic Care & Insurance Policy, 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
_______________________________________________________________________




1043. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-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 1395hh; 42 USC 1395ii; 42 USC 1395oo; 42 
USC 1395ww; 42 USC 205

CFR Citation:  42 CFR 405.1801 to 405.1877

Legal Deadline: None

Abstract: Under section 1878 of the Social Security Act, the Provider 
Reimbursement Review Board (PRRB) has the authority to adjudicate 
substantial reimbursement disputes between providers and 
intermediaries. This proposed rule would revise, update, and clarify 
various provisions of the regulations pertaining to provider appeals 
before intermediaries and the PRRB.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-727

Agency Contact: Morty Marcus, Office of Chronic Care & Insurance 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477

RIN: 0938-AF28
_______________________________________________________________________




1044. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-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 section 6020 of OBRA '89 and section 
4755 of 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: HSQ-191

Agency Contact: Robert Streimer, Deputy Director for Survey & 
Certification, Health Standards and Quality Bureau, 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
_______________________________________________________________________




1045. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) DEBTS 
(BPO-108-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  31 USC 3711; 42 USC 1395y(b)(2)(B)

CFR Citation:  42 CFR 411.39; 42 CFR 405.378

Legal Deadline: None

Abstract: This proposed rule would establish CFR provisions 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BP0-108

Agency Contact: John Albert, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing

[[Page 21714]]

Administration, S3-02-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________




1046. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (OMC-016-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395l; 31 USC 9701

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

Legal Deadline: None

Abstract: This regulation would impose a range of requirements on 
health care prepayment plans corresponding to certain provisions for 
prepaid health plans under section 1876 of the Social Security Act. The 
expanded regulatory requirements would increase beneficiary protections 
and strengthen Federal oversight of the HCFA program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-016

Agency Contact: Tracy Jensen, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-23-
25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1033

RIN: 0938-AF97
_______________________________________________________________________




1047. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-764-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 1395l(a); 42 USC 1395x(aa); 42 USC 
1395y(a)(14); 42 USC 1396a(a)(13)(E); 42 USC 263a; 42 USC 1302; 42 USC 
1395hh

CFR Citation:  42 CFR 405; 42 CFR 410; 42 CFR 491

Legal Deadline: None

Abstract: This rule would update our regulations to incorporate several 
health care coverage and payment provisions contained in OBRAs '87, 
'89, and '90 and would propose administrative changes that clarify 
policy related to sharing space between rural health centers and other 
entities, such as physician offices, the replacement of the provider-
based cost basis system with the all-inclusive rate payment system, and 
the allowance of separate payment under part B for more complex 
laboratory services. Some changes pertain to Federally qualified health 
centers as well as rural health clinics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-764

Agency Contact: Helen Klein, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-06-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4641

RIN: 0938-AG05
_______________________________________________________________________




1048. ALTERNATIVE SANCTIONS FOR RENAL DIALYSIS FACILITIES (HSQ-204-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr(c); 42 USC 1395rr(g)

CFR Citation:  42 CFR 405.2181; 42 CFR 405.2182; 42 CFR 405.2184

Legal Deadline: None

Abstract: This proposal would set forth the circumstances under which 
HCFA could impose denial of payment as a sanction instead of 
terminating coverage when an 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: HSQ-204

Agency Contact: Debbie Schoenemann, Office of Survey & Certification, 
Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S2-19-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6771

RIN: 0938-AG31
_______________________________________________________________________




1049. DESCRIPTION OF HCFA'S EVALUATION METHODOLOGY FOR THE PEER REVIEW 
ORGANIZATIONS FIFTH SCOPE OF WORK CONTRACTS (HSQ-207-NC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1320c; 42 USC 1320c-2

CFR Citation:  42 CFR 462

Legal Deadline: None

Abstract: This notice with comment period will provide general criteria 
and standards that will be used to evaluate the effective and efficient 
performance of Utilization and Quality Control Peer Review 
Organizations (know as PROs) for new contracts entered into on or after 
April 1, 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-207

Agency Contact: Heidi Gelzer, Health Standards & Quality Bureau, 
Department of Health and Human

[[Page 21715]]

Services, Health Care Financing Administration, S1-08-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________




1050. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395g(a); 42 USC 1395x; 42 USC 1395z; 42 USC 
1395cc(a); 42 USC 1395ii; 42 USC 1396a(a)(28); 42 USC 1396r(a) to (f); 
42 USC 1302; 42 USC 1395i-3(a) to (f); 42 USC 1395aa; 42 USC 1395hh; 42 
USC 1395oo; 42 USC 1395d(a) and (c) and (d)

CFR Citation:  42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 42 
CFR 405.1843; 42 CFR 405.1805; 42 CFR 483.151; 42 CFR 484.36; 42 CFR 
489.2; 42 CFR 489.18

Legal Deadline: None

Abstract: This rule would amend the regulations on provider agreements 
by clarifying the effect a change of ownership has on penalties and 
sanctions incurred by Medicare providers. It would provide that all 
Medicare penalties and sanctions are automatically assigned to a new 
owner. It would also extend the same principle to certain suppliers; 
i.e., we would require the new owner of certain suppliers to be liable 
for any Medicare overpayments, penalties, and sanctions incurred by or 
imposed on the previous owner.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: None

Government Levels Affected: Undetermined

Additional Information: HSQ-215
LEGAL AUTHORITY CONT: 42 USC 1395f(b) 42 USC 1395l 42 USC 1395ww

Agency Contact: Mike Goldman, Health Standarads and Quality Bureau, 
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
_______________________________________________________________________




1051. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL THERAPY, RESPIRATORY 
THERAPY, SPEECH PATHOLOGY, AND OCCUPATIONAL THERAPY (BPD-808-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395x(v)(5)

CFR Citation:  42 CFR 413.106

Legal Deadline: None

Abstract: This proposed rule would revise the salary equivalency 
guidelines for Medicare payment for the reasonable costs of physical 
and respiratory therapy services furnished by providers under 
arrangements with an outside contractor. It would also propose initial 
salary equivalency guidelines for speech language pathology and 
occupational therapy services furnished by providers under arrangements 
with an outside contractor. The guidelines would be used by Medicare 
fiscal intermediaries to determine the maximum allowable costs of those 
services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/28/97                    62 FR 14851
NPRM Comment Period End         05/27/97
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-808

Agency Contact: Jacqueline Gordon, Health Insurance Specialist, 
Division of Home Care and Therapy, 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-AG70
_______________________________________________________________________




1052. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (MB-082-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(10)(A)(ii); PL 103-66, Sec 13603; 42 
USC 1396a(2)

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 TB-related services. 
The rule would incorporate and interpret provisions of section 13603 of 
OBRA '93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: MB-082

Agency Contact: Ingrid Osborne, Medicaid Bureau, Department of Health 
and Human Services, Health Care Financing Administration, C4-19-24, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________




1053. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION (BPD-
745-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 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 
1395(hh)

CFR Citation:  42 CFR 482; 42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would 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.

Statement of Need: The purpose of the hospital conditions of 
participation is

[[Page 21716]]

to protect patient health and safety and help assure that quality care 
is furnished to all hospital patients. Hospitals must meet the 
conditions of participation in order to participate in Medicare or 
Medicaid. Revised conditions are necessary to ensure that our 
regulations focus primarily on the actual quality of care furnished to 
patients, and the outcomes of that care, rather than on procedural 
compliance. These changes are intended to give hospitals the 
flexibility needed to achieve high-quality outcomes in the most cost-
effective manner.
In addition, the regulations are intended to promote a cross-
functional, interdisciplinary approach to hospital performance, instead 
of an approach geared towards evaluating each department of a hospital 
as a stand-alone entity. This approach is in line with current best 
practices in hospitals, in which patients routinely encounter many 
caregivers and services that often cut across department lines.

Summary of the Legal Basis: Section 1861(e) of the Social Security Act 
(the Act) provides that a hospital participating in the Medicare 
program must meet certain specified requirements. In addition, section 
1861(e)(9) of the Act specifies that a hospital also must meet such 
requirements that the Secretary finds are necessary in the interest of 
the health and safety of the hospital's patients. Under this authority, 
the Secretary has established in regulations the requirements that a 
hospital must meet to participate in Medicare. These requirements are 
set forth in regulations at 42 CFR part 482, Conditions of 
Participation for Hospitals. Section 1905(a) of the Act provides that 
Medicaid payments may be applied to hospital services. Under 
regulations at 42 CFR 440.10(a)(3)(iii), hospitals generally are 
required to meet the Medicare conditions of participation in order to 
participate in Medicaid.

Alternatives: HCFA considered the possibility of revising individual 
sections of the current hospital regulations. However, we determined 
that the best means of achieving the systematic changes needed in the 
regulations was to revise the hospital conditions in their entirety. 
The specific areas that are likely to form the core of the revised 
requirements include patient rights, patient assessment, patient care, 
quality assessment and improvement, and information management.

Anticipated Costs and Benefits: There would not be significant costs 
associated with this proposed rule. The benefits that would be derived 
from the rule are discussed in the Need section, above.

Risks: By revising these regulations to focus on the quality of the 
actual care given to an individual and the effectiveness of that care 
for the individual patient, we hope to reduce risks to beneficiaries' 
health and safety. Revised procedures can better focus on ensuring that 
the care being given to a patient is the care that is actually 
necessary and effective for that patient. No quantitative estimates of 
risk reductions are available yet.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-745

Agency Contact: Charles Booth, Director, Office of Hospital Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C5-02-23, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AG79
_______________________________________________________________________




1054. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES (BPD-
809-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395nn; 42 USC 
1396b

CFR Citation:  42 CFR 411.351 to 411.361; 42 CFR 435.1012; 42 CFR 
455.108; 42 CFR 455.109

Legal Deadline: None

Abstract: This proposed rule would provide that a physician who has (or 
whose 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 proposed 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 proposed rule are based on sections 13562 and 
13624 of OBRA '93 of OBRA '93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-809

Agency Contact: Joanne Sinsheimer, Office of Chronic Care Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-11-23, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AG80
_______________________________________________________________________




1055. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-819-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; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 1395bbb

CFR Citation:  42 CFR 484

Legal Deadline: None

Abstract: This proposed rule would 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. They do 
not effectively support the mandate of the Omnibus Budget 
Reconciliation Act of 1987 (OBRA '87) to develop a

[[Page 21717]]

patient-centered, outcome-oriented survey process that focuses on the 
organization and delivery of quality care services.

Statement of Need: Because the existing survey process continues to 
focus on structure and process measures, the discrepancy between a 
Congressional mandate for outcome-oriented care and the authority for 
measuring the actual performance capabilities of HHAs in patient care 
services remains a problem. It presents difficulties for both providers 
and surveyors in areas of survey/certification, medical review, 
developing data based performance standards for HHA management and 
monitoring, and implementing a continuous quality improvement system 
for outcomes of care.
Regulations containing the Medicare HHA conditions of participation 
must be revised in order to provide a regulatory basis for a patient-
centered, outcome-oriented system of home health quality assurance. The 
implementation of such a system will enhance Medicare's ability to 
ensure that high-quality care is furnished to the patients of Medicare-
certified home health agencies. The Social Security Act authorizes us 
to regulate this area and no improvements in the survey process can be 
made without underlying regulatory authority.
The Health Care Financing Administration has already met with a variety 
of provider and consumer representatives to discuss the development of 
revised standards. Representatives of consumers, providers, and States 
participated in this effort. Additional consultations are ongoing.

Alternatives: Congress has mandated the implementation of an outcome-
oriented quality assurance system for home health. Therefore, the 
Medicare home health agency conditions of participation must be revised 
to provide the basis for implementation of such a system. Because of 
this mandate, no alternatives to this action have been considered.

Anticipated Costs and Benefits: The primary benefit of this rule will 
be the implementation of a more effective, efficient, and patient-
centered system of quality assurance for HHAs. Costs and benefits 
associated with the implementation of the rule have not yet been 
estimated, but costs should not be significant.

Risks: This rule would have the potential for reducing risks to patient 
health and safety. No quantitative estimates are available yet.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-819

Agency Contact: Susan Levy, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, C4-05-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9364

RIN: 0938-AG81
_______________________________________________________________________




1056. END-STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (BPD-818-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 405; 42 CFR 406; 42 CFR 409; 42 CFR 412; 42 CFR 
413; 42 CFR 414; 42 CFR 489; 42 CFR 492; 42 CFR 400; 42 CFR 410; 42 CFR 
488

Legal Deadline: None

Abstract: This proposed rule would revise current conditions of 
coverage for end-stage renal disease (ESRD) services covered by 
Medicare. It would update the conditions to reflect new developments in 
outcome-oriented standards technology and equipment, emphasize the 
total patient experience with dialysis and develop performance 
expectations for the facility that result in quality, comprehensive 
care for the dialysis patient.

Statement of Need: Section 1881(b)(1) of the Social Security Act 
stipulates that payment is made to individuals, providers of services, 
and renal dialysis facilities that meet the requirements for 
institutional dialysis services and supplies that are determined by the 
Secretary. These requirements are the end-stage renal disease (ESRD) 
conditions of coverage.
The ESRD conditions for coverage regulations have not been 
comprehensively revised since their inception in the late 1970s. The 
current regulations primarily focus on process-oriented requirements, 
which are unnecessarily burdensome. They do not provide adequate 
support for a modern survey system based on an outcome-oriented 
approach. As a result, revised regulations must be issued to bring the 
ESRD conditions for coverage up to current standards of practice in the 
ESRD community. They must also reflect new developments in technology 
and equipment, as well as addressing the outcome-oriented standards 
process.
The regulations would focus on the patient and the results of the care 
provided to the patients with the emphasis on total patient experience 
with dialysis and quality improvement. The revised regulations should 
focus on patient-centered, outcome-oriented standards where 
appropriate. In addition, they should emphasize patient functional 
well-being and indicate continuous quality improvement. Patient rights 
and satisfaction will also be key areas in the regulation. The revised 
regulations would develop performance expectations for the facility 
that would result in quality, comprehensive care for the dialysis 
patient.
In keeping with the Administration's policy of working with our private 
sector partners, we held a meeting with the industry to discuss the 
focus of revisions to the conditions for coverage. Following 
publication of the proposed rule, we will consult further with the 
industry.

Alternatives: In the past, HCFA has revised pieces of the ESRD 
regulations. However, we have determined that a complete and thorough 
revision would be a more effective mechanism for developing a 
comprehensive approach to quality care for the dialysis patient. In 
addition, this approach provides greater potential for successful 
implementation. Another option is to update the current regulations and 
maintain the process-oriented standards without developing an outcome-
oriented approach. However, for the reasons discussed, we believe it is

[[Page 21718]]

important to move forward with the outcome-oriented approach.

Anticipated Costs and Benefits: The purpose of this proposed rule is to 
ensure that ESRD beneficiaries are receiving quality care in the areas 
of dialysis and transplantation. We believe that revised regulations 
are necessary to ensure that all facilities are using the most 
effective technology and equipment. The primary benefit of updating the 
conditions for coverage is the development of performance expectations 
for the facility that would result in the comprehensive, integrated 
care and outcomes the patient needs and wants. As a result, the 
beneficiaries would receive an improved quality of care. In addition, 
the revised regulations would address the issue of adequacy of 
dialysis, which would have a significant impact on ensuring that 
patients are not being underdialyzed.
Items that have the potential to affect the cost of the ESRD program 
include data gathering and infection control. However, at this time the 
cost or savings to the Medicare program have not yet been established, 
but costs should not be significant.

Risks: If the ESRD regulations are not updated, our regulations will 
not reflect new developments in technology and equipment, thereby 
denying the improved protections to patients' health care that would 
result from this proposed rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-818

Agency Contact: Lynn Merritt-Nixon, Office of Hospital Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-05-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4652

RIN: 0938-AG82
_______________________________________________________________________




1057. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE SCHEDULES 
(HSQ-219-GNC)

Priority:  Other Significant

Legal Authority:  42 USC 263a(m)

CFR Citation:  42 CFR 493.638; 42 CFR 493.649

Legal Deadline: None

Abstract: This general notice with comment period will announce updated 
fees that laboratories must pay as required by CLIA'88. Fee increases 
are necessary to meet the costs of program administration, which are to 
be borne by the laboratories

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HSQ-219

Agency Contact: Judy Yost, Health Standards and Quality Bureau, 
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-AG87
_______________________________________________________________________




1058. LIABILITY FOR THIRD PARTIES TO PAY FOR CARE AND SERVICES (MB-080-
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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: MB-080

Agency Contact: Robert Nakielny, Health Insurance Specialist, Medicaid 
Bureau, 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
_______________________________________________________________________




1059. AMBULANCE SERVICES (BPD-813-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395x(s)(7)

CFR Citation:  42 CFR 410.40; 42 CFR 410.41; 42 CFR 424.124

Legal Deadline: None

Abstract: This rule updates and revises policy on coverage of ambulance 
services. It bases coverage and payment for ambulance services on the 
medical services needed to treat the beneficiary's condition. It also 
clarifies Medicare policy on coverage of non-emergency ambulance 
services for Medicare beneficiaries. It defines an ambulance by 
describing the requirements for furnishing both basic and advanced life 
support levels of ambulance services. The rule would require use of 
additional HCFA common procedure coding systems (HCPCS) codes to show 
the origin and destination of the ambulance transportation on the 
billing form. It requires use of international classification of 
diseases, 9th revisions, clinical modification (ICD-9-CM) codes to bill 
the Medicare program for basic and advanced levels of ambulance 
services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Additional Information: BPD-813

Agency Contact: Margot Blige, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4642

RIN: 0938-AH13

[[Page 21719]]

_______________________________________________________________________




1060. ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR 
LENSES (BPD-831-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 1395k(a)(2); 42 USC 1395l; 42 USC 1395z; 42 
USC 1395aa; 42 USC 2630

CFR Citation:  42 CFR 416

Legal Deadline:  NPRM, Statutory, October 31, 1995.

Abstract: This rule would establish 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                            04/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-831

Agency Contact: Cathaleen Ahern, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-09-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4515

RIN: 0938-AH15
_______________________________________________________________________




1061. DEFINITION OF SKILLED NURSING FACILITY (SNF) FOR COVERAGE OF 
DURABLE MEDICAL EQUIPMENT (DME) (BPD-834-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(n); 42 USC 1395i(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 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. This rule would identify non-
Medicare nursing homes as skilled facilities based upon the receipt of 
skilled care by a proportion of its residents population that is at 
least comparable to the proportion typically found in participating 
Medicare SNFs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-834

Agency Contact: Thomas Hoyer, Director, Office of Chronic Care and 
Insurance Policy, 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
_______________________________________________________________________




1062. ADDITIONAL SUPPLIER STANDARDS (BPD-864-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 1395hh; 42 USC 1395m(j)

CFR Citation:  42 CFR 424.57

Legal Deadline: None

Abstract: This rule would 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                            06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-864

Agency Contact: Larry Bonander, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-11-24, 7500 Security Boulevard, Baltimore, MD 21214
Phone: 410 786-4479

RIN: 0938-AH19
_______________________________________________________________________




1063. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (MB-096-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 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 taking the issue directly to court. 
The reconsidered decision would then be made without a hearing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: MB-096

Agency Contact: Robert Tomlinson, Office of Beneficiary Services, 
Medicaid Bureau, 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

[[Page 21720]]

_______________________________________________________________________




1064. CHANGES IN COVERAGE AND PAYMENT POLICIES FOR PHYSICIAN ASSISTANT 
SERVICES (BPD-829-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395k; 42 USC 1395u(b)(2); 42 USC 
1395u(b)(12); 42 USC 1395x(s)

CFR Citation:  42 CFR 410.10; 42 CFR 410.74; 42 CFR 410.150; 42 CFR 
414.1; 42 CFR 414.52; 42 CFR 491.2

Legal Deadline: None

Abstract: This proposed rule concerns the coverage and payment policies 
for services performed by physician assistants and services furnished 
as incident to these services. It would conform Medicare regulations to 
the provisions in section 6114 of OBRA '89. It would also provide 
consistent qualification requirements for physician assistants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-829

Agency Contact: Bernadette Schumaker, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4568

RIN: 0938-AH26
_______________________________________________________________________




1065. HOSPICE CARE--CONDITIONS OF PARTICIPATION (BPD-844-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 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-844

Agency Contact: Thomas Saltz, Bureau of Policy Development, Department 
of Health and Human Services, Health Care Financing Administration, C4-
05-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4480

RIN: 0938-AH27
_______________________________________________________________________




1066. LIMITATIONS ON PAYMENT FOR HOME OXYGEN THERAPY BASED ON INHERENT 
REASONABLENESS CRITERIA (BPD-845-PN)

Priority:  Other Significant

Legal Authority:  42 USC 1395m(a); 42 USC 1395u(b)(8) and (9)

CFR Citation:  42 CFR 405.502(g); 42 CFR 414.210(d)

Legal Deadline: None

Abstract: This proposed notice would set forth our rationale for 
determining that Medicare's Part B payment allowances for home oxygen 
are grossly excessive and specifies the proposed change in our 
methodology for determining home oxygen payment amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 04/00/97

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: BPD-845

Agency Contact: William J. Long, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-12-18, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-5655

RIN: 0938-AH28
_______________________________________________________________________




1067. MEDICARE COVERAGE OF SERVICES OF SPEECH-LANGUAGE PATHOLOGISTS AND 
AUDIOLOGISTS (BPD-843-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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-843

Agency Contact: Jackie Gordon, Bureau of Policy Development, 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
_______________________________________________________________________




1068. MEDICARE: AMOUNT OF PAYMENTS IF CUSTOMARY CHARGES FOR SERVICES 
FURNISHED ARE LESS THAN REASONABLE COSTS (BPD-860-P)

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

[[Page 21721]]

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% 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% of the DME 
fee schedule amount, the lesser of costs or charges provision no longer 
applies and should be deleted from the CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-860

Agency Contact: Ward Pleines, Office of Hospital Policy, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C5-03-03, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4528

RIN: 0938-AH49
_______________________________________________________________________




1069. SUPPLIER PARTICIPATION AGREEMENTS AND LIMITS ON ACTUAL CHARGES OF 
NONPARTICIPATING PHYSICIANS (BPD-862-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 1395w(h); 42 USC 1395hh; 42 USC 
1395 rr(b)(1)

CFR Citation:  42 CFR 400; 42 CFR 414; 42 CFR 489

Legal Deadline: None

Abstract: The Deficit Reduction Act of 1984 established a voluntary 
participation program for physicians and suppliers under which 
physicians and suppliers enter into an agreement with Medicare that 
binds them to accept payment on an assignment-related basis for all 
services they furnish to Medicare beneficiaries. This proposed rule 
would set forth the terms and conditions of the participation 
agreements. This proposed rule would reflect provisions of OBRA '93 as 
to the suppliers subject to the charge limits, and provisions of SSA 
'94 as to administrative procedures for enforcing the charge limits. 
This rulemaking will revise text in the CFR to reduce burden or 
duplication, or streamline requirements. It will give beneficiaries the 
opportunity to make informed consumer decisions regarding the choice of 
Medicare Part B services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-862

Agency Contact: Anita Heygster, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-04-27, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4486

RIN: 0938-AH50
_______________________________________________________________________




1070. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 1998 RATES (BPD-878-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413

Legal Deadline:  NPRM, Statutory, May 1, 1997. Final, Statutory, 
September 1, 1997.

Abstract: Medicare pays for hospital inpatient services under a 
prospective payment system (PPS) in which payment is made at a 
predetermined specific rate for the operating and capital-related costs 
associated with each discharge. These rules would announce the 
prospective payment rates for operating and capital-related costs for 
FY 1998. We would also revise the Medicare hospital inpatient 
prospective payment systems for operating costs and capital-related 
costs to implement necessary changes arising from our continuing 
experience with the systems. In addition, we would set forth rate-of-
increase limits as well as policy changes for hospitals and hospital 
units excluded from the prospective payment systems. These changes 
would be applicable to discharges occurring on or after October 1, 
1997.

Statement of Need: Section 1886(e)(5) of the Social Security Act 
requires the Secretary to publish a proposed rule on prospective 
payment system policies and payment rates in the Federal Register by 
May 1 and a final rule by September 1.

Summary of the Legal Basis: As noted above, publication of proposed and 
final rules concerning hospital PPS policies and payment rates is 
required by law. The statute sets forth several specific requirements 
concerning what must be included in the PPS proposed and final rules 
(See sections 1886(b)(3)(B), 1886(d)(1)(A), 1886(d)(2)(H), 
1886(d)(3)(A), 1886(d)(3)(E), 1886(d)(4)(C), 1886(e)(4), 1886(e)(5), 
and 1886(g)(1)(A) of the Act.)

Alternatives: Publication of these rules is not discretionary. Thus, no 
alternatives exist.

Anticipated Costs and Benefits: We are unable to estimate at this time 
the costs and benefits associated with these rules.

Risks: Not applicable.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97
Final Action                    09/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: BPD-878

Agency Contact: Charles Booth, Director, Office of Hospital Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C5-02-23, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AH55

[[Page 21722]]

_______________________________________________________________________




1071. CONDITIONS FOR CERTIFICATION OF COMMUNITY MENTAL HEALTH CENTERS 
AND COVERAGE REQUIREMENTS FOR PARTIAL HOSPITALIZATION SERVICES (BPD-871-
P)

Priority:  Other Significant

Legal Authority:  42 USC 1395k; 42 USC 1395x; 42 USC 1395cc

CFR Citation:  42 CFR 410.43; 42 CFR 410.110; 42 CFR 410.150; 42 CFR 
410.172

Legal Deadline: None

Abstract: This proposed rule would establish health and safety 
standards that Community Mental Health Centers (CMHCs) must meet to 
participate in the Medicare program. It would also establish 
requirements for coverage of partial hospitalization services furnished 
by CMHCs or furnished in hospital outpatient settings. These changes 
would provide oversight for CMHCs, help curtail inappropriate 
utilization of partial hospitalization services, and ensure Medicare 
payment of reasonable and necessary services to eligible individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-871

Agency Contact: Janet Samen, Office of Chronic Care & Insurance Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C4-08-15, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9161

RIN: 0938-AH58
_______________________________________________________________________




1072. ALLOWABLE COSTS FOR FICA AND OTHER PAYROLL TAXES; MEDICARE (BPD-
876-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v)

CFR Citation:  42 CFR 413.100

Legal Deadline: None

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 allow that portion of 
employees FICA or other taxes that have accrued up to the end of the 
reporting period to be credited as allowable cost in the current 
reporting period and the remainder in the following period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-876

Agency Contact: John Eppinger, Office of Hospital Policy, Bureau of 
Policy Development, 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
_______________________________________________________________________




1073. MEDICAID; ESTATE RECOVERIES (MB-083-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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/97

Small Entities Affected: Undetermined

Government Levels Affected: State

Additional Information: MB-083

Agency Contact: Ingrid Osborne, Medicaid Bureau, Department of Health 
and Human Services, Health Care Financing Administration, C4-22-06, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4461

RIN: 0938-AH63
_______________________________________________________________________




1074. MEDICARE AS SECONDARY PAYOR TO LIABILITY INSURANCE (BPD-848-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 1395i-1; 42 USC 1395nn; 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-848

Agency Contact: Anita Heygster, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, 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

[[Page 21723]]

_______________________________________________________________________




1075. REDUCTION AND ELIMINATION OF CERTAIN REQUIREMENTS FOR PEER REVIEW 
ORGANIZATIONS IN THE UTILIZATION AND QUALITY REVIEW PROCESS (HSQ-235-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 1302c-3; 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 412.46; 42 CFR 462.107; 42 CFR 466.71; 42 CFR 
466.73

Legal Deadline: None

Abstract: This proposed rule would eliminate the requirement that Peer 
Review Organizations (PROs) conduct quarterly random sample reviews. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-235

Agency Contact: Bill Roskey, Health Insurance Policy Specialist, Health 
Standards and Quality Bureau, 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
_______________________________________________________________________




1076. INITIATIVE TO RECOGNIZE HEMODIALYSIS FACILITIES OF ACHIEVEMENT 
(HSQ-232-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395rr

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces our planned initiatives to establish a 
quality measurement system for hemodialysis facilities that will permit 
facilities to track, on a routine basis, patient specific health and 
clinical measures. It is part of a long range strategy to recognize 
facilities that consistently achieve high patient health outcomes and 
reward high performance with reduction in regulatory oversight, 
provided that high quality care continues.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Although this notice does not revise CFR text, 
it is part of the Reinventing Government effort. HSQ-232

Agency Contact: Judith Kari, Health Insurance Specialist, Health 
Standards & Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, S2-19-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6829

RIN: 0938-AH71
_______________________________________________________________________




1077. CONDITIONS OF ENROLLMENT FOR HEALTH CARE PROVIDERS SERVING 
MEDICARE BENEFICIARIES (BPO-143-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395hh

CFR Citation:  42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would establish new conditions of 
enrollment to avoid abuse of Medicare billing numbers. This would 
ensure legitimate providers of serivces and suppliers are appropriately 
identified and paid by the Medicare program. Enrollment is designed to 
prevent fraudulent providers of services and suppliers from obtaining 
Medicare billing numbers, thereby protecting both beneficiaries and the 
Medicare trust funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPO-143

Agency Contact: Jeffery Grant, Office of Program Requirements, Bureau 
of Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, S1-03-08, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7160

RIN: 0938-AH73
_______________________________________________________________________




1078. USE OF THE OASIS AS PART OF THE CONDITIONS OF PARTICIPATION FOR 
HOME HEALTH AGENCIES (HSQ-238-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 1395(hh); 42 USC 1395x(o); 42 USC 
12395bbb

CFR Citation:  42 CFR 484

Legal Deadline: None

Abstract: This proposed rule would add additional requirements to the 
proposed revision to the conditions of participation for home health 
agencies (HHAs). Specifically, this proposed rule would require that 
HHAs use a standard core assessment data set, the ``Outcomes and 
Assessment Information Set'' (OASIS) when evaluating adult, non-
maternity patients. This proposed rule is an integral part of the 
Administration's efforts to achieve broad-based, measurable improvement 
in the quality of care furnished through Federal programs. It is a 
fundamental component in the transition to a quality assessment and 
performance improvement approach that focuses on stimulating measurable 
improved outcomes of care and patient satisfaction in the Medicare home 
health benefit and in home care services in managed care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11035
NPRM Comment Period End         06/09/97

Small Entities Affected: Businesses

Government Levels Affected: Local

Additional Information: HSQ-238

Agency Contact: Mary Vienna, Division of Hospitals & Ambulatory 
Services, Department of Health and Human Services, Health Care 
Financing Administration, S2-18-04, 7500

[[Page 21724]]

Security Boulevard, Baltimore, MD 21224
Phone: 410 786-6940

RIN: 0938-AH74
_______________________________________________________________________




1079.  UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE 
LIST OF COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS 
EFFECTIVE FOR CALENDAR YEAR 1998 (BPD-885-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 13951(i)

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)

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                            06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-885-P

Agency Contact: Joan Sanow, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 
Baltimore, MD 21244
Phone: 410 786-5723

RIN: 0938-AH81
_______________________________________________________________________




1080.  CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL CENTER 
(BPD-887-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 416(Revision)

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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-887

Agency Contact: Terri Harris, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd, C4--10-06, Baltiore, MD 21244
Phone: 410 786-6830

RIN: 0938-AH83
_______________________________________________________________________




1081.  DISCLOSURE OF PEER REVIEW ORGANIZATION INFORMATION IN 
RESPONSE TO BENEFICIARY COMPLAINTS (HSQ-241-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 466.70(a); 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 new 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 would require PRO 
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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPO-105-f

Agency Contact: William Roskey, Health Insurance Specialist, Health 
Standards and Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, S1-09-07, 
Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AH85
_______________________________________________________________________




1082.  MEDICARE PROGRAM; BENEFICIARY INCENTIVES PROGRAMS (BPO-
144-P)

Priority:  Other Significant

Legal Authority:  PL 104-191, sec 203

CFR Citation:  42 CFR 420.400; 42 CFR 420.405; 42 CFR 420.410

Legal Deadline: None

Abstract: This proposed rule would establish a program for payment to 
individuals who provide information on Medicare fraud and abuse. It 
would also establish a program to collect information on Medicare 
program efficiency, improvements and allow for payment to the 
individuals who provide the information. Overall, it would implement 
sections 203(b) and 203(c) of the Health Insurance Portability and 
Accountability Act of 1996 (Public Law n104-191), enacted on August 21, 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPO-144-P

Agency Contact: John Thomas, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Blvd, C3-02-16, Baltimore, 
MD 21244
Phone: 410 786-2908

RIN: 0938-AH86

[[Page 21725]]

_______________________________________________________________________




1083.  STANDARD PAYER IDENTIFIER (BPO-145-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320d; 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 421; 45 CFR 61

Legal Deadline: None

Abstract: This rule would implement a standard alphanumeric identifier 
to identify health plans that process 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-145

Agency Contact: Faye Broseker, Health Insurance Specialist, Benefit 
Coordin., Office of Program Requirements, Department of Health and 
Human Services, Health Care Financing Administration, Bureau of Program 
Operations, S3-04-05, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3342

RIN: 0938-AH87
_______________________________________________________________________




1084.  MEDICARE PROGRAM; SCHEDULE OF LIMITS ON HOME HEALTH 
AGENCY COST PER VISIT FOR COST REPORTING PERIODS BEGINNING ON OR AFTER 
JULY 1, 1997 (BPD-889-NC)

Priority:  Other Significant

Legal Authority:  42 USC 1395x(v)(1)(L); 42 USC 1395x(note)

CFR Citation:  None

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

Abstract: This notice sets forth a revised schedule of limits in home 
health agency costs that may be paid under the Medicare program. These 
limits replace the per-visit limits that were set forth in our July 1, 
1996 notice with comment period. This notice also responds to comments 
on the July 1, 1996 notice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      04/00/97

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: BPD-889

Agency Contact: Michael Bussacca, Health Ins. Specialist, Office of 
Chronic Care & Ins. Policy/Bureau of Policy Develop., Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Blvd., C4-06-28, Baltimore, MD 21244
Phone: 410 786-4602

RIN: 0938-AH88
_______________________________________________________________________




1085.  MEDICAID PROGRAM; AMENDMENT TO THE PREADMISSION SCREENING 
AND ANNUAL RESIDENT REVIEW PROGRAM (MB-107-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 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 rule would clarify the statutory 
change that repealed the Medicaid program requirement for annual review 
of nursing facility residents with mental illness or mental retardation 
and requires a review in the case of a significant change in the 
physical or mental condition of such residents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: MB-107

Agency Contact: Jan Earle, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-12-03, Baltimore, MD 21244
Phone: 410 786-3326
Fax: 410 786-3262

RIN: 0938-AH89
_______________________________________________________________________




1086.  ALLOCATION OF ENHANCED FEDERAL MATCHING FUNDS FOR 
INCREASED ADMINISTRATIVE COSTS (MB-103-NC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice will provide a formula for the allocation of a 
special $500 million fund for enhanced Federal matching for State 
Agency's expenditures attributable to additional Medicaid 
administrative costs of Medicaid eligibility determinations as a result 
of the provisions of 1931 of the Social Security Act as amended by the 
Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      04/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-103

Agency Contact: Richard Strauss, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-18-26, Baltimore, MD 21244
Phone: 410 786-2019

RIN: 0938-AH90
_______________________________________________________________________




1087.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIANS FEE 
SCHEDULE FOR CALENDAR YEAR 1998, (BPD-884-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-4

CFR Citation:  42 CFR 410; 42 CFR 414

Legal Deadline: None

Abstract: This proposed rule would update physician payments by 
Medicare as required by section 1848 of the Social Security Act. This

[[Page 21726]]

proposal would include several policy changes involving resources-based 
practice expense relative value units services and supplies incident to 
a physician's service, supervision of diagnostic tests, geographic 
practice cost index changes, general surgical services, clinical 
psychologist services, and drugs and biologicals covered incident to a 
physician's services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-884-P

Agency Contact: Stanley Weintraub, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-10-26, Baltimore, MD 21244
Phone: 410 786-4498

RIN: 0938-AH94
_______________________________________________________________________




1088.  MEDICARE COVERAGE OF CERTIFIED NURSE-MIDWIFE SERVICES, 
(BPD-496-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(s); 42 USC 1395x(gg)

CFR Citation:  42 CFR 405.2411; 42 CFR 405.2414; 42 CFR 405.2415; 42 
CFR 410.10; 42 CFR 410.77

Legal Deadline: None

Abstract: This proposed rule would implement section 4073 of OBRA 1987 
by amending Medicare regulations to reflect Part B coverage of the 
services of certified nurse-midwives furnished without the supervision 
of a physician. It would define ``certified nurse-midwife'' and 
``certified nurse-midwife services.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-496-P

Agency Contact: Roberta Epps, Health Insurance Specialist, Division of 
Ambulatory Care Services, BPD, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, C4-0516, 
Baltimore, MD 21244
Phone: 410 786-4475

RIN: 0938-AH96
_______________________________________________________________________




1089.  STANDARD HEALTH CARE PROVIDER (BDM-45-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d

CFR Citation:  45 CFR 61; 42 CFR 489.61; 42 CFR 489.63; 42 CFR 489.65; 
42 CFR 489.67; 42 CFR 489.69

Legal Deadline: None

Abstract: This rule would address the health care industry's need for a 
standardized provider identifier. It would implement one of the 
requirements for administrative simplification in section 262 of the 
Health Insurance Portability and Accountability Act of 1996. A standard 
provider identifier would save the health insurance industry 
significant costs incurred in maintaining multiple identifier systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: BDM-45-P

Agency Contact: Karen Trudel, Chief, Provider Processes Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, Bureau of Data Management and Strategy, 7500 Securtiy 
Blvd, N3-06-13, Baltimore, MD 212244
Phone: 410 786-9937

RIN: 0938-AH99
_______________________________________________________________________




1090.  MEDICARE PROGRAM; MEDICARE INTEGRITY PROGRAM; (OFH-020-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-191

CFR Citation:  42 CFR 421

Legal Deadline: None

Abstract: This proposed rule would implement section 202 of the Health 
Insurance Portability and Accountability Act of 1996 (Public Law 104-
191) 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, 
identify the services to be procured, set forth competitive 
requirements, establish procedures for identification, evaluation, and 
resolution of conflicts of interest, and set forth contractor 
indemnification rules.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OFH-020-P, PL 104-1191, sec. 202

Agency Contact: Sharon Harris, Deputy Director, Office of Acquistions 
and Grants, Department of Health and Human Services, Health Care 
Financing Administration, C2-21-15, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-9419

RIN: 0938-AI09
_______________________________________________________________________




1091.  MEDICARE PROGRAM; IMPROVEMENTS TO THE APPEALS PROCESS FOR 
MEDICARE BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (OMC-024-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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, Health Insurance Specialist, Office of 
Managed Care, Department of Health and Human Services, Health Care

[[Page 21727]]

Financing Administration, Baltimore, MD 21244
Phone: 410 786-1097

RIN: 0938-AI11
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1092. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435.831; 42 CFR 436.831

Legal Deadline: None

Abstract: This final rule amends and responds to comments on a final 
rule with comment period published in the Federal Register on January 
12, 1994. That rule permits States flexibility to revise the process by 
which incurred medical expenses are considered to reduce an 
individual's or a family's income in order for the individual or family 
to become Medicaid eligible. The revisions permit States greater 
flexibility by offering options that will allow them to simplify the 
administration of their Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/02/83                    48 FR 39959
NPRM Comment Period End         11/16/83
Interim Final Rule              01/12/94                     59 FR 1659
Final Rule With Comment Period  01/12/94                     59 FR 1659
Comment Period End              03/14/94
Effective Date                  03/14/94
Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: MB-020

Agency Contact: Jackie Wilder, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-23-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4579

RIN: 0938-AB07
_______________________________________________________________________




1093. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (BPD-309-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395k; 42 USC 
1395m(b); 42 USC 1395u(b) and (h); 42 USC 1395w(4); 42 USC 1395x(b) and 
(s) and (v); 42 USC 1395y(a)(14); 42 USC 1395cc(a); 42 USC 1395hh; 42 
USC 1395rr; 42 USC 1395ww; 42 USC 1395xx; 42 USC 1395zz

CFR Citation:  42 CFR 414.1; 42 CFR 414.2; 42 CFR 414.5; 42 CFR 
405.556; 42 CFR 431.54; 42 CFR 447.342

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
Final Action                    09/00/97
Final Action Effective          09/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-309

Agency Contact: Charles Spalding, Division of Ambulatory Care Services, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C4-05-24, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4496

RIN: 0938-AB50
_______________________________________________________________________




1094. EFFECTIVE DATES FOR PROVIDER AGREEMENTS AND SUPPLIER APPROVALS 
(HSQ-139-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 431; 42 CFR 442; 42 CFR 488; 42 CFR 489; 42 CFR 
498

Legal Deadline: None

Abstract: This rule will establish uniform criteria for determining the 
effective dates of Medicare and Medicaid provider agreements and of the 
approval of Medicare suppliers when the provider or supplier is subject 
to survey as a basis for determining participation in those programs. 
It also establishes appeal rights and procedures for entities that are 
dissatisfied with effective date determinations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/92                    57 FR 46362
NPRM Comment Period End         12/07/92
Final Action                    04/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: HSQ-139

Agency Contact: Robert Streimer, Depty Dir., Office of Survey & 
Certification, Health Standards and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-19-
26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-8475

RIN: 0938-AC88
_______________________________________________________________________




1095. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-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

[[Page 21728]]

duplication, or streamline requirements.

Legal Authority:  42 USC 1395y(a); 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
Final Action                    11/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-135

Agency Contact: Bill Roskey, Health Insurance Policy Specialist, 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
_______________________________________________________________________




1096. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-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 1395y(b)

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This rule will codify in the CFR the Medicare secondary 
payers (MSP) provision, under the Social Security Act, for disabled 
individuals who are covered under large group health plans (LGHPs). 
Under this provision LGHPs may not take into account that such 
individuals are entitled to Medicare. The rule contains procedures 
under which a plan can appeal a determination of nonconformance which 
could lead to an excise tax. It reflects statutory revisions mandated 
by OBRA '86, OBRA '89, and OBRA '93, some of which also affect the MSP 
provisions for persons who are entitled on the basis of age or end-
stage renal disease.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/08/90                     55 FR 8491
NPRM Comment Period End         05/08/90
Final Rule With Comment Period  08/31/95                    60 FR 45344
Effective Date                  10/02/95
Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-482

Agency Contact: Herbert Pollock, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-14, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AD73
_______________________________________________________________________




1097. REVISIONS TO REGULATIONS IMPLEMENTING CLIA (HSQ-226-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 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This rule will respond to public comments received on a final 
rule published on February 28, 1992. The rule revised regulations 
applicable to laboratories and implemented provisions of the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA), Public law 100-578. 
The regulations apply to laboratories that examine human specimens for 
the diagnosis, prevention, or treatment of any disease or impairment 
of, or the assessment of the health of, human beings. They specify the 
performance requirements, based on test complexity and risk factors 
related to erroneous test results as required by CLIA, that apply to 
laboratories that are subject to CLIA. They also list requirements that 
permit waiver of the certification and inspection requirements for 
laboratories performing only limited testing.

Statement of Need: On October 31, 1988, the Congress enacted 
comprehensive changes to existing laboratory regulations in CLIA. This 
statute requires the regulation of any facility (including physician 
offices) that performs tests on human beings for the purpose of 
providing information for the diagnosis, prevention, or treatment of 
any disease or impairment of, or the assessment of the health of, human 
beings. Historically, the Department had regulated laboratories by 
``location,'' rather than by the types of tests they performed. CLIA 
requires that the Department regulate by test, using what is commonly 
referred to as the ``complexity model'' to categorize individual 
laboratory tests based on the experience, skills, and judgment required 
to perform each test accurately. Requirements vary as a function of the 
complexity of the tests the laboratory conducts.
The law requires the Secretary to implement the numerous provisions 
through regulation to ensure the quality of laboratory testing, 
regardless of where it is provided or who is providing the testing. The 
law also requires the CLIA program be operated through the assessment 
of user fees paid by entities subject to these requirements.
On May 21, 1990, the Department published proposed rules to implement 
CLIA and received public comments from over 60,000 commenters. Based on 
analysis of these comments, the Centers for Disease Control and 
Prevention with the Health Care Financing Administration developed a 
final rule with comment period that set forth standards for all 
entities performing laboratory testing based on test complexity. This 
rule was published on February 28, 1992, and was effective September 1, 
1992. This regulation was

[[Page 21729]]

revised by regulations with comment period published on January 19, 
1993, December 6, 1994, and April 24, 1995.
Issues that will be addressed in this rule include quality control, 
quality assurance, personnel standards, cytology requirements; 
proficiency testing (PT) requirements; employee workplace drug testing; 
and other issues raised by commenters based on experience with CLIA 
implementation.
The Clinical Laboratory Improvement Advisory Committee (CLIAC), which 
is composed of members of professional organizations and private 
citizens, is actively involved in making recommendations regarding 
technical and scientific aspects of the regulations. In addition, we 
actively solicit comments from outside organizations such as the 
American Medical Association, the Association of State and Territorial 
Public Health Laboratory Directors, and other professional and medical 
organizations regarding the interpretive guidelines for surveyors.

Summary of the Legal Basis: This rule summarizes and responds to CLIAC 
recommendations and public comments to four previously published CLIA 
regulations.

Alternatives: HHS is currently developing a final rule that will 
address comments received on the final rule with comment period 
published February 28, 1992, and further comments received in response 
to the January 19, 1993, December 6, 1994, and April 24, 1995 rules 
with comment period. Based on these comments, modifications to improve 
the cost-effectiveness of the CLIA standards are under consideration.

Anticipated Costs and Benefits: It is not possible to project costs and 
benefits of the rule at this time. These regulations serve to ensure 
consistent, reliable laboratory testing that is an integral part of 
ensuring that individuals receive appropriate treatment.

Risks: Inferior and inappropriate laboratory testing can result in 
misdiagnosis causing patient harm. CLIA reduces the potential for 
inaccurate diagnosis resulting from poorly performed laboratory testing 
since entities must meet requirements (e.g., quality assurance, 
proficiency testing, quality control, personnel requirements) that have 
a direct impact on laboratory testing results. Overly stringent 
standards could, however, discourage needed testing and reduce early 
detection of health problems. The Department does not at this time have 
an estimate of the magnitude and severity of these types of risks, but 
believes that both the original regulations and the revisions will on 
balance contribute to better diagnosis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/21/90                    55 FR 20896
NPRM Comment Period End         09/21/90
Final Rule With Comment Period  02/28/92                     57 FR 7002
Comment Period End              04/28/92
Effective Date                  09/01/92
Final Rule Effective Date       01/19/93
Final Rule With Comment Period  01/19/93                     58 FR 5215
Comment Period End              03/22/93
Final Action                    12/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-226

Agency Contact: Robert Streimer, Deputy Director for Survey & 
Certification, Health Standards and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-19-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6763

RIN: 0938-AE47
_______________________________________________________________________




1098. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395i-3; 42 USC 1396r

CFR Citation:  42 CFR 483

Legal Deadline: None

Abstract: This final rule will provide Medicare and Medicaid nursing 
homes the requirements for a comprehensive, standardized, reproducible 
resident assessment instrument. All certified nursing homes are 
currently required to assess residents using a standardized data set 
known as the minimum data set (MDS). Nursing homes have been collecting 
this information manually since October 1990. Most States implemented a 
second generation assessment instrument, known as MDS 2.0, on January 
1, 1996. The use of the MDS as the core of the comprehensive assessment 
requirement has improved the quality of nursing home services by 
assuring that the assessment is consistently based on all information 
that is necessary to evaluate a resident's needs. Accurate and 
comprehensive resident assessments have improved the accuracy of the 
care planning process and ultimately, the care provided by the nursing 
home. However, in order to realize the full benefits of the MDS, the 
information needs to be computerized, and configurable as an analytical 
tool. Publication of this rule will allow this goal to be realized by 
requiring electronic reporting of MDS data and provide support for the 
computerization of the MDS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/28/92                    57 FR 61614
NPRM Comment Period End         02/26/93
Final Action                    06/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HSQ-180

Agency Contact: Sue Nonemaker, Health Standards Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-20-08, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6825

RIN: 0938-AE61
_______________________________________________________________________




1099. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OMC-
003-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395mm

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule will require health maintenance organizations 
(HMOs) or competitive medical plans (CMPs) that cease to contract with 
HFCA under section 1876 of the Social Security Act to arrange for 
supplemental coverage for former Medicare enrollees who would otherwise 
be subject to a pre-existing condition exclusion under a Medicare 
supplemental policy; provide a 30-day open enrollement period for

[[Page 21730]]

individuals who would otherwise lose prepaid Medicare coverage as a 
result of termination, non-renewal or reduction in service area of a 
risk contract; accelerate the deadline for risk contracting HMOs and 
CMPs to furnish a copy of an executed enrollment application form to 
Medicare applicants; and, require health care prepayment plans to 
comply with HMO/CMP beneficiary application procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/11/94                    59 FR 11230
NPRM Comment Period End         05/09/94
Final Action                    08/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: OMC-003

Agency Contact: Tracy Jensen, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1033

RIN: 0938-AE63
_______________________________________________________________________




1100. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-685-
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 implement 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
Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-685

Agency Contact: Marc Hartstein, Health Insurance Specialist, Division 
of Hospital Services, 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
_______________________________________________________________________




1101. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE FACILITIES, 
AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED (BPD-650-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 1395x(e); 42 USC 
1395i-3; 42 USC 1396d; 42 USC 1396r

CFR Citation:  42 CFR 482.41(b)(1); 42 CFR 483.70(a); 42 CFR 
483.470(j)(2)(i)(C); 42 CFR 483.470(j)(1)

Legal Deadline: None

Abstract: This final rule with comment period will revise the fire 
safety certification standards for hospitals, long-term care 
facilities, and intermediate care facilities for the mentally retarded 
under the Medicare and Medicaid Programs. It will require compliance 
with the latest edition of the Life Safety Code of the National Fire 
Protection Association rather than with previous editions that are now 
outdated. The revisions will update the health and safety requirements 
that health care facilities furnishing services to Medicare 
beneficiaries must meet to ensure that patients, residents and 
personnel are safe from fire.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/01/90                    55 FR 31196
NPRM Comment Period End         10/01/90
Final Rule With Comment Period  07/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-650

Agency Contact: James Kenton, Division of Skilled Nursing Care, Bureau 
of Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-11-06, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-5629

RIN: 0938-AE97
_______________________________________________________________________




1102. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395x(s)(14); 42 USC 1395x(nn); 42 USC 
1395y(a)(1)(F)

CFR Citation:  42 CFR 410.10; 42 CFR 410.32; 42 CFR 410.56; 42 CFR 
411.15

Legal Deadline: None

Abstract: This rule will establish 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
Final Action                    07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-705

Agency Contact: Joyce Eng, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-02-26, 7500 Security 
Blvd., Baltimore, MD 21244

[[Page 21731]]

Phone: 410 786-4619

RIN: 0938-AE98
_______________________________________________________________________




1103. MEDICARE COVERAGE OF AND APPLICATION OF THE OUTPATIENT MENTAL 
HEALTH TREATMENT LIMITATION TO, CLINICAL PSYCHOLOGIST, AND CLINICAL 
SOCIAL WORKER SERVICES (BPD-706-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395l(c); 42 USC 1395x(hh)(2); 42 USC 
1395x(ii)

CFR Citation:  42 CFR 410; 42 CFR 417; 42 CFR 424

Legal Deadline: None

Abstract: This rule will address provisions of section 6113 of OBRA '89 
and section 4157 of OBRA '90. Section 6113 of OBRA '89 provides 
coverage for the services of clinical psychologists (CPs) and clinical 
social workers. It requires CPs to agree to consult with the patient's 
primary care or attending physician. (Also, it will eliminate the 
dollar limitation that previously applied to mental health services, 
although the 62.5 percent limitation still applies). OBRA '89 also 
provides coverage for clinical social worker services, but places two 
limitations on separate payment, which apply to services provided to 
inpatients of hospitals and skilled nursing facilities that are 
Medicare participating. Section 4157 of OBRA '90 unbundled CP services 
from the definition of ``inpatient hospital services.'' It also 
implements sections 104 (psychology services in hospitals) and 147 
(consultation by social workers) of the Social Security Act Amendments 
of 1994.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/29/93                    58 FR 68829
NPRM Comment Period End         02/28/94
Final Action                    07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-706

Agency Contact: Regina Walker, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-16, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6735

RIN: 0938-AE99
_______________________________________________________________________




1104. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (OMC-
018-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(m); 42 USC 1396a(e)(2)(A)

CFR Citation:  42 CFR 434.20 to 44; 42 CFR 435.212; 42 CFR 435.362

Legal Deadline: None

Abstract: This rule will require certain health insuring organizations 
to be subject to the regulations governing prepaid health plans. This 
rule will also allow State-only funds to be paid to Medicaid 
contracting entities. These funds will not be considered when computing 
the rate at which Federal financial participation is made. Further, 
this rule will incorporate several technical amendments from section 
4732 of OBRA '90.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/09/94                    59 FR 23820
NPRM Comment Period End         07/08/94
Final Action                    09/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-018

Agency Contact: Jane McClard, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4460

RIN: 0938-AF15
_______________________________________________________________________




1105. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (MB-046-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 1396a(a); 42 USC 1396b(i); 42 USC 1396r-8; 42 
USC 1396b(a); 42 USC 1302

CFR Citation:  42 CFR 447; 42 CFR 441

Legal Deadline: None

Abstract: This rule 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 
also 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
Final Action                    10/00/97

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: MB-046

Agency Contact: Estelle Chisholm, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-15-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3286

RIN: 0938-AF42
_______________________________________________________________________




1106. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH 
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (OMC-015-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm; 42 USC 300e; 42 USC 300e-5; 42 USC 
300e-9; 31 USC 9701

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

Legal Deadline: None

Abstract: This rule will implement section 4204(e) of OBRA '90. It will

[[Page 21732]]

permit HCFA to make retroactive payments for up to 90 days when there 
is a delay in notifying HCFA that a beneficiary has enrolled under a 
section 1876 (of the Social Security Act) risk contract through an 
employer health plan. In addition, the rule will permit the Secretary 
to authorize retroactive disenrollment in specific cases.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/27/93                    58 FR 68366
Comment Period End              02/25/94
Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-015

Agency Contact: Anne Manley, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1096

RIN: 0938-AF98
_______________________________________________________________________




1107. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ww(a)(4)

CFR Citation:  42 CFR 412.2(c); 42 CFR 413.40

Legal Deadline: None

Abstract: This rule will finalize provisions published in an interim 
final rule with comment period on January 12, 1994, and responds to 
comments received on that rule. The interim final rule implemented 
section 4003 of OBRA '90, entitled ``Expansion of DRG Payment Window,'' 
which amended the statutory definition of ``operating costs of 
inpatient hospital services'' to include certain preadmission services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Effective Date                  01/12/94                     59 FR 1654
Interim Final Rule With Comment 
Period                          01/12/94                     59 FR 1654
Comment Period End              03/14/94
Final Action                    06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-731

Agency Contact: Nancy Edwards, Director, Division of Prospective 
Payment System, Department of Health and Human Services, Health Care 
Financing Administration, C5-06-27, 7500 Seurity Blvd., Baltimore, MD 
21244
Phone: 410 786-4531

RIN: 0938-AG00
_______________________________________________________________________




1108. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL 
EMPLOYEE HEALTH BENEFITS (BPD-748-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:  5 USC 8904(b)

CFR Citation:  42 CFR 489

Legal Deadline: None

Abstract: This final rule will amend current Medicare regulations to 
require that payment limitations apply to hospitals that furnish 
inpatient hospital services to retired Federal workers, aged 65 or 
older, who are enrolled in a Federal Employee Health Benefits (FEHB) 
plan but not covered under Medicare part A (Hospital Insurance). The 
payment amount will approximate the Medicare diagnosis-related group 
payment rates established under the inpatient hospital Medicare 
prospective payment rate. This rule will also amend current Medicare 
regulations to authorize HCFA to consider terminating or nonrenewing a 
hospital's Medicare provider agreement if the hospital repeatedly fails 
to accept the Medicare rate as payment in full for inpatient hospital 
services provided to retired Federal workers enrolled in a fee-for-
service from a FEHB plan who do not have Medicare part A coverage. This 
rule will implement section 7002(f) of OBRA '90, enacted November 5, 
1990. It will clarify that an institutional provider may not 
discriminate against Medicare patients in providing services because it 
is dissatisfied with the level of Medicare payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/94                     59 FR 6228
NPRM Comment Period End         04/11/94
Final Action                    09/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-748

Agency Contact: Paul Olenick, Director, Division of Beneficiary and 
Insurance Issues, Department of Health and Human Services, Health Care 
Financing Administration, C4-07-07, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4472

RIN: 0938-AG03
_______________________________________________________________________




1109. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(r)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice sets forth revised general functional 
requirements for the Medicaid Management Information System (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
Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-038

Agency Contact: Richard Friedman, Director, Office of Information 
Systems and Data Analysis, Department of Health and Human Services, 
Health Care Financing Administration, C4-22-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4451

RIN: 0938-AG10

[[Page 21733]]

_______________________________________________________________________




1110. END-STAGE RENAL DISEASE (ESRD) PAYMENT EXCEPTION REQUESTS AND 
ORGAN PROCUREMENT COSTS (BPD-763-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 1395rr

CFR Citation:  42 CFR 413.170; 42 CFR 413.172; 42 CFR 413.174; 42 CFR 
413.176; 42 CFR 413.178; 42 CFR 413.179; 42 CFR 413.180; 42 CFR 
413.182; 42 CFR 413.184; 42 CFR 413.186; 42 CFR 413.188; 42 CFR 
413.190; 42 CFR 413.192; 42 CFR 413.194; 42 CFR 413.196; ...

Legal Deadline: None

Abstract: This final rule will specify the criteria HCFA will use to 
determine if a facility furnishing dialysis services to patients with 
end-stage renal disease qualifies for a higher payment under an 
exception to the prospectively determined payment rate; and the 
procedures used to evaluate ESRD payment exceptions requests. The rule 
will also revise the way HCFA computes acquisition costs for organs 
that are transplanted into Medicare beneficiaries. The rule is part of 
the Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/26/94                    59 FR 44097
NPRM Comment Period End         10/25/94
Final Action                    10/00/97

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-763

Agency Contact: Michael Powell, Health Insurance Specialist, Division 
of End-Stage Renal Disease, Department of Health and Human Services, 
Health Care Financing Administration, C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4557

RIN: 0938-AG20
_______________________________________________________________________




1111. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

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                    07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-781

Agency Contact: Francine Spencer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, 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
_______________________________________________________________________




1112. TELEPHONE AND ELECTRONIC REQUESTS FOR REVIEW OF PART B INITIAL 
CLAIM DETERMINATIONS (BPO-121-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 1395ff; 42 USC 1395hh; 42 USC 1395ii; 42 USC 
405a; 42 USC 1302; 42 USC 1395u(b)(3)(c)

CFR Citation:  42 CFR 405.807

Legal Deadline: None

Abstract: This rule will make it easier for beneficiaries, providers, 
and physicians (and other suppliers) who are entitled to appeal 
Medicare part B initial claim determinations to request review of the 
carrier's initial determination. Currently, these appeals must be in 
writing. This expanded rule will also allow appeals to be made by 
telephone or electronically, which will expedite the appeal process, 
and save time and costs for all parties. Allowing the use of telephone 
and electronic requests will supplement, not replace, the current 
review procedures. By providing quick and easy access to the appeals 
process, this rule will also improve carrier relationships with the 
provider and beneficiary communities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/10/95                    60 FR 35544
NPRM Comment Period End         09/08/95
Final Action                    07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-121

Agency Contact: Rosalind Little, Bureau of Program Operations, 
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
_______________________________________________________________________




1113. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE SERVICES UNDER 
THE MEDICARE PROGRAM (BPD-820-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 1395f(i); 5 USC 561 to 590

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: The Medicare hospice benefit has been in effect since 1983. 
This rule will update the wage index used to adjust payment rates to 
reflect local differences in area wage levels. This rule is the 
successful result of a

[[Page 21734]]

``negotiated rulemaking'' proceeding under the Negotiated Rulemaking 
Act of 1990, and is part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent                10/14/94                    59 FR 52129
NPRM                            09/04/96                    61 FR 46579
NPRM Comment Period End         11/04/96
Final Action                    06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-820

Agency Contact: Janice Flaherty, Director, Division of Home Care & 
Therapy, Department of Health and Human Services, Health Care Financing 
Administration, C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4637

RIN: 0938-AG93
_______________________________________________________________________




1114. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HSQ-225-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 263a

CFR Citation:  42 CFR 493.2; 42 CFR 493.7; 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.

Statement of Need: This final rule will clarify and expand the waiver 
criteria and streamline the waiver process so that more tests may be 
categorized as waived; that is, free from CLIA performance and 
personnel requirements.

Summary of the Legal Basis: The Clinical Laboratory Improvement 
Advisory Committee (CLIAC) was established to advise and make 
recommendations on technical and scientific aspects of the regulations. 
The CLIAC recommended that the criteria for categorizing tests as 
waived be better defined. As a result of the comments concerning waived 
tests and the CLIAC recommendations, the Centers for Disease Control 
and Prevention developed criteria for placing tests in the waived 
category as outlined in this proposal.

Alternatives: Performance standards based on current analysis specific 
criteria would continue to limit technology and inhibit innovative 
ideas.

Anticipated Costs and Benefits: This regulation decreases burden, 
especially for physician office laboratories due to virtually no 
regulatory oversight. It increases access to a greater variety of 
tests. Physician office laboratories may expand the range of tests they 
perform without an increase in costs/burden. The regulation creates 
incentives for manufacturers to develop more test systems that meet the 
clarified waiver criteria and criteria for approval for home use. It 
eliminates inspection fees for many of the 60,000 physician offices and 
other small laboratories performing tests that will fall into the 
expanded waived category.

Risks: The expansion of the waived criteria and development of a 
process protocol will provide for consistent application of detailed 
standards in order to ensure that tests categorized as waived preclude 
any reasonable risk of harm to patient as a result of testing error.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/13/95                    60 FR 47534
NPRM Comment Period End         11/13/95
Final Action                    08/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-225

Agency Contact: Judy Yost, Director for Center for Laboratories, Health 
Standards & Quality Bureau, 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
_______________________________________________________________________




1115. MEDICAID COVERAGE OF PERSONAL CARE SERVICES (MB-071-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d(a)(24)

CFR Citation:  42 CFR 440.70; 42 CFR 440.167; 42 CFR 440.170

Legal Deadline: None

Abstract: This rule will revise the Medicaid regulations by 
incorporating the OBRA '93 provisions relating to coverage of personal 
care services. Personal care services furnished to an individual who is 
not an inpatient or resident of a hospital, nursing facility, 
intermediate care facility for the mentally retarded or an institution 
for mental disease are an optional Medicaid benefit, effective October 
1, 1994. The services may be furnished both in the home and in other 
locations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/08/96                     61 FR 9405
NPRM Comment Period End         05/07/96
Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-071

Agency Contact: Terese Klitenic, Office of Long Term Care Services, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, C4-25-02, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-5942

RIN: 0938-AH00
_______________________________________________________________________




1116. UPDATE OF THE REASONABLE COMPENSATION EQUIVALENT LIMITS FOR 
SERVICES FURNISHED BY PHYSICIANS (BPD-816-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395xx

CFR Citation:  42 CFR 405.482(f)

Legal Deadline: None

Abstract: This notice sets forth updated payment limits on the amount 
of allowable compensation for services furnished by physicians to 
providers

[[Page 21735]]

that are not covered by the prospective payment system or per resident 
payments for graduate medical education. These services are paid by 
Medicare on a reasonable cost basis. The revised reasonable 
compensation equivalent limits are based on updated economic index data 
and replace the limits that were published in the Federal Register on 
February 20, 1985.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-816

Agency Contact: Ward Pleines, Health Insurance Specialist, Office of 
Hospital Policy, Department of Health and Human Services, Health Care 
Financing Administration, C5-03-03, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4528

RIN: 0938-AH14
_______________________________________________________________________




1117. DELEGATION OF CIVIL MONEY PENALTIES (BPO-135-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 405(a); 42 USC 1302; 42 USC 1320a-7a; 42 USC 
1395cc; 42 USC 1395u(j)(2); 42 USC 1395hh; 42 USC 1395ii

CFR Citation:  42 CFR 402

Legal Deadline: None

Abstract: This final rule with comment period will contain the 
processes and procedures to be undertaken in the imposition of civil 
money penalties and assessments and in the appeals process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-135

Agency Contact: Joel Cohen, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S3-11-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3349

RIN: 0938-AH22
_______________________________________________________________________




1118. CLIA PROGRAM: CYTOLOGY PROFICIENCY TESTING (HSQ-233-N)

Priority:  Other Significant

Legal Authority:  42 USC 263a(f)(4)(B)(IV)

CFR Citation:  42 CFR 493.855

Legal Deadline: None

Abstract: In publishing a notice of proposed rulemaking (NPRM), HHS 
complied with a Federal court order requiring publication of an NPRM 
that would require that cytology proficiency testing be conducted to 
the extent practicable, under normal working conditions. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/95                    60 FR 61509
NPRM Comment Period End         01/29/96
Notice                          06/00/97

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: 770 488-7670

RIN: 0938-AH35
_______________________________________________________________________




1119. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (MB-047-F)

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 435.2; 42 CFR 435.3; 42 CFR 435.10; 42 CFR 
435.186; 42 CFR 435.188

Legal Deadline: None

Abstract: This rule will provide for continuation of payment of health 
insurance premiums for individuals who are entitled to elect COBRA 
continuation coverage under a group health plan provided by an employer 
with 75 or more employees; require Medicaid recipients to apply for 
enrollment in employer-based cost effective group health plans as a 
condition of Medicaid eligibility; require State agencies to pay for 
premiums, deductibles, coinsurances and other cost sharing obligations 
under employer-based cost effective group health plans, and define 
``COBRA continuation coverage'' and ``COBRA beneficiaries.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/20/94                    59 FR 31569
NPRM Comment Period End         08/19/94
Final Action                    07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: MB-047

Agency Contact: Mark Ross, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-20-20, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5855

RIN: 0938-AH48
_______________________________________________________________________




1120. TERMS, DEFINITIONS, AND ADDRESSES: TECHNICAL AMENDMENTS (BPD-877-
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:  42 USC 1302; 42 USC 1395x(v)(1)(A); 42 USC 1395hh

CFR Citation:  42 CFR 413.118; 42 CFR 413.122

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

[[Page 21736]]

and formulas, clarify which steps of the appeals process are binding 
and which are final, remove content that is duplicative or unnecessary, 
and make other clarifying editorial changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-877

Agency Contact: Luisa Iglesias, Special Assistant-Office of 
Regulations, Health Financing Center, Department of Health and Human 
Services, Health Care Financing Administration, Room 409-B Humphry 
Bldg, 200 Independence Ave SW., Washington, DC
Phone: 202 690-6383

RIN: 0938-AH53
_______________________________________________________________________




1121. HOME HEALTH AGENCY PHYSICIAN CERTIFICATION REGULATIONS (BPD-875-
NC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395nn; 42 USC 1395hh; 42 USC 1395f; 42 USC 
1395n

CFR Citation:  42 CFR 424.22

Legal Deadline: None

Abstract: This notice with comment period will deal with the 
applicability of current Medicare regulations pertaining to the 
indirect compensation of physicians who certify or recertify the need 
for home health services or who establish or review the home plan of 
care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-875

Agency Contact: Jennifer Carter, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4615

RIN: 0938-AH59
_______________________________________________________________________




1122. MEDICARE PROGRAM; ESTABLISHMENT OF AN EXPEDITED REVIEW PROCESS FOR 
MEDICARE BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (OMC-25-FC)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm(c)(5)

CFR Citation:  42 CFR 417.600; 42 CFR 417.604; 42 CFR 417.606; 42 CFR 
417.608; 42 CFR 417.609; 42 CFR 417.614; 42 CFR 417.616; 42 CFR 
417.617; 42 CFR 417.618; 42 CFR 417.620

Legal Deadline: None

Abstract: This final rule with comment period establishes a new 
administrative review requirement for Medicare beneficiaries enrolled 
in health maintenance organizatinos (HMOs), competitive medical plans 
(CMPs), and health care prepayment plans (HCPPs). This rule implements 
section 1876(c)(5) of the Social Security Act, which specifies the 
appeal and grievance rights for Medicare enrollees in HMOs and CMPs. 
This rule requires that an HMP, CMP, or HCPP establish and maintain, as 
part of the health plan's appeals procedures, and expedited process for 
making organization determinations and reconsidered determinations when 
adverse determination could seriously jeopardize the life or health of 
the enrollee or the enrollee's ability to regain maximum function. This 
rule also revises the definition of appealable determinations to 
clarify that it includes a decision to discontinue services. This final 
rule with comment period establishes a new administrative review 
requirement for Medicare beneficiaries

Statement of Need: Results of HCFA's efforts to gain more beneficiary 
input and studies by various external organizations clearly indicate 
the need for more rapid turnaround on decisions involving medically 
necessary, covered services. Delays in such decisions could affect 
quality of care and the health status of Medicare enrollees. In 
addition, the need for expedited review in cases where a beneficiary's 
life, health status, or ability to function could be in serious 
jeopardy has been identified, and is becoming increasingly available to 
under-65 enrollees of managed care plans. Last, there has been 
confusion as to the appeal rights of Medicare enrollees who have 
received covered services, particularly from skilled nursing facilities 
and home health agencies, but for whom such services are subsequently 
terminated or reduced. This rule would clarify the Medicare enrollee's 
right to appeal in these situations.

Summary of the Legal Basis: Section 1876(c)(5) of the Social Security 
Act requires that the contracting HMO/CMP provide meaningful procedures 
for hearing and resolving grievances between the organization and the 
member. Subpart Q of 42 part 417 sets forth specific regulatory 
requirements for implementation of this provision. In a final 
regulation issued in November 1994, HCPPs were required to provide the 
appeal protections of this subpart.

Alternatives: Various time frames for conducting preservice and other 
service-related denials were considered. This regulation proposes 
following time frames being recommended for adoption by the National 
Association of Insurance Commissioners (NAIC) in their Health Carrier 
Grievance Procedure Model Act, which will likely be used by State 
legislatures as a licensure requirement for HMOs and other managed care 
plans. Conformity with NAIC model requirements will enhance consumer/
beneficiary understanding and utilization of appeal protections, 
eliminate confusion on the part of health plan staff responsible for 
the appeals process, and improve plan performance in this area.

Anticipated Costs and Benefits: Although the costs and benefits 
associated with this rulemaking have not yet been estimated, no 
significant budgetary impact is anticipated. Medicare contracting 
health plans would experience additional costs associated with these 
appeals improvements, including a higher volume of appeals. These costs 
would be absorbed within the plans' Medicare payment amount. HCFA will 
experience some additional administrative costs associated with 
expansion of its reconsideration contract. These costs are justified by 
the improved protections available to beneficiaries who choose Medicare 
managed care. The appeals process is an integral and critical component 
to prepaid, managed systems of care. That is, the incentives of prepaid 
health plans to manage utilization of services is balanced by quality 
checks and balances, including the appeals process. A strong appeals 
process helps ensure

[[Page 21737]]

that Medicare enrollees receive all medically necessary covered 
services.

Risks: There is bipartisan and industry support for this rule and there 
are no apparent risks.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: Federal

Additional Information: OMC-025

Agency Contact: Maureen Miller, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-21-
17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1097

RIN: 0938-AH62
_______________________________________________________________________




1123. UTILIZATION CONTROL AND DISCONTINUED REVIEW ACTIVITIES; MEDICAID 
(MB-101-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 1396a(a)(30); 42 USC 1396(a)(44); 42 USC 
1396b(g); 42 USC 1396b(i)(4)

CFR Citation:  42 CFR 400; 42 CFR 440; 42 CFR 441; 42 CFR 456; 42 CFR 
483

Legal Deadline: None

Abstract: This proposed rule would codify in regulations the statutory 
requirements that make physician certification and development of a 
plan of care (formerly utilization control requirements) State plan 
requirements under the Medicaid program. States would no longer be 
required to make quarterly showings that they have complied with those 
requirements or with the utilization review requirements. Obsolete 
provisions would be removed.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-101

Agency Contact: Wanda White, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2638

RIN: 0938-AH64
_______________________________________________________________________




1124. MEDICARE TECHNICAL CONFORMING AMENDMENTS (BPD-858-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 1395(k)

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. This rule will update our regulations to 
reflect that payment for durable medical equipment is on the basis of a 
fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  08/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-858

Agency Contact: Martha Kuespert, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, 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
_______________________________________________________________________




1125. WAIVER OF STAFFING REQUIREMENTS FOR END STAGE RENAL DISEASE (ESRD) 
FACILITIES PARTICIPATING IN AN EXPERIMENT (HSQ-236-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 1395kk; 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-236

Agency Contact: William Roskey, Health Insurance Specialist, Health 
Standards & Quality Bureau, 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

[[Page 21738]]

_______________________________________________________________________




1126. 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 (BPD-882-IFC)

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

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

Legal Authority:  42 USC 201

CFR Citation:  45 CFR 148 (New)

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

Abstract: This interim final rule with comment period sets forth 
provisions that assure access on a guaranteed issue and renewable 
basis, w without preexisting condition exclusions, for certain 
``eligible individuals.'' It guarantees access to individual coverage 
for people who lose their group coverage, and sets forth requirements 
imposed on health insurance issuers. It provides States with the option 
of implementing an acceptable mechanism in order to meet these 
requirements.

Statement of Need: The Health Insurance Portability and Accountability 
Act of 1996, (HIPAA, or Pub. L. 104-191) requires the Secretaries of 
Labor, Treasury, and Health and Human Services to promulgate 
implementing regulations for that Act by April 1, 1997. If this is not 
done timely, the effective date of the protections under the law shall 
be delayed, with potential harm to protected eligible individuals.

Summary of the Legal Basis: HIPAA includes provision at a new section 
2792 of the Public Health Service Act requiring and authorizing the 
Secretary of Health and Human Services to promulgate such regulations 
as may be necessary or appropriate to carry out the provisions of the 
Act. Other provisions of the Act specify implemented through 
regulation.

Alternatives: HIPAA requires that its provisions be implemented through 
regulations. This is a new area for Federal oversight, and no related 
prior regulations exist.

Anticipated Costs and Benefits: These rules will benefit eligible 
individuals by assuring them of continuity of health coverage when they 
lose coverage under a group health plan as a result of termination of 
employment, or as a result of certain other events, of the individual 
or of a person under whose coverage the individual had been a 
dependent. As a result, many people will not become uninsured, and many 
others will be able to maintain coverage without the imposition of new 
pre-existing condition limitations on coverage.
This regulation will assist small employers by assuring that they will 
have access to group coverage for their employees in the small group 
market. It also will impose costs on small insurance companies. 
Overall, there may some increase in premium costs for all participants 
in the small group and individual insurance markets.
A full cost analysis is not complete. Congressional Budget Office 
analyses of the impact on plans and insurers of mandated coverage 
showed the cost of that coverage would be on the order of $400 million 
annually.

Risks: The promulgation of these regulations will put in place 
protections in the insurance market that will assure eligible 
individuals continuity of coverage and relief of new pre-existing 
condition limits. Failure to timely promulgate these regulations will 
delay their effect, and will result in harm to some of those 
individuals who would otherwise have been protected.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule with Comment 
Period                          04/08/97                    62 FR 16985
Interim Rule Effective Date     04/08/97
Interim Rule Public Comment 
Period End                      07/07/97

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: BPD-882-IFC

Agency Contact: Gertrude Saunders, Insurance Reform Implementation Task 
Force, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5888

RIN: 0938-AH75
_______________________________________________________________________




1127.  CLIA PROGRAM; SIMPLIFYING CLIA REGULATIONS TO 
ACCREDITATION EXEMPTION OF LABORATORIES UNDER A STATE LICENSURE PROGRAM, 
AND PROFICIENCY TESTING AND INSPECTION (HSQ-239-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 263a; 42 USC 1302; 42 USC 1395x(e); 42 USC 
1395x(s)(11) to x(s)(16)

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This final rule with comment period will respond to various 
comments received on an earlier final rule with a comment period 
implementing the Clinical Laboratory Improvement Amendments of 1988, 
which was published in the Federal Register on February 28, 1992, in 
the areas of proficiency testing and inspections for clinical 
laboratories. This rule will follow the Administration's regulatory 
reform initiative by reducing duplicative material, emphasizing 
outcome-oriented results, and simplifying regulations. We are also 
streamlining our regulation in the areas of State exemption, and 
granting deemed status to laboratories accredited by an approved 
accreditation organization.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-239

Agency Contact: Judy Yost, Director, Center for Laboratories Health 
Standards and Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, Baltimore, MD 
21244
Phone: 410 786-3531

RIN: 0938-AH82
_______________________________________________________________________




1128.  CLINICAL LABORATORY REQUIREMENTS-EXTENSION OF CERTAIN 
EFFECTIVE DATES FOR CLINICAL LABORATORY REQUIREMENTS UNDER CLIA (HSQ-
237-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 263a; 42 USC 1302; 42 USC 1395x(e); 42 USC 
1395x(s)(11) to (s)(16)

[[Page 21739]]

CFR Citation:  42 CFR 493.1202; 42 CFR 493.1443; 42 CFR 493.1203

Legal Deadline: None

Abstract: This final rule with comment period will extend certain 
effective dates for clinical laboratory phase-in of current quality 
control requirement for moderate and high complexity tests. It will 
include provisions that allow laboratories to meet certain CLIA quality 
control requirements by following manufactures' FDA CLIA-cleared 
instructions and the date doctoral-degreed individuals with 
certification to qualify as a director of a laboratory that performs 
high complexity tests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  04/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Rhonda S. Whalen, Senior Health Scientist, Center for 
Disease Control and Prevention, Department of Health and Human 
Services, Health Care Financing Administration, 4770 Buford Hwy, NE., 
MS F11, Atlanta, GA 30341-3724
Phone: 770 488-7655

RIN: 0938-AH84
_______________________________________________________________________




1129.  MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE REFORM (MB-
109-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

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 With Comment 
Period                          06/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-109

Agency Contact: Jackie Wilder, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-20-06, Baltimore, MD 21244
Phone: 410 786-4579

RIN: 0938-AH92
_______________________________________________________________________




1130.  FINAL LIMITATIONS ON AGGREGATE PAYMENTS TO 
DISPROPORTIONATE SHARE HOSPITALS: FEDERAL FISCAL YEAR 1997 (MB-110-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396(a)(13); 42 USC 1396r-4(f)

CFR Citation:  42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299

Legal Deadline:  Other, Statutory, April 1997.
Regulatory Deadline

Abstract: This notice announces the final Federal fiscal year 1997 
national target and individual State allotments for Medicaid payment 
adjustments made to hospitals that serve a disproportionate number of 
Medicaid recipients and low-income patients with special needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-110

Agency Contact: Richard Strauss, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-17-27, Baltimore, MD 21244
Phone: 410 786-2019

RIN: 0938-AH93
_______________________________________________________________________




1131.  MEDICARE APPEALS OF INDIVIDUAL CLAIMS, (BPD-453-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1320; 42 USC 1320; 42 USC 1320.3; 
42 USC 1320.4; 42 USC 1395; 42 USC 1395hh; 42 USC 1395ii; 42 USC 1395; 
42 USC 1395u(b)(3)(c); 42 USC 300e; 42 USC 300e-5; 42 USC 300.9; 31 USC 
9701

CFR Citation:  42 CFR 405.717 to 718; 42 CFR 405.724; 42 CFR 405.730; 
42 CFR 405.732; 42 CFR 405.750; 42 CFR 405.801 to 803; 42 CFR 405.806; 
42 CFR 405.833 to 836; 42 CFR 405.853; 42 CFR 405.855 TO 857; 42 CFR 
405.860; 42 CFR 417.634; 42 CFR 473.46

Legal Deadline: None

Abstract: Medicare beneficiaries and, under certain circustances, 
providers or suppliers of health care services may appeal adverse 
determinations regarding claims for benefits under Medicare Part A or 
Part B. This final rule with comment period will expand our regulations 
to recognize the right of Part B appellants to a hearing before an 
administrative Law Judge (ALJ) for claims if at least $500.00 remains 
in dispute and the right to judicial review of an adverse ALJ decision 
if at least $1000.00 remains in controversy. Also this rule codifies in 
regulations: (1) limitations on the review by ALJs and the courts of 
national coverage determinations, and (2) the statutory authority for 
an expedited appeals process under Part A and Part B.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-453-FC

Agency Contact: Morty Marcus, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd, Baltimore, MD 21244

[[Page 21740]]

Phone: 410 786-4477

RIN: 0938-AH97
_______________________________________________________________________




1132.  REVISION TO THE DEFINITION OF AN UNEMPLOYED PARENT, (MB-
106-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 607; 42 USC 1396V

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 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

________________________________________________________________________

Interim Final Rule              05/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-106

Agency Contact: Judith Rhoades, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, CA-20-05, Baltimore, MD 21244
Phone: 410 786-4462
Fax: 410 786-3252

RIN: 0938-AH98
_______________________________________________________________________




1133.  MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICARE INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 1998 
(OACT-055-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395r

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 30, 1997.

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) enrollees, in the 
Medicare Supplementary Insurance (SMI) Program for the 12 months 
beginning January 1, 1998. It also announces the monthly SMI premium 
rate to be paid by all enrollees during the 12 months beginning January 
1, 1998

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, Deputy Director, Office of Medicare 
and Medicaid Cost Estimates, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, Baltimore, MD 
21244
Phone: 410 786-6396

RIN: 0938-AI03
_______________________________________________________________________




1134.  HEALTH INSURANCE REFORM: PARITY IN THE APPLICATION OF 
CERTAIN LIM ITS TO MENTAL HEALTH BENEFITS (BPD-891-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 300gg-5

CFR Citation:  45 CFR None

Legal Deadline:  Final, Statutory, January 1, 1998.

Abstract: This interim final rule will include requirements for the 
group market on parity for mental health benefits. It will set forth 
standards imposed on group health plans that offer mental health 
benefits.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/00/97

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Michelle Bruggy, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4675

RIN: 0938-AI05
_______________________________________________________________________




1135.  PORTABILITY AND NONDISCRIMINATION IN THE GROUP HEALTH 
INSURANCE MARKET (BPD-890-IFC)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 201

CFR Citation:  45 CFR 146 (New)

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

Abstract: This interim final rule sets forth minimum requirements 
applicable with respect to group health plans and health insurance 
issuers 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 includes 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 
renewability in multi employer plans and multiple employer welfare 
arrangements.

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

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: BPD-890-IFC

Agency Contact: Julie Walton, Insurance Reform Implementation Task 
Force, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4622

RIN: 0938-AI08

[[Page 21741]]

_______________________________________________________________________




1136.  PART A PREMIUM FOR 1998 FOR THE UNINSURED AGED AND FOR 
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-
056-N)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395 i-2; 42 USC 1395 i-20

Legal Deadline:  Other, Statutory, September 30, 1997.
Notice publication

Abstract: This notice announces the hospital insurance premium for 
calendar year 1998 under Medicare's hospital insurance program (Part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement. The uninsured aged are those individuals 
who are not insured under the Social Security or Railroad Retirement 
Acts and do not otherwise meet the requirements for entitlement to 
Medicare Part A. The disabled beneficiaries are those who lose monthly 
Social Security cash payments because they returned to work even though 
their disability continues. Section 1818(d) of the Social Security Act 
specifies the method to be used to determine this amount.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Deputy Director, Office of Medicare and 
Medicaid Cost Estimates, Department of Health and Human Services, 
Health Care Financing Administration, N3-26-00, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AI10
_______________________________________________________________________




1137.  INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED 
CARE SERVICES COINSURANCE AMOUNTS FOR 1998 (OACT-057-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395e

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 15, 1997.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 1998 under Medicare's hospital 
insurance program (Medicare Part A). The Medicare statute specifies the 
formula to be used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Deputy Director, Office of Medicare and 
Medicaid Cost Estimates, Department of Health and Human Services, 
Health Care Financing Administration, N3-36-24, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AI12
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1138. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (BPD-393-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395x; 42 USC 1395cc; 42 USC 1395dd

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

Legal Deadline: None

Abstract: This final rule will require Medicare participating hospitals 
with emergency departments to provide upon request medical examinations 
and treatments for individuals with emergency medical conditions and 
women in labor. A participating hospital that has specialized 
capabilities or facilities (such as burn, shock trauma, or neonatal 
intensive care units) must accept an appropriate transfer if they have 
the capacity to treat the individual. Hospitals failing to meet those 
requirements may have their Medicare provider agreements terminated, 
and hospitals and responsible physicians may be subject to civil money 
penalties. Under section 9122 of COBRA '85, Medicare participating 
hospitals are required to accept CHAMPUS and CHAMPVA payment as payment 
in full for services provided to CHAMPUS and CHAMPVA beneficiaries. 
These regulations also implement section 9305(b) of OBRA '86, which 
requires Medicare hospitals to give patients a notice of their 
discharge rights.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/88                    53 FR 22513
NPRM Comment Period End         08/15/88
Final Action Effective          08/15/88
Final Rule With Comment Period  06/22/94                    59 FR 32086
Effective Date                  07/22/94
Comment Period End              08/22/94
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-393

Agency Contact: Tzvi Hefter, Director, Division of Hospital Services, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1304

RIN: 0938-AC58
_______________________________________________________________________




1139. CRITERIA AND PROCEDURES FOR DEVELOPING MEDICAL SERVICES COVERAGE 
POLICY (BPD-432-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395y

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

Legal Deadline: None

Abstract: This rule will announce generally applicable criteria and

[[Page 21742]]

procedures for determining whether a service is ``reasonable and 
necessary'' under the Medicare program. It will also announce generally 
applicable criteria and procedures for determining whether a service is 
``reasonable and necessary'' under the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-432

Agency Contact: Ron Milhorn, Bureau of Policy Development, Department 
of Health and Human Services, Health Care Financing Administration, C4-
10-07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5663

RIN: 0938-AD07
_______________________________________________________________________




1140. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES 
(BPD-425-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395k; 42 USC 1395l; 42 USC 1395w-4; 42 USC 
1395x(s); 42 USC 1395x(p); 42 USC 1395cc(e)

CFR Citation:  42 CFR 410; 42 CFR 485; 42 CFR 486; 42 CFR 400; 42 CFR 
424; 42 CFR 484; 42 CFR 489; 42 CFR 498

Legal Deadline: None

Abstract: This rule would implement section 9337 of OBRA '86 which 
provides Medicare coverage for outpatient occupational therapy services 
furnished by providers and independent practitioners, identical to the 
coverage for outpatient physical therapy. It also would implement 
section 6133(a) of OBRA '89 which increased the payment limit for 
outpatient occupational therapy services provided by independent 
practitioners.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-425

Agency Contact: Sheridan Gladhill, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-03-18, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1782

RIN: 0938-AD32
_______________________________________________________________________




1141. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (BPD-
426-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395y(a)(14); 42 USC 1395cc(a)(1)(H); 42 USC 
1395cc(g); 42 USC 1395x(w)(1)

CFR Citation:  42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 412; 42 CFR 
489; 42 CFR 1003

Legal Deadline: None

Abstract: This final rule, to be issued jointly by HCFA and the 
Department's Office of Inspector General (OIG) will prohibit Medicare 
payment for nonphysician services furnished to a hospital outpatient by 
a provider or supplier other than the hospital, unless the services are 
furnished under an arrangement with the hospital. The hospital is 
obligated by its provider agreement to furnish the services directly or 
under an arrangement. These regulations will also authorize the OIG to 
impose a civil money penalty, not to exceed $2,000, against any 
individual who knowingly and willfully presents, or causes to be 
presented, a bill or request for payment, for items or services 
furnished under Medicare, that is inconsistent with an arrangement 
under section 1866(a)(1)(H) of the Social Security Act or is in 
violation of the requirements for an arrangement. These regulations 
implement section 9343(c) of OBRA '86, section 4085(i)(17) of OBRA '87, 
and section 4157 of OBRA '90.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/05/88                    53 FR 29486
NPRM Comment Period End         10/04/88
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-426

Agency Contact: Janet Wellham, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-11-16, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4510

RIN: 0938-AD33
_______________________________________________________________________




1142. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-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 418; 42 CFR 440; 42 CFR 441; 42 CFR 482; 42 CFR 
483; 42 CFR 431; 42 CFR 405; 42 CFR 413; 42 CFR 430; 42 CFR 434 to 436; 
42 CFR 447; 42 CFR 466; 42 CFR 498

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
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-488

Agency Contact: Bill Ullman, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-11-06, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5667

RIN: 0938-AD81

[[Page 21743]]

_______________________________________________________________________




1143. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (MB-023-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 a spouse 
institutionalized and the spouse remaining in the community. It would 
also provide special post-eligibility rules for institutionalized 
individuals who have spouses in the community. The revision would allow 
spouses in the community to retain more income to meet living expenses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: MB-023

Agency Contact: Roy Trudel, Medicaid Bureau, 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
_______________________________________________________________________




1144. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HSQ-169-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-2; 42 USC 1395bbb; 42 USC 1395hh

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).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/91                    56 FR 37054
NPRM Comment Period End         10/01/91
Final Action                    00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-169
TIMETABLE CONT: Pending completion of RIN 0938-AG81 (BPD-819)

Agency Contact: Wayne Smith, Ph.D., Director, Center for Hospital and 
Community Care, Health Standards and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-11-
07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6762

RIN: 0938-AE39
_______________________________________________________________________




1145. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (MB-28-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
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: MB-028

Agency Contact: Cindy Ruff, Office of Medical Services, Medicaid 
Bureau, 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
_______________________________________________________________________




1146. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-175-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.

[[Page 21744]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Effective 
Date                            10/19/94
Interim Final Rule Comment 
Period End                      11/18/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-175
TIMETABLE: This regulation may be published only with the concurrence 
of the U.S. District Court in Smith v. Shalala.

Agency Contact: Helene Fredeking, Codirector, Center for Long Term 
Care, Health Standards and Quality Bureau, Department of Health and 
Human Services, Health Care Financing Administration, S2-21-27, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7304

RIN: 0938-AF02
_______________________________________________________________________




1147. CASE MANAGEMENT (MB-27-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d; 42 USC 1396n

CFR Citation:  42 CFR 431.51(c); 42 CFR 440.169; 42 CFR 440.250; 42 CFR 
441.10; 42 CFR 441.18; 42 CFR 447.327; 42 CFR 431.54

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
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: MB-027

Agency Contact: Pat Helphenstine, Office of Long-Term Care Services, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, C4-13-13, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-5900

RIN: 0938-AF07
_______________________________________________________________________




1148. PRESUMPTIVE LIMITS ON PAYMENTS TO HMOS, CMPS, AND HCPPS (OMC-006-
F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm(h); 42 USC 1395x(v)(1)(A)

CFR Citation:  42 CFR 417.532(a)(3); 42 CFR 417.802; 42 CFR 417.800(c)

Legal Deadline: None

Abstract: This rule establishes presumptive limits for Medicare cost 
payments to Health Maintenance Organizations and Competitive Medical 
Plans, and to Health Care Prepayment Plans (HCPPs) that furnish 
inpatient hospital care. It also revises the criteria that HCFA uses to 
determine reasonable costs for HCPPs that do not furnish inpatient 
hospital care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/22/94                     59 FR 8435
NPRM Comment Period End         04/25/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-006

Agency Contact: A. G. D'Alberto, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1100

RIN: 0938-AF16
_______________________________________________________________________




1149. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (MB-051-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396k

CFR Citation:  42 CFR 433.160; 42 CFR 433.135; 42 CFR 433.137; 42 CFR 
433.151

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
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-051

Agency Contact: Robert Nakielny, Office of Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-21-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4466

RIN: 0938-AF68
_______________________________________________________________________




1150. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS AND CHILDREN UNDER AGE 19 (MB-052-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 
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 '90m PL 101-508.

[[Page 21745]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/23/94                    59 FR 48805
Interim Final Rule With Comment 
Period                          09/23/94                    59 FR 48805
Effective Date                  10/24/94
Comment Period End              11/22/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-052

Agency Contact: Robert Tomlinson, Health Insurance Specialist, Medicaid 
Bureau, 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-AF69
_______________________________________________________________________




1151. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH PURPOSES 
(HSQ-208-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-9; 42 USC 1302

CFR Citation:  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. Currently, PROs can only 
disclose to the public nonconfidential aggregate data where no one is 
specifically identified. The statute, however, provides for limited 
disclosure in cases where there are circumstances to assure adequate 
protection of the rights established by regulation, and interest of 
patients, health care practitioners, or 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: State, Federal

Additional Information: HSQ-208

Agency Contact: Mike Rappaport, Director, Division of Systems 
Management, Health Standards and Quality Bureau, Department of Health 
and Human Services, Health Care Financing Administration, S1-09-26, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6759

RIN: 0938-AG33
_______________________________________________________________________




1152. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
exclude from coverage electrostimulation of the salivary glands in the 
treatment of xerostomia secondary to Sjogren's Syndrome. Public Health 
Service (PHS) studies show that there is insufficient data to establish 
the clinical utility of electrostimulation to evaluate its long-term 
effectiveness, or to identify those xerostomia patients who would 
benefit from this procedure. Also, PHS reports that electrostimulation 
is not widely accepted as a treatment for xerostomia secondary to 
Sjogren's Syndrome.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 05/23/94                    59 FR 26653
Comment Period End              07/22/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-782

Agency Contact: Francine Spencer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, 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-AG45
_______________________________________________________________________




1153. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION OF 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (BPD-815-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395i-3; 42 USC 1396r; 42 USC 1302; 42 USC 
1895hh

CFR Citation:  42 CFR 409; 42 CFR 483; 42 CFR 413

Legal Deadline: None

Abstract: In this proposed rule we 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. In conjunction with this change we 
propose an alternative approach for calculating Medicare payments to a 
skilled nursing facility (SNF). This new ``distinct costing'' procedure 
would enable a participating SNF to establish a distinct costing area 
within the SNF for its relatively high intensity residents so that it 
can isolate and fully capture the routine cost of their care without 
resorting to the use of arbitrary certification boundaries to achieve 
this result. This proposed rule would also prohibit nursing homes from 
financially screening private pay applicants for admission. Instead, 
nursing homes would be permitted to charge up to a 2-month deposit 
before admission to ensure that sufficient funds are available to pay 
for care to which the individual may be entitled.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-815

Agency Contact: William Ullman, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-13-15, 7500 Security Blvd, Baltimore, 
MD 21244
Phone: 401 786-5667

RIN: 0938-AG84

[[Page 21746]]

_______________________________________________________________________




1154. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW 
SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HSQ-222-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 263a

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

Legal Deadline: None

Abstract: As part of the CLIA program (see RIN 0938-AE47), this rule 
will develop criteria for simple and easy-to-use test systems that have 
demonstrated accuracy and precision through scientific studies. We have 
proposed to waive the routine 2-year survey of users of accurate and 
precise technology (APT) tests, conducting surveys only if there are 
indications of problems or complaints. We also proposed that a small 
number of surveys be conducted to validate the criteria for determining 
APT and to assure quality.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/95                    60 FR 47982
NPRM Comment Period End         11/14/95
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-222

Agency Contact: Judy Yost, Center for Laboratories, Health Standards 
and Quality Bureau, 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-AG98
_______________________________________________________________________




1155. MEDICARE COVERAGE OF ORGAN TRANSPLANTATION (BPD-835-PN)

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This proposed notice would announce changes in Medicare's 
national coverage policy for organ transplantations.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-835

Agency Contact: Lana Price, Director, Division of End Stage Renal 
Disease, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533

RIN: 0938-AH17
_______________________________________________________________________




1156. CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO CERTAIN DEVICES 
AND RELATED SERVICES (BPD-841-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 1395y(a)(1)(A)

CFR Citation:  42 CFR 405; 42 CFR 411

Legal Deadline: None

Abstract: In the National Performance Review, Vice President Gore 
directed the health agencies of the Department of Health and Human 
Services to review their policies and processes to determine which 
requirements could be reduced or eliminated without lowering health and 
safety standards. In accordance with this directive, FDA reviewed its 
Medicare coverage policies for medical devices that have not received 
full FDA approval. As a result, a final rule with comment period was 
published on August 18, 1995 and effective November 1, 1995. It 
provided that certain medical devices with an investigational device 
exemption approved by the FDA may be covered under Medicare. The rule 
was published at 42 CFR part 405, subpart B. It set forth the process 
by which the FDA is to assist HCFA in identifying nonexperimental 
investigational devices that may be potentially covered under Medicare. 
It is intended to provide Medicare beneficiaries with greater access to 
advances in medical technology.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  08/19/95                    60 FR 48417
Comment Period End              10/20/95
Effective Date                  11/01/95
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-841

Agency Contact: Sharon Hippler, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4633

RIN: 0938-AH21
_______________________________________________________________________




1157. LIMITATIONS ON LIABILITY (BPD-859-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 and 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 Security Act, which limits beneficiary liability for 
certain medical equipment and supplies. This rulemaking is part of the 
Reinventing Government effort. Toward this end, we are working with 
industry representatives to develop guidelines that will streamline 
requirements and reduce burden and duplication. It will give 
beneficiaries the opportunity to make informed consumer decisions 
regarding certain medical equipment and supplies.

[[Page 21747]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-859

Agency Contact: Denis Garrison, Division of Beneficiary and Insurance 
Issues, 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
_______________________________________________________________________




1158. MEDICARE SECONDARY PAYER CLARIFICATIONS AND AMENDMENTS (BPD-865-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                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-865

Agency Contact: Herb Pollock, Health Insurance Specialist, 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
_______________________________________________________________________




1159. DESIGNATION OF INDEPENDENT RURAL PRIMARY CARE HOSPITALS (RPCHS) 
(BPD-784-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-4; 42 USC 1395cc; 42 USC 1395ww

CFR Citation:  None

Legal Deadline: None

Abstract: This notice will announce the availability of Rural Primary 
Care Hospital (RPCH) status to facilities located in areas of the 
United States outside the States of California, Colorado, South Dakota, 
Kansas, West Virginia, New York, and North Carolina. Facilities wishing 
to be designated as RPCHs must apply to the Health Care Financing 
Administration (HCFA) for this status. Application materials may be 
obtained upon request in writing to HCFA. Based on the applications 
received, HCFA may designate up to 15 facilities as independent RPCHs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-784

Agency Contact: Thomas Hoyer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-02-17, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-5661

RIN: 0938-AH60
_______________________________________________________________________




1160. MEDICAID HOSPICE CARE (MB-007-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395hh; 42 USC 1395g(e); 42 USC 1395h(e)(5); 
42 USC 1395x(dd); 42 USC 1302; 42 USC 1396a(a)(10); 42 USC 
1396a(a)(13)(D) and (d); 42 USC 1396d(a)(18); 42 USC 1395d(d)

CFR Citation:  42 CFR 418.24; 42 CFR 418.28; 42 CFR 418.98; 42 CFR 
435.725; 42 CFR 435.726; 42 CFR 435.733; 42 CFR 435.735; 42 CFR 
435.832; 42 CFR 436

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, and makes conforming technical revisions to the Medicare 
regulations governing hospice care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: MB-007

Agency Contact: Terry Pratt, Technical Director, Medicaid Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-19-28, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5831

RIN: 0938-AH65
_______________________________________________________________________




1161. DETERMINATION OF SUBSTANDARD CARE IN SNFS AND NFS (HSQ-240-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-3; 42 USC 1395r

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.

[[Page 21748]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-240

Agency Contact: Pat Miller, Health Insurance Specialist, Health 
Standards & Quality Bureau, 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
_______________________________________________________________________




1162.  MEDICAID PROGRAM; REDETERMINATIONS OF MEDICAID 
ELIGIBILITY DUE TO WELFARE REFORM (MB-105-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435.1003

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 and the Contract With America Advancement 
Act of 1996 made statutory changes affecting the eligibility of large 
numbers of Medicaid recipients. Changes were made to the definition of 
disability for children and eligibility requirements of non-U.S. 
citizens and individuals receiving disability cash assistance based on 
a finding of alcoholism and drug addiction. In order to protect Federal 
financial participation in State Medicaid expenditures for States with 
unusual volumes of eligibility redeterminations caused by these 
statutory changes, we published a final rule with comment period on 
January 13, 1997. That rule changed our regulations to provide 
additional time for States to process redeterminations and provide 
services pending the redeterminations. We are analyzing the public 
comments to the January 13 rule to determine whether a final rule will 
be necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action Published          01/13/97                     62 FR 1682
Final Action Effective          01/13/97
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Bob Tomlinson, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
Medicaid Bureau, C4-20-21, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4463

RIN: 0938-AH76
_______________________________________________________________________




1163.  MEDICAID PROGRAM; COVERAGE AND PAYMENT FOR FEDERALLY 
QUALIFIED HEALTH CENTER SERVICES (MB-43-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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: MB-43

Agency Contact: David Worgo, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Cf-22-06, Baltimore, MD 21244
Phone: 410 786-4577
Email: Dworgo

RIN: 0938-AH95
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1164. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND 
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405.370 to 405.378; 42 CFR 413.5; 42 CFR 413.90; 
42 CFR 413.153

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action Published          12/02/96                    61 FR 63740
Final Action Effective          01/02/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: James Conrad
Phone: 410 786-6976

RIN: 0938-AC99
_______________________________________________________________________




1165. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS (BPD-
646-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 485; 42 CFR 405; 42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No Further Action 
Necessary.                      04/11/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Claude Mone
Phone: 410 786-5666

RIN: 0938-AE48

[[Page 21749]]

_______________________________________________________________________




1166. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-F)

Priority:  Other Significant

CFR Citation:  42 CFR 417

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action Published          12/31/96                    61 FR 69034
Final Action Effective          01/01/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tony Hausner
Phone: 410 786-1093

RIN: 0938-AF74
_______________________________________________________________________




1167. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER ENTITIES 
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 421.214

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action Published          09/19/96                    61 FR 49271
Final Action Effective          09/19/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bob Shaw
Phone: 410 786-3312

RIN: 0938-AF85
_______________________________________________________________________




1168. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 421.100; 42 CFR 421.200

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged with RIN 0938-AI09 (OFH-
020-P)                          04/04/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Alan Bromberg
Phone: 410 786-7441

RIN: 0938-AG06
_______________________________________________________________________




1169. APPOINTMENT OF REPRESENTATIVES FOR MEDICARE APPEALS (BPO-120-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/28/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betsy Horn
Phone: 410 786-0973

RIN: 0938-AG30
_______________________________________________________________________




1170. MEDICARE PROGRAM: UNIFORM ELECTRONIC COST REPORTING FOR SKILLED 
NURSING FACILITIES AND HOME HEALTH AGENCIES (BPD-788-F)

Priority:  Other Significant

CFR Citation:  42 CFR 413.24

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action Published          01/02/97                       62 FR 26
Final Action Effective          02/01/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Talbott
Phone: 410 786-4592

RIN: 0938-AH12
_______________________________________________________________________




1171. MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND FIVE-YEAR 
REVIEW OF AND ADJUSTMENTS TO RELATIVE VALUE UNITS UNDER THE PHYSICIAN 
FEE SCHEDULE FOR CALENDAR YEAR 1997 (BPD-852-FC)

Priority:  Economically Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 410; 42 CFR 411; 42 CFR 412; 42 CFR 413; 42 CFR 
414; 42 CFR 415; 42 CFR 417; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action Published          11/22/96                    61 FR 59490
Final Action Effective          01/01/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay
Phone: 410 786-4497

RIN: 0938-AH40
_______________________________________________________________________




1172. MEDICARE PROGRAM: PHYSICIAN FEE SCHEDULE UPDATE FOR CALENDAR YEAR 
1997 AND PHYSICIAN VOLUME PERFORMANCE STANDARD RATES OF INCREASE FOR 
FEDERAL FISCAL YEAR 1997 (BPD-853-FN)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action Published          11/22/96                    61 FR 59717
Final Action Effective          01/01/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Don Thompson
Phone: 410 786-4586

RIN: 0938-AH41
_______________________________________________________________________




1173. MEDICARE PROGRAM; SCHEDULE OF LIMITS ON HHA COSTS PER VISIT FOR 
COST REPORTING PERIODS BEGINNING ON OR AFTER JULY 1, 1996 (BPD-867-NC)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged with RIN 0938-AH88       03/27/97

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Federal

Agency Contact: Michael Bussacca
Phone: 410 786-4602

RIN: 0938-AH54
_______________________________________________________________________




1174.  MEDICAID PROGRAM; PRELIMINARY LIMITATIONS ON AGGREGATE 
PAYMENTS TO DISPROPORTIONATE SHARE HOSPITALS: FEDERAL FISCAL YEAR 1997 
(MB-104-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396(a)(13); 42 USC 1396r to 4(f)

CFR Citation:  None

Legal Deadline:  Other, Statutory, October 1, 1996.

Abstract: This notice announces the preliminary Federal Fiscal Year 
1997 national target and individual State allotments for Medicaid 
payment adjustments made to hospitals that

[[Page 21750]]

serve a disproportionate number of Medicaid recipients and low-income 
patients with special needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          01/31/97                     62 FR 4772

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-104

Agency Contact: Richard Strauss, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-17-27, Baltimore, MD 21244
Phone: 410 786-2019

RIN: 0938-AH91
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1175. TITLE IV-E FOSTER CARE ELIGIBILITY REVIEWS AND CHILD AND FAMILY 
SERVICES STATE PLAN REVIEWS

Priority:  Other Significant

Legal Authority:  42 USC 627; 42 USC 671; 42 USC 1302; 42 USC 1320a-1a

CFR Citation:  45 CFR 1355; 45 CFR 1356; 45 CFR 1357

Legal Deadline:  Final, Statutory, July 1, 1995.

Abstract: This NPRM will propose requirements that implement the 
statutory provisions of 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. It will also propose 
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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: This action was previously reported under RIN 
0970-AB60.

Agency Contact: Daniel H. Lewis, Deputy Associate Commissioner, 
Children's Bureau, Adm. on Children, Youth & Families, Department of 
Health and Human Services, Administration for Children and Families, 
P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8594

RIN: 0970-AA97
_______________________________________________________________________




1176. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL CHILDREN

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1302

Legal Deadline: None

Abstract: This NPRM will specify a process by which an Indian tribe may 
identify and establish an alternative agency to provide Head Start 
Services if the agency previously serving the tribe is terminated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Organizations

Government Levels Affected: 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-AB52
_______________________________________________________________________




1177. 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 NPRM will establish 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                            05/00/97

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
_______________________________________________________________________




1178. DATA COLLECTION AND REPORTING UNDER THE TEMPORARY ASSISTANCE FOR 
NEEDY FAMILIES BLOCK GRANT

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 103

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: ACF will propose regulations to define data elements and 
specify data collection, verification, and other procedures to meet the 
requirements of the Temporary Assistance for Needy Families Block 
Grant.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

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-AB64

[[Page 21751]]

_______________________________________________________________________




1179. METHODOLOGY FOR DETERMINING CHILD POVERTY RATES

Priority:  Other Significant

Legal Authority:  42 USC 613(i)(5)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This NPRM will propose a methodology to be used by States to 
determine their child poverty rates: section 413(i) of the Social 
Security Act, as amended, requires that the Secretary establish this 
methodology by regulation and mentions three specific factors which 
shall be included in the methodology. States must begin reporting their 
rates within 90 days of enactment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Don Oellerich, Director, Division of Data and Technical 
Analysis OASPE, Department of Health and Human Services, Administration 
for Children and Families, Room 404E, 200 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 690-6805

RIN: 0970-AB65
_______________________________________________________________________




1180. BONUS TO REWARD HIGH PERFORMANCE STATES UNDER THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 103

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: ACF, in consultation with the National Governor's Association 
and the American Public Welfare Association, will propose a 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                            08/00/97

Small Entities Affected: None

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
_______________________________________________________________________




1181. STATE DIRECTORY OF NEW HIRES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193, sec 313(b)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This regulation specifies the information on wages and 
unemployment compensation paid to individuals that the State Directory 
of New Hires will be required to provide to the National Directory of 
New Hires on a quarterly basis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Anne M. Benson, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
OCSE, DHHS, 370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-1467
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB67
_______________________________________________________________________




1182. STATE CASE REGISTRY AND EXPANSION OF FPLS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193, sec 311 and 316

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This regulation specifies what constitutes the minimum amount 
of information on child support cases recorded in the State Case 
Registry that is necessary to operate the Federal Case Registry. It 
also specifies the necessary information to identify the individuals 
who owe or are owed support and the State or States which have the 
case.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/97

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Anne M. Benson, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
OCSE, DHHS, 370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-1467
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB68
_______________________________________________________________________




1183. STATE LAW CONCERNING PATERNITY ESTABLISHMENT

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193, sec 331

CFR Citation:  45 CFR 303.5

Legal Deadline: None

Abstract: This regulation covers voluntary paternity establishment 
services offered by hospitals and birth record agencies and specifies 
the types of other entities that may offer voluntary paternity 
establishment services. The provision of such services must include a 
requirement that such an entity use the same notice provision, 
materials, training, and evaluation as the ones used by the voluntary 
paternity establishment programs of hospitals and birth record 
agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/97

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Jan Rothstein, Program Specialist, Division of Policy 
and Planning, Department of Health and Human Services, Administration 
for Children and Families, OCSE, DHHS, 370 L'Enfant Promenade SW., Mail 
Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5375
Fax: 202 401-5559

RIN: 0970-AB69

[[Page 21752]]

_______________________________________________________________________




1184. AUTOMATED DATA PROCESSING REQUIREMENTS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193, sec 344

CFR Citation:  45 CFR 302.85; 45 CFR 304.20; 45 CFR 307

Legal Deadline:  Final, Statutory, August 22, 1998.

Abstract: This regulation, which should be finalized not later than two 
years after date of enactment of the Personal Responsibility and Work 
Opportunity Reconciliation Act of 1996 (P.L. 104-193), sets a deadline 
of October 1, 2000, for implementation of new Automated Data Processing 
requirements for the Child Support Enforcement Program. The deadline, 
however, shall be extended by one day for each day that the Secretary 
misses the two-year deadline.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Michael P. Fitzgerald, Senior Computer Specialist, 
Department of Health and Human Services, Administration for Children 
and Families, DHHS Room 326F, 200 Independence Avenue SW., Washington, 
DC 20201
Phone: 202 401-6403

RIN: 0970-AB70
_______________________________________________________________________




1185. AUTOMATED DATA PROCESSING FUNDING LIMITATION

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 344

CFR Citation:  45 CFR 307.30

Legal Deadline: None

Abstract: This regulation will set the allocation formula for the total 
amount payable to a State for fiscal years 1996 through 2001 based on 
the $400 million in federal funds for automated child support 
enforcement systems enhancements under the Personal Responsibility and 
Work Opportunity Reconciliation Act of 1996 (P.L. 104-193).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Helen Morgan Smith, Electronic Benefits Transfer 
Specialist, Department of Health and Human Services, Administration for 
Children and Families, OPS/OSS/OD, Room 326F, DHHS/HHH, 200 
Independence Avenue SW., Washington, DC 20201
Phone: 202 690-6639
Fax: 202 401-6400

RIN: 0970-AB71
_______________________________________________________________________




1186. GRANTS TO STATES FOR ACCESS AND VISITATION PROGRAMS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193, sec 391

CFR Citation:  45 CFR 300

Legal Deadline: None

Abstract: This regulation specifies the monitoring, evaluating, and 
reporting of State grants designed to support and facilitate absent 
parents' access to and visitation of their children.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: David Arnaudo, Technical Advisor, Department of Health 
and Human Services, Administration for Children and Families, OCSE/
DHHS, 370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, Washington, DC 
20447
Phone: 202 401-5364
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB72
_______________________________________________________________________




1187. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 375

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This NPRM will specify how tribes may enter into cooperative 
agreements with States or obtain direct payments from DHHS for 
provision of child support enforcement services if they have an 
established tribal court system or submit a plan meeting the 
requirements of title IV-D.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/98

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, OCSE/DHHS, 370 L'Enfant Promenade, S.W, Mail 
Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-9386
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB73
_______________________________________________________________________




1188. CHILD CARE PROPOSED RULE

Priority:  Other Significant

Legal Authority:  42 USC 618; 42 USC 9858

CFR Citation:  45 CFR 98.14; 45 CFR 98.33; 45 CFR 98.43; 45 CFR 98.50; 
45 CFR 98.51; 45 CFR 98.52; 45 CFR 98.53; 45 CFR 98.60; 45 CFR 98.61; 
45 CFR 98.62; 45 CFR 98.63; 45 CFR 98.64; 45 CFR 98.66; 45 CFR 98.81; 
45 CFR 98.83; ...

Legal Deadline: None

Abstract: The Administration for Children and Families, will amend 
existing regulations which govern the administration of the Child Care 
and Development Block Grant program. The purpose of this regulatory 
package will be to implement the legislative changes contained in the 
Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Joan Lombardi, Associate Commissioner, Child Care 
Bureau, Department of Health and Human Services, Administration for 
Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 401-6947

RIN: 0970-AB74

[[Page 21753]]

_______________________________________________________________________




1189. TANF PENALTIES AND ADMINISTRATIVE COSTS

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 103

CFR Citation:  45 CFR 201

Legal Deadline: None

Abstract: This regulation will discuss the audit and penalty 
requirements of TANF and will include a discussion of the reasonable 
cause exception, a description of corrective compliance plans, and 
provide information on an appeals process. This regulation will also 
discuss the 15% administrative costs cap for TANF.

Statement of Need: This regulation is necessary to implement the 
provision of the new welfare reform legislation requiring penalties and 
corrective actions be taken in certain, specified situations.

Summary of the Legal Basis: Section 409 and section 410 of the Social 
Security Act, as amended by the Personal Responsibility and Work 
Opportunity Reconciliation Act of 1996.

Alternatives: There are no viable alternatives.

Anticipated Costs and Benefits: No additional costs to the public.

Risks: None.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

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: MS[email protected]

RIN: 0970-AB76
_______________________________________________________________________




1190. TANF WORK REQUIREMENTS

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 204

Legal Deadline: None

Abstract: This regulation will describe the work participation rate 
requirements of welfare reform, discuss the two-year time limit for 
receiving TANF benefits, and will explain how participation rates can 
be reduced based on caseload reductions.

Statement of Need: This regulation is necessary to ensure objective 
implementation of the TANF work and time limit penalties by helping 
States fully understand their responsibilities to assure welfare 
recipients will be able to leave welfare and enter the work force 
within prescribed periods of time.

Summary of the Legal Basis: Sections 407 and 409 of the Social Security 
Act, as amended by the Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996.

Alternatives: There are no viable alternatives.

Anticipated Costs and Benefits: No additional costs to the public.

Risks: None.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

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: MS[email protected]

RIN: 0970-AB77
_______________________________________________________________________




1191. TRIBAL PROGRAM REQUIREMENTS

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 103

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This NPRM proposes a process for determining that tribal plan 
requirements are met, criteria to determine minimum work participation 
requirements and time limits, and a process for determining tribal 
family assistance grant funding when there is a disagreement with State 
submittal data.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: None

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
_______________________________________________________________________




1192. ILLEGITIMACY REDUCTION BONUS

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This regulation specifies the requirements for grants that 
each eligible State is entitled to receive from the Secretary for each 
bonus year for which the State demonstrates a net decrease in out-of-
wedlock births. The regulation specifies the amount of grant, defines 
``eligible State,'' and gives the appropriate years for the grant.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: Undetermined

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: 202 690-6562
Email: [email protected]

RIN: 0970-AB79
_______________________________________________________________________




1193.  CASE CLOSURE REGULATION

Priority:  Substantive, Nonsignificant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in

[[Page 21754]]

the CFR to reduce burden or duplication, or streamline requirements.

Legal Authority:  42 USC 651 to 658; 42 USC 660; 42 USC 663; 42 USC 
664; 42 USC 666; 42 USC 667; 42 USC 1302; 42 USC 1396a(a)(25); 42 USC 
1396(d)(2); 42 USC 1396b(o); 42 USC 1396b(p); 42 USC 1396(k)

CFR Citation:  45 CFR 303.11

Legal Deadline: None

Abstract: Revisions in response to the President's reform initiative to 
streamline child support enforcement program regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Agency Contact: Amy Keys Shaw, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5490
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB82
_______________________________________________________________________




1194.  REFUGEE RESETTLEMENT PROGRAM: RESPONDING AND CONFORMING 
TO TANF REPLACING AFDC

Priority:  Substantive, Nonsignificant

Legal Authority:  8 USC 1522(a)(9)

CFR Citation:  45 CFR 400

Legal Deadline: None

Abstract: This regulation will revise refugee resettlement program 
regulations to respond and conform to the Temporary Assistance to Needy 
Families (TANF) program replacing the Aid to Families with Dependent 
Children (AFDC) program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

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
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1195. 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                    11/00/97

Small Entities Affected: 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-AB24
_______________________________________________________________________




1196. STANDARDS FOR PURCHASE OF FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This regulation establishes standards for the purchase of 
facilities as required by the Head Start Improvement Act of 1992.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/94                    59 FR 61575
NPRM Comment Period End         01/30/95
Final Action                    05/00/97

Small Entities Affected: 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-AB31
_______________________________________________________________________




1197. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES

Priority:  Substantive, Nonsignificant

Legal Authority:  45 USC 9801 et seq

CFR Citation:  45 CFR 1305

Legal Deadline: None

Abstract: This Final Rule will revise the income eligibility criteria 
used in enrolling Head Start children and families to allow Indian 
tribes, in certain situations, to enroll more children whose families 
do not meet Head Start's income criteria than would otherwise be 
possible.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/95                    60 FR 54648
NPRM Comment Period End         12/26/95
Final Action                    06/00/97

Small Entities Affected: Organizations

Government Levels Affected: 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-AB53

[[Page 21755]]

_______________________________________________________________________




1198. INCOME AND RESOURCE DISREGARDS RELATED TO INTERESTS OF INDIVIDUAL 
INDIANS IN TRUST OR RESTRICTED LANDS

Priority:  Substantive, Nonsignificant

Legal Authority:  25 USC 1408

CFR Citation:  45 CFR 233

Legal Deadline: None

Abstract: These rules incorporate statutory disregards in the AFDC 
program and the Adult Assistance programs in Guam, Puerto Rico and the 
Virgin Islands. The first provides that up to $2,000 per year of income 
derived from interests of individual Indians in trust or restricted 
lands shall not be considered in determining assistance under the 
Social Security Act or any other Federally assisted program. The second 
is a provision requiring that interests of individual Indians in trust 
or restricted lands shall not be considered a resource in determining 
eligibility for assistance under the Social Security Act or any other 
Federally assisted program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/94                    59 FR 51536
Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack A. Storrs, Director, Division of AFDC Program, 
Office of Family Assistance, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9289

RIN: 0970-AB59
_______________________________________________________________________




1199.  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 666

CFR Citation:  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              01/00/98

Small Entities Affected: None

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: m.cohen@@acf.dhhs.gov

RIN: 0970-AB81
_______________________________________________________________________




1200.  PERSONAL RESPONSIBILITY AND WORK OPPORTUNITY 
RECONCILIATION ACT OF 1996(PRWORA) 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 601 note; 42 USC prec. 601; 42 USC 601-610; 42 
USC 612; 42 USC 613; 42 USC 615-617

CFR Citation:  45 CFR 200

Legal Deadline: None

Abstract: This regulation will eliminate regulations repealed by title 
I of the Personal Responsibility and Work Opportunity Reconciliation 
Act of 1996 (P.L. 104-193).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/00/98

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

Agency Contact: Ann Burek, Program Analyst, Office of Legislative 
Affairs and Budget, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9223

RIN: 0970-AB84
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1201. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING 
PUBLIC ASSISTANCE AGENCIES

Priority:  Other Significant

CFR Citation:  45 CFR 205.50 (a)(4); 42 CFR 431.307(a); 42 CFR 431.307 
(b)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/13/96                    61 FR 58140
Final Action Effective          11/13/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: Mack Storrs
Phone: 202 401-9289

RIN: 0970-AB32
_______________________________________________________________________




1202. FAMILY PRESERVATION AND SUPPORT

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:  45 CFR 1355; 45 CFR 1356; 45 CFR 1357

[[Page 21756]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/18/96                    61 FR 58632
Final Action Effective          12/18/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Daniel H. Lewis
Phone: 202 205-8594

RIN: 0970-AB34
_______________________________________________________________________




1203. BLOCK GRANT PROGRAMS (LOW INCOME HOME ENERGY ASSISTANCE PROGRAM --
LIHEAP)--FY 1995 AND FY 1996 PROVISIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 96

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/01/97

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Janet M. Fox
Phone: 202 401-9351

RIN: 0970-AB47
_______________________________________________________________________




1204. HEAD START FELLOWSHIP PROGRAM

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1311

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/10/97                     62 FR 1399
Final Action Effective          02/10/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Douglas Klafehn
Phone: 202 205-8569

RIN: 0970-AB56
_______________________________________________________________________




1205. EXTENSION OF DEADLINE FOR CERTIFIED STATEWIDE SYSTEMS AND 
REVISIONS FOR THE PRESIDENT'S REFORM INITIATIVE

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 301; 45 CFR 302; 45 CFR 303; 45 CFR 304; 45 CFR 
306; 45 CFR 307

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/20/96                    61 FR 67235
Final Action Effective          12/20/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: Elizabeth C. Matheson
Phone: 202 401-5373

RIN: 0970-AB57
_______________________________________________________________________




1206. ON-SITE FOSTER CARE ELIGIBILITY REVIEWS

Priority:  Other Significant

CFR Citation:  45 CFR 1356; 42 CFR 672

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Combined With RIN 0970-AA97     01/30/97

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Daniel H. Lewis
Phone: 202 205-8594

RIN: 0970-AB60
_______________________________________________________________________




1207. TANF PROGRAM AND FINANCIAL REQUIREMENTS

Priority:  Other Significant

CFR Citation:  45 CFR 200

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Not Necessary       01/30/97

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Mack Storrs
Phone: 202 401-9289
Fax: 202 205-5887
Email: MS[email protected]

RIN: 0970-AB75
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1208. 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:  PL 102-375

CFR Citation:  45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45 
CFR 1328

Legal Deadline: None
Unknown until law is reauthorized.

Abstract: The Administration on Aging (AoA) anticipates revising 
current rules to reflect the changes resulting from the pending 
reauthorization of the Older Americans Act which incorporates greater 
flexibility for the States. PURPOSE: The purpose of these revisions is 
to implement the newly enacted law in the development and provision of 
community-based services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - OAA Amendments in FY '97 11/00/97

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

[[Page 21757]]

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 1997 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. 97-8016 Filed 04-24-97; 8:45 am]
BILLING CODE 4150-04-F